Ethical Considerations for Research Involving Prisoners, Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, 2006

Ethical Considerations for Research Involving Prisoners, Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, 2006

• Feb. 16, 2016 • Topics: Medical, Medical Experiments/Exploitation

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Ethical Considerations for Research Involving
Prisoners
Committee on Ethical Considerations for Revisions to
DHHS Regulations for Protection of Prisoners Involved
in Research
ISBN: 0-309-66300-8, 316 pages, 6x9, (2006)
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Ethical Considerations for Research Involving Prisoners
http://www.nap.edu/catalog/11692.html

Ethical Considerations for
Research Involving
Prisoners
Committee on Ethical Considerations for
Revisions to DHHS Regulations for
Protection of Prisoners Involved in Research
Board on Health Sciences Policy
Lawrence O. Gostin, Cori Vanchieri, and Andrew Pope, Editors

Ethical Considerations for Research Involving Prisoners
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This study was supported by Award No. N01-OD-4-2139, TO #149 (DHHS5294-249) between the National Academy of Sciences and the DHHS/ National
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Ethical Considerations for Research Involving Prisoners
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COMMITTEE ON ETHICAL CONSIDERATIONS FOR
REVISIONS TO DHHS REGULATIONS FOR
PROTECTION OF PRISONERS
INVOLVED IN RESEARCH
LAWRENCE O. GOSTIN (Chair), Georgetown University Law
Center, Washington, DC
HORTENSIA AMARO, Northeastern University, Boston, MA
PATRICIA BLAIR, University of Texas Health Center at Tyler, Tyler,
TX
STEVE J. CAMBRA, Jr., Cambra, Larson & Associates. Elk Grove,
CA
G. DAVID CURRY, University of Missouri-St. Louis, St. Louis, MO
CYNTHIA A. GÓMEZ, University of California, San Francisco
BRADFORD H. GRAY, The Urban Institute, Washington, DC
MICHAEL S. HAMDEN, North Carolina Prisoner Legal Services, Inc.,
Raleigh, NC
JEFFREY L. METZNER, University of Colorado School of Medicine,
Denver, CO
JONATHAN MORENO, University of Virginia, Charlottesville, VA
LARRY I. PALMER, University of Louisville, Louisville, KY
NORMAN G. POYTHRESS, Jr., University of South Florida, Tampa,
FL
WILLIAM J. ROLD, New York City, NY
JANETTE Y. TAYLOR, University of Iowa, Iowa City, IA
WENDY VISSCHER, RTI International, Research Triangle Park, NC
BARRY ZACK, Centerforce, San Quentin, CA
Expert Advisor and
Liaison, Board on Health Sciences Policy
NANCY DUBLER, Montefiore Medical Center, Bronx, NY

Ethical Considerations for Research Involving Prisoners
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Consultants
BEN BERKMAN, Georgetown University Law Center, Washington,
DC
SARAH SHALF, Bondurant, Mixson & Elmore, LLP, Atlanta, GA
CORI VANCHIERI, Silver Spring, MD
Intern
JASON E. FARLEY, The Johns Hopkins University, Baltimore, MD
IOM Staff
ANDREW POPE, Study Director (from August 2005)
ADRIENNE STITH BUTLER, Senior Staff Officer (from August
2005)
TRACY G. MYERS, Study Director (through August 2005)
EILEEN SANTA, Research Associate (from August 2005)
SUSAN MCCUTCHEN, Research Associate
VILIJA TEEL, Senior Project Assistant

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BOARD ON HEALTH SCIENCES POLICY*
FRED H. GAGE (Chair), The Salk Institute for Biological Studies, San
Diego, CA
GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, IN
JAMES F. CHILDRESS, University of Virginia, Charlottesville
ELLEN WRIGHT CLAYTON, Vanderbilt University Medical School,
Nashville, TN
DAVID COX, Perlegen Sciences, Mountain View, CA
LYNN R. GOLDMAN, Johns Hopkins Bloomberg School of Public
Health, Baltimore, MD
BERNARD GOLDSTEIN, University of Pittsburgh, PA
MARTHA N. HILL, Johns Hopkins University School of Nursing,
Baltimore, MD
ALAN LESHNER, American Association for the Advancement of
Science, Washington, DC
DANIEL MASYS, Vanderbilt University Medical Center, Nashville,
TN
JONATHAN MORENO, University of Virginia, Charlottesville
E. ALBERT REECE, University of Arkansas, Little Rock
MYRL WEINBERG, National Health Council, Washington, DC
MICHAEL J. WELCH, Washington University School of Medicine,
St. Louis, MO
OWEN N. WITTE, University of California, Los Angeles
MARY WOOLLEY, Research!America, Alexandria, VA
IOM Council Liaison
BERNARD LO, University of California, San Francisco
IOM Staff
ANDREW POPE, Director
DAVID CODREA, Financial Associate
AMY HAAS, Administrative Assistant

IOM Boards do not review or approve individual reports and are not asked to
endorse conclusions and recommendations. The responsibility for the content of
the report rests with the authoring committee and the institution.
vii

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Independent Report Reviewers

This report has been reviewed in draft form by individuals chosen for
their diverse perspectives and technical expertise, in accordance with
procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as
sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge.
The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
George J. Annas, Department of Health Law, Bioethics and Human
Rights, Boston University School of Public Health
B. Jaye Anno, Consultants in Correctional Care, Santa Fe, New Mexico
Kenneth Appelbaum, Correctional Mental Health Program, University
of Massachusetts Medical School
Ronald Braithwaite, Rollins School of Public Health, Emory University
Vivian Brown, PROTOTYPES: Centers for Innovation in Health,
Mental Health and Social Services, Culver City, California
Jeff Cohen, HRP Associates, Inc., New York, New York
Amy Craddock, Department. of Criminology, General Education
Program, Indiana State University
Madeline Delone, The Innocence Project, Benjamin N. Cardozo School
of Law, Yeshiva University
Nicholas Freudenberg, Department of Urban Public Health, Hunter
College, City University of New York
George Gasparis, Institutional Review Board - Human Research
Protection Program, Columbia University
ix

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INDEPENDENT REPORT REVIEWERS

John K. Irwin, Professor Emeritus, San Francisco State University
Leodus Jones, Community Assistance for Prisoners, Philadelphia,
Pennsylvania
Nancy E. Kass, Berman Bioethics Institute, Johns Hopkins Bloomberg
School of Public Health
Elaine L. Larson, School of Nursing, Columbia University
John T. Monahan, School of Law, University of Virginia
Jonathan Seltzer, Applied Clinical Intelligence, Bala Cynwyd,
Pennsylvania
Anne C. Spaulding, Department of Epidemiology, Emory University
Rollins School of Public Health
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report
before its release. The review of this report was overseen by Neil R.
Powe, Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, and Elena O. Nightingale,
Scholar-in-Residence at the Institute of Medicine. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report
was carried out in accordance with institutional procedures and that all
review comments were carefully considered. Responsibility for the final
content of this report rests entirely with the authoring committee and the
institution.

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Preface

The Committee’s task—to review the ethics regarding research involving prisoners—was as challenging as it was important. Research is
critically important in providing knowledge needed for informed and
enlightened prison policy, as well as for affording health benefits to prisoners. At the same time, research could impose unacceptable risks on
prisoners, complicated by serious concerns about the potential for coercion in the prison environment. The history of prisoner research is
plagued with illustrations of unconscionable abuses. Getting the balance
right between scientifically rigorous research and ethically appropriate
treatment of prisoners is vital in a decent, humane society. It was a difficult task in which the Committee had to take account of history, demography, vulnerability, and the restrictions of prisoner life.
The charge of our Committee, the Institute of Medicine Committee on Ethical Considerations for Revisions to the DHHS Regulations for
Protection of Prisoners Involved in Research, was to explore whether the
conclusions reached in 1976 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research remain
appropriate today. The Commission’s path-breaking report on the ethical
values of human subject research resulted in regulation of all human subject research funded by the U.S. Department of Health and Human Services (DHHS). The provisions regarding research on prisoners are
contained in Subpart C of the regulations.
Specifically, the Committee was asked to: (1) consider whether the
ethical bases for research with prisoners differ from those for research
with non-prisoners, (2) develop an ethical framework for the conduct of
research with prisoners, (3) based on the ethical framework developed,
identify considerations or safeguards necessary to ensure that research
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PREFACE

with prisoners is conducted ethically, and (4) identify issues and needs
for future consideration and study.
Past abuse in biomedical research in prisons has engendered deep
distrust among prisoners and their advocates. It is impossible to ignore
the historical exploitation of prisoners and their current misgivings about
the biomedical research enterprise. The prison population, moreover, has
markedly changed since 1976. It is vastly larger in number with disproportionate representation of African Americans, Latinos, persons with
mental illness, and other historically disenfranchised populations. Many
women and children are also incarcerated in American prisons today.
Prisoners are particularly vulnerable to exploitation not only because of
their low socioeconomic status, but also due to the realties of prison life.
Although conditions are widely variable, overall prisoners are subjected
to high levels of coercion (explicit and implicit). The prison environment
makes it difficult to assure even minimal standards for ethical research
such as voluntary informed consent and privacy.
Given these realities, the easiest thing would have been to recommend a virtual ban on human subject research involving prisoners. Yet,
the Committee felt that this would be a mistake. Research affords the
potential of great benefit as well as burden. It can help policymakers to
make correctional settings more humane and effective in achieving legitimate social goals such as deterrence and rehabilitation. Research can
also help policy makers better understand and respond to the myriad
health problems faced by prisoners such as HIV/AIDS, tuberculosis,
hepatitis C, mental illness, and substance abuse. Respect for prisoners
also requires recognition of their autonomy. If a prisoner wants to participate in research, his or her views should be taken into account. The
overall goal, then, is to permit scientifically rigorous research to the extent that it confers significant benefit without undue risk and in accordance with the prisoner’s wishes.
The critical question facing the Committee was whether, given all
these factors, current federal regulation is ethically sound and has
achieved an appropriate balance between scientific knowledge and prisoner vulnerability. Our answer, after an exhaustive study, was an emphatic “no.” Although the ethical principles articulated by the National
Commission are still largely apt, the Committee found that the federal
system of human subject protection is deficient.
The Committee was surprised and disappointed to find that there
were no systematic data sources on the quantity and quality of prisoner
research in the United States. Committee members searched the literature

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PREFACE

and determined there is a great deal of research involving prisoners taking place that appears to be largely unregulated. The most glaring problem is that the federal rules cover only a small fraction of the research
being undertaken in prisons. This is because the regulations (45 C.F.R. §
46) do not cover human subject research unless it is funded by a few federal agencies, or the sponsoring institution has voluntarily adopted Subpart C. Much of the research supported through other sources (e.g.,
federal, state, or private) is outside the scope of regulatory protection.
Subpart C also only applies to narrowly defined “prisoners,” not including individuals who are under state imposed limitations of liberty but not
in traditional prison settings. There appears to be no morally defensible
reason for excluding a large number of prisoners from human subject
protection, as is currently the case.
The Committee boldly recommends five paradigmatic changes in the
system of ethical protections for research involving prisoners. First, expand the definition of “prisoner” to include a much larger population of
persons whose liberty is restricted by virtue of sentence, probation, parole, or community placement. Second, ensure universal, consistent standards of protection so that safeguards based on sound ethical values
apply to prisoner research irrespective of the source of funding. Third,
shift from a category-based to a risk-benefit approach to defining ethically acceptable research so that prisoners are never exposed to research
risks unless there is a distinctly favorable benefit-to-risk ratio. Fourth,
update the ethical framework established by the National Commission to
include collaborative responsibility—the concept that research should be
conducted in meaningful collaboration with the key stakeholders notably
prisoners and prison staff. Finally, enhance systematic oversight of research involving prisoners so that human subject protections are more
rigorous and more reliable than those that exist under the existing Institutional Review Board (IRB) mechanism.
The treatment of prisoners (both respect for their rights and concern
for their health and well-being) is a principal measure of a decent and
civilized society. Therefore, the committee strongly encourages the executive and legislative branches to give due consideration to the proposals in this report.
Finally, and importantly, I express my sincere gratitude to the DHHS
Office for Human Research Protections (OHRP) for commissioning this
project, the Institute of Medicine (IOM) leadership for its support and
insights, and to my fellow Committee members for their exceptional
wisdom and service. Committee members worked hard and long in de-

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PREFACE

vising solutions to apparently intractable problems. The Committee is
particularly grateful to the 10 members of the prisoner liaison committee
who educated us about prison life. Without their involvement, we could
not have fully understood the problems or solutions. Cori Vanchieri and
her team (Ben Berkman and Sarah M. Shalf) wrote extraordinarily incisive drafts for the Committee to review. Andrew Pope is not only the
Director of the IOM Board on Health Sciences Policy, but also brilliantly
assumed the position of Study Director of our Committee. His leadership
is warmly appreciated.
Lawrence O. Gostin, Chair
Committee on Ethical Considerations
for Research Involving Prisoners

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Contents

SUMMARY

INTRODUCTION
Why Now?, 26
Committee’s Task and Approach, 29
Methods and Approach, 31
Organization of This Report, 32

TODAY’S PRISONERS: CHANGING DEMOGRAPHICS,
HEALTH ISSUES, AND THE CURRENT RESEARCH
ENVIRONMENT
35
Changing Demographics and Health Issues, 36
Descriptions of Prisons, Jails and other Correctional Settings, 36
The Prisoner Population, 37
Summary of Findings on Changing Demographics,
and Health Issues, 68
Current Research Environment, 69
Current Status of Prisoner Research, 69
Results from the Surveys with Key DOC Personnel, 70
Published Literature: A Review of Selected Prisoner Studies, 71
Data Retrieval Needs Improving, 75
Summary of Findings on Current Research Environment, 77

FEDERAL REGULATORY LANDSCAPE
Adoption of DHHS Human Subjects Protection Regulations, 88
The Common Rule, 88
Subpart C: Prisoners as Research Subjects, 91
xv

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CONTENTS

Report of the SACHRP Subcommittee, 95
Other Federal Human Subjects Protections, 98
Subpart D, 100
Other DHHS Agencies: FDA Regulations, 103
DOJ Regulations, 104
Analysis, 109
Existing Authority for Broader Regulation, 111
Can DHHS Be Guaranteed Broader Authority?, 112
Alternatives to Comprehensive Regulation, 116
4

DEFINING PRISONERS AND CORRECTIONAL
SETTINGS
119
Ethical Foundations of Current Research Regulations, 119
Current Regulations Pertinent to Places of Prisoner Research, 121
Correctional Settings Encompass More than Prisons and Jails, 122
Proposed Definition of Prisoner, 126
Delineation of Settings, 128
When Proposed Regulations Should Apply, 129
When Proposed Regulations Should Not Apply, 130
When Liberty Status Changes, 130

THE ETHICAL FRAMEWORK FOR RESEARCH
INVOLVING PRISONERS
The 1976 Commission’s Ethical Framework, 134
Historical Context, 134
Justice and Respect for Persons, 135
An Updated Ethical Framework, 136
Respect for Persons, 137
Justice, 149

SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND
PROTECTIONS
Overarching Principle, 161
Defining and Reviewing Prisoner Research, 162
What Is Reviewed, 164
Who Reviews, 165
How Reviews Are Conducted, 167
When Reviews Are Done, 176
Systematic Oversight of Research with Prisoners, 177
Prison Research Subject Advocate, 179

133

161

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CONTENTS

IRB Postapproval Monitoring, 182
National Oversight, 183
Applying Safeguards for Particular Kinds of Research, 186
Sample Situations, 190
Other Categories and Types of Research Involving
Prisoners Prohibited, 198
Impact of Committee Recommendations on
Stakeholder Responsibilities, 198
APPENDIXES
A Data Sources and Methods, 203
B The Nationals Commission’s Deliberations and Findings, 223
C Report of the SACHRP Subcommittee and Human Subjects Protections, 231
D Code of Federal Regulations Title 45: Public Welfare Part 46:
Protection of Human Subjects, 237
E Acronyms, 281
F Committee and Staff Biographies, 285

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Summary

ABSTRACT In the past 30 years, the population of prisoners in the
United States has expanded more than 4.5-fold, correctional facilities
are increasingly overcrowded, and more of the country’s disadvantaged
populations—racial minorities, women, people with mental ilnessl, and
people with communicable diseases such as HIV/AIDS, hepatitis C, and
tuberculosis—are under correctional supervision. Because prisoners
face restrictions on liberty and autonomy, limited privacy, and often inadequate health care, they require specific protections when involved in
research, particularly in today’s correctional settings. Given these issues, the Department of Health and Human Services’ Office for Human
Research Protections commissioned the Institute of Medicine to review
the ethical considerations regarding research involving prisoners. The
resulting analysis emphasizes five broad actions to provide prisoners
involved in research with critically important protections: (1) expand the
definition of “prisoner;” (2) ensure universally and consistently applied
standards of protection; (3) shift from a category-based to a risk-benefit
approach to research review; (4) update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight
of research involving prisoners.

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ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS

In many important ways, the U.S. correctional system is different
than it was in the 1970s, when current regulations regarding prisoners as
research subjects were promulgated. The total correctional population
(persons in prisons, jails, probation, and parole) increased more than 4.5fold between 1978 and 2004, to nearly 7 million individuals (BJS, 2000a,
2005a,b,c; U.S. Census, 1998, 1994). Correctional facilities are increasingly overcrowded (BJS, 2005a), and access to programs, services, and
health care has not kept pace with the rising tide of prisoners (Metzner,
2002; Sturm, 1993). More of our country’s disadvantaged populations
are under correctional supervision: racial minorities, women, persons
with mental illness, and persons with communicable diseases such as
HIV/AIDS, hepatitis C, and tuberculosis (BJS, 2005c; NCCHC, 2002).
Prisoners have been exploited in the past, carrying a heavier burden
of the risks of research than the general population (Hornblum, 1998;
Jones, 1993; Murphy, 2005). Although the level of severity varies depending on the correctional setting, prisoners face restrictions on liberty
and autonomy, limited privacy, and potentially inadequate health care
services. These factors can be barriers to the prerequisites of ethical research, namely the acquisition of voluntary informed consent, protection
of privacy, and access to adequate health care such that a choice between
research participation and nonparticipation is not simply a desperate action to obtain treatment.
However, research can impart benefits. Responsible research has the
potential of improving the health and well-being of prisoners as well as
improving the conditions in which they live. Adherence to the highest
ethical values, however, is critically important in designing and conducting human research involving prisoners.
Title 45 § 46 of the Code of Federal Regulations (45 C.F.R. § 46)
contains Subpart A, the basic DHHS regulations for the protection of
human research subjects, also known as the Common Rule. The Common Rule provides requirements and guidance on issues such as review
by an institutional review board (IRB), informed consent by subjects,
analysis of risks and benefits, protecting privacy, plus further requirements for approval of proposed research. Additional subparts of 45
C.F.R. § 46 provide more specific protections for certain particularly
vulnerable populations: pregnant women, fetuses, and neonates (Subpart
B); prisoners (Subpart C); and children (Subpart D). Subpart C (Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects), the principal focus of this report, was first
finalized in 1978 and was developed in response to the Report and Rec-

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SUMMARY

ommendations: Research Involving Prisoners by the National Commission for the Protection of Human Subjects of Biomedical and Behavior
Research (1976). The general stance of Subpart C is that only research
that fits within four or five categories is permitted in prisoner populations.
The committee’s review of current research revealed that most research involving prisoners is taking place outside the purview of Subpart
C, and many prisoner studies are being conducted without IRB review.
There is no ethically defensible reason to exclude certain prisoners from
most, if not all, human subject protections afforded by federal regulation.
All of these factors point to a population that is more vulnerable and requires stronger protections than those inspired by the national commission in the 1970s.
With these concerns in mind, the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (DHHS)
commissioned the Institute of Medicine to review the ethical considerations in research involving prisoners as a basis for updating DHHS regulations to protect prisoners as research subjects.
The committee was charged with the following tasks:
•
•
•
•

consider whether the ethical bases for research with prisoners
differ from those for research with nonprisoners.
develop an ethical framework for the conduct of research with
prisoners.
identify considerations or safeguards necessary to ensure that research with prisoners is conducted ethically.
identify issues and needs for future consideration and study.

Note: The committee decided to exclude children (unless treated as
adults), military personnel, and persons under restricted liberty due to
mental illness and outside the criminal justice system, for example those
detained under the U.S. Patriot Act. By excluding these groups, the committee emphasizes that they face very similar circumstances and that very
strong ethical safeguards are required. However, the committee lacks the
expertise to address the needs of these special populations and such an
inquiry exceeds the committee’s charge. Parallel studies, such as the one
undertaken by this committee, may be needed to explore ethical issues of
research involving these groups If, however, juveniles are transferred
from the original jurisdiction of the family court (or the equivalent, such
as a juvenile court) to the jurisdiction of a state or federal criminal court,
then they would fall under the provisions of this report.

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ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS

MAJOR RECOMMENDATIONS
The committee developed each recommendation in this report with
the interests of prisoners in mind. Throughout its deliberations, the committee was well aware of the dark history of research involving prisoners
(Hornblum, 1998; Jones, 1993; Murphy, 2005) and was determined not
to permit the exposure of prisoners to the kind of research abuses that
occurred before the national commission released its report
(NCPHSBBR, 1976). In this report, in fact, the committee adds further
protections both by expanding the population of prisoners covered by
rigorous ethical rules and by recommending additional ethical safeguards. At the same time, access to research may be critical to improve
the health of prisoners and the conditions in which they live, as the
committee was told by prisoners during prison site visits. The task was to
strike a a balance between potential benefits and risks of specific research protocols. The goal is to ensure rigorous responsible research that
improves the well-being of prisoners while taking great care to protect
their health, well-being, and human rights.
The recommendations discussed later (and presented in Box S-1,
page 18) will allow research, in limited circumstances, that might benefit
prisoners. These limited circumstances cannot be captured by a rigid
categorical approach but need to be rooted in an ethically relevant riskbenefit analysis that grapples with the balance between a need for protection and access to potentially beneficial research protocols. During the
course of the committee’s deliberations, five themes emerged as organizing categories for the committee’s recommendations: (1) expand the
definition of “prisoner,” (2) ensure universal, consistent ethical protection, (3) shift from a category-based to a risk-benefit approach to research review, (4) update the ethical framework to include collaborative
responsibility, and (5) enhance systematic oversight of research with
prisoners.
Expand the Definition of Prisoner
Subpart C defines a prisoner as any person who is “involuntarily
confined or detained in a penal institution” as a result of violating a
criminal or civil statute, detained in other facilities as an alternative to

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criminal prosecution or incarceration, or detained pending arraignment,
trial, or sentencing (45 C.F.R § 46.303[c]). The present regulation’s emphasis on custodial detention is too narrow. Of the nearly 7 million persons under adult correctional supervision in 2004, only 2.1 million were
in prisons and jails. The rest—4.9 million—were on parole and probation, groups that do not clearly fit under the definition in the current
regulations (BJS, 2005d). The committee, therefore, recommends an expansion of the definition of prisoner to afford protections for a larger
population of prisoners involved in human subjects research.
Recommendation: Redefine “prisoners” to expand the
reach of human subjects protections. The Department
of Health and Human Services and other relevant
agencies that write, implement, or enforce regulations
pertaining to research with prisoners should expand
the definition of “prisoner” to include all settings,
whether a correctional institution or a community setting, in which a person’s liberty is restricted by the
criminal justice system. (Recommendation 4.1)
The goal of this recommendation is to expand the reach of the regulatory procedures and oversight mechanisms recommended in this report
to the fuller population of individuals whose liberty is restricted by the
criminal justice system. These individuals face greater risks than those in
the general population. The freedom of a prisoner to make a choice as
well as the ability to protect his or her privacy can be hampered in any of
the correctional settings that restrict liberty. Throughout this report, the
term “prisoner” is used with this expanded meaning in mind. An exclusion, however, was provided by the committee so that prisoners living in
a noncustodial community setting could enroll in research that is open to
any citizen in the community when his or her status as a prisoner is not
relevant or related to enrollment in the study.
Ensure Universal, Consistent Ethical Protection
The committee was asked to make recommendations regarding research under the oversight jurisdiction of OHRP, but currently OHRP
jurisdiction is severely limited by the terms and conditions of Subpart C;
its oversight extends only to research funded by 3 of 17 federal agencies.

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The Department of Justice’s Bureau of Prisons (BOP) has its own set of
rules (BOP, 1999, 2005), and other federal agencies and nonfederal entities (e.g., state and private) that support research with prisoners are not
required by statute or regulation to offer special protections for prisoner
subjects. The committee recommends more uniform application of regulations and oversight of all prisoner research regardless of the source of
funding or supervising agency as well as a better accounting of research
involving prisoners and greater openness throughout the universe of
prisoner research.
Recommendation: Establish uniform guidelines for all
human subjects research involving prisoners. Congress should mandate a uniform set of guidelines for
human research participant protection programs1 for
all research involving prisoners. (Recommendation 3.1)
All human subjects research involving prisoners should be regulated
by the same ethical standards irrespective of source of funding, supporting agency, or type of correctional facility (federal, state, local, or private) or program that houses the prisoner. This would mean that all 17
federal agencies that are signatories to the Common Rule, any additional
federal agencies, and all nonfederal sponsors of research would be required to comply with a newly drafted Subpart C.2 All research involving
prisoners, therefore, would be under OHRP oversight (see Recommendations 6.5 and 6.6). There is no justification for variability across agencies, sponsors, and facilities regarding their approaches to protecting the
rights, health, and dignity of prisoners participating in human subjects
research, individuals who are among the most vulnerable human subjects
of research.
Establishing uniformity within the research protections systems specific to prisoners would enable a second, important step to be realized.
1

The term “human research participant protection program” is used throughout this report to mean the network of entities with direct responsibility for the safety of those enrolled in the studies carried out under its purview. The HRPPP most often includes the
research organization, the study sponsor, investigator, IRB, and, when relevant, the data
safety monitoring board (IOM, 2003). In the contexts described in this report, prison
research subject advocates would be an important part of this network as well.
2
Federal regulation of state and private research would be constitutionally permissible
by using, for example, the federal spending power. See, e.g., South Dakota v. Dole, 483
U.S. 203, 211 (1987) (upholding the constitutionality of a federal statute conditioning
states’ receipt of federal funds on adoption of a minimum drinking age of 21).

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Currently, there is no central repository of information about the amount
and type of research with prisoners as subjects. For the same reasons that
registries of clinical research on drugs and biologics exist and have garnered strong support (DeAngelis, 2004; IOM, 2006), a national database
would bring clarity to the currently murky landscape of research involving prisoners.
Recommendation: Maintain a public database of all
research involving prisoners. The Department of
Health and Human Services, in cooperation with the
Department of Justice, should systematically and
comprehensively document all human subjects research with prisoners. (Recommendation 2.1)
The establishment of a publicly available, national registry of research involving prisoners should include data such as who is conducting
research with what support, with what kind of research on what populations, and the nature and extent of ethical oversight provided. A national
registry would shed light on the totality of research taking place on prisoners and the quality of ethical oversight provided for each protocol. To
enable consideration of questions of justice, it could be used to examine
the magnitude and volume of prisoners in different types of research to
determine the allocation of benefits and burdens of research among prisoners. A registry would also enhance the application of research findings
to prisoner populations.
Recommendation: Ensure transparency and accountability in the research enterprise. Human research
participant protections programs and prison administrations conducting human subject research should
be open, transparent, and accountable.
(Recommendation 6.7)
A sound, ethical protection program involves an open, transparent
research process. It requires that the mechanisms used to protect participants from undue harm and to respect their rights and welfare must be
apparent to everyone involved. This transparency requires open communication and interaction with the local community, research participants,
investigators, and other stakeholders in the research enterprise. Accountability entails maintaining fidelity to the methodology stipulated in the

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protocol as well as accountability to ensure the quality and performance
of the protection program itself.
Shift from a Category-Based to a Risk-Benefit Approach
to Research Review
The current categorical approach used in Subpart C to review proposals for research involving prisoners is dependent on narrowly defined
stipulated research categories that are subject to various interpretations.
If a protocol does not fit a category, it is not allowed. This approach does
not provide sufficient or reliable protections for the human subject because it does not consider the potential benefits and risks involved in the
study and might disallow research that would be quite acceptable on riskbenefit grounds. In addition, the present structure does not address the
actual conditions of confinement or the restrictions on liberty experienced by the prisoner subject (whether incarcerated or subject to restraints on liberty in connection with community-based alternatives to
incarceration).
Recommendation: Apply a risk-benefit framework to
research review. The U.S. Department of Health and
Human Services should revise regulations regarding
research with prisoners from a model based on categories to a system based on weighing of risks and
benefits for the individual human subject, similar to
the approach currently used in Subpart D.
(Recommendation 5.1)
A risk-based approach is preferable because it requires human research participant protection programs (HRPPPs) and OHRP to (1) focus
on the potential benefits and harms of each suggested research protocol
and (2) identify the particular ethical issues that each protocol raises in
the specific context of the correctional setting. As in Subpart D (45
C.F.R. § 46.407), protections should increase as the risk-benefit scale
tilts more toward risk (IOM, 2004).
A risk-benefit approach should apply to all types of research: biomedical, social/behavioral, and epidemiological. Ethically permissible
research must offer potential benefits to prisoners that outweigh the risks.
Under this framework, it is clear that studies offering no potential benefit

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to subjects would be precluded (i.e., testing of cosmetic products). Biomedical research in correctional settings would be severely limited.
Phase 1 and 2 studies, as defined by the Food and Drug Administration
(FDA), for example, would not be allowable because safety and efficacy
are not yet clear in these early phases of biomedical research; therefore,
risk would overshadow potential benefit.
Biomedical research involving prisoners in two narrow circumstances may be ethically acceptable:
1. In normal circumstances, a biomedical research study may be
ethically acceptable if:
•
•

for research on new therapies or preventive measures, there
is already some evidence of safety and efficacy, as in Phase
3 testing for new drugs, as defined by the FDA; and
the ratio of prisoner to non-prisoner subjects does not exceed
50 percent.

2. In exceptional circumstances, a biomedical research study may
be ethically acceptable even if the benefit of an intervention has not
been completely established, or if the research population is disproportionately comprised of prisoners. These two criteria may be
waived if the research addresses a condition or behavior that is solely
or almost exclusively found in incarcerated populations (e.g., repetitive sexual assaults). Studies of this nature could only proceed, however, with a federal-level review. The protocol must be submitted to
a national, specially convened panel of experts, who, in a public
process, consider the ethical acceptability of a particular protocol,
and make recommendations to the responsible government authority
(OHRP) regarding the special circumstances that do or do not provide a basis for research and the safeguards that must apply. This review would be very similar to the process outlined under Subpart D
(45 CFR 46.407) that requires DHHS Secretarial consultation for
studies that are not otherwise approvable which present an opportunity to understand, prevent, or alleviate a serious problem affecting
the health or welfare of prisoners (rather than children), except that
the panel of experts could be convened by an entity outside DHHS if
appropriate."

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This approach comports with the committee’s risk-benefit approach.
Given the history of and continued potential for prisoner exploitation,
biomedical research should be permitted only if there is a strongly favorable benefit-risk ratio for the prisoner. The distribution of burdens should
also be considered, thus the requirement that at least half of research subjects must come from nonprisoner populations. Research should only
involve prisoners to provide a benefit to prisoners, not because they are a
convenient source of subjects. This approach would enable fair distribution of potential benefits and burdens to prisoners.
To provide extra protections in the area of biomedical intervention
research, which likely carries the greatest risks for subjects, the only
benefits that should be considered are the benefits to the subjects themselves. Benefits to prisoners as a class are not a strong enough justification for a biomedical intervention study to proceed. These biomedical
inquiries may include drug studies and surgical, radiological, or any
interventional study in which the outcome of the biomedical intervention
is the question of interest.
There may be research proposals, most likely within social/behavioral and epidemiological categories, that carry very low risks
for the prisoner subjects but no personal benefit for the subjects. Instead,
the potential benefits may be for prisoners as a class (e.g., studies to
identify factors that predict recidivism or that seek to understand the effects of prior trauma on antisocial behavior). Applying a risk-benefit
analysis may determine that, because the risks are very low and important knowledge or benefits may accrue for prisoners as a class, the research is ethically acceptable. The same may hold true for
epidemiological studies that require analysis of biomedical samples, such
as tissue, blood, or urine, but are not designed to assess outcomes of an
intervention.
For all studies under consideration, the greater the risk and the more
restrictive the correctional setting, the stronger the design and monitoring
safeguards need to be.
Update the Ethical Framework to Include
Collaborative Responsibility
In the Belmont Report (NCPHSBBR, 1979), the national commission identified respect for persons, justice, and beneficence as the fundamental ethical principles that should guide the conduct and regulation

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of research with prisoners. These three principles should continue to anchor discussions of research with prisoners. However, ideas about ethical
research have evolved over the past three decades, leading the committee
to suggest that collaborative responsibility be added as a derivative of the
principle of justice to give attention to the needs and responsibilities of
all parties who will be involved with or affected by a research endeavor.
Recommendation: Use a collaborative research approach. Under an ethic of collaborative responsibility,
investigators should find ways to obtain input from
prisoners and other stakeholders on the design and
conduct of any research protocol involving prisoners.
(Recommendation 5.2)
Collaborative responsibility is intended to convey the idea that, to the
extent feasible, all aspects of research (design, planning, and implementation) should include the active participation of relevant institutional
stakeholders (prisoners, correctional officers, medical staff, administrators). A focus on collaboration would help cope with the reality that each
institution has its own unique conditions and may facilitate openness of
the research environment. The responsibility for collaboration lies with
investigators, who need to make the effort to engage prison administration and prisoners themselves for their input, and with the other components of the HRPPP, which must determine that the effort was made.
This report contains two additional recommendations that are part of
the updated ethical framework aimed at protecting prisoners:
Recommendation: Ensure adequate standards of care.
Human research participant protection programs, together with the prison administration and prison
health care professionals, are responsible for ensuring
that research with prisoners occurs in an environment
that is appropriate to the health and well-being of
prisoners, including access to existing medical and
mental health care that is adequate, protection from
inmate attempts to coerce or manipulate participation
or nonparticipation in research, and prompt access to
decent health care services in case the research causes
physical or mental harm. (Recommendation 5.3)

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Justice requires more than the protection of prisoners from harm
caused by the research itself. Ethical research carries with it a responsibility to grapple with the fact that potential harm is ubiquitous in everyday prison life, creating an environment for research in which the choice
to participate in a study can be inherently coercive and potentially dangerous. Thus, in order for research to be ethical, justice requires that it
must be done in a setting in which there is an adequate standard of health
care in place.
Ethical research requires an environment that is humane and provides reasonable access to supportive care, particularly when human subjects are exposed to physical or psychological risks. Without adequate
medical or psychological care, subjects may be vulnerable to undue inducements to participate in research in order to gain access to medical
care or other benefits they would not normally have. Finally, researchers
have an ethical obligation, if they expose subjects to risk, to rapidly and
professionally remedy any harms caused by the research.
Recommendation: Support critical areas of correctional research. Government agencies should fund and
researchers should conduct research to identify
needed supports to facilitate prisoners’ successful reentry into society, reduce recidivism, and inform policy makers about the most humane and effective
strategies for the operation of correctional systems.
(Recommendation 5.4)
Society creates a correctional system for clear purposes such as deterrence to future crime and rehabilitation of those who are convicted of
committing offenses. It is of utmost social importance to better understand how best to achieve the purposes of incarceration, including reduction of recidivism and successful introduction back into the community.
Perhaps unavoidably, the criminal justice system inflicts some harm on
those it punishes. As ethical people, we strive to develop and use corrective measures that are effective and humane without causing unnecessary
physical or mental harm to prisoners. However, prisoners are a vulnerable population subject to abuse and exploitation. Indeed, several subclasses of prisoners are some of society’s most vulnerable populations,
such as young people, persons with mental disabilities, racial minorities,
women, and people with diseases (addiction, hepatitis, HIV, hypertension, diabetes) that may or may not be treated during imprisonment. It is,

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therefore, especially important to better understand how to protect and
promote the welfare and well-being of this large and growing segment of
our society. Scientific knowledge and information about best practices
gained from high-quality research are critically important to understanding how best to achieve all of the legitimate purposes of the criminal justice system.
Enhance Systematic Oversight of Research
Involving Prisoners
If limited opportunities for research are to be allowed, safeguards
and oversight must be strengthened, made consistent, and applied in relation to the levels of study risk and liberty restrictions experienced by the
prisoner population. Informed consent must be obtained and privacy protected in the context of the correctional setting.
Approval of research by the IRB is a critical step, but it is not sufficient. Research involving prisoners must be monitored throughout the
course of the study to verify that procedures are being conducted as approved and to detect adverse events or unanticipated problems in a
timely manner. The monitoring process may need to differ depending on
the setting or study type. Studies that take place in closed institutions,
where liberty restrictions are the greatest, require more proactive monitoring than studies within community settings, where subjects can more
easily pick up the phone to express concerns or complaints. Similarly,
higher risk or more intrusive studies (e.g., research that involves medical,
pharmaceutical, or biological interventions) would likely require more
intrusive monitoring than social/behavioral studies of nonsensitive issues
(e.g., involving questionnaires). The committee suggests that monitoring
be accomplished by a prison research subject advocate (PRSA) who is
familiar with the local correctional setting but not an employee of the
facility to ensure credibility among the prisoner-subjects and maintain
independence. The IRB should have free access to the PRSA and be able
to meet with the PRSA separate from the investigator and correctional
staff.
Recommendation: Strengthen Monitoring of Research Involving Prisoners. Institutional Review
Boards that review and approve research involving
prisoners should establish an on-site, ongoing moni-

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toring function through a prison research subject advocate (PRSA). (Recommendation 6.3)
The activities of the PRSA go beyond the routine annual reviews that
IRBs currently conduct. The PRSA’s activities are study specific (although a single person could be a PRSA for more than one study) and are
“on the ground” activities, involving varying degrees of direct observation of specific research activities (depending on the type & risk level of
the research).
Recommendation: Modify IRB considerations for independent ethical review of research protocols. Institutional Review Boards (IRBs) should focus on the
particular ethical issues that each protocol raises in
the specific context of the correctional setting. IRBs
would no longer be required to forward research
proposals to OHRP for certification, except for those
rare proposals that require federal-level review.
(Recommendation 6.4)
IRBs should:
1. review studies at the local level, make the initial assessments of
risk and potential benefits, and approve or reject individual studies
based on detailed information about the protocol and correctional
setting;
2. determine if a study requires federal-level review;
3. evaluate investigator efforts to obtain input from prisoners and
other stakeholders on the design and conduct of the protocol;
4. evaluate the proposed research environment in terms of adequacy of existing health services;
5. calibrate the extent of safeguards and monitoring to the level of
restrictions imposed upon prisoners in the particular correctional setting and the degree of risk involved in study participation;
6. receive monitoring reports directly from PRSAs and researchers,
at a scope and frequency determined during study review.
The committee recommends that, although IRBs should retain the
bulk of the approval and monitoring functions to keep these at a local

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level, a national independent body is also needed as an additional safeguard.
Recommendation: Enhance OHRP’s capacity to provide systematic oversight of research involving prisoners. The Department of Health and Human Services
should strengthen the capacity of the Office for Human Research Protections to provide systematic oversight of research involving prisoners that is within its
purview. (Recommendation 6.5)
Four necessary functions are currently lacking in whole or in part in
oversight of research involving prisoners:
●
●
●
●

maintain a national registry of all prisoner research that is conducted,
make determinations if a study requires federal-level review,
enforce compliance with the regulations, investigate reports of
possible problems, intervene to curtail abuses, and impose sanctions for noncompliance, and
serve as a national resource for HRPPPs to promote a uniform
understanding and consistent application of the regulations.

OHRP is designed to perform three of the four functions above, but
does not currently have the funding or personnel to adequately carry out
the tasks. OHRP needs to be revitalized and refocused to carry out the
three functions already within its purview. In addition, it should be
charged with the task of creating and maintaining a national registry of
research involving prisoners. This recommendation, however, covers
only research supported by DHHS and two other federal agencies. The
majority of research involving prisoners is being conducted in the absence of any obligation to provide safeguards or oversight. To remedy
that inadequacy and ensure that these protections apply to all research
involving prisoners, the enhanced OHRP model must be replicated for all
agencies and privately funded research.
Recommendation: Establish systematic oversight of all
research involving prisoners. Congress should establish a national system of oversight that is applied uni-

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formly to all research involving prisoners. (Recommendation 6.6)
To expand prisoner protections beyond the narrow jurisdiction of
DHHS, Congress should establish a national system of oversight that is
applied uniformly to all research involving prisoners, performing all of
the functions listed in Recommendation 6.5. The vast majority of research involving prisoners does not fall within OHRP overview jurisdiction. Strengthening the safeguards provided for all prisoners involved in
research, regardless of funding source, will facilitate safe and ethical research across the full range of research involving prisoners. These functions could be performed by the revitalized and properly funded OHRP if
OHRP’s jurisdiction were extended to the entire range of research involving prisoners regardless of funding source (i.e., federal or nonfederal, public or private). An alternative is to compose a national entity to
perform the necessary oversight functions. Placing the functions within
OHRP may be more feasible and less disruptive, but it must be done with
serious attention to the extra support needed within OHRP to undertake
those tasks fully and much more broadly than its current limits to Common Rule agencies. The committee is calling for substantial improvements to the existing system of oversight, and if a new entity is necessary
to make it happen, then it should be created.
Recommendation: Ensure voluntary informed consent. Human research participant protection programs should ensure that voluntary informed consent
is obtained from subjects in all research involving
prisoners. (Recommendation 6.1)
Informed consent is vital to autonomous decision making and respect
for persons and is considered a bedrock of ethical research. Informed
consent is an interactive and ongoing process to ensure that participants
are voluntarily participating in research and that they understand the
level and nature of the risks and the uncertainty of potential benefits. The
written consent form—one part of the process—is the mechanism for
documenting that communication with the participant regarding relevant
considerations to enrollment in a protocol has taken place. The informed
consent process must help the prisoner to exercise autonomous decision
making. The process poses special challenges in the correctional setting,
where autonomy is incompatible with institutional order and judicially

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imposed limitations on liberty. In a correctional setting, a prisoner’s capacity to exercise independent judgment may have atrophied. The consent process and discussion must focus on the risks and potential benefits
of the research in the context of confinement and the nature of restrictions imposed on the prisoner’s liberty. This would include the impact of
research data on a prisoner (e.g., how would testing positive for a communicable disease impact housing, work opportunities, medical treatment, family visiting). There is no question that, within correctional
settings, it is more difficult to provide integrity to the process of informed consent, but this does not remove the obligation. If it is determined that voluntary informed consent is not obtainable, then a research
proposal should not go forward.
Recommendation: Protect the privacy of prisoners engaged in research. Human research participant protections programs should collaborate with prison
officials, probation officers and other staff relevant to
the correctional setting to protect the privacy of subjects in prisoner research. (Recommendation 6.2)
Privacy is considered one of the necessary prerequisites for ethical
research. In most circumstances, this means nondisclosure of the identity
of the research subject and ensuring confidentiality of the specific data
collected. Privacy is exceedingly difficult to attain in prison settings,
however, because of the inherently coercive and institutionalized contexts and the controlled and public nature of physical movement. Maximizing privacy within a correctional setting will require collaborative
planning efforts specific to the particular correctional setting that involve
potential subjects and staff from the correctional setting to consider the
impact of participation on privacy issues.
Given that it may not be possible to guarantee absolute privacy in
some situations, researchers and IRBs should consider the extent to
which core privacy issues can be protected from disclosure through realistic and practical approaches. For instance, it may be clear to prisoners
and staff that medical research is being conducted, but the specific nature
of the study or the characteristics common to human subjects need not be
generally known or discernible. These measures, and their limits, should
be discussed in detail with prospective participants in the context of the
consent process.

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CONCLUDING REMARKS
The recommendations offered within this report are intended to encourage the development of a uniform system that provides critically
important protections for prisoners involved in research. Research has
the potential to help society better understand how to protect and promote the welfare and well-being of this large and growing segment of
our society. For any research to go forward, however, it must offer more
benefits than risks to prisoners, and the setting in which the prisoners are
consigned must allow for the ethical conduct of research, including
autonomous decision making, voluntary informed consent, and privacy
protection. Strengthening systems of oversight and requiring collaboration at every level of the research process will require substantial commitments from every stakeholder (Table ES-1). The committee
acknowledges that the collaboration model, for example, will be new
within most correctional settings and among many researchers. However,
if research is to be supported to improve the welfare of prisoner populations, which the committee recommends, it must be done with rigorous
safeguards and under a comprehensive HRPPP. The hallmark of a decent
society is to ensure humane, respectful treatment of all prisoners. Responsible, ethically appropriate research is one important aspect of the
kind of society to which we aspire.

BOX S-1
Ethical Considerations for Revisions to DHHS Regulations for
Protection of Prisoners Involved in Research
Recommendations
Expand the Definition of “Prisoner” Redefine “prisoner” to expand the reach
of human subjects protections. (4.1)
Ensure Universal, Consistent Ethical Protection
● Establish uniform guidelines for all human subjects research involving
prisoners. (3.1)
● Maintain a public database of all research involving prisoners. (2.1)
● Ensure transparency and accountability in the research enterprise.
(6.7)
Shift from a Category-Based to a Risk-Benefit Approach to Research Review
● Apply risk-benefit framework to research review. (5.1)

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Update the Ethical Framework to Include Collaborative Responsibility
● Use a collaborative research approach. (5.2)
● Ensure adequate standards of care. (5.3)
● Support critical areas of correctional research. (5.4)
Enhance Systematic Oversight of Research Involving Prisoners
● Strengthen Monitoring of Research Involving Prisoners (6.3)
● Modify IRB considerations for independent ethical review of research
protocols. (6.4)
● Enhance OHRP’s capacity to provide systematic oversight of research
involving prisoners. (6.5)
● Establish systematic oversight of all research with prisoners. (6.6)
● Ensure voluntary informed consent. (6.1)
● Protect the privacy of prisoners engaged in research. (6.2)

TABLE S-1 Impact of Committee Recommendations on Stakeholder
Responsibilities
Stakeholders
Congress

Current Duties

DHHS/OHRP

1. DHHS agencies
follow Sub-part C,
OHRP also has oversite for research involving prisoners for
two other agencies
(CIA, SSA) that
signed on to Subpart
C.
2. For above mentioned studies involv-

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Proposed Duties Based on
Committee Recommendations
5. Revitalize OHRP to enhance its capacity to provide
uniform oversight.
6. Maintain a national registry
of all prisoner research.
7. OHRP no longer certifies
all studies, although it still
oversees process of “exceptional” study review.
8. OHRP focus shifts to national oversight, data collection, compliance, enforcement,
and technical assistance role.

Stakeholders
DHHS/OHRP
(con’t)

Current Duties
ing prisoners, OHRP
must certify that IRB
has followed Subpart
C.
3. If a protocol does
not fit within one of
five catargories, regardless of risk benefit, it is not approved.

Other federal agencies

Only CIA, SSA follow
Subpart C.

1. All federal agencies follow
Subpart C.
2. Support critical areas of
correctional research.

Nonfederal and
private sponsors

Not required to follow
Subpart C.

Must follow revised Subpart C.

Correctional settings 1. No clear, standard
expectations for providing input in design
or access for onsite
monitoring.
2. May or may not
require IRB review for
research at their facility.

1. Be open to providing input
to investigators regarding the
design and conduct of research
protocols involving prisoners.
2. Require that research be
approved by an IRB before it
is conducted at their facility.
3. Assist in protection of subject privacy.
4. Provide for timely and adequate medical response to adverse events experienced by
the research subjects.
5. Ensure that PSRAs have
open access to monitor research activities.

HRPPP/IRB

1. Protocol review is
based on categories.
2. For DHHS-

1. Review shifts from category-based to risk-benefit approach, with focus on the

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SUMMARY

Stakeholders
HRPPP/IRB
(con’t)

Current Duties
supported research
involving prisonersm
submit to OHRP for
certification, and if
necessary, federallevel review.
3. Wait for OHRP
certification before
study can be approved.
4. Ensure informed
consent.
5. Protect subject
privacy.
6. Include prisoner
representative as voting
member of IRB

Investigators

1. Present studies to
IRB and await IRB
approval and OHRP
certification.
2. No standards for
getting input or ensuring adequate medical
response.
3. Obtain informed
consent.

Proposed Duties Based on
Committee Recommendations
particular ethical issues that
each protocol raises in the specific context of the correctional setting.
2. Only “exceptional” studies
are submitted to OHRP for
federal-level review.
3. Evaluate investigator efforts to obtain input from prisoners and other stakeholders
on the design and conduct of
research protocols involving
prisoners.
4. Evaluate the proposed research environment in terms of
adequacy of existing health
services to ensure that prisoner
participation is truly voluntary
and assess existing capacity to
provide for timely and adequate medical response to adverse events experienced by
the research subjects.
5. Ensure informed consent.
6. Protect subject privacy.
7. Include prisoner representative as voting member of IRB
8. Be open, transparent, and
accountable.
1. Present study to IRB for
approval. Only requires OHRP
review for “exceptional” studies
2. Demonstrate efforts to obtain input on study design and
implementation from stakeholders, including prisoners.
3. Demonstrate to the IRB
that the proposed research
environment provides for
timely and adequate medical

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Proposed Duties Based on
Committee Recommendations
response to adverse events
experienced by the research
subjects.
4. Obtain informed consent.
5. Be open, transparent, and
accountable.

Stakeholders
Investigators
(con’t)

Current Duties

PRSAs

Do not exist.

Provide assurance, via ongoing, onsite monitoring, such
that research subjects within a
specific facility or program are
protected.
Multisite studies would likely
have more than one PRSA.
Duties expand as potential
risks to participants increase.

Prisoners

1. Provide informed
consent.

1. Provide informed consent.
2. Provide input, on request,
on study design and implementation.

NOTE: OHRP, Office for Human Research Protections; DHHS, Department of Health
and Human Services; CIA, Central Intelligence Agency; SSA, Social Security Administration; IRB, institutional review board; PRSA, prison research subject advocate.

REFERENCES
BOP (Bureau of Prisons). 1999. Program Statement 1070.07. [Online] Available: http://www.bop.gov/DataSource/execute/dsPolicyLoc [accessed January
4, 2006]
BOP (Bureau of Prisons). 2005. Program Statement 6031.01. [Online] Available: http://www.bop.gov/DataSource/execute/dsPolicyLoc [accessed January
4, 2006]
BJS. 2000a. Prisoners in Custody 1977-1998. [Online]. Available:
http://www.ojp.usdoj.gov/bjs/prisons.htm [Accessed January 3, 2006].
BJS. 2000b. Incarcerated Parents and Their Children. Washington, DC: U.S.
Department of Justice.
BJS. 2005a. Prisoners in 2004. [Online]. Available: http://www.ojp.usdoj.gov/
bjs/abstract/p04.htm [Accessed January 23, 2006].
BJS. 2005c. Prison and Jail Inmates at Midyear 2004. Washington DC: U.S.
Department of Justice. NCJ 208801.

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BJS. 2005d. Probation and Parole in the United States, 2004. NCJ 210676.
[Online]. Available: http://www.ojp.usdoj.gov/bjs/pub/pdf/ppus04.pdf [Accessed December 20, 2005]
DeAngelis C.D., Drazen J.M., Frizelle F.A., Haug C., Hoey J., Horton R.,
Kotzin S., Laine C., Marusic A., Overbeke A.J., Schroeder T.V., Sox H.C.,
and M.B. Van Der Weyden. 2004. International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International
Committee of Medical Journal Editors. Journal of the American Medical Association 292(11):1363-1364.
Hornblum AM. 1998. Acres of Skin. Routledge, New York. 320 pp.
IOM, 2003. Responsible Research: A Systems Approach to Protecting Research
Participants. Washington, D.C. National Academies Press.
IOM. 2004. The Ethical Conduct of Clinical Research Involving Children.
Washington, DC: National Academies Press.
IOM, 2006. Developing a National Registry of Pharmacologic and Biologic
Clinical Trials Workshop Report. Washington, D.C. National Academies
Press. [[in press]]
Jones JH. 1993. Bad Blood: The Tuskeegee Syphilis Experiment. New York: The
Free Press.
Metzner JL. 2002. Class Action Litigation in Correctional Psychiatry. Journal
American Academy of Psychiatry and the Law. 30:19-29.
Murphy D. 2005. Health care in the federal bureau of prisons: fact or fiction.
California Journal of Health Promotion. 3(2):23-37.
NCCHC (National Commission on Correctional Health Care). 2002. The Health
Status of Soon-to-Be-Released Inmates: Executive Summary. [Online]. Available: http://www.ncchc.org/stbr/Volume2/ExecutiveSummary.pdf [Accessed
October 10, 2005].
NCPHSBBR (National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research) 1976. Report and Recommendations:
Research Involving Prisoners. Washington, D.C.
NCPHSBBR (The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research) 1979. The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research
http://ohsr.od.nih.gov/guidelines/belmont.html
Sturm SP. 1993. The legacy and future of corrections litigation. University of
Pennsylvania Law Review. 142:638-738.
U.S. Census. 1998. Table No. 377: Federal and State Prisoners: 1970 to 1996.
In: Statistical Abstracts of the United States: 1998. [Online]. Available:
http://www.census.gov/prod/3/98pubs/98statab/sasec5.pdf [Accessed December 23, 2005].
U.S. Census. 2004. Table: Number and rate of sentenced prisoners under jurisdiction of State and Federal correctional authorities on December 31.
[Online]. Available: http://www.albany.edu/sourcebook/pdf/t6282004.pdf
[Accessed December 23, 2005].

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1
Introduction

Prisoners are an especially vulnerable class of potential research participants who historically have been exploited by physicians and researchers seeking expedient solutions to complex research problems (Hornblum,
1997, 1998, Mitford, 1974). They are the classic “captive population.”
The ethical issues surrounding research on any human population require serious consideration. Certain unique circumstances faced by prisoners1, however, require particular attention. Numerous ethical problems
surrounding research with prisoners grow out of the complexity of the correctional settings and the disempowered status of the potential research
participants. Although the limitations on personal choice and control are
perhaps most evident and oppressive in locked detention facilities (e.g.,
jails, prisons), the power differential between criminal justice agents and
prisoners exists in many other contexts as well (e.g. probation, parole); the
differences are a matter of degree.
First among the problems are those related to informed consent, ensuring that the setting permits the processes of informed consent and refusal.
Second, privacy is much more difficult to ensure within a correctional setting. In a prison or jail, everyone sees who moves where and can speculate
on what that movement means. For example, an inmate’s trip to a medical
clinic that is investigating AIDS or hepatitis C makes quite clear what the
inmate’s visit portends.
Third, ethical research involves ensuring, as a prerequisite for research,
that the standard of medical health care available in the correctional setting
1

The term “prisoner” is defined by the Committee in Chapter 4 and used throughout this
report to mean all persons whose liberty has been restricted by decisions of the criminal
justice system. The setting is not limited to prisons and jails but can include community
settings, such as work release programs, probation, parole, etc.

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permits the inmate to have a meaningful choice between the existing care
that is available and the experimental intervention. In addition, other matters that generally are not complex issues in research outside of correctional settings appear as ethical dilemmas in the prison or jail. For example,
in a correctional setting it may be difficult to distinguish between a refusal
of care and a denial of care. Likewise, there can be difficulties in distinguishing between compliance and noncompliance in the research protocol.
For example, if an inmate does not appear for a scheduled research meeting, which may also provide access to health care, it may not be clear
whether the inmate has (1) decided not to come, (2) been barred or precluded from coming, (3) been taken to court for an unanticipated appearance, or (4) been presented with an unscheduled family visit.
These concerns are readily apparent in the context of research involving prisoners. However, what about questions of justice and fairness? How
much of the burden of research should prisoners be asked to bear? How
many of the potential benefits of research will be directed toward the prisoner-subjects? The acne medication Retin-A was basically developed in
the Philadelphia prison system, with serious harms and few benefits afforded the prisoners who were involved in the research (Hornblum, 1998).
Alternatively, many inmates would choose to live and work in a research
unit if they could, regardless of the risks and benefits associated with research participation. Should that be encouraged, permitted, or, as it is now,
barred from the prison setting? What if the burdens of research are actually
experienced by inmates as benefits to be coveted in the deprived and stark
setting of the prison? Should that overcome the current stance of the regulations in the U.S. DHHS (2005a) Code of Federal Regulations 45 C.F.R. §
46 (see Appendix D)?
WHY NOW?
In response to a request from the Office for Human Research Protections (OHRP), the Institute of Medicine (IOM) formed the Committee on
Ethical Considerations for Protection of Prisoners Involved in Research to
address ethical considerations for protecting prisoners involved in research.
The broad purpose was to examine whether the conclusions reached in
1976 by the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research (see Appendix B) remain appropriate
today. The national commission’s report (NCPHSBBR, 1976) was the basis for 45 C.F.R. § 46, which contains four subparts. Subpart A, also

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known as the Common Rule, is “Basic U.S. DHHS Policy for Protection of
Human Research Subjects” (U.S. DHHS, 2005a). Subparts B, C, and D of
45 C.F.R. § 46 provide further and more specific protection for certain particularly vulnerable populations: pregnant women, fetuses, and neonates;
prisoners; and children, respectively (U.S. DHHS, 2005a). Subpart C,
“Additional Protections Pertaining to Biomedical and Behavioral Research
Involving Prisoners as Subjects,” the focus of this project, was first finalized in 1978 (U.S. DHHS, 2005a).
This examination will consider the impact of developments in correctional systems since that time (1976) as well as societal perceptions of the
balance between burdens and potential benefits of research.
Many changes have occurred within the U.S. correctional system since
the late 1970s, and these changes have important ramifications for research
involving prisoners. They include:
●

●

an escalating prisoner population. For example, persons under
prison supervision grew from 216,000 in 1974 to 1.4 million in
2004, largely as a result of the war on drugs, harsher sentencing
laws, and high recidivism rates (BJS, 2003, 2005a; HRW, 2003;
Jacobson, 2005). The overall correctional population, including
persons in prison, jail, and on parole and probation, has jumped
from 1.5 million in 1978 to nearly 7 million in 2004 (BJS, 2005a,
b, c, d).
the overrepresentation of men and women of color in prisoner
populations (BJS, 2003). One out of eight black men in their late
20s is under the jurisdiction of the criminal justice system, including, jail, prison, probation, and parole (Lotke, 1997; Mauer and
King, 2004).
increased overcrowding in correctional facilities, resulting in diminished availability of and access to programs and services. Construction has not kept pace with the increasing number of inmates
(Jacobson, 2005).
inadequate health care services is a reality of some correctional settings, notwithstanding Eighth Amendment proscriptions against
“deliberate indifference to the serious medical needs” of prisoners
(Braithwaite, 2005; HRW, 2003; Metzner, 2002; Restum, 2005;
Sturm, 1993).
increasing population of female inmates—growing at a faster rate
than that of male inmates—who face unique challenges (BJS,
1999). As with male prisoners, female inmates are more likely to

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●

be a minority, poor, and undereducated, but as women they are
more likely to be the primary caregiver for children and they suffer
disproportionate victimization from sexual and physical abuse
(BJS, 1999).
increased number of prisoners serving their sentences in alternative
programs, outside the traditional “bricks and mortar” prisons and
jails (BJS, 2004). The environments in which prisoners are consigned have expanded to include work-release programs, halfway
houses, electronic monitoring programs, and other alternatives to
incarceration (BJS, 2004).
increased number of prisoners serving their sentences in alternative
programs, outside the traditional “bricks and mortar” prisons and
jails (BJS, 2004). The environments in which prisoners are consigned have expanded to include work-release programs, halfway
houses, electronic monitoring programs, and other alternatives to
incarceration (BJS, 2004).
overrepresentation of communicable diseases, such as HIV/AIDS,
hepatitis B and C, and tuberculosis, in prisons (Hammett, et al.,
2002; Khan, et al., 2005; MacNeil, et al., 2005; NCCHC, 2002). In
addition, among an aging prison population, chronic diseases such
as diabetes and hypertension are critical management issues
(NCCHC, 2002).
increasing admissions of mentally ill prisoners with the closing of
the large state mental institutions (HRW, 2003). Mental illness
(BJS, 1999; NFCMH, 2004) and violence take a heavy toll on the
prisoner population.

At the same time that prison populations have been expanding, there
has been a considerable amount of confusion and disagreement in the research community regarding the interpretation and application of Subpart
C of 45 C.F.R. § 46 (“Additional Protections Pertaining to Biomedical and
Behavioral Research Involving Prisoners as Subjects” [U.S. DHHS,
2005a]) to current issues of research involving prisoners. The OHRP’s responsibilities include implementation of the U.S. DHHS Regulations for
the Protection of Human Subjects (U.S. DHHS, 2005a) and the provision
of guidance on ethical issues in biomedical and behavioral research. OHRP
has oversight and educational responsibilities wherever U.S. DHHS funds
are used to conduct research involving human participants. The Secretary’s
Advisory Committee for Human Research Protections (SACHRP), the ad-

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visory committee to OHRP, has asked OHRP to rewrite Subpart C, taking
into consideration the current prison environment (see Appendix C).
OHRP recommended that, before such an effort is undertaken, there
should be a thorough review of the ethical considerations in research involving prisoners, which could serve as the basis for developing new regulations. Beyond its importance regarding revisions to Subpart C, such a
review would be instructive for developing ethical bases for making future
changes to the U.S. DHHS Regulations for the Protection of Human Subjects and the Common Rule.
COMMITTEE’S TASK AND APPROACH
This report addresses ethical considerations for the protection of prisoners involved in research. The overall purpose of the committee was to
examine whether the conclusions reached by the national commission in
1976 remain appropriate today. This examination considered the impact of
developments in correctional systems since that time and societal perceptions of the balance between research burdens and potential benefits of research. The committee was asked to:
●
●
●

●

consider whether the ethical bases for research with prisoners differ from those for research with nonprisoners,
develop an ethical framework for the conduct of research with
prisoners,
based on the ethical framework developed, identify considerations
or safeguards necessary to ensure that research with prisoners is
conducted ethically, and
identify issues and needs for future consideration and study.

The committee was asked to address the following specific questions:
1. What are the unique features of the prison setting as an environment
for research with respect to the general characteristics of the prison population, its specific and general health care needs, the adequacy of existing
health care services, and the legal constraints placed on prisoners and the
institutions that house them? Considerations include the following:
●

How should “prisoner” be defined?

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●
●
●
●

What features of the current system of incarceration must be considered in conducting and reviewing research?
What constitutes voluntariness in the prison setting? Are special
measures needed to ensure informed consent in this setting?
Must there be a finding that no alternative population is available
in order for ethical research involving prisoners to occur?
What safeguards are necessary to ensure that research proceeds
ethically? For example, how can privacy and confidentiality be
protected in a setting in which individuals are institutionalized?

2. What criteria or factors are relevant to determining whether research with prisoners can be conducted ethically? Specifically,
●

●
●
●

does the national commission’s conclusion that research involving
prisoners should only be conducted if it benefits prisoners individually or as a group merit continued support?
what should constitute minimal risk in the context of research with
prisoners?
should prisoner research be limited to “not greater than minimal
risk?”
what are the priorities for research involving prisoners?

3. What is an appropriate ethical framework for the conduct of such
research? How should the concepts of minimal risk, voluntary informed
consent, privacy and confidentiality, and distributive justice be incorporated into such a framework? Specifically,
●

●
●

●

are the criteria for allowing prisoner research expressed by the national commission regarding voluntariness and openness (e.g., public scrutiny, grievance procedures) still appropriate?
what measures beyond exclusion from research are appropriate for
protecting the rights and welfare of prisoners?
how should the standard of existing medical care be valued when
reviewing research protocols involving control or placebo-control
arms?
should there be a risk threshold for allowing research with prisoners? If so, how should the prospect of benefit affect that threshold?

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Note: The committee decided to exclude children (unless treated as adults),
military personnel, and persons under restricted liberty due to mental illness and outside the criminal justice system, for example those detained under the U.S. Patriot Act. By excluding these groups, the committee
emphasizes that they face very similar circumstances and that very strong
ethical safeguards are required. However, the committee lacks the expertise
to address the needs of these special populations and such an inquiry exceeds the committee’s charge. Parallel studies, such as the one undertaken
by this committee, may be needed to explore ethical issues of research involving these groups. If, however, juveniles are transferred from the original jurisdiction of the family court (or the equivalent, such as a juvenile
court) to the jurisdiction of a state or federal criminal court, then they
would fall under the provisions of this report.

Methods and Approach

In conducting its work, the committee cast a broad net for the
collection of information. In addition to the traditional sources of
information (e.g. literature, workshops, commissioned papers (see
Box A-1)), the committee also had a liaison group (see Box A-2) and
visited two correctional facilities. Appendix A provides a detailed
summary of the committee’s methods and data sources.

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ORGANIZATION OF THIS REPORT
This report is organized into six chapters. This introduction is followed
by a thorough discussion of the demographics of today’s correctional system in Chapter 2, which also details the committee’s efforts to determine
the type and scope of research involving prisoners within the past 2 years.
Chapter 3 provides a description of the current federal regulatory landscape, with a discussion of its limitations. Chapter 4 introduces the committee’s broadened definition of prisoner aimed at expanding protections to
a wider group of people who have restricted liberties because of decisions
of criminal courts. Chapter 5 describes a new framework for research involving prisoners, based on the ethical principles of respect for persons and
justice, and introduces the derivative concept of collaborative responsibility as being particularly important for planning and implementing research
involving this vulnerable population. Finally, Chapter 6 contains the committee’s recommendations for a new, more comprehensive system of oversight, safeguards, and protections for research involving prisoners, with
more intrusive monitoring for higher risk studies. Appendix A contains a
thorough description of the committee’s methods and data sources; Appendix B, the national commission’s deliberations and findings; Appendix C,
the report of the SACHRP Subcommittee and Human Subjects Protections;
Appendix D, the Code of Federal Regulations 45 § 46 (Protection of Human Subjects); Appendix E, a list of acronyms used in the report, and Appendix F, brief biosketches of the committee members, liaison group, and
IOM staff.
REFERENCES
Braithwaite RI, Treadwell HM, Arriola KRJ. 2005. Health disparities and incarcerated women: A population ignored. American Journal of Public Health
95(10):1679–1680.
BJS (Bureau of Justice Statistics). 1999. Mental Health and Treatment of Inmates
and Probationers. [Online]. Available: http://www.ojp.usdoj.gov/bjs/pub/pdf/
mhtip.pdf [accessed December 23, 2005].
BJS. 2003. Prevalence of Imprisonment in the U.S Population, 1974–2001.
[Online]. Available: http://www.ojp.usdoj.gov/bjs/pub/pdf/piusp01.pdf [accessed December 30, 2005].
BJS. 2004. Probation and Parole in the United States, 2003. [Online]. Available:
http://www.ojp.usdoj.gov/bjs/pub/pdf/ppus03.pdf [accessed January 20, 2005].
BJS. 2005a. Prison and Jail Inmates at Midyear 2004. [Online]. Available:
http://www.ojp.usdoj.gov/bjs/pub/pdf/pjim04.pdf [accessed January 20, 2006].

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INTRODUCTION

BJS. 2005b. Prisoners in Custody, 1977-98. [Online]. Available:
http://www.ojp.usdoj.gov/bjs/prisons.htm#selected [accessed April 4, 2006].
BJS. 2005c. Adults on Probation, Federal and State by State, 1977-2004. [Online].
Available: http://www.ojp.usdoj.gov/bjs/pandp.htm#selected [accessed April 4,
2006].
BJS. 2005d. Adults on Parole, Federal and State by State, 1977-2004. [Online].
Available: http://www.ojp.usdoj.gov/bjs/pandp.htm#selected [accessed April 4,
2006].
Hammett TM, Harmon MP, Rhodes W. 2002. The burden of infectious disease
among inmates of and releasees from US correctional facilities, 1997. American
Journal of Public Health. 92:1789-1794.
Hornblum AM. 1997. They were cheap and available: prisoners as research subjects in twentieth century America. British Medical Journal 315:1437–1441.
Hornblum AM. 1998. Acres of Skin: Human Experiments at Holmesburg Prison.
New York: Routledge.
Human Rights Watch (HRW). 2003. Ill-Equipped: U.S. Prisons and Offenders
with Mental Illness. [Online]. Available: http://www.hrw.org/reports/2003/usa
1003/index.htm [accessed October 13, 2005].
Jacobson, M. 2005. Downsizing Prisons: How to Reduce Crime and End Mass
Incarceration. New York: New York University Press.
Khan AJ, Simard EP, Bower WA, Wurtzel HL, Khristova M, Wagner KD, Arnold
KE, Nainan OV, LaMarre M, Bell BP. 2005. Ongoing transmission of hepatitis
B virus infection among inmates at a state correctional facility. American Journal of Public Health 95(10):1793–1799.
Lotke E. 1997 Hobbling a Generation: Young African American Men in D.C.’s
Criminal Justice System Five Years Later. National Center on Institutions and
Alternatives. [Online]. Available: http://66.165.94.98/stories/hobblgen0897.html
[accessed April 6, 2006].
MacNeil JR, Lobato MN, Moore M. 2005. An unanswered health disparity: Tuberculosis among correctional inmates, 1993 through 2003. American Journal of
Public Health 95(10):1800–1805.
Mauer M, King RS. 2004. Schools and Prisons: Fifty Years After Brown V. Board
of Education. [Online]. Available: http://sentencingproject.org/pdfs/brownv
board.pdf [accessed January 2, 2006].
Metzner JL. 2002. Class action litigation in correctional psychiatry. Journal
American Academy of Psychiatry and the Law 30:19–29.
Mitford J. 1974. Kind and usual punishment. New York: Vintage.
NCCHC (National Commission on Correctional Health Care). 2002. The Health
Status of Soon-to-Be-Released Inmates: Executive Summary. [Online]. Available: http://www.ncchc.org/stbr/Volume2/ExecutiveSummary.pdf [accessed October 10, 2005].
NCPHSBBR (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). 1976. Report and Recommendations: Research Involving Prisoners. Washington, DC: NCPHSBBR.

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NFCMH (New Freedom Commission on Mental Health). 2004. Subcommittee on
Criminal Justice Background Paper’ DHHS Pub. No. SMA-04-3880, Rockville,
MD. Available: http://www.mentalhealthcommission.gov/papers/CJ_ADA
Compliant.pdf [accessed March 20, 2006].
Restum ZG. 2005. Public health implications of substandard correctional health
care. American Journal of Public Health 95(10):1689–1691.
Sturm SP. 1993. The legacy and future of corrections litigation. University of
Pennsylvania Law Review 142:638–738.
U.S. DHHS (U.S. Department of Health and Human Services). 2005a. Code of
Federal Regulations: Title 45. Public Welfare. Part 46: Protection of Human
Subjects. Washington, DC: U.S. DHHS.
U. S. DHHS. 2005b. Report of the Subpart C Committee to SACHRP. [Online].
Available: http://www.hhs.gov/ohrp/sachrp/mtgings/present/SubpartC.htm [accessed January 20, 2006].

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2
Today’s Prisoners:
Changing Demographics, Health Issues, and
the Current Research Environment

The conditions of confinement in today’s prisons and jails have
many of the same characteristics that were of concern to the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research some 30 years ago (see Appendix B). Yet important
new factors have emerged that require consideration. The correctional
population has expanded more than 4.5-fold between 1978 and 2004—
from 1.5 million to almost 7 million as a result of tougher sentencing
laws and the war on drugs (BJS, 1997b, 2005a, 2005f, 2005g, 2005h;
HRW, 2003; Jacobson, 2005). Just within prisons and jails, the population grew from 454,444 to 2.1 million (BJS, 2005a, 2005f). The rest of
the expansion occurred among probationers and parolees (BJS, 2005g,
2005h).
In addition, with the closing of large state mental institutions, prisons
have effectively become the new mental illness asylums. Prisoners suffer
higher rates of communicable diseases, such as HIV/AIDS and hepatitis,
than the general population, and chronic diseases such as diabetes are on
the rise, especially among the growing older, “graying” population of
prisoners (NCCHC, 2002). Health care within some prison systems is
less than satisfactory. Through class action lawsuits over the inadequacies of state prison health care systems, the most serious problems were
largely addressed and health care delivery systems were put in place
(Metzner, 2002; Sturm, 1993). However, problems remain. Most recently, a federal district court judge placed California’s entire prison
medical health care system into federal receivership, taking it out of control of the state and placing it under the control of a trustee appointed by

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the court.1 In addition, the entire state prison mental health system is being monitored by another federal court after being found to be providing
constitutionally inadequate mental health services to inmates with serious
mental illnesses (Coleman v. Wilson, 912 F.Supp. 1282 [E.D.Cal 1995]).
And New York regulators have faulted the private firm Prison Health
Services in several deaths within the state’s prison system (Von Zielbauer, 2005d). This follows by 30 years the case of Estelle v. Gamble, in
which the U.S. Supreme Court articulated a constitutionally protected
right to health care in prisons and jails (U.S. Supreme Court, 1976).
The committee’s review of current research indicated that the majority of research involving prisoners is happening outside the purview of
Subpart C, and many prisoner studies are being conducted without review or approval by an institutional review board (IRB). Prison research
committees that may serve some type of proxy IRB role only infrequently include prisoners or prisoner representatives among their membership. All of these factors point to a population of prisoners who may
be more vulnerable and require stronger protections than those inspired
by the commission in the 1970s.
CHANGING DEMOGRAPHICS
AND HEALTH ISSUES
Descriptions of Prisons, Jails, and Other Correctional
Settings
Within the United States, correctional settings, which constrain liberty, entail more than prisons. Local jails, usually county or city facilities, house prisoners from arraignment through conviction and for
sentences usually no longer than 1 year. State and federal prisons incarcerate those sentenced for longer periods. About 6 percent, or close to
99,000 prisoners, are held in privately operated facilities that incarcerate
the state and federal overflow (BJS, 2005a,c). In six states, all in the
West, at least one-quarter of all persons in prisons are in private facilities
(BJS, 2005a). Several other alternatives to prisons and jails that constrain
liberty, including restitution centers, camps, treatment facilities, and electronic monitoring programs, are listed in Table 4-1 (see Chapter 4); spe1
U.S. District Court for the Northern District of California. Findings of Fact and Conclusions of Law Re Appointment of Receiver, Marciano Plata, et al vs. Arnold Schwarzenegger, et al., October 3, 2005, page 2.

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cific options within the state of California are provided in Table 4-2 (see
Chapter 4). Parole and probation are two other settings in which individuals have restricted liberties by virtue of involvement in the criminal
justice system. Parole is used for offenders who are conditionally released from prison to community supervision. An offender is required to
observe the conditions of parole and is under the supervision of a parole
agency. Parole differs from probation, which is determined by judicial
authority and is usually an alternative to initial confinement.
The Prisoner Population
The Incarcerated Population Has Grown Enormously
The total estimated correctional population in the United States in
2004 was very close to 7 million, according to the Bureau of Justice Statistics (BJS, 2005a). Table 2-1 indicates that the majority of these individuals were on probation (4 million), followed by confinement in prison
(1.4 million), on parole (765,355), and confinement in jail (713,990).
Overall, the population in 2004 was more than 4.5 times larger than it
was in 1978.
TABLE 2-1 Persons Under Adult Correctional Supervision, 1978-2004
Total Estimated

Year
1978
1980a
1995
2000
2001
2002
2003
2004

Correctional
Population
1,531,596
1,840,400
5,342,900
6,445,100
6,581,700
6,758,800
6,936,600
6,996,500

Probation
899,305
1,118,097
3,077,861
3,826,209
3,931,731
4,024,067
4,144,782
4,151,125

Parole
177,847
220,438
679,421
723,898
732,333
750,934
745,125
765,355

Jail
158,394
82,288
507,044
621,149
631,240
665,475
691,301
713,990

Prison
296,050
319,598
1,078,542
1,316,333
1,330,007
1,367,547
1,392,796
1,421,911

1980 figures from BJS, 2003c.
SOURCES: U.S. Census, 1998, 1994, BJS, 1997b, 2000a, 2003c, 2004b, 2005a, 2005f,
2005g, 2005h

At year-end 2004, the nation’s prisons and jails incarcerated 2.1 million persons (BJS, 2005a) compared with 216,000 in 1974 (BJS, 2003a).

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Today, two-thirds of inmates are housed in federal and state prisons, and
the other third are in local jails.
The numbers in Table 2-1 are point-in-time figures. Annual flow in
and out of jail, where incarceration time is comparatively short, provides
a useful picture as well. Nearly a quarter (23 percent) of all jail inmates
spend 14 days or less in jail, 29 percent are held from 2 to 6 months, 7
percent are held for a year or more (BJS, 2004c). The transitory nature of
jail confinement can have an impact on research participation, as discussed in chapter 4.
Using Department of Justice statistics and trends, the Washington,
DC-based Justice Policy Institute (JPI) estimated in 2000 that the United
States had the world’s largest incarcerated population and highest incarceration rate. Just 6 weeks into the new millennium, America had onequarter of the world’s prison population, despite having less than 5 percent of the world’s population (JPI, 2002). The U.S. incarceration rate
was highest, with 686 per 100,000 of the national population (Walmsley,
2003), followed by the Cayman Islands (664), Russia (638), Belarus
(554), Kazakhstan (522), Turkmenistan (489), and Belize (459). More
than 62 percent of countries worldwide have rates below 150 per
100,000. By 2004, the U.S. rate had risen to 724 per 100,000 (BJS,
2005a)
Calling the 1990s “the punishing decade,” JPI noted that the imprisoned population grew at a faster rate during the 1990s than during any
decade in recorded history (see Figure 2-1). The prison growth during the
1990s dwarfed the growth in any previous decade; it exceeded the prison
growth of the 1980s by 61 percent and is nearly 30 times the average
prison population growth of any decade before the 1970s (JPI, 2002).
This growth has led to serious overcrowding. According to BJS data for
2004 (BJS, 2005a), 24 state departments of corrections and the federal
prison system are operating above capacity. The federal prison system is
operating at 40 percent above capacity.
The population of prisoners under jail supervision who are confined
in settings outside of a jail facility has doubled since 1995 (see Table 22). This point is important for the Chapter 4 discussion regarding the
definition of “prisoner.” In 2004, jail authorities supervised 70,548 men
and women in the community in work-release, weekend reporting, electronic monitoring, and other alternative programs.

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FIGURE 2-1 The punishing decade: number of prison and jail inmates, 19102000.
Reprinted, with permission, from The Punishing Decade: Prison and Jail Estimates at the Millennium (May 2000). Copyright 2000 by Center on Juvenile and
Criminal Justice.

TABLE 2-2 Persons Under Jail Supervision, by Confinement Status and
Type of Program, Midyear 1995, 2000, and 2002-2004
Confinement Status and
Type of Program

Number of Persons Under Jail Supervision
1995
2000
2002
2003
2004

Total

541,913

687,033

737,912

762,672

784,538

Held In Jail

507,044

621,149

665,475

691,301

713,990

34,869

65,884

72,437

71,371

70,548

Supervised outside of jail
facilitya

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Confinement Status and
Type of Program
Weekender programs
Electronic monitoring
Home detentionb
Day reporting
Community service
Other pretrial supervision
Other work programsc
Treatment programsd
Other/uspecified

Number of Persons Under Jail Supervision
1995
2000
2002
2003
2004
1,909
14,523
17,955
12,111
11,589
6,788
10,782
9,706
12,678
11,689
1,376
332
1,037
594
1,173
1,283
3,969
5,010
7,965
6,627
10,253
13,592
13,918
17,102
13,171
3,229
6,279
8,702
11,452
14,370
9,144
8,011
5,190
4,498
7,208
NA
5,714
1,256
1,891
2,208
887
2,682
9,663
3,080
2,513

NOTE: NA, not available.
a
Excludes persons supervised by a probation or parole agency.
b
Includes only those without electronic monitoring.
c
Includes persons in work-release programs, work gangs, and other work alternative programs.
d
Includes persons under drug, alcohol, mental health, and other medical treatment.
SOURCE: BJS, 2005c.

Why Has the Prisoner Population Grown?
The exponential growth of prison and jail populations in the last two
decades has many causes. Some relate to changes in federal and state
sentencing policies, and some reflect the actions of American society in
those years as it engaged in a war against drugs. BJS reports that, in
1997, 21 percent of state prisoners and more than 60 percent of federal
prisoners were incarcerated for drug offenses (BJS, 1999c). Between
1995 and 2003, 49 percent of the total growth in the federal prison population was from drug offenses (BJS, 2005a). Michael Jacobson, former
Commissioner of the New York City Departments of Correction and
Probation, argues in his book, Downsizing Prisons (2005), that mandatory minimum sentencing, parole agencies intent on sending people back
to prison, three strike laws (defined below), for-profit prisons, and other
changes in the legal system have contributed to the spectacular rise of the
general prison population. The Sentencing Project came to the same conclusion, stating that rigid sentencing formulas such as mandatory sentencing and truth in sentencing often result in lengthy incarceration (TSP,
2001). According to Human Rights Watch (2003), the U.S. rate of incarceration soared to the highest in the world for the reasons stated previously: “Championed as protecting the public from serious and violent
offenders, the new criminal justice policies in fact yielded high rates of
confinement for nonviolent offenders. Nationwide, nonviolent offenders
account for 72 percent of all new state prison admissions.”

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Three strikes laws impose mandatory life terms or extremely long
prison terms without parole for criminals who have been convicted of
three felonies involving violence, rape, use of a deadly weapon, or molestation. In some states, such as California, the third felony does not
have to be a violent crime. California's three-strikes law is considered the
toughest in the country, because it can be invoked when a third felony
conviction is for a nonviolent crime -- even one that could have been
charged as a misdemeanor if the prosecutor had wanted to [JPI, 2004,
TSP, 2001].) Nationally, half of the states have enacted some form of
three strikes legislation, but only a handful have convicted more than 100
individuals using the statute, led by a wide margin by California, according to The Justice Policy Institute and The Sentencing Project (JPI, 2004,
TSP, 2001). “As of mid 1998, only California (40,511 individuals),
Georgia (942), South Carolina (825), Nevada (304), Washington, (121),
and Florida (116) had been using the ‘three strikes’ legislation to any
significant extent” (TSP, 2001, Pg. 3). Moving into 2004, three strikes
was most heavily used in three states, with 42,322 persons incarcerated
under the three-strikes law in California, 7,631 in Georgia, and 1,628 in
Florida (JPI, 2004).
Reported rates of recidivism for adult offenders in the United States
are extraordinarily high, as noted in a report by the Open Society Institute (OSI [1997]): “The national re-arrest rate is around 63 percent and
the re-imprisonment rate averages around 41%.” Among probationers
and parolees, recidivism is lower but still occurs. In 2003, 16 percent of
probationers were incarcerated because of a rule violation or a new offense (BJS, 2004b). That same year, 38 percent of parolees were incarcerated because of violations of parole conditions (26 percent) or
committing a new crime (11 percent [BJS, 2004b]). Parole officers are
spending more time on policing whether conditions are violated (with
more drug tests, more tracking of movement, etc.) and less on promoting
re-integration (Petersilia, 2000).
Finally, admissions to state and federal prisons are outpacing releases (BJS, 2005c). There was also a large increase in parole violators
returning to prison between 1990 and 1998. The number of returned parole violators increased 54 percent between 1990 and 1998 (from
133,870 to 206,152) and has since slowed to a 2 percent annual increase
(BJS, 2005a,c).

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Who Is in Prison and Jail?
Men far outnumber women in prisons and jails. Men make up 93
percent of all inmates (BJS, 2005a). At year-end 2004, 104,848 women
and 1,391,781 men were in state or federal prisons. The female prisoner
population has been rising at a faster rate than the male prisoner population (Table 2-3). The overall increase since 1995 for male prisoners is 32
percent and for female prisoners, 53 percent (BJS, 2005a).
More women are entering the correctional system Between 1980
and 1998, the number of female inmates under the jurisdiction of federal
and state correctional authorities increased more than 500 percent, from
about 13,400 in 1980 to roughly 84,400 at year-end 1998, according to
the U.S. General Accounting Office ([GAO] 1999). In 2004 (BJS,
2005a), that number had risen to 104,848 (Table 2-3). A large percentage
of these women (85 percent) were on parole or probation (BJS, 1999b).
Within jails specifically (Table 2-4), between 1990 and 2004, the
female inmate population grew 134 percent, whereas the male inmate
population grew by 70 percent.
TABLE 2-3 Prisoners Under the Jurisdiction of State or Federal Correctional
Authorities, by Gender, 1995, 2003, and 2004
Variable
Men
Women
All inmates
1995
1,057,406
68,468
2003
1,363,813
100,384
2004
1,391,781
104,848
Average annual change, 1995-2004
3.1%
4.8%
Sentenced to > 1 year
2003
1,315,790
92,571
2004
1,337,668
96,125
Percent change, 2003-2004
1.7%
3.8%
Incarceration rate
1995
789
47
2004
920
64
a
Total number of prisoners with a sentence of more than 1 year per 100,000 U.S. residents on December 31.
SOURCE: BJS, 2005a.

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TABLE 2-4 Jail Populations by Gender, 1990-2004 (1-Day Count)
Year
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004

Adult Males
365,821
384,628
401,106
411,500
431,300
448,000
454,700
498,678
520,581
528,998
543,120
551,007
581,411
602,781
619,908

Adult Females
37,190
39,501
40,674
44,100
48,500
51,300
55,700
59,296
63,791
67,487
70,414
72,621
76,817
81,650
86,999

SOURCE: BJS, 2005e.

Not only is the female population becoming larger, but it is also becoming more diverse. Increasingly, incarcerated women are older and
more likely minority and drug abusers than earlier populations of women
prisoners (BJS, 2005a; GAO, 1999, 2000).
In “Gender-Responsive Strategies for Women Offenders” (2005), the
National Institute of Corrections (NIC) staff characterize women in the
criminal justice system: “Women offenders typically have low incomes
and are undereducated and unskilled. They have sporadic employment
histories and are disproportionately women of color. They are less likely
than men to have committed violent offenses and more likely to have
been convicted of crimes involving drugs or property. Often, their property offenses are economically driven, motivated by poverty and by the
abuse of alcohol and other drugs.” Women prisoners in general have
poorer health than men, with higher rates of mental illness(BJS 1999a)
and HIV infection (BJS 1999b). Women prisoners also are more likely to
report medical problems after admission than men (BJS, 2001b). These
data and the rising rates of incarceration among women make health
care for women in prison a pressing issue (Young and Reviere, 2001).
Women offenders have needs that are different from those of men,
stemming in part from their disproportionate victimization from sexual
and physical abuse and their responsibility for children, according to the
authors of “Women Offenders: Programming Needs and Promising Ap-

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proaches” (BJS, 1998b). In an American Journal of Public Health editorial, Braithwaite et al. (2005) noted that the diverse needs of women are
forgotten and neglected in the criminal justice system. Medical concerns
that relate to reproductive health and to the psychosocial matters that surround imprisonment of single female heads of households are often overlooked. The authors state that “women in prison complain of a lack of
regular gynecological and breast examinations and say their medical
concerns are often dismissed.” They also note the poor physical health of
women as they enter the correctional system, with higher than average
risk for high-risk pregnancies, HIV/AIDS, hepatitis C, and human papillomavirus infection, a risk factor for cervical cancer. Nearly 6 in 10
women in state prisons had experienced physical or sexual abuse in the
past (BJS, 1999b).
In a survey of prisoners in
“Women have more severe substance-abuse
New Jersey (Blitz et al, 2005), histories by the time they come to the attention
researchers found that women of the criminal-justice system,” said Nena P.
were more likely to be classi- Messina, Ph.D., a criminologist at University
fied as special needs inmates of California, Los Angeles Integrated Substance Abuse Programs. “That means they are
(those with behavioral health using drugs on a daily basis. They are more
disorders) than men (37 per- likely to be injecting drugs, using multiple
cent vs. 16 percent). An active drugs, and trading sex for drugs and money.
addiction disorder was present Their histories and their paths to substance
in one-half to three-quarters of abuse and crime are very different than
men’s.” Dr. Messina described her experience
women with behavioral health with women prisoners at the July 2005 meetdisorders. National data col- ing of this IOM committee.
lected by the BJS in 1998, also
showed more women than men (20 percent vs. 16 percent) are diagnosed
with mental disorders (BJS, 1999a).
Although substance abuse is common, drug rehabilitation programs
are not common in these institutions (Braithwaite et al., 2005). Consequently, when women prisoners are released, they are at high risk of falling back into addiction with exposure to the environmental pressures
that led them there in the first place.
Women are also more likely than men to be solely responsible for
their children. Two-thirds of incarcerated women have children younger
than 18 years (BJS, 1999b). Approximately 1.3 million children in the
United States have mothers under correctional supervision (Table 2-5).
Just under a quarter million children have mothers who are serving time
in prison or jail (BJS, 1999b).

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Racial and ethnic disparities Blacks and Hispanics are disproportionately represented in prison and jail populations. At midyear 2004, an estimated 12.6 percent of all black males in their late 20s were in prisons or
jails compared with 3.6 percent of Hispanic males and 1.7 percent of
white males (BJS, 2005c ). Young black men are particularly hit hard.
One in eight black men in their late 20s is incarcerated on any given day
(Mauer & King, 2004). A report of the National Center on Institutions
and Alternatives (Lotke, 1997) indicated that in the District of Columbia,
50 percent of young black men ages 18 to 35 were under criminal justice
supervision (in prison, jail, probation, parole, out on bond, or being
sought on a warrant). Table 2-6 shows jail incarceration rates by race and
ethnicity from 1990 through 2004.
TABLE 2-5 Children of Women Under Correctional Supervision, 1998
Variable
Total
Probation
Jail
State prisons
Federal prisons

Women
Offenders
869,600
721,400
63,800
75,200
9,200

Women Offenders
with Minor Children
615,500
516,200
44,700
49,200
5,400

Minor Children
1,300,800
1,067,200
105,300
117,100
11,200

NOTE: Only children under age 18 are counted.
SOURCE: BJS, 1999b.

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TABLE 2-6 Jail Incarceration Rates by Race and Ethnicity, 1990-2004a
Year
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004

White
Non-Hispanic
89
92
93
94
98
104
111
117
125
127
132
138
147
151
160

Black
Non-Hispanic
560
594
618
633
656
670
640
706
716
730
736
703
740
748
765

Hispanic
of Any Race
245
247
251
262
274
263
276
293
292
288
280
263
256
269
262

NOTE: U.S. resident population estimates for sex, race, and Hispanic origin were made
using a U.S. Census Bureau Internet release, December 23, 1999, with adjustments for
census undercount. Estimates for 2000-2004 are based on the 2000 Census and then estimated for July 1 of each year.
a
Per 100,000 U.S. residents.
SOURCE: BJS, 2005a

Educational level and reading skills of prisoners Often individuals
come into the correctional system with little education and, therefore,
poor reading, writing, math, and oral communication skills (Haigler et al,
1994; Spangenberg, 2004). Poor reading and communication skills pose
a challenge to informed consent, which is often handled through written
documents, and points to the importance of ensuring that informed consent procedures are monitored to determine that prisoners truly understand what they are consenting to. The BJS (2003b) reported on the poor
education level of prisoners. Forty-one percent of inmates in the nation’s
state and federal prisons and local jails and 31 percent of probationers
had not completed high school or its equivalent (Table 2-7). In comparison, 18 percent of the general population age 18 or older had not finished
Grade 12. Minority prisoners had lower education levels than whites (53
percent of Hispanics, 44 percent of blacks, and 27 percent of whites had
no diploma or general equivalency diploma). The same report indicates
that less educated prisoners were less likely to have jobs before they en-

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tered prison and more likely to have a prior sentence, to be sentenced as
juveniles, and to return to prison after release.
Prisoners tend to leave the system poorly educated as well. According to a 1997 report by the Open Society Institute (OSI), “Education As
Crime Prevention: Providing Education to Prisoners,” in the shift from
rehabilitation to punishment and the exponential population growth, educational and vocational programs, which, OSI notes, correlate positively
with the ability to remain out of prison, have been substantially reduced.
Despite evidence supporting the connection between higher education
and lowered levels of recidivism, the Violent Crime Control and Law
Enforcement Act of 1994 ended access to federal Pell Grants for undergraduate education to all prisoners. At least 25 states cut back on vocational and technical training programs since the Pell Grants were cut. In
1990, there were 350 higher education programs for inmates; by 1997,
only 8.
Eight in 10 state prisons offer basic education and high school
courses (BJS, 2003b). Fewer than one in three offer college classes. College, vocational, and high school courses are most common in federal
prisons and least common in private prisons. For example, college
courses are offered by 80 percent of federal prisons and 27 percent of
private prisons. However, less than 20 percent of prisoners participated
in college courses while incarcerated; this percentage dropped between
1991 and 1997 (Table 2-8). Vocational courses are more popular, taken
by about one in three inmates in state and federal prisons.
TABLE 2-7 Educational Attainment for Correctional Populations and
the General Population, 1997
Education
≤ Some high
school (%)
GED (5)
High school
diploma (%)
Postsecondary
(%)

Total
Incarcerated
41.3

Prison Inmates
State
Federal
39.7
26.5

Local
General
Jail
Probation Population
46.5
30.6
18.4

23.4
22.6

28.5
20.5

22.7
27.0

14.1
25.9

11.0
34.8

NA
33.2

12.7

11/4

23/9

13.9

23.6

48.4

NOTE: GED, general equivalency diploma; NA, not available; Gen. Pop., general population.
SOURCE: BJS, 2003b.

NOTE: Detail may not add to total because of rounding or inmates’ participation in more than one program.
NA, not available; GED, general equivalency diploma; ESOL, English speakers of other languages.
SOURCE: BJS, 2003b.

TABLE 2-8 Participation in Educational Programs Since Most Recent Incarceration or Sentence, for State
And Federal Prison Inmates, 1997 and 1991, for Local Jail Inmates, 1996, and for Probationers, 1995
Local Jail
State
Federal
Inmates Probationers
Variable
1991
1997
1991
1997
1996
1995
Educational programs
Total (%)
56.6
51.9
67.0
56.4
14.1
22.9
Basic
5.3
3.1
10.4
1.9
0.8
0.4
GED/high school
27.3
23.4
27.3
23.0
8.6
7.8
College courses
13.9
9.9
19.9
12.9
1.0
6.1
ESOL
NA
1.2
NA
5.7
NA
NA
Vocational
31.2
32.2
29.4
31.0
4.8
7.0
Other
2.6
2.6
8.4
5.6
2.1
3.4
Number of inmates
709,042
1,046,136
53,753
87,624 501,159
2,055,942

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Age of inmates The U.S. prison population is aging (BJS, 2004d). By
year end 2003, 28 percent of all inmates were ages 40 to 54 (up from 22
percent in 1995). Inmates age 55 and older have experienced the largest
percent change—an increase of 85 percent since 1995. However, they
are still a small group, relative to inmates in other age groups, accounting
for 4.3 percent of all inmates in 2003, up from 3.0 percent in 1995 (BJS,
2004d; TSP, 2005b). According to The Sentencing Project, California’s
three strikes law contributed to a rapid aging of the California prison
population in the first 7 years since it was instituted (King & Mauer,
2001). The authors projected that, in 2026, 30,000 three strikes prisoners
will be serving sentences of 25 years to life. In California, new felony
admissions of prisoners older than 40 increased from 15.3 percent in
1994 to 23.1 percent in 1999.
A survey by The New York Times (Liptak, 2005) found that 132,000
of the nation’s prisoners are serving life sentences. The number of “lifers” has almost doubled in the last decade, far outpacing the overall
growth of the prison population. About one-third of the lifers sentenced
between 1988 and 2001 are serving time for crimes other than murder,
including burglary and drug crimes. Fewer lifers have a chance of parole.
In 1993, The New York Times survey found that about 20 percent of lifers
had no chance of parole. In 2004, that number rose to 28 percent. As a
result, the United States has a large and permanent population of prisoners who will die of old age behind bars. According to The Sentencing
Project (Mauer et al, 2004), the increase in life sentences reflects changes
in state policies, not continuous increases in violent crimes.
These figures on the graying of the prison population indicate that a
small, but growing segment of today’s prisoners face chronic diseases,
such as diabetes and heart disease.
Health Status of Inmates
A highly disproportionate number of inmates suffer from infectious
diseases, chronic diseases, and mental illness compared with the rest of
the nation’s population. According to a 3-year study requested by Congress and delivered in May 2002 by the National Commission on Correctional Health Care (“The Health Status of Soon-to-Be-Released
Inmates”), tens of thousands of inmates are being released into the community every year with undiagnosed or untreated communicable disease,
chronic disease, addiction, and mental illness (NCCHC, 2002, page 4).

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The report paints a picture of a large and concentrated population at high
risk for communicable and chronic diseases.
Communicable diseases During 1996, about 3 percent of the U.S.
population spent time in a prison or jail; however, between 12 and 35
percent of the total number of people with certain communicable diseases in the nation passed through a correctional facility during that same
year (NCCHC, 2002). There were an estimated 107,000 to 137,000 cases
of sexually transmitted diseases (STDs) among inmates in 1997 and at
least 465,000 STD cases among releasees.
Hepatitis Hepatitis B and C are viral diseases that attack the liver.
Both can cause lifelong infection, cirrhosis of the liver, cancer, liver failure, and death (BJS, 2004a; NIH, 2002). Both viruses are spread through
infected blood, most commonly via shared needles used to inject illegal
drugs and through sexual contact. Nearly 2 percent of the U.S. population is chronically infected with hepatitis C virus (Hammett et al., 2002),
while studies in prison populations in California, Virginia, Connecticut,
Maryland, and Texas have found evidence of hepatitis C infection in 29
to 42 percent of prisoners (CDC, 2002). Across the country, hepatitis C
infection rates for prisoners are estimated at 15 to 30 percent. Between
1.3 and 1.4 million prisoners released from prison or jail in 1996 were
infected with hepatitis C (NCCHC, 2002). The prevalence of hepatitis B
infection among incarcerated individuals has been reported to range from
8 to 43 percent (Khan, et al., 2005), while the rate in the U.S.population
as a whole is 4.9 percent. In a state correctional facility in Georgia (housing up to 1340 male inmates, one third of whom are transferred or released each year), and within Rhode Island’s prison system, there was a
high prevalence of hepatitis B, and a high rate of ongoing HBV transmission (Khan, 2005).
Antiviral therapies for chronic hepatitis B and C are complicated,
have limited effectiveness, and are not appropriate for everyone (CDC,
2002). Hepatitis B vaccination is recommended for incarcerated individuals (CDC, 2003). Although vaccination is offered to some inmate
populations in state and federal correctional settings, universal immunization is not common (Khan et al., 2005).
HIV/AIDS At year-end 2003, 23,659 inmates in state and federal
prisons were known to be infected with HIV (BJS, 2005d). Female prisoners were more likely to be HIV positive than male prisoners. Overall,

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1.9 percent of male inmates and 2.8 percent of all female inmates were
known to be HIV positive. In two states, more than 10 percent of the female inmate population was HIV positive (New York State: 14.6 percent; Maryland: 11.1 percent).
The overall rate of confirmed AIDS cases among the prison population (0.51 percent) was more than three times the rate in the U.S. general
population (0.15 percent). In 2002 the percentage of deaths from AIDS
was more than two times higher in the prison population than in the U.S.
general population among individuals ages 15 to 54 years. About 1 in
every 11 prisoner deaths were attributable to AIDS-related causes compared with 1 in 23 deaths in the general population. AIDS is the second
leading cause of death in prisons (BJS, 2003d).
Tuberculosis Tuberculosis (TB) is an airborne disease that thrives
among people who live in close quarters (Restum, 2005). About 12,000
people who had active TB during 1996 served time in a correctional facility during that year (NCCHC, 2002). More than 130,000 inmates
tested positive for latent TB infection in 1997. An estimated 566,000 inmates with latent TB infection were released in 1996. More recent data
(MacNeil, et al., 2005) indicate that TB rates remain higher in prison systems than in the general population, and that prisoners with TB are less
likely than noninmates to complete treatment. From 1993 to 2003, the
percentage of TB cases among local jail inmates increased from 42.8% to
53.5%. Cases among federal inmates increased from 2.9% to 11.8%. Inmates with TB were more likely to be co-infected with HIV, than noninmates with TB. Outbreaks of multi-drug resistant TB related to HIV
coinfection have been documented in correctional facilities. The authors
note: “correctional systems, especially jails, offer distinct logistical obstacles to screening and treatment; inmates are moved frequently or are
released, making evaluation and completion of therapy difficult at best.”
Chronic diseases The National Commission on Correctional Health
Care report (NCCHC, 2002) provided 1995 prevalence estimates for certain chronic diseases among federal, state, and local inmates: Asthma
was estimated at 8 to 9 percent, diabetes at 5 percent, and hypertension at
18 percent. Figures on federal prisoners alone (BJS, 2001b) are somewhat lower: asthma at about 4 percent, diabetes at 4 percent, and hypertension at 8 percent. BJS (2001b) noted that inmate self-reported data
may underestimate the prevalence of some medical conditions, especially
those problems that require more sophisticated diagnosis and those that

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are more sensitive in nature. For many conditions, inmate self-reports are
the only source of information.
Most state prison systems lack comprehensive and accessible data on
the health status of their prisoners. A 1998 inventory of state and federal
correctional information systems found that 20 states had electronic information systems that could identify offenders with physical disabilities
at admission, 22 had systems that could identify inmates with mental or
emotional problems, and 22 could identify inmates with specialized
medical conditions. Eighteen states had this information electronically on
current medical conditions for more than 75 percent of their inmates
(BJS, 1998c).
Mental illness “Prisons are the largest mental health institutions in our
country,” stated Darrel A. Reiger, M.D., M.P.H., deputy medical director
of the American Psychiatric Association, in his October 19, 2005, remarks to the committee. More than a quarter million mentally ill individuals were incarcerated in a prison or jail at midyear 1998 (BJS,
1999a). In 1998, more than 179,000 offenders in state prisons, 7,900 in
federal prisons, 96,700 in local jails, and almost 548,000 probationers
were identified as mentally ill (Table 2-9). In this BJS survey, prisoners
were counted as mentally ill if they answered “yes” to either of two questions, “Do you have a mental or emotional condition?” or “Because of
emotional or mental condition, have you ever been admitted to a mental
hospital, unit, or treatment program where you stayed overnight?” Mental illness is identified more often in women and whites, and the incidence increases with age. Mentally ill prisoners tend to serve longer
sentences and experience more disciplinary problems while in prison. In
addition, approximately 75 percent of people with serious mental illnesses in the criminal justice system have a co-occurring substance abuse
disorder (NFCMH, 2004).
Anxiety disorders and major depression were the most common
mental illness diagnoses in jails and state prisons (Table 2-10). The
prevalence of mental illnesses appears to rise when moving from local
jails to state prisons.

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TABLE 2-9 Inmates and Probationers Identified as Mentally Ill, by
Gender, Race/Hispanic Origin, and Age, Midyear 1998

Offender
Characteristic
Total
Gender (%)
Male
Female
Race/Hispanic
Orgin (%)
Whitea
Black a
Hispanic
Age (%)
24 or younger
25-34
35-44
45-54
55 or older

Inmates
179,200

State
Inmates
7,900

Federal
Inmates
96,700

Jail
Probationers
547,800

15.8
23.6

7.0
12.5

15.6
22.7

14.7
21.7

22.6
13.5
11.0

11.8
5.6
4.1

21.7
13.7
11.1

19.6
10.4
9.0

14.4
14.8
18.4
19.7
15.6

6.6
5.9
7.5
10.3
8.9

13.3
15.7
19.3
22.7
20.4

13.8
13.8
19.8
21.1
16.0

Excludes Hispanics.
SOURCE: BJS, 1999a.

TABLE 2-10 Estimated Prevalence of Mental Illness, 1999
Illness
Schizophrenia
Major depression
Bipolar disorder
Dysthymia
Anxiety disorder
Posttraumatic stress disorder

Jail Inmates (%(
1
8-15
1-3
2-5
14-20
4-9

State Prison
Inmates (%)
2-4
13-19
2-5
8-14
22-30
6-12

SOURCE: NCCHC, 2002.

Six in 10 mentally ill prisoners received treatment while incarcerated
in a state or federal prison. Only 4 in 10 in local jails received treatment
(BJS, 1999a). Women were more likely than men to receive mental
health services while incarcerated (Table 2.11). Whites were more likely
than blacks and Hispanics to receive mental health services (NFCMH,
2004). Mental health treatment is lacking for probationers and parolees
as well. In 1998, probationers serving their current sentence had less exposure to mental health treatment compared with confined prisoners.

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Specifically, mentally ill probationers were less likely than state and federal prisoners to have taken a psychiatric medication, to have received
any mental health service, or to have been hospitalized for their condition, although they were just as likely to have received counseling or
therapy (BJS, 1999a). Furthermore, less than half of the probationers (43
percent) who were required to engage in mental health treatment had actually participated (BJS, 1999a).
Human Rights Watch (2003) has called prison mental health services
“woefully deficient.” Too often, they state, seriously ill prisoners are neglected, accused of malingering, or treated as disciplinary problems.
Without the necessary care, mentally ill prisoners suffer painful
symptoms and their conditions can deteriorate. They are afflicted
with delusions and hallucinations, debilitating fears, extreme and
uncontrollable mood swings. They huddle silently in their cells,
mumble incoherently, or yell incessantly. They refuse to obey
orders or lash out without apparent provocation. They beat their
heads against cell walls, smear themselves with feces, selfmutilate, and commit suicide. Prisons were never intended as facilities for the mentally ill, yet that is one of their primary roles
today. Many of the men and women who cannot get mental
health treatment in the community are swept into the criminal
justice system after they commit a crime. In the United States,
there are three times more mentally ill people in prisons than in
mental health hospitals, and prisoners have rates of mental illness that are two to four times greater than the rates of members
of the general public.
TABLE 2-11 Percent of Mentally Ill Receiving Mental Health Services
While Incarcerated, 1998
Variable
Gender (5)
Male
Female
Race/ethnicity (%)
White
Black
Hispanic

State Prison

Federal Prison

Local Jail

59.9
67.3

57.4
76.5

38.4
56.2

64.1
56.4
59.9

65.4
50.0
62.5

44.7
34.2
40.6

SOURCE: BJS, 1999a.

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Substance abuse Drug and alcohol use and abuse play major roles in
the lives of prisoners. Overall, three of four state prisoners and four of
five federal prisoners are characterized as alcohol- or drug-involved offenders, according to a BJS report (BJS, 1999c). A history of drug and
alcohol use and abuse was also common among probationers and parolees. In 1995, a U.S. Department of Justice survey found that 70 percent
of probationers reported drug use in the past, 32 percent during the
month before the crime, and 14 percent at the time of the crime (BJS,
1998a). A large number of parolees were also involved with drugs and
alcohol. In 1991, more than half of parolees (54 percent) had used drugs
in the month preceding their most recent crime, and 41 percent reported
daily use during the same time period (BJS, 1995).
Injury, violence, rape, and suicide Prisoners face violence and injury
within correctional settings. More than one-quarter of state and federal
inmates reported being injured since admission to prison (Table 2-12).
The likelihood of injury increases with time served in prison, as does the
likelihood of a medical problem (Table 2-13).
In 2000, there were 34,355 assaults by state and federal prisoners
against other inmates, and 51 prisoners died as a result of those violent
actions (BJS, 2003d). These numbers do not capture assaults against officers and others who work in the nation’s jails.
In 1999, nearly 22 percent of state inmates had a history of being injured while in prison (BJS, 2001b). Overall, 7 percent of state inmates
were injured in a fight while in prison.
According to the 2003 Prison Rape Elimination Act,2 more than 1
million people have been sexually assaulted in prisons over the past 20
years. The act also describes the devastating effects of sexual assault in
this context: an increase in other types of violence, including murder,
involving inmates and staff, and long-lasting trauma, which makes it
even more difficult for people to succeed in the community after release.

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TABLE 2-12 Reason for Injury During Incarceration, 1999

Injury
Assult/fight
Assidental, total
Occupational
Recreational
Accidental, otherb

Number
3,134
25,975
6,844
11,141
7,859

Percenta
2.7
22.1
5.8
9.5
6.7

Percentages are based on the average daily population. If they were based on the total
who had spent any time in prison in 1999, they would be lower.
b
U.S. Bureau of Prisons distinguishes occupational and recreational injuries from accidental injuries.
SOURCE: BJS, 2001b.

TABLE 2-13 Likelihood of Injury Based on Time in Prison, 1999
Time Since Admission
Less than 12 months
12-23 months
24-47 months
48-71 months
72 months or more

Injured (%)
13.2
19.8
26.7
36.8
45.9

Medical Problem
(Excluding Injury) (%)
15.8
19.1
20.4
20.3
30.4

SOURCE: BJS, 2001b.

In 2005, the BJS completed the first-ever national survey of administrative records on sexual violence in adult and juvenile correctional facilities (BJS, 2005b). This covers only reported incidents and thus
provides just a partial picture. The survey included 2,700 adult and juvenile facilities. Nationwide in 2004, 8,210 allegations of sexual violence
were reported: 42 percent of allegations involved staff sexual misconduct; 37 percent, inmate-on-inmate nonconsensual sexual acts; 11 percent, staff sexual harassment; and 10 percent, abusive sexual contact.
Correctional authorities reported 3.15 allegations of sexual violence per
1,000 inmates held in 2004. Males comprised 90 percent of victims and
perpetrators of inmate-on-inmate nonconsensual sexual acts in prison and
jail.

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Where Are Prisoners Incarcerated and How Are They Provided
Services?
Since 1995, the federal system has grown at a much faster rate than
state systems, peaking at 6 percent growth in the first 6 months of 1999
(BJS, 2005a). In 2004, the number of federal inmates increased 4.2 percent, more than twice the rate of state growth (1.6 percent). In 2004, private facilities held 6.6 percent of all state and federal inmates. However,
six states, all in the West, had at least one-quarter of their prisoners in
private facilities (BJS, 2005a). This does not account for the much larger
population of prisoners on probation and parole and those who can be
found in a wide variety of “alternative-to-incarceration” or community
settings (see Tables 4-1 and 4-2).
Dislocation of inmates from local to distant jurisdictions Many
states are outsourcing their prisoners to other state institutions away from
urban areas and to a growing for-profit correctional business. In October
1999, according to a GAO (1999) report, about 30 percent of female inmates and 24 percent of male inmates in federal prisons were assigned to
facilities more than 500 miles from their release residences. In situations
in which prisoners are housed great distances from their homes, prisoners
can lose total contact with their families. Because 64 percent of federal
inmates have minor children, this is a great hardship for them and a burden for their children (BJS, 2000b). Schafer (1994) conducted a survey
of visitors to two men’s prisons and found that maintenance of family
ties during incarceration is significantly related to successful completion
of parole.
Increased use of isolation in punishment of inmates The United
States has more than 60 supermaximum confinement facilities, housing
well over 20,000 people (NIC, 1997). Rhodes (2005) describes the fortress-like facilities that force complete isolation and says that U.S. reliance on isolation is due to many factors, including political pressure for
harsh sentencing, population pressure inside prison systems, and the internal architectural and staffing features of general population units. A
study in Washington State (Lovell et al., 2000), which provides mediumand maximum-security psychiatric facilities, noted that the number of
mentally ill inmates far exceeds available beds. As a consequence, some
disturbed prisoners are held in supermaximum units. They found that 20

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to 25 percent of supermaximum inmates showed strong evidence of mental illness.
Human Rights Watch (HRW, 2000) described life in isolation in supermaximum confinement in its 2000 report, Out of Sight: SuperMaximum Security Confinement in the United States:
Prisoners in [supermaximum] facilities typically spend their
waking and sleeping hours locked in small, sometimes windowless, cells sealed with solid steel doors. A few times a week they
are let out for showers and solitary exercise in a small, enclosed
space. Supermax prisoners have almost no access to educational
or recreational activities or other sources of mental stimulation
and are usually handcuffed, shackled and escorted by two or
three correctional officers every time they leave their cells. Assignment to supermax housing is usually for an indefinite period
that may continue for years. Although supermax facilities are ostensibly designed to house incorrigibly violent or dangerous inmates, many of the inmates confined in them do not meet those
criteria.
Quality of health care provided The U.S. Supreme Court ruled in
Estelle v. Gamble (429 U.S. § 97 [1976]) that “deliberate indifference to
serious medical needs of prisoners constitutes the ‘unnecessary and wanton infliction of pain’ proscribed by the Eighth Amendment.” The court
in Estelle v. Gamble made clear, however, that a right to adequate medical care did not mean that “prisoners will have unqualified access to
health care.”
Coleman et al. (2005) noted that inadequacies of health care in most
correctional settings existed in the 1970s and continue today: “Federal
court decisions have documented continuing and severe health deprivations in many states.”

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Model programs exist, however, NCCHC states that “many correctional agencies are doing too little to address communicable disease,
chronic disease, and mental illness” [NCCHC, 2002, Executive Summary, page xii]. Few prison or
“I have litigated my whole life about health
jail systems have implemented care in prisons, seeing that it needs improvecomprehensive HIV-prevent- ment,” said Jack Beck, director of the Prison
Project at the Correctional Associaion programs in all their facili- Visiting
tion of New York at an October 2005 meeting
ties. About 10 percent of state of the committee. “However, it is an overand federal prisons and 50 per- statement to say that no appropriate health
cent of jails do not adhere to care occurs in prisons throughout the United
CDC standards for screening States. I think there are some places where it
does occur. Is it a minority? Absolutely. But I
and treating latent TB infection think it does occur in some places.” Mr. Beck
and active disease. Most pris- is a member of the committee’s Prisoner Liaions and jails fail to conform to son Panel.
nationally accepted health care guidelines for mental health screening
and treatment. Finally, of 41 state correctional systems responding to a
survey conducted for the NCCHC report, just over half (24) reported
having protocols for diabetes, 25 for hypertension, and 26 for asthma.
In July 2005, a federal judge ordered that a receiver take control of
California’s prison health care system and correct what he called deplorable conditions that led to 64 unnecessary inmate deaths each year because of poor medical care (see Box 2-1). California houses
approximately 164,000 inmates at 33 state prisons. The state expects to
spend $1.1 billion on prison health care this year (Sterngold, 2005, July
1). Many U.S. state systems have been sued over the quality of their
health care (Metzner, 2002; Sturm, 1993).
Health care for profit does not always offer a better alternative, according to a blistering series published in 2005 in The New York Times.
The entry of Prison Health Services at Rikers Island in January 2001
made New York State’s jail system the largest in the nation to entrust its
health care to a commercial enterprise (Von Zielbauer, 2005b). Since
then, state regulators have faulted Prison Health Services in several
deaths (Von Zielbauer, 2005d).

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BOX 2-1
California Prison Systems Medical Care System in Receivership
By all accounts, the California prison medical care system is broken
beyond repair. The harm already done in this care to California’s prison
inmate population could not be more grave, and the threat of future injury
and death is virtually guaranteed in the absence of drastic action. The
Court has given defendants every reasonable opportunity to bring its
prison medical system up to constitutional standards, and it is beyond
reasonable dispute that the State has failed. Indeed, it is an uncontested
fact that, on average, an inmate in one of California’s prisons needlessly
dies every six to seven days due to constitutional deficiencies in the
CDCR’s (California Department of Corrections and Rehabilitation’s)
medical delivery system. This statistic, awful as it is, barely provides a
window into the waste of human life occurring behind California’s prison
walls due to the gross failures of the medical delivery system.
It is clear to the Court that this unconscionable degree of suffering and
death is sure to continue if the system is not dramatically overhauled.
Decades of neglecting medical care while vastly expanding the size of
the prison system has led to a state of institutional paralysis. The prison
system is unable to function effectively and suffers a lack of will with respect to prisoner medical care.
SOURCE: Findings of Fact and Conclusions of Law Re Appointment of Receiver,
Marciano Plata, et al. vs. Arnold Schwarzenegger, et al.. U.S. District Court for the
Northern District of California, October 3, 2005, p. 2.

A year-long examination of Prison Health [Services] by The New
York Times reveals repeated instances of medical care that has
been flawed and
“Medical care within the Federal Bureau of
sometimes lethal.
Prisons (FBOP) is symbolic, with minimal expecThe
company’s
tations of improving prisoners’ health,” writes
performance
Daniel S. Murphy, a member of the committee’s
around the nation
prisoner liaison panel who experienced prison
medical care firsthand and then obtained a dochas
provoked
torate degree and completed an in-depth analysis
criticism
from
of medical directives and policies and the realities
judges and sherof medical care (2005). His article contains seviffs, lawsuits from
eral firsthand accounts from prisoners whose
medical needs were not met. He concludes:
inmates’ families
“Many prisoners are condemned to death due to a
and
whistlelack of fundamental medical care.”
blowers, and condemnations by federal, state and local authorities. The company
has paid millions of dollars in fines and settlements. Despite a
tarnished record, Prison Health has sold its promise of lower

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TODAY’S PRISONERS

costs and better care, and become the biggest for-profit company
providing medical care in jails and prisons. It has amassed 86
contracts in 28 states, and now cares for 237,000 inmates, or
about one in every 10 people behind bars. (Von Zielbauer,
2005a, p. 1)
The New York City
“They put you out of the prison at midnight, to
Department
of
save a day of expenses. If you are lucky, you get a
month’s worth of medications, but maybe only 10
Health and Mental
days. Unless you live in Rhode Island, ConnectiHygiene,
which
cut, and maybe Massachusetts, you don’t get disoversees the work
charge planning,” explained David P. Paar, M.D.,
of Prison Public
director, AIDS Care and Clinical Research Program, University of Texas Medical Branch in GalHealth Services Inc.
veston. “They put you out of the prison into
at Rikers Island and
another traumatic situation. ‘Where are my drugs
at a jail in Lower
coming from? Where am I going to get medical
Manhattan, found
care? Who is going to take care of my kids.’ You
that during the first
immediately go back to substance use and you
miss the opportunity to change your life. That is
quarter of 2005,
the linkage between posttraumatic stress disorder,
Prison Health failed
acquisition of blood-borne diseases, prison, and
to earn a passing
recidivism.” Dr. Parr spoke to the committee at its
grade on 12 of 39
July 2005 meeting.
performance standards the city sets for treating jail inmates. Some of the problems, like incomplete medical records or slipshod evaluations of
mentally ill inmates, have been evident since 2004 but have not
been corrected, according to health department reports. The
company did not meet standards on practices ranging from HIV
and diabetes therapy to the timely distribution of medication to
adequately conducting mental health evaluations. (von Zielbauer,
2005c, p. B-1)

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Public health implications of inadequate health care for prisoners
The high recidivism rate in state and federal prisons, poor screening3 and
treatment for prisoners, and inferior follow-up health care on their release are a growing threat to U.S. rates of deadly communicable diseases,
such as HIV/AIDS, hepatitis B and C, and TB (NCCHC, 2002; Restum,
2005). Prisoners are leaving prisons and jails and returning to their communities with a plethora of unaddressed health issues (NCCHC, 2002),
including mental health and substance abuse problems. In 1992, prisoners who were expecting to be released to the community without supervision by 1999 had the following mental health and substance abuse
problems: 14 percent were mentally ill, 25 percent were alcohol dependent, 42 percent reported the use of alcohol at the time of the offense, 59
percent reported drug use in the month before the offense and 45 percent
at the time of the offense, 25 percent reported intravenous drug use in the
past, and 12 percent were homeless when they were arrested (BJS,
2001a).
Mental illness and addiction disorders amplify the difficulties that
prisoners face on release (Pogorzelski et al., 2005). In a study including
adult women returning home from New York City jails (Freudenberg et
al., 2005), annual incomes were well below poverty level, anxiety and
depression increased in the postrelease period (from 15 percent to 25
percent), and rearrest rates were high (39 percent for adult women at 15
months after release). The authors concluded that public policies created
a class of people who are perpetually labeled as unqualified for public
support, limiting or precluding access to health insurance, public housing, and employment opportunities.
History of Research with Prisoners
In 1997, Hornblum detailed the history of prisoners as research subjects in 20th-century America, stating that “from the early years of this
3

For example, 21% of state prison facilities do no testing for hepatitis C (BJS 2004a).
Macalino et al. (2005) argue that following risk-based screening guidelines, such as those
on hepatitis C from the Centers for Disease Control and Prevention may not be enough.
CDC issued recommendations in 2003 to screen all inmates with a history of injection
drug use or other risk factors for hepatitis C. A study in the Rhode Island Department of
Corrections indicated that 66 percent of prisoners who were hepatitis C positive did not
report injection drug use (Macalino et al., 2005) and, therefore, would not have been
screened. Therefore, risk-based testing underestimates hepatitis C virus prevalence in the
correctional setting and is a missed opportunity for diagnosis and prevention of hepatitis
C infection.

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century, the use of prison inmates as raw material for medical experiments became an increasingly valuable component of American scientific research. Postwar American research grew rapidly, as prisoners
became the backbone of a lucrative system predicated on utilitarian interests. Uneducated and financially desperate prisoners “volunteered” for
medical experiments that ranged from tropical and sexually transmitted
diseases to polio, cancer, and chemical warfare.” By the 1960s, new
drug-testing regulations mandated by the Food and Drug Administration
permitted increased human experimentation as large pharmaceutical
companies sought stronger relationships with penal institutions. This article references earlier work by Jessica Mitford (1974), plus reports of
prisoner involvement in studies of treatments for malaria, syphilis vaccines, radiation experiments, and more. In his 1998 book, Acres of Skin:
Human Experiments at Holmesburg Prison, Hornblum details the medical experimentation that went on in one facility, Holmesburg Prison, a
county facility in Philadelphia, which he says became a “supermarket of
investigatory opportunity,” where an array of studies explored everything
from simple detergents and diet drinks to dioxin and chemical warfare
agents. Sponsors included major pharmaceutical houses, RJ Reynolds,
Dow Chemical, and the U.S. Army. From 1962 to 1966, a total of 33
pharmaceutical companies tested 153 experimental drugs at Holmesburg
Prison alone, including Retin-A. After the national commission’s 1976
report, medical research in prisons was sharply curtailed.
Echoes of Tuskegee and Retin-A Attitudes of blacks toward medical
care in general and medical care within the prison system are extremely
complicated and have become even more so since the emergence of
AIDS. In communities of color, among some community members and
advocates there was, and still is a suspicion that AIDS was created in
some form or fashion by sinister forces, either government or otherwise
as a part of a scourge on black persons (Dalton, 1989). This suspicion
was grafted onto an existing and ongoing refusal to participate in research, which is considered in the black communities, as “being used as
guinea pigs.” Much of this is the legacy of Tuskegee and of Retin-A. In
the first, the Tuskegee experiments, black men in Tuskegee, Alabama, in
the 1930s were enrolled in a research project designed and funded by the
U.S. Public Health Service and intended to gather data on the natural
history of syphilis, although the subjects were not told the real purpose.
They were lied to and thought that they were gaining some sort of access
to medical care and to funding for a burial on death. In the years after the

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project’s funding, treatments were developed but were not offered to this
cohort. Indeed, if the men moved from the Tuskegee site they were followed and a nurse was charged with ensuring that they did not gain access to care at another location.
After having been discussed in the scholarly literature for decades,
the study was finally exposed in the popular press The public was horrified by the conduct, planning, and execution of the study. This study,
revealed in 1972 (Jones, 1993), was still alive in the consciousness of
communities of color in the early 1980s when AIDS was identified and
treatments began to be developed. A set of realities then converged: All
treatment for AIDS during the 1980s was under protocols through the
1980s; a disproportionate number of persons of color and inmates had
AIDS because needle sharing was one of the main routes of transmission; the war on drugs placed drug users in prison; and the only available
treatment was provided under the label of research.
Retin-A was developed in Holmesburg Prison in Pennsylvania
(Hornblum, 1998). In these experiments, it appears that prisoners were
not told the possible immediate and long-term consequences of their participation and were not adequately treated for pain and suffering. Paradoxically, however, the AIDS epidemic was the occasion for some
prisoner advocacy groups to contest the categorical restrictions of Subpart C. Inmates told prisoners’ rights groups that they wanted “access to,
not protection from” protocols offering treatments for AIDS. Despite the
fact that these protocols described research and not treatment, they were
sought as the only alternative to certain death. However, even in these
requests, the mix of treatment and research, the lack of quality medical
treatment in general, the history of mistreatment of prisoners in medical
research (such as the Retin-A studies), and the epidemiology of AIDS
made discussions of research in prisons fraught with emotion.
Implications of Demographics for the Ethical Conduct of Research
The limitations on personal freedoms and inadequacies in health care
carry important challenges for the ethical conduct of research involving
prisoners. (A more complete discussion of an ethical framework for research with prisoners is contained in Chapter 5.) Two areas in which the
impact is clear are informed consent and privacy.

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The ability of prisoners to provide ethically adequate informed consent Obtaining informed consent is a challenge due to several factors
discussed in this chapter. Many prisoners have poor reading and communication skills (Spangenberg, 2004; Haigler et al, 1994), yet informed
consent documents are often written for college-level readers (Sharp,
2004). In addition, correctional institutions are closed facilities that are
designed to confine and punish. Medical care is designed to diagnose,
comfort, and cure. These are mutually incompatible purposes from which
flow many of the ethical dilemmas of care and, secondarily, of research
in these settings (Anno, 2001). Over the last three decades, the goal of
rehabilitation has largely been replaced by goals of confinement and punishment. During the same period, despite the Supreme Court’s holding
that a constitutional right to health care exists for prisoners, problems
remain in health care delivery (NCCHC, 2002; Restum, 2005).
When correctional health care services are inadequate, voluntary informed consent becomes a greater challenge (Anno & Dubler, 2001).
The absence of adequate health care arguably creates a coercive influence on prisoners, who may feel compelled to join investigative trials to
access decent medical treatment available only through research protocols. Within correctional settings, the problem of dual loyalty— conflicts
between the ethic of undivided loyalty to patients and pressure to use
clinical methods and judgment for social purposes and on behalf of third
parties—is a particular challenge (PHR, 2003; Bloche 1999). Although
NCCHC standards require an independent medical staff, to the extent
that the medical staff is part of the prison, their role as patient advocates
may be discouraged. For example, prison physicians have been asked to
medicate prisoners to quell physical resistance, to restore competence to
stand trial, or to prepare for execution. Some states have put a stop to
these practices, for example, forbidding psychiatrists from medicating
condemned prisoners to make them competent for execution (Bloche
2006); but some have not.
Barriers to privacy and right to consent or refuse care The sanctity
of the provider-patient relationship, the right to privacy and confidential
care, and the voluntary informed decision whether to consent to or refuse
care can be compromised in correctional settings. Maintaining privacy
can be a monumentally difficult task. Confidential health information
may be surmised from factors as simple as in an inmate’s movement, a
cell search, or a pattern of scheduled visits. It is a given, even in an independent medical service that information that might be relevant to cor-

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rectional officials will be shared for the good of the community, such as
for the purpose of avoiding danger to the inhabitants (Dubler & Sidel,
1989).
It is but just that the public be required to care for the
prisoner, who cannot, by reason of the deprivation of his
liberty, care for himself.
Spicer v. Williamson,
Supreme Court of North Carolina (1926)4
Because of incarceration, the legal context of providing medical,
dental, and mental health services is different in prisons and jails from
that in the outside community. In no other setting are such services constitutionally guaranteed. Drawing upon the prohibition against “cruel and
unusual punishment” in the Eighth Amendment to the Constitution (and
the “Due Process” Clauses of the Fifth and Fourteenth Amendments for
juveniles, pre-trial detainees, and federal prisoners), the courts require
that institutions with custody of human beings provide for their basic
necessities, including health care.
The legal framework was established in the 1976 landmark decision
of Estelle v. Gamble,5 in which the Supreme Court ruled that prisoners
have a right to be free of “deliberate indifference to their serious health
care needs.” In the hundreds of published cases following Estelle, three
basic rights have emerged: the right to access to care, the right to care
that is ordered, and the right to a professional medical judgment. The
failure of correctional officials to honor these rights has resulted in protracted litigation and the issuance of injunctions regarding the delivery of
health care services. (Winner, 19816; Todaro v. Ward7; Martinez v.
Mancusi8; Williams v. Vincent9).
A mentally competent adult has a constitutional right to refuse medical treatment, including the direction that life-saving or other extraordinary measures be withdrawn in terminal cases. (Cruzan v. Missouri

Spicer v. Williamson, 132 E.E. 291, 293 (N.C. 1926).
Estelle v. Gamble, 429 U.S. 97, 97 S.Ct. 285 (19760.
6
Winner, “An Introduction to the Constitutional Law of Prison Medical Care,” 1 J. of
Prison Health 67 (1981).
7
Todaro v. Ward, 431 F.Supp. 1129 (S.D.N.Y.), aff'd, 565 F.2d 48 (2d Cir. 1977).
8
Martinez v. Mancusi, 443 F.2d 1192 (2d Cir. 1970).
9
Williams v. Vincent, 508 F.2d 541, 544-5 (2d Cir. 1974).
5

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Department of Health)10. As Judge Cardozo stated almost 80 years ago:
“Every human being of adult years and sound mind has a right to determine what shall be done with his own body” (Schloendorff v. Society of
New York Hospitals)11. This right extends to prisoners as well (White v.
Napoleon)12. The right to refuse is based on the concept of informed consent:
A prisoner’s right to refuse treatment is useless without
knowledge of the proposed treatment. Prisoners have a
right to such information as is reasonably necessary to
make an informed decision to accept or reject proposed
treatment, as well as a reasonable explanation of the viable alternative treatments that can be made available in
a prison setting.
White v. Napoleon13
The right has never been regarded as absolute, however, (see
Comm’n of Correction v. Myers)14; and it may be over-ridden if there are
strong public health reasons to administer treatment, as when the Supreme Court upheld mandatory smallpox vaccination in 1905, despite the
patient’s religious objections (Jacobson v. Massachusetts)15. Inmates
have been required, for example, to submit to blood and tuberculosis
tests and to diphtheria and tetanus injections (Thompson v. City of Los
Angeles; Zaire v. Dalsheim; Ballard v. Woodard).16 Involuntary administration of anti-psychotic medication has also been upheld when accompanied by appropriate clinical findings and procedural protections for the
inmate patient. (Washington v. Harper).17

Cruzan v. Missouri Department of Health, 497 U.S.261, 110 S.Ct. 2841 (1990).
Schloendorff v. Society of New York Hospitals, 211 N.Y. 125, 129 (1914).
12
White v. Napoleon, 897 F.2d 103 (3d Cir. 1990).
13
White v. Napoleon, 897 F.2d 103, 113 (3d Cir. 1990).
14
Commission of Correction v. Myers, 399 N.E.2d 452 (Mass. 1979).
15
Jacobson v. Massachusetts, 197 U.S. 11 (1905).
16
Thompson v. City of Los Angeles, 885 F.2d 1439 (9th Cir. 1989); Zaire v. Dalsheim,
698 F.Supp. 57 (S.D.N.Y. 1988); Zaire v. Dalsheim, 698 F.Supp. 57 (S.D.N.Y. 1988).
17
Washington v. Harper, 494 U.S. 210, 110 S.Ct. 1028 (1989).
11

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Summary of Findings on Changing Demographics
and Health Issues
1. The correctional population has expanded more than 4.5 fold between 1978 and 2004—from 1.5 million to almost 7 million. Prisons
and jails house 2.1 million prisoner; an additional 4.9 million are on
probation and parole.
2. Distrust of the AIDS/HIV movement in the 1990s within some
minority communities resulted in more skepticism about physicians
and researchers. This means that there is now, compared with the
1970s, a more compelling need for collaboration among all parties
(details on collaborative responsibility are presented in Chapter 5).
3. The graying of the prisoner population, the high number of prisoners with mental illness, and the poor reading and communication
skills among prisoners means that there are now increased concerns
about prisoners’ capability to give informed consent, calling for a
greater focus than before on the informed consent process and validation of prisoner consent to test their comprehension of research
disclosures (see Chapter 6).
4. Because the possibility of poor health care delivery exists in correctional settings, new regulations should include instructions that
IRBs consider the adequacy of health care in considering whether to
approve biomedical protocols in the correctional setting (see Chapter
6).

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CURRENT RESEARCH ENVIRONMENT
Current Status of Prisoner Research
As the committee approached its task of addressing possible ethical
considerations for revisions to the U.S. Department of Health and Human
Services (U.S. DHHS) regulations for the protection of prisoners involved in research, it faced a dearth of information as to the recent and
current landscape of research involving prisoners as participants. There
were no comprehensive reviews18 and no central repository of information about the amount and different types of research involving prisoners.
To better describe the volume and scope of contemporary research with
prisoners, the committee undertook several activities:
1. An extensive survey, conducted by telephone or face-to-face interviews with key personnel from the departments of corrections
(DOC) in four large states (California, Florida, New York, Texas)
and two smaller states (Iowa, Utah). The questions were designed to
reveal policies and procedures that govern research activities in those
organizations and yield estimates of the volume of research activities
over the past 2 years.19
2. A similar survey of somewhat more limited scope conducted by
e-mail with key DOC informants from the remaining 44 states; 42
responded.
3. A review of a random sample of articles published from 1999 to
2005 that involved prisoners as research participants.
The committee also considered several commissioned papers (see
Box A-1). Because of the wide array of research objectives, methodologies, and designs, a brief typology of research was developed to describe
relevant types of research (see Appendix A).

18
Reviews of limited scope were identified and reviewed. See, for example, Tewksbury
and Mustaine (2001).
19
For both surveys the committee confined its efforts to state DOCs. Information on
policies, procedures, and practices related to research in other settings that fit into a
broader definition of prisoner sites (e.g., jails, juvenile justice detention facilities, residential community programs that may serve as alternatives to traditional incarceration or
transitional facilities) was not solicited.

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Results from the Surveys with Key DOC Personnel
This section summarizes key findings from the surveys of key DOC
personnel (from in-depth interviews with personnel from six states plus
e-mail survey responses by 42 additional state DOCs). See Appendix A
for additional details of this survey.
Types of Research Permitted and Research Personnel
1. The vast majority of states permit research that involves administrative records reviews and DOC program evaluations (46 of 48).
2. Social/behavioral studies of a nontherapeutic nature involving
minimal risk designs (e.g., survey, questionnaire, or nonintervention
correlational studies [36 of 48]) are also commonly permitted.
3. Just about half of the states permit social/behavioral studies of a
therapeutic intervention implemented by an outside investigator (i.e.,
not a standing DOC program).
4. Few states permit nontherapeutic social/behavioral studies that
involve greater than minimal risk (5 of 48).
5. Therapeutic biomedical research is permissible in 15 of 48 state
DOCs. Some states prohibit this research by legislation and others by
DOC policy.
6. Three states permit biomedical studies of a nontherapeutic nature.
7. Many research activities (mainly records reviews and program
evaluations) are initiated by in-house staff, according to the six state
DOCs that responded to the more in-depth interviews. Each receives
applications from external investigators as well, most commonly institutions of higher learning (university faculty and graduate students), federal agencies (e.g., National Institute on Drug Abuse), and
private research groups (e.g., Rand Corporation). Given that most
states in this sample prohibit, either by state law or DOC policy,
medical/biomedical studies, pharmaceutical companies were not
commonly mentioned as sources of extramural research applications.
Policies and Procedures for Application Review and Study
Implementation
1. About 30 state DOCs require IRB review before research can
commence. Certain states (e.g., California, Iowa, New York, and

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Utah) only require external IRB review for applications from external investigators.
2. Eighteen state DOCs use an internal IRB for proposal review.
Just five of those include a prisoner or prisoner representative as a
member of the IRB.
3. Financial or other incentives to inmates for research participation
are prohibited by five of the six state DOCs interviewed in depth. In
some cases, this prohibition has been waived on a case-by-case basis.
4. Fewer than half of the states have a procedure in place for reporting adverse events associated with research activity.
Published Literature:
A Survey of Selected Prisoner Studies20,21
Key findings from the literature survey include the following:
1. Locus of research activity: Just over half of the prisoner studies
were conducted in higher security confinement settings, including
jails and prisons (see Figure 2-2). More than one-third occurred in alternatives to incarceration, which included, in order of importance,
juvienile detention centers, probation, residential drug treatment programs, parole, mental health facilities, community corrections, home
confinement, and boot camps.
2. Types of research: Very little research in the published literature
involves medical clinical trials or other biomedical studies (see Figure 2-3). The majority of published studies were minimal risk, nontherapeutic social and behavioral studies (41 percent), DOC program
evaluations (26 percent), administrative records review (21 percent),
or social/behavioral therapeutic studies (6 percent).

20
The committee would like to thank John Weir and James Ray, graduate students at
the University of South Florida, who reviewed the articles and provided the codings on
which these data are based.
21
See Appendix A for a description of the literature selection strategy and additional
findings.

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Boot Camps,
1%

Juvenile Detention
Center,
12%

Other,
10%

Mental Health
Facilities,
4%
Community
Corrections,
Day Treatment
4%
Centers,

Prisons, Jails,
53%

0%
Halfway Houses,
0%

Parole,
4%
Probation,
7%

Home
Residential Drug
Confinement, Treatment,
1%
4%

FIGURE 2-2 Facilities/location of studies

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Medical, Therapeutic, No
Standard of Care,
Medical, Therapeutic,
Biomedical,
1%
Standard of Care Exists,
Nontherapeutic,
2%
1%
Social/Behavioral, Nontherapeutic, Greater than
Minimal Risk,
0%

Social/Behavioral, Nontherapeutic, Minimal Risk,
41%

Other, 2%
Social/Behavioral,
Therapeutic,
6%

Administrative
Records Review,
21%
Department of Corrections
Program Evaluation,
26%

FIGURE 2-3 Type of study (same as FIGURE A-5)
NOTE: Greater than minimal risk included any biomedical (nontherapeutic)
study; any medical therapeutic study (regardless of the existence of a standard of
care); any social/behavioral therapeutic study; and any nontherapeutic study
involving a manipulation that the research assistant (RA) judged to involve potentially serious physical or emotional stress (e.g., long sleep deprivation). Not
greater than minimal risk included any study based on review of administrative
records; any program evaluation study; any nontherapeutic social/behavioral
study that involved either no manipulation (e.g., innocuous questionnaires/surveys) or involved a manipulation that the RA judged not to involve
potentially serious physical or emotional stress (e.g., long sleep deprivation).

3. Study content/design: Prisoner research is dominated by epidemiological studies (e.g., surveys, 39 percent) and correlational designs (27 percent). Other studies are described as examining
behavioral issues (14 percent), medical outcomes (5 percent), case
studies (6 percent), nonmedical experiments (1 percent), or “other”
(8 percent). An alternative classification of study content reveals that
health status questions (43 percent) and personality characteristics
(19 percent) are the focus of most research. Other studies deal with
aspects of being confined (10 percent) or reentry into the community
(11 percent) or bear no clear relationship to prisoner status (9 percent).

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4. Sources of funding: It was sometimes challenging to determine
or to categorize the source of funding for prisoner research from published reports. Approximately 20 percent of the studies reviewed did
not indicate the source of support (see Figure 2-4), and another 29
percent fit the “other” coding category (e.g., a medical school grant;
university small grants; a study supported by a veterans affairs office) Prisoner research is funded by a wide variety of state and federal entities. Federal resources cited in the present sample included
two DHHS agencies (National Institutes of Health [NIH; 8 percent]
and Centers for Disease Control and Prevention [CDC; 3 percent]),
National Institute of Justice (5 percent), and “other” federal (10 percent). Also mentioned were state funds (11 percent), foundation
grants (5 percent), and prison system funding (4 percent).

Prison System
4%
Meta Analysis
(No Funding)
1%

Joint
4%

Other
29%

Foundation
5%

National Institute
of Justice
5%

Centers for Disease
Control
3%
National Institutes
of Health
8%

Did Not Specify
20%

Other, Federal
10%
State
11%

FIGURE 2-4 Source of funding (same as Fgure A-1).

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5. Mechanisms of research approval: For 15 percent of the studies,
a statement in the report indicated that the investigators had obtained
IRB approval for the research; for another 19 percent of studies, the
approval of some other reviewing body (e.g., a research committee)
was referenced. For most studies (66 percent), the reports did not indicate whether, or by whom, the research was approved (in terms of
human subjects protections).22
A review of 10 years of correctional and scientific literature on
HIV/AIDS studies involving prisoners (Farley, unpublished) yielded
similar findings. The studies reviewed lacked transparency. Fewer than
one-third of the studies mentioned review by an IRB, and nearly one-half
made no mention of informed consent.
Data Retrieval Needs Improving
The dearth of information regarding the contemporary landscape of
prisoner research led the
“[Prisoners’] only single armor against being
committee to gather system- subjected to experimental abuse hangs on a sinatic information concerning gle thread, on a single federal regulation in fedthe frequency and types of erally-funded research only,” said Vera Hassner
Sharav, founder and president of the Alliance for
prisoner research currently Human Research Protection. “Chimpanzees, by
being conducted and the re- contrast, are protected by mandatory rules,
search-related policies and oversight, and enforcement mechanisms since
procedures of state agencies the Animal Welfare Act of 1966. The U.S. Dethat house large numbers of partment of Agriculture must submit annual
reports to Congress documenting the disposition
prisoners. It was conceded at of every chimp, dog, rabbit, and hamster. No one
the outset that the scope of keeps track of how many human beings have
the committee’s efforts in died or been harmed in clinical research.” Ms.
this regard would be limited. Sharav painted this stark comparison of protections for prisoners with protections for animals
For example, the surveys of in research at the committee’s July 2005 meetkey personnel in prisons ing.
were limited to state DOCs
and did not include the federal prison system or the myriad city, county,
and municipal jails in which offenders may be at least temporarily
22

This does not necessarily mean, however, that human subjects reviews were not conducted or that appropriate approvals were not obtained. Journals and journal editors vary
considerably in their requirements for reporting (or not) that the research had prior IRB or
other human subjects review and approval.

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housed. Similarly, the review of published literature was of limited scope
and was not supplemented with efforts to uncover, sample, and review
unpublished reports in the possession of state, federal, or private agencies
or research institutions.
There is no central reJeffrey Ian Ross, an associate professor in the
pository of information about Division of Criminology, Criminal Justice, and
the amount and type of re- Social Policy at the University of Baltimore, and
member of the committee’s Prisoner Liaison
search involving prisoners. aPanel,
agreed at the committee’s October 2005
For the same reason that reg- meeting that a registry is needed. “I would make
istries of clinical research on it a point to have some sort of clearinghouse that
drugs and biologics exist and actually tracks this kind of research on a regular
have
recently
garnered basis so we know if it is increasing, decreasing,
and whether it is more behavioral, social scistrong support (DeAngelis et ence, criminologic, or medical.”
al., 2004; IOM, 2006), a national database would bring clarity to the currently murky landscape of
research involving prisoners.
Recommendation 2.1 Maintain a Public Database of All
Research Involving Prisoners
The Department of Health and Human Services, in cooperation with the Department of Justice, should systematically
and comprehensively document all human subjects research
with prisoners.23
The establishment of a national registry of research involving
prisoners should include data, such as who is conducting research, with what support, what kind of research, on what populations, and the nature and extent of ethical oversight provided.
There is currently no central repository of information about the
amount and type of research involving prisoners, however a government-run registry of clinical research does exist
(www.Clinicaltrials.gov) and could be a starting point and leveraging mechanism to make this endeavor feasible and not cost
prohibitive. A national registry would shed light on the totality
of research taking place on prisoners and the quality of ethical
oversight provided for each protocol. To enable consideration of
23

The term “prisoner” is defined by the Committee in Chapter 4 and used
throughout this report in a broader way that it is commonly used. In this report, the
term “prisoner” refers to all persons, including parolees and probationers, whose
liberty has been restricted by decisions of the criminal justice system.

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questions of justice, it could be used to examine the magnitude
and volume of prisoners in different types of research to determine the allocation of benefits and burdens of research among
prisoners. A registry would also enhance the application of research findings to prisoner populations. In the absence of such a
registry, the committee was unable to accurately determine the
nature and extent of prisoners’ participation as subjects of research.
Cost is always a consideration when suggesting a database be developed. The director of Clinicaltrials.gov, the federal government’s public
database of clinical research, indicated that the annual costs for that database, which is maintained at the National Library of Medicine, is $3.2
million per year (Deborah Zarin, personal communication, May 17,
2006). She noted, however, that there may not be a reason to start a new
registry for research involving prisoners. The existing clinicaltrials.gov
could add a field that indicated if prisoners were included in a study, and
then users could customize the view to see only those studies. At present, clinicaltrials.gov does not include social/behavioral research, but
could be a starting point and leveraging mechanism to make Recommendation 2.1 feasible and not cost prohibitive.

Summary of Findings on Current
Research Environment
Findings from the surveys of DOC personnel and the literature review shed light on the possible impact of the national commission’s
“Report and Recommendations—Research Involving Prisoners”
(NCPHSBBR, 1976) and indicate practical and political complexities
that may hamper efforts to create a uniform and comprehensive system
of protections for prisoners as research participants. Findings and implications from these data include the following.
1. The reach of the Subpart C regulations to protect prisoners involved in research does not extend to the vast majority of prisoner
research participants. The current regulations are binding only with
respect to research supported by DHHS or in those institutions that
voluntarily extend the regulations to non-DHHS funded studies involving prisoners (currently the Central Intelligence Administration

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and Social Security Administration; see Chapter 3). Survey responses from key DOC personnel reveal that a significant amount of
research with prisoners is initiated and conducted internally, and that
extramural research applications come from a wide variety of investigators, some (perhaps many) of whom may not be supported by
DHHS funding, and thus not bound by the regulations. Similarly, the
review of published prison research studies indicates that only about
11 percent of studies are DHHS funded, through NIH and the CDC
(the percentage may be slightly higher given that NIH and CDC may
jointly fund some studies coded as having multiple funding sources).
2. It is not clear that all studies involving prisoners are being conducted with IRB review and approval. Also, prison research committees, which may serve some type of proxy IRB role, only
infrequently include prisoners or prisoner representatives among
their membership.
3. Biomedical research involving prisoners, particularly that of a
nontherapeutic nature, is rare, perhaps as a consequence of the national commission’s 1976 report. Across the two surveys, one-third
of respondets indicated that therapeutic medical studies might be
permissible, and only 5 percent (two states) indicated that nontherapeutic biomedical research might be permissible. Several DOCs report that biomedical research, including potentially therapeutic
research, is prohibited by state law or DOC policy. Further, medical
studies with the potential for therapeutic outcome make up only 2
percent of the published prisoner research studies. Although the current regulations permit therapeutic medical studies with prisoners
under certain circumstances, little such research appears to be taking
place.
4. Some DOC research implementation policies may preclude potential remedies that some have suggested to ensure fair and equitable research participation by prisoners. For example, some have
suggested the prisoner participants be allowed to receive incentives
that, if not equal, are at least proportional to those available to nonprisoner participants in the community. Five of the six state DOCs
interviewed in depth prohibit prisoner participants from receiving financial or other incentives for research participation.

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79
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BJS. 2003b. Education and Correctional Populations. Washington, DC: U.S.
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4, 2006].
Blitz CL, Wolff N, Pan K-Y, Pogorzelski W. 2005. Gender-specific behavioral
health and community release patterns among New Jersey prison inmates: Implications for treatment and community reentry. American Journal of Public
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Braithwaite RI, Treadwell HM, Arriola KRJ. 2005. Health disparities and incarcerated women: A population ignored. American Journal of Public Health
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Regulation of Research with Human Subjects. Dayton, OH: Lexis/Nexis.
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DeAngelis CD, Drazen JM, Frizelle FA, Haug C., Hoey J, Horton R, Kotzin S,
Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden
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Farley JE. 10 Years of HIV/AIDS Research Behind Bars: Time for Change.
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from jail: The social and health consequences of community reentry for
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22.pdf [accessed November 23, 2005].
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1991 and 1997. Washington, DC: U.S. Government Printing Office.
Haigler KO, Harlow C, O’Connor P, Campbell A. 1994. Literacy Behind Prison
Walls: Profiles of the Prison Population from the National Adult Literacy
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15, 2005].
Hammett TM, Harmon MP, Rhodes W. 2002. The burden of infectious disease
among inmates of and releasees from US correctional facilities, 1997. American Journal of Public Health. 92:1789-1794.
Hornblum AM. 1997. They were cheap and available: prisoners as research subjects in twentieth century America. British Medical Journal 315:1437–1441.

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Hornblum AM. 1998. Acres of Skin: Human Experiments at Holmesburg
Prison. New York: Routledge.
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Confinement in the United States [Online]. Available: http://www.hrw.org/
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[Online]. Available: http://www.hrw.org/reports/2003/usa1003/index.htm (accessed October 13, 2005)
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http://hrw.org/reports/2005/us1005/ [accessed October 17, 2005].
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Clinical Trials: Workshop Report. Washington, DC: National Academies
Press.
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Free Press.
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punishing/punishing.html [accessed October 14, 2005].
Khan AJ, Simard EP, Bower WA, Wurtzel HL, Khristova M, Wagner KD, Arnold KE, Nainan OV, LaMarre M, Bell BP. 2005. Ongoing transmission of
hepatitis B virus infection among inmates at a state correctional facility.
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Later. [Online]. Available: http://www.sentencingproject.org/pdfs/9087.pdf
[accessed October 14, 2005].
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The New York Times, p. 1.
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custody? A Washington State study. Federal Probation 61(3):40–45.
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Criminal Justice System Five Years Later. National Center on Institutions and
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screening of prisoners. American Journal of Public Health 95(10):1739–1740.
MacNeil JR, Lobato MN, Moore M. 2005. An unanswered health disparity: Tuberculosis among correctional inmates, 1993 through 2003. American Journal
of Public Health 95(10):1800–1805.
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Board of Education [Online]. Available: http://sentencingproject.org/pdfs/
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Mauer M, King RS, Young MC. 2004. The Meaning of “Life”: Long Prison
Sentences in Context. [Online]. Available: http://www.sentencingproject.org/
pdfs/lifers.pdf [accessed October 17, 2005].
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American Academy of Psychiatry and the Law 30:19–29.
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California Journal of Health Promotion 3(2):23–37.
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Status of Soon-to-Be Released Inmates: Executive Summary. [Online]. Available: http://www.ncchc.org/stbr/Volume2/ExecutiveSummary.pdf [accessed
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Biomedical and Behavioral Research). 1976. Report and Recommendations:
Research Involving Prisoners. Washington, DC.
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Current Practice. Longmont, CO: U.S. Department of Justice.
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Schafer NE. 1994. Exploring the link between visits and parole success: a survey of prison visitors. International Journal of Offender Therapy and Comparative Criminology 38(1):17–32.
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3
Federal Regulatory Landscape

The current regulatory scheme for research with human subjects is a
patchwork of regulations and enforcement mechanisms that do not lend
themselves to broad or easy application, particularly with regard to research involving prisoners. The environment when the existing regulations were adopted resulted in a set of regulations promulgated by U.S.
Department of Health and Human Services (DHHS) that were intended
to be restrictive with respect to research involving prisoners: The default
position is that no such research should occur, and the four or five categories of research allowed under the regulations are essentially exceptions to that general rule. The Office for Human Research Protections
(OHRP) applies these regulations with the assumption that if the research
described does not appear to fit into any given category, it cannot be approved, even if it otherwise seems beneficial and appropriate.
The restrictiveness of the DHHS regulations regarding prisoners may
have had the unintended effect of creating widely varying regulatory
schemes applicable to research involving prisoners, because of the unwillingness of other federal agencies to adopt the same set of regulations.
Under the current framework, although they can voluntarily agree to
more, research institutions are only required to abide by DHHSpromulgated regulations when they conduct research funded by DHHS
(including DHHS agencies such as National Institutes of Health [NIH],
Food and Drug Administration [FDA], Centers for Disease Control and
Prevention, and Substance Abuse and Mental Health Services Administration, which is actually a very small portion of all research involving
prisoners conducted in the United States). In order for the regulations to
apply to other federally funded research, absent the consent of research
institutions, it was necessary for every other department or agency fund85

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ing such research to incorporate the DHHS-promulgated regulations into
that department or agency’s own regulations. Sixteen other departments
and agencies of the federal government adopted the generally applicable
Common Rule regarding research with human subjects, thus partially
accomplishing a goal of uniformity in the ethical regulations applicable
to federally funded research.
However, perhaps because of the restrictiveness of the regulations,
nearly all of the same departments or agencies did not adopt the additional protections for prisoners. At least one of the departments adopting
the Common Rule, the Bureau of Prisons (BOP) at the Department of
Justice (DOJ), instead adopted its own regulations that apply to all research with prisoners in BOP’s custody (not merely research that is
funded by the DOJ). Additionally, the FDA promulgated its own rules,
consistent to the extent practical with the Common Rule, governing clinical research associated with the products it regulates. However, the
FDA’s attempt to adopt parallel regulations that were essentially the
same as DHHS’s prisoner protections 1 was the subject of a lawsuit
brought by prisoners wishing to participate in such research. Therefore,
the FDA does not have provisions comparable to DHHS Subpart C for
prisoner populations.
Outside of DHHS and its agencies, only the Central Intelligence
Agency (CIA) and the Social Security Administration (SSA) have
adopted the DHHS’s prisoner protections (Figure 3-1).
In sum, regarding research involving prisoners as human research
subjects, the applicable regulations are far from uniform and range from
no protection at all (for research that is not funded by one of the 17 agencies that have adopted the Common Rule), to basic Common Rule protection, to heightened, overlapping, and possibly inconsistent regulations
(e.g., for persons in BOP’s custody participating in therapeutic clinical
trials). This chapter describes the components of the patchwork of regulations: the Common Rule, Subpart C (DHHS’s protections for prisoners
as research subjects), and the alternative regulations applied by other departments.

45 C.F.R. Part 46, Subpart C.

FIGURE 3-1 Chart of applicable regulations to research involving human subjects. SOURCE: NBAC, 2001, 157, Figure C-1.

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ADOPTION OF DHHS HUMAN SUBJECTS
PROTECTION REGULATIONS
The first federal protections for human subjects were issued in 1966
by NIH. This document, the Public Health Service’s policy on Clinical
Investigations Using Human Subjects, served as an initial attempt to protect human subjects. It required prospective review of human subjects
research, focusing on the rights of potential participants by balancing
risks and benefits while ensuring appropriate informed consent procedures (PHS, 1966).
These NIH policies, which initially applied only to extramural research, were later raised to regulatory standards for the entire Department of Health, Education, and Welfare (DHEW) in 1974. These
regulations were later modified in 1981 and codified at Title 45 Part 46
of the Code of Federal Regulations. Revisions have occurred several
times since then; the most recent changes took effect in 1991 with the
development of the Federal Policy for the Protection of Human Subjects,
also known as the Common Rule.
The Common Rule
The Common Rule is incorporated as Subpart A of 45 C.F.R. Part
46, the basic DHHS regulations for the protection of human research
subjects. The regulatory framework outlined in the Common Rule applies to 17 federal agencies that are involved in conducting or funding
human subjects research.2 The Common Rule provides guidelines on
conducting certain types of research with human subjects. Specifically, it
discusses issues such as review by institutional review boards (IRBs),
informed consent, balancing risks and benefits, protecting privacy, and
additional requirements for approval. Failure to adhere to these regulations can result in sanctions. Agency or department support of the research can be suspended or terminated, or additional conditions can be
imposed on the individual project or on the research organization/institution.
Human subjects are defined as persons about whom a research investigator obtains either (1) identifiable private information or (2) data as a
2

See Figure 3-1. The FDA adopted a modified version of the Common Rule applicable
to research involving all products it regulates.

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FEDERAL REGULATORY LANDSCAPE

result of an intervention or interaction with the person.3 The Common
Rule defines research as any “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”4
The Common Rule also identifies certain categories of research that
are exempt. Notably, these exemption categories cannot be applied to
any research involving prisoners; therefore, both the general protections
(Subpart A) and the heightened protections (Subpart C) provided under
45 C.F.R. Part 46 still apply.5
IRBs
A number of protections for human subjects involved in research are
specified in the Common Rule. IRBs are required to review and approve
any nonexempt research that involves human subjects, with its membership specified, functions defined, and review processes outlined.6 The
Common Rule also includes criteria for IRB approval of research and
identifies certain categories of research that can be approved on an expedited basis.7 It also specifies that, when “some or all of the subjects are
likely to be vulnerable to coercion or undue influence,” the IRB must
find that “additional safeguards have been included to protect the rights
and welfare of those subjects.”8 IRBs are empowered to suspend or terminate research that has been approved and are required to maintain records that document all IRB activities.9
In some cases, IRB review of individual research projects can be expedited if the project involves no more than minimal risk and fits certain
categories (e.g., collection of small amounts of blood, analysis of existing materials) or involves minor changes to a previously approved research project. Minimal risk for the Common Rule is defined as:
The probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those
3

45 C.F.R. § 46.102(f).
45 C.F.R. § 46.102(d).
5
45 C.F.R. § 46.101(i), n.1.
6
45 C.F.R. § 46.107-09.
7
45 C.F.R. § 46.110-11.
8
45 C.F.R. § 46.109(b).
9
45 C.F.R. § 46.113.
4

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ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests.10
Under expedited procedures that bypass the full IRB process, the
IRB chair or one or more experienced IRB members who is designated
by the chair can review and approve the research. Although regulations
do not preclude the use of expedited review for research involving prisoners, OHRP recommends that such research be reviewed by the full
committee.
Informed Consent
Informed consent processes are also defined in the Common Rule.
The basic disclosure requirements for obtaining informed consent are (1)
a description of the study and its purposes; (2) identification of any foreseeable risks or discomforts to the participant; (3) a description of any
benefits that could be expected; (4) disclosure of alternative treatments
that may also be beneficial; (5) a description of how confidentiality of
records will be maintained; (6) for treatment involving more than minimal risk, an explanation of the potential consequences resulting from
participation in the research; (7) contact information for answering questions; and (8) a statement that the individual’s participation in the research must be voluntary, that refusal to participate will not result in a
penalty or loss of benefits to which the individual is otherwise entitled,
and that the individual may withdraw at any time.11 Additional information may also be required, depending on the specific nature of the research.12 The investigator must document that the person agreed to
participate in the research project by obtaining the individual’s signature
or the signature of an authorized representative.13
Institutional Assurances
Generally, the Common Rule requires that the departments or agencies applying the Common Rule obtain some form of written assurance
from all research institutions engaging in covered research that the re10

45 C.F.R. § 46.102(i).
45 C.F.R. § 46.116(a).
12
45 C.F.R. § 46.116(b).
13
45 C.F.R. § 46.117.
11

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search complies with the regulations.14 If a research organization frequently conducts research supported by one of the signatory federal
agencies, it may apply for a federal-wide assurance (FWA), a special
kind of assurance process administered by DHHS. The research organization seeking an FWA certifies that (1) all research will be performed in
accordance with the ethical principles in the Belmont Report and (2) for
any research that the organization conducts for which it receives any federal funds,15 certain procedures will be followed that ensure compliance
with the Common Rule and any other applicable subparts the organization chooses to sign on to.
In lieu of requiring its own form of written assurance, a department
or agency other than DHHS may accept the FWA.16 In that case, once the
FWA is approved by DHHS, it allows individual research proposals to be
approved by the organization and its local IRB rather than by the individual federal department or agency that is funding the research, and any
reports required are made both to the department or agency and OHRP.17
Note that most organizations that conduct federally funded research hold
an FWA.

Subpart C: Prisoners as Research Subjects
Beyond the Common Rule contained in Subpart A, additional subparts of 45 C.F.R. Part 46 provide further and more specific protection
for certain particularly vulnerable populations: pregnant women, fetuses,
and neonates (Subpart B); prisoners (Subpart C); and children (Subpart
D). Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects,” the focus of this project, was first finalized in 1978. These additional protections were
developed in response to the National Commission’s Report and Recommendations: Research Involving Prisoners (NCPHSBBR, 1976).
They represent further safeguards that must be met when conducting research with this vulnerable population group. To date, Subpart C has
only been adopted by DHHS, the CIA, and the SSA.
14

45 C.F.R. § 46.103.
If the organization voluntarily extends its assurance to all research regardless of funding source, the organization’s certification extends to that research as well.
16
45 C.F.R. § 46.103(a).
17
45 C.F.R. § 103(a).
15

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Key Definitions Within Subpart C
Subpart C defines a prisoner as any person who is “involuntarily
confined or detained in a penal institution” as a result of violating a
criminal or civil statute, a person who is committed to other facilities as
an alternative to criminal prosecution or incarceration, or someone who
is detained pending arraignment, trial, or sentencing.18 Research with this
population must present no more than minimal risk. Here, that is defined
as:
The probability and magnitude of physical or psychological
harm that is normally encountered in the daily lives, or in the
routine medical, dental, or psychological examination of healthy
persons.19
Subpart C identifies four categories of research that are permitted
with prisoners.
i. Study of the possible causes, effects, and processes of incarceration, and of criminal behavior provided that the study
presents no more than minimal risk and no more than inconvenience to the subjects;
ii. Study of prisons as institutional structures or of prisoners
as incarcerated persons, provided that the study presents no
more than minimal risk and no more than inconvenience to the
subjects;
iii. Research on conditions particularly affecting prisoners as a
class (for example, vaccine trials and other research on hepatitis
which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism,
drug addiction, and sexual assaults) provided that the study may
proceed only after the Secretary has consulted with appropriate
experts, including experts in penology, medicine, and ethics, and
published notice in the Federal Register, of the intent to approve
such research; or
18

45 C.F.R. § 46.303(c).
45 C.F.R. § 46.303(d).

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iv. Research on practices, both innovative and accepted, which
have the intent and reasonable probability of improving the
health or well-being of the subjects. In cases in which those
studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups
which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate
experts, including experts in penology, medicine, and ethics,
and published notice, in the Federal Register, of the intent to
approve such research.20
There has been confusion among researchers and correctional departments regarding the exact meaning of the categories stated previously and the specific circumstances in which they should be applied
(See later discussion on the Subpart C Subcommittee of Secretary’s Advisory Committee on Human Research Protections [SACHRP] on page
95). In October 2002, the Secretary of DHHS published a notification in
the Federal Register proposing to waive certain provisions of Subpart C
to epidemiological research involving prisoners that involved no more
than minimal risk and no more than inconvenience to potential subjects.21
The regulations, which became final in June 2003, allow for epidemiological research on specific diseases that describes the prevalence or incidence of the disease by identifying all cases, including prisoner cases, or
studies of potential risk factor associations for these diseases in which
prisoners were included in the population of interest but were not the sole
study group.22

Implementation of an epidemiological research project involving prisoners requires that an IRB must approve the research, document that one of the two conditions described previously has been met,
and determine that the research involves minimal risk and no more than
inconvenience to the prisoner-subjects.23

45 C.F.R. § 46.306(a)(2) (emphasis added).
67 Fed. Reg. 62432 (October 7, 2002).
22
68 Fed. Reg. 36929 (June 20, 2003).
23
68 Fed. Reg. 36930 (2003).
21

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Additional Requirements for IRBs
When research is proposed that involves prisoners, IRBs must approve each individual project. IRBs for prisoner research are not only
required to meet the conditions of the Common Rule (outlined previously) but also must have among its membership a prisoner or prisoner
representative.
Further, the IRB must find that the research proposal meets both the
Common Rule requirements as well as additional requirements specific
to the prisoner setting. These additional requirements are as follows:
●
●

●
●
●
●
●

the research is within one of the four permissible categories of
research for prisoners;
benefits that accrue as a result of the prisoner’s participation
should not be so great in comparison to what is available in the
correctional environment that the ability to provide informed
consent is impaired;
risks are commensurate with those that would be accepted by
nonprisoner volunteers;
selection procedures are fair and not subject to arbitrary intervention by either prison authorities or other prisoners;
the consent form is written in language that is easily understood
by the prisoner;
the person’s participation in the research project will not be a
consideration in parole or probation decisions; and
adequate provisions are made for follow-up care, should it be
needed, once the research study ends.24

OHRP Certification
Once the IRB has found that the research meets the criteria described
previously and approves the study, OHRP certification must be obtained
for research in Categories i through iv and for epidemiological waivers
as well (Table 3-1). If OHRP certifies that the category is appropriate
and that the criteria have been met, the research is approved. This certification step adds an average of 3-4 weeks to the review process.

45 C.F.R. § 46.305(a).

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TABLE 3-1 Approximate OHRP Prisoner Certifications January 2000–
October 12, 2005
Subpart C Category
46.306(a)(2)(i)
46.306(a)(2)(ii)
46.306(a)(2)(iii)
46.306(a)(2)(iv)
Epidemiology
waiver
Disapproved
Not DHHS
Total

2000
12
1
0
12

2001
26
1
2
35

2002
18
6
1
20

2003
23
4
1
34
2

2004
53
5
0
27
11

2005
56
3
0
31
2

Total
18
20
4
159
15

2
1
67

1
4
101

3
11
106

6
16
408

NOTE: OHRP, Office for Human Research Protections; DHHS, Department of Health
and Human Services.
SOURCE: Gorey 2005.

Report Of The SACHRP Subcommittee
In 2003, the SACHRP asked its Subpart C Subcommittee to review
the text and application of Subpart C, primarily to determine whether the
current DHHS interpretation and application of Subpart C’s requirements
should be modified. Among the topics the subcommittee addressed were:
●
●
●
●
●
●

the definition of “prisoner” under Subpart C;
the application of research protections to those who become incarcerated after agreeing to participate in a nonprisoner study;
issues with identifying a prisoner representative for prisonerresearch IRBs and particularly in multisite studies;
conduct of expedited review in prisoner research;
the definition of minimal risk under Subpart C (which is different from the Subpart A definition); and
the requirement of secretarial review when prisoners in the control group are merely provided the standard of care. (SACHRP,
2005)

Definition of Prisoner
The subcommittee recommended that a modified Subpart A analysis
apply when a subject who is enrolled in a study may not be fully within

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the definition of prisoner for the duration of the study. First, the subcommittee affirmed that the interpretation of prisoner should remain defined by the words of the regulation and not be expanded to include other
individuals whose liberty is restricted, such as those in community correctional facilities or on probation or parole. Although these individuals
deserve heightened protection, the subcommittee recommended that
DHHS rely on Subpart A’s protections for individuals “vulnerable to
coercion or undue influence” without including them as prisoners under
Subpart C. Likewise, when an individual is incarcerated after enrolling in
a study, the concerns about coercion and undue influence are not as
great, and it may be difficult to modify the research protocol to comply
with Subpart C. Therefore, the subcommittee suggested that Subpart A’s
general requirement of heightened protection instead apply. The subcommittee recommended that an IRB should review a researcher’s request to continue the research when an individual subsequently becomes
incarcerated, taking into account the new conditions of incarceration but
without fully engaging in a new Subpart C approval process.
Prisoner IRB Representative
The subcommittee discussed a variety of problems with identifying a
representative who would be skilled and knowledgeable enough to be
effective but not so unlike the rest of the IRB as to be marginalized. The
subcommittee recommended that OHRP should assist IRBs in searching
for an appropriate prisoner representative, which might include family
members of prisoners, former prisoners (especially people in recovery
from substance addiction who have also had experience as prisoners),
and service providers who assist in the correctional process. OHRP
should provide functional criteria that might help IRBs (and investigators, who are also responsible for the composition of an IRB that will
properly evaluate ethical issues) identify persons who can be an effective
voice for prisoners within the IRB. With respect to multisite studies, the
subcommittee recommended that, although Subpart C only requires one
prisoner representative on a central IRB for multisite research, the IRB
must nevertheless consider the individual circumstances of each prison
site, which can vary widely. With respect to expedited review, the subcommittee recommended that, if expedited review of a protocol is required, a prisoner representative be one of the reviewers.

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Defining Minimal Risk and Benefit to Participant
The subcommittee considered two issues regarding the distinction
between using as the ethical baseline other healthy prisoners as opposed
to other healthy persons generally. First, the subcommittee affirmed that
the different definition of minimal risk in the Subpart C regulations compared with Subpart A regulations was appropriate. The Subpart C regulations specify that the determination of minimal risk must be in
comparison to the ordinary experience of a healthy person, interpreted as
meaning a healthy person outside the prison environment. The subcommittee cautioned that the greater situational risk in the prison setting
should not influence the baseline for the IRB’s decision; rather, the
minimal risk should be compared with the risk to a healthy person in a
safe environment. OHRP should provide guidance, using examples, of
how the minimal risk might be viewed in different protocols.
At the same time, the subcommittee viewed the current OHRP interpretation of when a protocol does not provide a benefit to the participant
as overly restrictive. OHRP’s position is that using standard of care as a
control arm does not provide any benefit to the participant and thus requires secretarial review and expert panel consideration. The subcommittee’s view is that, because the participant receives the standard of care
and does ultimately benefit from the results of the research, even if not
immediately, such a control arm should not require heightened review.
The subcommittee recommended that only when the control group is
placebo only (and thus deviating from the standard of care) should the
protocol be considered to include an arm not benefiting from the research.
The subcommittee also pointed out the problems with the jurisdiction
of Subpart C. Because it has been adopted by so few agencies, it has limited application to federally funded research. In addition, it does not
automatically apply to institutions that have signed an FWA unless they
specifically request that it be part of their obligation. Because of these
two enormous gaps in coverage, most research involving prisoners does
not fall under the special protections of Subpart C.
Recommendations for Further Consideration by the IOM
In addition to its recommendations on these issues, the subcommittee
noted with approval that the IOM had been charged with studying the

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human research protections for prisoners. The subcommittee recommended the IOM committee’s consideration of:
●
●
●

the need for a requirement that research only be conducted in
prisons providing standard of care to the general population (and
how best to get such services in place);
the interpretation of the requirement that follow-up care be provided when the prisoner has been released from confinement;
and
the limited jurisdiction of Subpart C (i.e., to DHHS-supported
research only).

OTHER FEDERAL HUMAN SUBJECTS PROTECTIONS
The full panoply of DHHS protections for prisoners in Subpart C
presently apply only to research funded by DHHS, the CIA, and the
SSA. Some of the other 14 departments and agencies that have adopted
the Common Rule accept the OHRP-approved FWA as assurance of
compliance with ethical regulations regarding human research subjects.
However, those departments and agencies have not adopted Subpart C,
so the assurance will only require certification of compliance with the
Common Rule (Subpart A).25 Although institutions holding an FWA and
engaging in research funded by one of those other departments or agencies may voluntarily extend their protections to include those under the
other subparts (including Subpart C), OHRP estimates that only about 60
percent of institutions holding an FWA have done so.
Moreover, prisoner research that is funded by another department or
agency (other than DHHS) falls outside of the protections of OHRP
oversight even if the institution has requested in its FWA that Subpart C
apply, because OHRP does not monitor the institution’s compliance with

One exception is the Department of Education, which has adopted Subpart D but has
not adopted Subparts B or C of the DHHS regulations.

DOJ Subpart A
BOP research policy

Non-medical Research

DOJ Subpart A
BOP research policy

Varies by state

FDA Subpart A,
state policy

Adult
FDA Subpart A

Varies by state

FDA Subpart A,
FDA Subpart D,
state policy

State
Juvenile
FDA Subpart A,
FDA Subpart D,
state policy

NOTE: FDA, Food and Drug Administration; DOJ, Department of Justice; DHHS, Department of Health and
Human Services; BOP, Bureau of Prisons.
SOURCES: DOJ Human Research Protections, 28 CFR Part 46, Subpart A (1996); BOP, 1999; FDA Human Research Protections, 21 CFR Part 50, Subparts A, D (2000); DHHS Human Research Protections, 45 C.F.R. Part
46, Subparts A, C.

DOJ Subpart A
[Applicable DHHS
regulations incorporated by reference in
BOP policy]

DOJ Subpart A
[Applicable DHHS
regulations incorporated by reference in
BOP policy]
FDA Subpart A
FDA Subpart D
DOJ Subpart A
[Applicable DHHS
regulations incorporated by reference in
BOP policy]

Federal
Juvenile
Not permitted

DOJ Subpart A
[Applicable DHHS
regulations incorporated by reference in
BOP policy]
FDA Subpart A

Adult
Not permitted

Non-FDA-regulated
medical treatment therapeutic

Variable
Medical treatment
Non-therapeutic/
Cosmetic
Pharmaceutical/medical
device - therapeutic (for
specific inmate’s condition)

TABLE 3-2 Summary of Regulations Applicable to Research Even If It Is Not Federally
Funded by Any Agency

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a voluntary assurance regarding Subpart C. Additionally, an organization
that does not receive its funding from any of these sources generally will
not hold an FWA and would not be required to comply with the Common Rule or any of the subparts.26
In evaluating the effectiveness of Subpart C, it is useful to compare
other human research subjects protections to these regulations. In particular, Subpart D contains DHHS’s regulations regarding children, and
provides a different framework for assessing the risks and benefits (and
according appropriate protections). Within DHHS, the FDA has promulgated additional human subjects protections regarding research conducted on drugs and medical devices (but has not succeeded in
attempting to regulate such research in the prison context). In contrast,
the BOP has established a set of regulations regarding all research conducted with the prisoners in its custody.
Subpart D
Recall that there are four categories of permissible research established in Subpart C: (1) study of the possible causes, effects, and processes of incarceration (presenting no more than minimal risk); (2) study
of prisons as institutional structures or of prisoners as incarcerated persons (presenting no more than minimal risk); (3) research on conditions
particularly affecting prisoners as a class (after consultation with experts
and notice in the Federal Register); and (4) research on practices, both
innovative and accepted, that have the intent and reasonable probability
of improving the health or well-being of the subjects, when there is a
control group that is nontherapeutic, after consultation with experts and
notice in the Federal Register.27 If biomedical or behavioral research
does not fall into one of these categories as described, it is not permitted.28
Subpart D, although similar in some ways to Subpart C, takes a different approach to the definition of categories of permissible research
involving children (IOM, 2004). Specifically, Subpart D gradually increases the protections as the risk-benefit scale tilts more toward risk
26

See Figure 3-1. However, various human subjects protections may still apply, independently of the funding source, as discussed in more detail below. See Table 3-2.
27
45 C.F.R. § 46.306(a)(2).
28
45 C.F.R. § 46.306(b).

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and, at the top end of the scale, has a case-by-case escape clause for research that is not otherwise approvable but that presents an exceptional
opportunity to learn about a problem particularly affecting children.29
As to the risk-benefit analysis, the protection is tailored as shown in
Table 3-3.
Thus, the scheme gradually steps up the requirements for approval as
the risk increases and the prospect of direct benefit to the individual decreases.
Moreover, this scheme allows for appropriate research that might fall
through the cracks under the Subpart C framework. First, IRBs may find
Subpart D’s descriptions of categories easier to understand than those of
Subpart C because they specify how the risks and benefits are to be analyzed and how the protections should be increased to match. Second, the
framework is more flexible in that 45 C.F.R. § 46.407 allows for research
that does not neatly fit into one of the previous three categories, if, after
expert consultation and public review and comment, the secretary finds it
is both sufficiently important and well designed and is conducted in accordance with sound ethical principles.
Overall, the Subpart D framework is a more natural fit with the overarching ethical framework. Rather than determining in advance that certain kinds of research appropriately balance risks and benefits and
forbidding all others, as in Subpart C, Subpart D allows the IRB discretion to determine the balance of risk to the individual with the prospect
of benefit (direct or indirect) to the individual, requires appropriate assurance of informed and voluntary participation and draws a line when
the risk outweighs the benefit to such an extent that it can be presumed
that individuals would not consent if their consent was completely voluntary.

45 C.F.R. § 46.404-407.

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TABLE 3-3 Subpart D Framework
Risk-Benefit
No greater than minimal risk
(§ 46.404) 30

IRB Finding/Protection
1. Adequate provision made for informed
consent, minimizing risks, protecting
privavy and confidentiality

More than minimal risk but either
1. An intervention with prospect of
direct benefit for the individual or
2. A monitoring procedure likely to
contribute to individual’s well-being (§
46.405)

1. Risk justified by benefit
2. Relation of risk to benefit is at leat as
favorable to subjects as in alternative approaches
3. Adequate provision made for informed
consent, minimizing risks, protecting privacy and confidentiality

More than minimal risk and no prospect of direct benefit but likely to yield
generalizable knowledge about the
subject’s disorder or condition
(§46.406)

1. Risk is a minor increase over minimal
2. Intervention or procedure is “reasonably
commensurate with those inherent in their
actual or expected situations”
3. The generalizable knowledge is “of vital
importance for the understanding or amelioration of the subjects’ disorder or condition”
4. Adequate provision made for informed
consent, minimizing risks, protecting privacy and confidentiality

Research not otherwise approvable but
presents an “opportunity to understand,
prevent or alleviate a serious problem
affecting the health or welfare of children” (§ 46.407)

IRB finds:
1. The research does, in fact, provide such
an opportunity
Secretary, after consultation with experts
and opportunity for public review and comment, finds:
1. Research will be conducted in accord
with sound ethical principles
2. Adequate provision is made for informed consent, minimizing risks, protecting privacy and confidentiality

SOURCE: 45 C.F.R. Part 46, Subpart D.

30
Note that minimal risk is defined in the same manner in Subpart D as in Subpart A
(the Common Rule). The definition of minimal risk in Subpart C is different, as noted
previously.

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Other DHHS Agencies: FDA Regulations
As noted previously, the FDA has adopted a modified form of the
Common Rule in 21 C.F.R. Part 50, Subpart A, as well as regulations
regarding research with children as subjects in Subpart D. Apart from the
FDA’s definition of the scope of its regulations, the differences between
these and the Common Rule are, for present purposes, minimal.31 Rather,
the FDA regulations on protection for human research subjects are interesting primarily because of their scope and secondarily because of the
reason why they do not contain a Subpart C.
Unlike DHHS as a whole, which only enforces its requirements in
DHHS-funded research, the FDA has the authority to regulate a broad
category of research governing medical treatments and devices regardless of the source of funding or the FDA’s ability to control the subjects
or direct the research. Specifically, the FDA’s regulations apply to “all
clinical investigations regulated by the [FDA]32…as well as clinical investigations that support applications for research or marketing permits
for products regulated by the [FDA].”33 Thus, the FDA’s regulations
reach all research regarding the application, safety, and effectiveness of
any drug, medical device, biological product, nutritional supplement,
food or color additive, or other product subject to FDA approval. Moreover, because compliance with the FDA standards is required of all research that will be used to support and effort to gain FDA approval, it is
in the interest of the research sponsor who intends to use the research to
support an FDA application to use care in developing research protocols
31
The primary difference is in the regulations governing informed consent, which provide specific exceptions to informed consent for (1) emergent care treatments for lifethreatening conditions in which the subjects cannot be identified in advance (e.g., treatments for stroke or heart attack victims) and (2) certain Department of Defense treatments of armed forces personnel, if authorized by the President, but which otherwise
forbid any waiver or exception to informed consent.
32
The clinical investigations regulated by the FDA are those involving drugs and medical devices approved solely for investigational use because their safety and effectiveness
cannot otherwise be reasonably ensured.
33
Given the different scope of the FDA regulations compared with the Common Rule,
the clinical investigation covered by the FDA regulations is limited to “any experiment
that involves a test article and one or more human subjects” that is either regulated by the
FDA or the results of which is intended to be submitted to the FDA, and it does not apply
to nonclinical laboratory studies [Electronic Records; Electronic Signatures. 21 C.F.R.
§ 50.1(c), (2000)]. Human subject is also defined differently as “an individual who is or
becomes a participant in research, either as a recipient of the test article or as a control”
(Electronic Records; Electronic Signatures 21 C.F.R. § 50.1[g]).

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that comply with these regulations; supportive research can be rendered
worthless because of noncompliance.
Nevertheless, although FDA regulations contain a Subpart D governing children as research subjects that is similar to Subpart D of the
DHHS regulations, the FDA regulations do not contain a Subpart C governing research with prisoners as subjects. The FDA developed such
regulations and posted them in the Federal Register in 1978, and it
adopted a final rule on the regulations applicable to prisoner research in
1980.34 Before the regulations became effective, however, a group of
prisoners brought suit in federal court to have these regulations declared
invalid as violating the prisoners’ rights to participate in medical research. The FDA decided to delay the effective date of the regulations
until 5 months after the court’s decision in the case, and it ultimately settled the case by declaring the regulations indefinitely suspended. According to the notices posted in the Federal Register, research was being
conducted on a small number of persons in a small number of prisons, so
it was not worth the FDA’s time and expense to litigate the suit to uphold
the validity of the regulations.35 Since then, the indefinitely suspended
regulations have been removed from the Code of Federal Regulations,
and Subpart C of 21 C.F.R. Part 50 is simply “reserved.”
DOJ Regulations
As a general matter, the DOJ (including its research and development arm, the National Institute of Justice) has adopted the Common
Rule at 28 C.F.R. Part 46.36 With respect to research involving prisoners
in the custody of the BOP, however, the DOJ was concerned that Subpart
C did not adequately address the level of risk in the third category of
Subpart C (research on conditions particularly affecting prisoners as a
class) and did not fully consider the difficulty in ensuring confidentiality
of prisoners’ personal information in the prison environment. For those
reasons, as well as to conform the review process to other BOP and local
prison procedures, the department developed its own regulations that
34

45 Fed. Reg. 36386 (May 30, 1980).
46 Fed. Reg. 18951 (March 27, 1981); 46 Fed. Reg. 35085 (July 7, 1981).
36
According to the Bureau of Justice Statistics (2005), federal prisons have not housed
any inmates under age 18 since 1999, and accordingly, there are no separate regulations
dealing with juvenile prisoners.
35

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apply to prisoners in BOP custody. The resulting BOP policy is found in
two separate program statements: PS 1070.07 regarding research (BOP,
1999)37 and PS 6031.01 regarding patient care (BOP, 2005).
Addressing the DOJ’s concern about the kinds of research allowed,
the BOP regulations forbid nontherapeutic medical research or pharmaceutical trials and cosmetic research. However, they do allow the following:
●

●

therapeutic medical research, including clinical trials, “that may
be warranted for a specific inmate’s diagnosis or treatment” if
the research is (1) approved by the prison’s medical director, (2)
conducted with prior written consent, and (3) “conducted under
conditions approved by the Department of Health and Human
Services,” which presumably means that it is conducted in accordance with Subpart C;
research regarding disease prevalence, response to accepted
therapeutic interventions, behavioral, and other nonmedical research pursuant to the program statement on research. (See Table
3-2).

Thus, research of medical treatments, including clinical trials of
pharmaceuticals and medical devices, is either not permitted or, at least
in theory, is conducted in compliance with Subpart C requirements. Research involving federal prisoners is conducted pursuant to regulations
other than Subpart C only when it involves behavioral, epidemiological,
or other nonmedical research.38 Of course, prisoners in BOP custody account for less than 10 percent of the total incarcerated population, so the
remainder of incarcerated persons (of whom nearly two-thirds are housed
in state prisons and over one-third in local jails) are not covered by these
regulations.39
The BOP program statement on research contains many protections
similar to those in Subparts A and C but with more detail on the subject
of confidentiality, some differences in informed consent, and more con37
This policy is codified, minus interpretive commentary, as a regulation at 28 C.F.R.
Part 512.
38
It is not clear from the BOP program statement whether nonpharmacological treatments for mental illness are considered medical research.
39
Additionally, all 2,477 prisoners under age 18 in custody of the BOP are housed in
state facilities, where no uniform set of regulations governs protections of human research subjects.

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cern that the research protocol be approved by all levels of prison administration.
Confidentiality
The BOP research program statement specifically provides that personal identifiable information may not be released without the subject’s
prior written consent and, in particular, may not be admitted as evidence
or used for any other purpose in any judicial, administrative, or legislative proceeding. At the same time, as part of the process of informed
consent, the subject must be told that confidentiality may not be guaranteed as to information that the subject intends to commit a crime, harm
him- or herself or someone else, or leave a facility in which he or she is
incarcerated.
The concern for confidentiality of records also places specific limits
on the researcher. Records that contain information that may be traced to
an individual generally must not be placed on any electronic retrieval
system. Additionally, nonemployee researchers can only have access to
BOP records if the information does not identify the individual and will
only be used “as a statistical research or reporting record,” unless the
information is available under the Freedom of Information Act.
Informed Consent
BOP policies relating to informed and voluntary consent appear to have
been tailored to their assessment of the requirements of the prison setting. First, the disclosures that are required for informed consent are
modified slightly from the Common Rule requirements. In some cases,
the disclosure is required to be more specific. For instance, where the
Common Rule requires disclosure of “which procedures are experimental,” the BOP regulations require a somewhat more specific disclosure of
“the purpose of each procedure” and further require “identification of the
principal investigator(s),” which is not specifically required by the
Common Rule. As noted previously, the program statement regarding
confidentiality contains an exception for when an inmate threatens to
harm him- or herself or others, or to leave the facility. Certain other information that is required under the Common Rule’s informed consent
disclosure requirement, such as alternative treatments and information

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regarding treatment for research-related injury, is not expressly required
to be disclosed under the BOP program statement on research,40 perhaps
because such disclosures are less relevant in a setting in which medical
treatment is controlled by the institution. Nevertheless, the BOP program
statement allows the possibility that other information might be required
“as needed to describe adequately the nature and risks of the research.”
More striking on the issue of informed (and voluntary) consent is the
BOP program statement’s treatment of incentives for participating in research. Where Subpart C provides a standard against which to measure
incentives—that incentives should not be “of such a magnitude that his
or her ability to weigh the risks of the research against the value of such
advantages in the limited choice environment of the prison is impaired”41—BOP policy simply forbids any incentives for research subjects in BOP custody. However, “soft drinks and snacks to be consumed
at the test setting may be offered,” and steps may be taken to avoid prisoners being put at a disadvantage (e.g., because of work schedule) by
participating in the research.
Review of Research Protocols
Review under the BOP research program statement reflects further
BOP control over the research protocol and review process. The review
is conducted at three levels. First, an application meeting the detailed
informational requirements set forth in the policy is submitted to the
warden, who convenes a local research review board (LRRB).42 The
LRRB not only reviews the proposal for compliance with the research
policy but also consults with prison operational staff and evaluates the
research protocol’s compliance with prison policies. The warden takes
the LRRB review, formulates recommendations, and forwards the application to the regional director, who then sends the application to a central
IRB, called the Bureau Research Review Board (BRRB). After BRRB
40

Because DOJ’s adoption of the Common Rule renders the informed consent requirements applicable to all research conducted by, supported by, or subject to regulation by
DOJ, the Common Rule’s informed consent requirements should nevertheless control (28
C.F.R. § 46.101[a]; cf. 28 C.F.R. § 46.116-17).
41
45 C.F.R. § 46.305(a)(2).
42
If the request is for multisite research, the request goes to the Office of Research and
Evaluation, which administers all BOP research, for determination of a proper review
process.

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review and recommendations, the chief of the Office of Research and
Evaluation (ORE), who chairs the BRRB, sends the proposal to the director of BOP, who has the final authority to approve or disapprove all
research proposals. Finally, the warden has the opportunity to review the
project in its final form, consult with the LRRB, and request reconsideration if necessary. Furthermore, each research project is reviewed on an
annual basis, and the director has the authority to terminate a project at
any time if it violates the policy or “may prove detrimental to the inmate
population.”
Perhaps in recognition of the difficulty of convening a fully qualified
local IRB, and because the LRRB’s decision is always reviewed by the
BRRB, membership requirements for LRRBs are not as strict as in Subpart C and, in fact, need not necessarily meet the requirements of an IRB
as set out in Subpart A. As a general rule, the LRRB “is encouraged, but
not required” to meet the membership requirements set forth in the
Common Rule. However, the program statement specifies that the LRRB
must have the chief psychologist at the prison as the chairperson, and
representatives of departments that will be involved with the project must
serve as consultants to the LRRB. When the facility allows more than
one research project per year, it is “specially encouraged” to require
membership, including a prisoner’s representative, that would comply
with DHHS’s Subpart C.
The BRRB is necessarily an IRB and, as described by the research
policy requirements, meets Subpart C requirements. The BRRB is composed of the chief of the ORE, who serves as the chair; at least four other
members; and one alternate, who serves in the event of a conflict of interest of a member. A majority cannot be BOP employees, and the membership must include an individual with legal expertise (usually someone
from the BOP general counsel’s office) and “a representative for inmates
whom the Director determines is able to identify with inmate concerns
and evaluate objectively a research proposal’s impact on, and relevance
to, inmates and to the correctional process” (who is generally a prison
chaplain). The implementation guidelines further specify that the members shall have varying backgrounds, genders, and racial/cultural
makeup, shall not be associated with the conduct of the research, and
shall include at least one scientist and one nonscientist. Thus, the research program statement’s description of the BRRB meets Subpart C
requirements and also sets out a few additional requirements not contained in Subpart C.

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Overall, the BOP guidelines are a useful tool for comparison with
Subpart C because they govern all research involving prisoners in federal
custody, whether or not it is funded by DOJ (or DHHS). Moreover, they
reflect the BOP’s decisions regarding which aspects of Subpart C are not
feasible or are unnecessary and which aspects are inadequate, because
they either do not provide enough protection for subjects in the prison
environment or are not specific enough about what is required.
ANALYSIS
The SACHRP Subpart C Subcommittee requested that the IOM consider the limited reach of the DHHS regulations under the current regime. The committee agrees that the limited reach of the regulations,
combined with the patchwork of different regulatory schemes, inhibits
the impact of the regulations to the detriment of prisoners involved in
research.
Recommendation 3-1 Establish Uniform Guidelines for All
Human Subjects Research Involving Prisoners
Congress should mandate a uniform set of guidelines for
human research participant protection programs43 for research involving prisoners.
All human subjects research involving prisoners should be regulated by the same ethical standards irrespective of the source of
funding, the supporting agency, or the type of correctional facility (federal, state, local, or private) or program that houses the
prisoner. Under the current system of research regulation, this
would mean that all 17 federal agencies that are signatories to
the Common Rule, any additional federal agencies, and any nonfederal sponsors of research would be required to comply with a

43
The term human research participant protection program (HRPPP) is used throughout this report to mean the network of entities with direct responsibility for the safety of
those enrolled in the studies carried out under its purview. The HRPPP most often includes the research organization, the study sponsor, investigator, IRB, and, when relevant, the data safety monitoring board (IOM, 2003). In the contexts described in this
report, prison research subject advocates would be an important part of this network as
well.

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newly drafted subpart C.44 All research involving prisoners,
therefore, would be registered with the Office for Human Research Protections. There is no justification for variability across
agencies and facilities regarding their approaches to protecting
the rights, health, and dignity of prisoners participating in human
subjects research, individuals who are among the most vulnerable human subjects of research.
The primary policy forming the basis of the DHHS regulations regarding the protection of human subjects is at 42 U.S.C. § 3515b (Prohibition on Funding Certain Experiments Involving Human Participants):
None of the funds appropriated by this Act or subsequent Departments of Labor, Health and Human Services, and Education,
and Related Agencies Appropriations Acts shall be used to pay
for any research program or project or any program, project, or
course which is of an experimental nature, or any other activity
involving human participants, which is determined by the Secretary or a court of competent jurisdiction to present a danger to
the physical, mental, or emotional well-being of a participant or
subject of such program, project, or course, without the written,
informed consent of each participant or subject, or a participant’s
parents or legal guardian, if such participant or subject is under
eighteen years of age. The Secretary shall adopt appropriate
regulations respecting this section.45
In addition, the Public Health Service Act contains more specific
statutes requiring IRB review as a precondition to funding.46 Because
the primary statute is explicit about being limited to research funded by
these departments, the comprehensive regulations promulgated by DHHS
regarding human participants are, in part, limited to research funded by
DHHS, which the secretary has full and unquestionable authority to
regulate.
44
Federal regulation of state and private research would be constitutionally permissible
by using, e.g., the federal spending power. See, e.g., South Dakota v. Dole, 483 U.S. 203,
211 (1987), upholding the constitutionality of a federal statute conditioning states’ receipt
of federal funds on adoption of a minimum drinking age of 21.
45
Prohibition on Funding Certain Experiments Involving Human Participants. 42
U.S.C. § 3515(b).
46
42 U.S.C. §§ 289, 289a-1.

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However, most of the Common Rule was also drafted to apply to research not funded by DHHS but regulated by the Department.47 The
catch is that the regulation defines research subject to regulation quite
narrowly as “those research activities for which a federal department or
agency has specific responsibility for regulating as a research activity
(for example, investigational new drug requirements administered by the
Food and Drug Administration).”48 Regulation in such a narrow area is
likewise on quite solid ground as a natural extension of its authority to
regulate the research activity.
The jurisdictional limits of these regulations demonstrate a conservative approach to regulation, limiting the scope of the regulations to those
areas where DHHS’s authority is unquestionable. Two issues remain:
whether DHHS presently has some implicit authority to regulate beyond
these two narrow areas (if it were willing to go beyond the specific authorization) and, if not, whether Congress could grant it such authority.
Existing Authority for Broader Regulation?
The authority for any regulation promulgated by an executive department such as DHHS must be traced to a statute authorizing DHHS to
create regulations in that area. In turn, the statutory authority for the executive department to create rules and regulations in a certain subject
area must be traced to a specific constitutional authority for the federal
government to oversee that area, because the federal government has no
general power to regulate. The DHHS authorizing statute is not entirely
clear (although it does not foreclose the possibility of regulation), but it
is clear that Congress could, if it so chose, expressly expand DHHS’s
authority to regulate human research subjects protection.
DHHS’s authorizing statute is actually an enactment of the 1953 reorganization plan transmitted by President Eisenhower, transferring the
responsibilities of the Federal Security Agency to the newly created
DHEW.49 DHEW was created “to improve the administration of the vital
health, education, and social-security functions now being carried on in

45 C.F.R. § 46.101(a)(2).
45 C.F.R. § 46.102(e) (emphasis added).
49
Establishment of Department; effective date. 42 U.S.C. § 3501.
48

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the Federal Security Agency.”50 The SSA and Department of Education
were originally agencies within DHEW; the Department of Education
was created in 1979 (at which point the department was renamed
DHHS), and the SSA was separated from DHHS in 1994. Thus, the remaining function of DHHS is dedicated to various health- and safetyrelated activities.
Can DHHS Be Granted Broader Authority?
Nevertheless, for reasons similar to why the FDA is constitutionally
possible, it is possible for DHHS to be given authority to regulate research involving human subjects.
The Constitution of the United States
The Congressional spending power derives from the Federal Constitution, which provides in pertinent part:
Section 8. The Congress shall have power to lay and collect taxes, duties, imposts and excises, to pay the debts
and provide for the common defense and general welfare
of the United States; but all duties, imposts and excises
shall be uniform throughout the United States . . ..
U.S. Constitution, Article I, Section 8, cl. 1.
The Scope of the Congressional Spending Power
For generations, the “spending power” has provided the legal basis
for legislation touching upon myriad subjects. The Court has long recognized the broad authority conferred under the Spending Clause.
“[W]hen money is spent to promote the general welfare, the concept of
welfare or the opposite is shaped by Congress . . ..” Helvering v. Davis,
301 U.S. 619 (1937).
South Dakota v. Dole, 483 U.S. 203 (1987) remains the primary
precedent for the authority of Congress to pass Spending Clause legisla50

Reorganization Plan No. 1 of 1953, 5 U.S.C. App. 1, 18 Fed. Reg. 2053, 67 Stat. 631
(March 12, 1953).

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tion. In that case, the Supreme Court upheld a federal statute that reduced federal highway funding to states with a minimum drinking age
below 21. The Court found that the legislation was sufficiently related to
the federal interest in promoting safe highway travel, and concluded that
the statute did not exceed Congress’s spending power under U.S. Const.
Art. I, § 8, cl. 1. Id. at 208 – 209. The Supreme Court affirmed the
broad scope of the spending power, though it acknowledged that congressional authority is limited in the following ways:51
The first of these limitations is derived from the language of the
Constitution itself: the exercise of the spending power must be in
pursuit of “the general welfare.” In considering whether a particular expenditure is intended to serve general public purposes,
courts should defer substantially to the judgment of Congress.
Second, we have required that if Congress desires to condition
the States’ receipt of federal funds, it “must do so unambiguously . . . , enabl[ing] the States to exercise their choice knowingly, cognizant of the consequences of their participation.”
Third, our cases have suggested (without significant elaboration)
that conditions on federal grants might be illegitimate if they are
unrelated “to the federal interest in particular national projects or
programs.” Finally, we have noted that other constitutional provisions may provide an independent bar to the conditional grant
of federal funds.
South Dakota v. Dole, 483 U.S. 203, 207 - 208 (citations and footnote omitted). Considering the legislation at issue – limiting the drinking
age – was considered sufficiently related not only to the general welfare
and to the states’ receipt of federal highway funds, these “limitations” are
51
A more recent Spending Clause case is Rumsfeld v. Forum for Academic and Institutional Rights (FAIR), WL 521237 (US Sup. Ct. March 6, 2006). This case held, among
other things, that universities that accept federal money could not refuse to allow the
military to recruit on campus, even if military hiring and retention policy violated the
university’s own regulations on sexual orientation discrimination. However, this was
based on both the Spending Power (Art. I Sec. 8, Cl 1), and the Power to Raise Armies
(Art. I, Sec. 8, Cl. 12). The Court held that Congress had the constitutional authority
(i.e., in order to raise armies) to directly impose restrictions regarding access of military
recruiters, regardless of funding, so it certainly had the power to do so as a condition of
providing the funding. As such, it does not provide a good test of the limits of Spending
Clause authority.

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evidently not exceedingly rigorous. In sum, it is clear that Congress has
well established and broad authority to condition federal funding upon
acceptance of specified conditions that, in a general sense, pertain to the
purpose of the legislation.52
The Spending Power is a familiar basis for congressional action.
There are numerous examples of legislation – for example, Title VI of
the Civil Rights Act, Title IX of the Education Amendments, § 504 of
the Rehabilitation Act, and The Religious Land Use and Institutionalized
Persons Act of 2000, 42 U.S.C. § 2000cc, et seq. (2000) – all of which
contain conditions based on the Spending Clause power. One particularly
pertinent example of Spending Power legislation is The Prison Rape
Elimination Act of 2003 [PREA] (42 U.S.C. § 15601, et. seq.). Section
15605 (d) of PREA provides in pertinent part:
(d) Applications.
(1) In general. To request a grant under this section, the chief
executive of a State shall submit an application to the Attorney General at such time, in such manner, and accompanied
by such information as the Attorney General may require.
(2) Contents. Each application required by paragraph (1)
shall—
(A) include the certification of the chief executive that
the State receiving such grant-(i) has adopted all national prison rape standards that, as
of the date on which the application was submitted, have
been promulgated under this Act [42 U.S.C. §§ 15601, et
seq.] . . ..
52
In the recent assisted suicide case, Gonzales v. Oregon, 126 S.Ct. 904, 923 (2006),
the United States Supreme Court acknowledged the power of Congress to “set uniform
national standards in regulating health and safety,” including (hypothetically) the practice
of medicine. The Court ultimately rejected the federal government’s argument that the
Controlled Substances Act trumped the authority of doctors to prescribe lethal doses of
medication under state law because the federal statute did not reveal a congressional intent to override traditional state regulation of medical practice. See also, Gonzales v.
Raich, 125 S.Ct. 2195 (2005) (noting that Congress can regulate the channels, the instrumentalities, and activities that substantially affect interstate commerce).

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This legislation conditions the release of federal funds upon fairly
demanding and relatively intrusive terms, but because of the conditional
nature of spending power legislation, it likely would withstand a legal
challenge under principles articulated by the United States Supreme
Court.53
Spending Power legislation could easily be used to require compliance with the DHHS regulations in state as well as federal institutions.
Every state receives federal assistance for corrections (U.S. Census Bureau, 2006), and that assistance is itself based, at least in part, on Spending Clause legislation.54 Hence, if Congress were so inclined, it could
enact legislation (or amend the existing legislation) to require the state
agency’s adoption of a regulatory scheme governing the involvement of
prisoners in research as a condition for receiving the federal funds.
There are many rationales that would likely be sufficient justification for
such legislation. For example, the federal government’s interest in
“set[ting] uniform national standards in regulating health and safety,” as
articulated in Gonzales v. Oregon, 126 S.Ct. 904, 923 (2006), and in particular, in ensuring reliable results from health sciences research, would
be sufficient. This assisted suicide case addressed Congress’s more limited authority to directly impose requirements, but the interest articulated
by the Court would be sufficient to impose conditional requirements.
Additionally, the PREA was based in part on the federal government’s
interest both in ensuring states do not violate prisoners’ federal civil and
constitutional rights by their deliberate indifference to the problem of
prison rape, and its interest in ensuring the “effectiveness and efficiency”
of federally-funded research and grant programs relating to health care
and other prisoner-related research, which (Congress stated) were compromised (directly and indirectly) by state officials’ failure to monitor
and address the problem of prison rape. 42 U.S.C. § 15601 (13-14).
Clearly these rationales would also support legislation requiring states to
impose (at a minimum) the ethical limitations on research required by
DHHS, as a condition of receiving the same federal funding.
The regulations could only be imposed in this manner if the states
did in fact accept the federal funding. However, because the federal
53

No cases could be found in which Congress’s authority to pass the PREA had been
challenged.
54
The legislation is the Edward Byrne Memorial State and Local Law Enforcement Assistance Program, PL 100-690 (BJS, 2001).

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government only seeks to require the states to establish the same ethical
regulations as those promulgated by DHHS, and not to spend money on
any new programs, the committee is confident that the states would
choose simply to enact the DHHS regulations rather than foregoing substantial federal monies to avoid compliance.
Alternatives to Comprehensive Regulation
If a change in the statutory authority for these regulations is not possible (either constitutionally or practically), DHHS might, at a minimum,
work with the FDA (and perhaps the BOP) to develop regulations for
research involving prisoners, which the FDA might then consider adopting (either in whole or in a modified form) for all research within its jurisdiction. The result would be uniform regulation by the FDA of all
research relating to pharmaceuticals, medical devices, and other products
within FDA’s jurisdiction, both in state and federal prisons, supplemented by DHHS’s regulation of federally supported research. Although
not ideal, this framework may still reduce the amount of patchwork regulation applicable to research involving prisoners and be a step toward
uniformity of ethical standards used in biomedical research in the prison
setting. However, the more desirable approach, which the committee
recommends (i.e., to establish a uniform set of guidelines for all research
involving prisoners), will require congressional action.
REFERENCES
BJS (Bureau of Justice Statistics). 2001. Justice Variable Passthrough Data,
1997 (NCJ 190359). Washington, DC: U.S. Department of Justice.
BJS 2005. Prison and Jail Inmates at Midyear 2004 (NCJ 208801). Washington,
DC: U.S. Department of Justice.
BOP (Bureau of Prisons). 1999. Program Statement 1070.07. [Online]. Available: http://www.bop.gov/DataSource/execute/dsPolicyLoc [accessed March
27, 2006].
BOP. 2005. Program Statement 6031.01. [Online]. Available: http://www.bop.
gov/DataSource/execute/dsPolicyLoc [accessed March 27, 2006].

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Gorey J. 2005. Statement of Task: Committee on Ethical Considerations to
DHHS Regulations for Protection of Prisoners Involved in Research. Presented at the Institute of Medicine Meeting 4 of the Committee on Ethical
Considerations to DHHS Regulations for Protection of Prisoners Involved in
Research, Washington, DC.
IOM (Institute of Medicine). 2004. The Ethical Conduct of Clinical Research
Involving Children. Washington, DC: National Academies Press.
NBAC (National Bioethics Advisory Commission). 2001. Ethical and Policy
Issues in Research Involving Human Participants. [Online]. Available:
http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf [accessed March 27, 2006].
NIJ (National Institute of Justice) Introduction to Human Subject and Privacy
Protections at the National Institute of Justice [Online]. Available: http://
www.ojp.usdoj.gov/nij/funding/humansubjects/hs_01.html [accessed April 11,
2006].
PHS (Public Health Service). 1966. Clinical investigations using human subjects. In Final Report (Supplemental Vol. I). Washington, DC: U.S. Government Printing Office. Pp. 475–476.
SACHRP (Secretary’s Advisory Committee on Human Research Protections).
2005. Report of the Subpart C Subcommittee to SACHRP, April 18, 2005
[Online]. Available: http://www.hhs.gov/ohrp/sachrp/mtgings/present/Subpart
C.htm [accessed March 27, 2006].
U.S. Census Bureau. 2006. Federal Aid to States for Fiscal Year 2004. U.S.
Government Printing Office, Washington, D.C.

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4
Defining Prisoners
and Correctional Settings

This chapter provides the committee’s recommendation for new
definition of “prisoner,” which considers the contexts, or “places,” relevant to research with prisoners. The goal of this definition is to expand
the reach of the regulatory procedures and oversight mechanisms recommended in this report to the fuller population of individuals who are
under restricted liberty and, therefore, face potentially greater risks than
the general population when participating in research. It identifies the
personal interests that may be violated because of research participants’
status as prisoners1 and the settings in which protections against such
potential violations are required. As a point of departure, this chapter
briefly reviews the ethical foundations that underpin research regulations
and current regulatory language relevant to prisoner settings and notes
the relevant ethical principles that led the committee to expand the definition of prisoner for purposes of protecting those involved in research.
ETHICAL FOUNDATIONS OF CURRENT
RESEARCH REGULATIONS
The ethical foundations of research protections in the United States
are based on two key ethical considerations identified by the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research (NCPHSBBR, 1976). They are respect for persons
1

Using the place-centric term “prisoner” to define individuals also found outside of the
typical prison setting may be confusing to some readers. This definition is aimed, however, at a systemic approach to oversight of research involving those subject to restricted
liberty through the criminal justice system.

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and justice. The principle of respect for persons invokes the protection of
individuals’ autonomy and personal dignity and requires that informed
and voluntary consent be obtained from subjects before their involvement in research. This basic principle is often difficult to implement in a
correctional setting because of the power dynamics and inherent deprivations within such a setting, especially with respect to voluntariness. Privacy and confidentiality play central roles within the principle of respect
for persons as well. The principle of justice concerns the fair treatment of
persons and groups. In the context of research involving prisoners, justice requires that prisoners not bear a disproportionate share of the research burden without a commensurate share of benefit, and also that
prisoners have the freedom to decide questions of research participation
for themselves. Justice becomes particularly important to encouraging
research on a system that disproportionately affects the disadvantaged
and racial and ethnic minorities (Chapter 2).
The competence and freedom of a prisoner to make a choice as well
as the reality of privacy protection through confidentiality can be hampered in any of the correctional settings that restrict liberty, whether by
the correctional officers or other prisoners within the prison walls or by
probation officers, for example, in the community. If, for instance, researchers plan to study the effectiveness of electronic monitoring as
compared with parole supervision, a system of oversight should be in
place to protect the persons involved in the study—who currently are not
covered under Supart C protections. An expanded definition of prisoner
is offered in this chapter. A fuller description of the ethical framework
followed by the committee is found in Chapter 5.

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CURRENT REGULATIONS PERTINENT TO
PLACES OF PRISONER RESEARCH
In Subpart C of 45 C.F.R. § 46.303(c) (DHHS, 2005), prisoner is defined as:
Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to an institution under a criminal or civil statute,
individuals detained in other facilities by virtue of statutes or
commitment procedures which provide alternatives to criminal
prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. (emphases
added)
The current regulations clearly emphasize custodial confinement as a
consequence of the state’s exercise of its power via the criminal justice
system. The potential impact of confinement in highly controlled institutional settings on individual autonomy is explicitly recognized in other
sections of the current regulations. For example, 45 C.F.R. § 46.305
(a)(2)-(7) (DHHS, 2005) includes the following regarding the issue of
voluntariness to ensure that the subject’s participation in the research is
not coerced:
●

●
●

any possible advantages accruing to the prisoner through his
or her participation in research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison are not of such
magnitude that his or her ability to weigh the risks of the research against the value of such advantages in a limited
choice environment of the prison is impaired;
the risks involved in the research are commensurate with
risks that would be accepted by nonprisoner volunteers;
adequate assurance exists that parole boards will not take
into account participation in making parole decisions, and
prisoners will be informed that participation will have no effect on parole.

IRBs, however, have received guidance from OHRP that suggests
the definition may include parolees but not probationers. There is clearly

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confusion as to the parameters of the definition as it stands today. The
important issue, as noted by the National Commission is that “prisoners
are, as a consequence of being prisoners, more subject to coerced choice
and more readily available for the imposition of burdens which others
will not willingly bear” (NCPHSBRR, 1976, p. 8).
CORRECTIONAL SETTINGS ENCOMPASS MORE THAN
PRISONS AND JAILS
Although this committee believes that research in correctional institutional settings should be subject to federal regulations, it also believes
that the present emphasis on custodial detention is too narrow and results
in depriving many other justice-involved individuals of human subjects
protections appropriate to prisoner research participants. Several tables in
Chapter 2 provide details relevant to this issue. Table 2-1 provides a
broad snapshot of the number of individuals within the correctional
population and notes that, as of December 2003, only 2.1 million of the 7
million total correctional population were in prisons and jails (BJS,
2004). The rest had restricted liberties but outside the razor wire, in programs such as those listed in Table 4-1. These 4.9 million individuals (up
from 1 million in 1978) require special protections when participating in
research as well. Table 4-2 illustrates the vast array of incarceration options within the state of California and details a long list of alternatives to
incarceration offered, including community service, electronic monitoring, and probation.
TABLE 4-1 Alternatives to Incarceration that May Be Available to Offenders
Program
Bail supervision programs

Description
While awaiting trial, the accused, rather than
being held in custody, is supervised by a member of the community.

Alternative measures
programs

The offender is diverted from the criminal justice
system before or after being charged. The offender enters into a kind of contractual agreement
to answer for the crime. The agreement can include community service work, personal service
to the victim, charitable donation, counseling, or
any other reasonable task or condition.

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Program
Restitution programs
Community service order

Description
The offender must pay back the victim for damages or loss. A condition on a probation order,
or a separate disposition in the case of young
offenders, that requires the offender to perform
work in the community.

Probation

The offender is supervised in the community and
follows the set of conditions (rules) set out in the
probation order. Conditions of probation include
keeping the peace, good behavior, obeying the
law, and reporting regularly to a probation officer
and may include a range of other, optional conditions.

Intensive supervison
probation

An alternative to incarceration in the United
States similar to probation but which involves
more frequent surveillance and greater controls.

Eletronic Monitoring

Offenders are fitted with an anklet or bracelet
that transmits signals of their whereabouts to the
correctional officer, allowing offenders to continue with employment or education commitments in the community.

Parole

A period of conditional community supervision
after a prison term. If the conditions of supervision are violated, the parolee can be returned to
prison to serve any of the remaining portion of
the sentence.
● Discretionary parole exists when a parole
board has authority to conditionally release
prisoners based on a statutory or administrative determination of eligibility.
● Mandatory parole generally occurs in jurisdictions using determinate sentencing statutes
in which inmates are conditionally released
from prison after serving a specified portion
of their original sentence minus any good
time earned.

SOURCE: Adapted from the John Howard Society of Alberta. 1998. Community Corrections. [Online]. Available: http://www.johnhoward.ab.ca/PUB/C29.htm [accessed June
27, 2005].

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TABLE 4-2 Descriptions of Various Criminal Justice Agencies and Facilities in California
Facility

Description

Reference

Facilities supervised by department of corrections or camps division
State facilities
State prisons
Provides housing for
California penal code §
persons committed to
2000 –2048.7, 4504,
DOC
welfare and institutions
code § 1753–1760
City or county facilities
California penal code §
Facilities used to hold
City facilities
4004.5
prisoners for examination or trial
County jails, farms,
camps

Persons committed on
criminal process and
detained for sentencing
or already convicted.

California penal code §
4000, 4050, 4100,
6031.4

Regional jail camps

Provides housing for
persons sentenced to
long jail terms

Californa penal code §
6300–6304

Youth correctional
centersa

Provides treatment for
young offenders assigned to CYA or DOC
administration by the
county

Penal code § 6250–
6253, welfare and institutions code § 1850–
1852

Community correctional Contact facilities providing housing for persons
centersa
committed to DOC

Penal code § 6250–
6253, welfare and institutions code § 3307–
3310

Temporary emergency
detention facilities a

CYA facilities for
county commitments
< 18 years of age

Welfare and institutions
code § 1752.15

Conservation centers,
forestry camps

Provides housing and
work assignments for
persons committed to
DOC and CYA

Penal code § 6200–
6203, welfare and institutions code § 1760.4

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Facility

Description

Reference

Restitution centersa

Provides housing for a
select group of persons
committed to DOC with
restitution orders

Penal code § 6220–6228

Community treatment
programsa

Prisoners mother program houses women
who have 1 or more
children < 6 years of age

Penal code § 3410–3416

Facilities supervised by DOCs
Penal code § 6258, 6259
Community correctional Contract facilities for
persons committed to
reentry centers
DOC who have < 120
days left to serve
Work furlough programs Contract facilities for
persons committed to
DOC who are within
120 days of release

Penal code § 6260–6263

Halfway houses

Contract facilities in
metropolitan areas used
for persons committed to
DOC who are addicted

Welfare and institutions
code § 3153

Substance abuse
correctional detention
centers

Facilities operated
jointly by the state and
county with primary
funding for construction
from the state, persons
committed to DOC will
use ≥ 50% of total beds

Penal code § 6240–6242

Substance abuse
treatment control unit

Provides housing for
persons committed to
DOC or CYA who are
on parole and are addicted or in imminent
danger of addition; DOC
and CYA facilities are
separate; 90-day maxi-

Health and safety code §
11560–11563

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Facility
Parole DOC

Description
mum stay; “dry-out
beds”
Authority and
requirements related to
DOC power to parole

Reference
Penal code § 3040–3071

NOTE: DOC, Department of Corrections; CYA, California Youth Authority.
a
Facilities authorized by the California Penal Code for the placement of adult offenders,
which provide additional community corrections alternatives.

According to the Bureau of Justice Statistics (BJS, 2001), among
state parole discharges in 1999, 43 percent were returned to prison, a statistic relatively unchanged since 1990. This high rate of return to incarceration demonstrates that significant power dynamics continue for
persons who are outside the prison walls but still under some form of
community correction. Thus, the element of voluntariness in the informed consent process is conceptually very similar for persons incarcerated and those under some form of disposition alternative to
incarceration.
A logical system of oversight would expand the definition of prisoner to include parole and probation. There is little logic in providing
protections, as do the current regulations, to a person detained before
trial and not yet convicted of a crime, but not to a person who has been
convicted of a crime and is subject to incarceration because of violations
of parole or probation conditions. The expanded definition is also supported by the findings of one researcher that policing whether conditions
are violated (with more drug tests, more tracking of movement, etc.) is
becoming more of a priority for parole officers than promoting reintegration (Petersilia, 2000).
PROPOSED DEFINITION OF PRISONER
This section articulates the committee’s revised definition of prisoner, which places an emphasis on liberty restrictions resulting from the
interactions with the criminal justice system. These restriction includes,
but are not limited to, custodial confinement. The aim is to expand the
reach of regulations to protect prisoners and others with restricted liberty.
Such an individual may be ordered to reside in settings in which
freedom of movement is restricted (e.g., precinct holding pen, jail,

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prison, halfway house or prerelease center) or in the community under
constraints ordered by the criminal justice system (e.g., probation, parole
or house arrest, drug court sentence).
Recommendation 4-1 Redefine “Prisoners” to Expand the
Reach of Human Subjects Protections
The Department of Health and Human Services and other
relevant agencies that write, implement, or enforce regulations
pertaining to research with prisoners should expand the definition of “prisoner” to include all settings, whether a correctional institution or a community setting, in which a person’s
liberty is restricted by the criminal justice system.
It is not custodial confinement alone that creates the potential for
coercion and threatens an individual’s right to autonomous decision making (consent or refusal to participate in research). Rather,
it is restrictions of freedom or the imposition of other sanctions by
an agent of the criminal justice system who observes, scrutinizes,
supervises or monitors, and ultimately determines the imposition
of punishments for an individual’s behavior. Persons on parole
and others subject to limits on liberty or privacy are particularly
vulnerable to the risk of reinstitutionalization based on decisions
made by parole officers and other personnel of the criminal justice
system. This threat to independence creates the potential for coercion and requires that prisoners be afforded additional levels of research protection as well. Note that persons who become prisoners
while in a nonprisoner study must also be afforded special protections on entering a correctional setting.
A prisoner, for the purposes of this report, is any person whose liberty is restricted as a result of the interaction with the criminal justice
system. Although the limitations on personal choice and control are perhaps most evident and oppressive in locked detention facilities (e.g.,
jails, prisons), the power differential between criminal justice agents and
prisoners exists in many other contexts as well; the differences are a matter of degree. Individuals involved in a wide variety of community-based
criminal justice programs, ranging from probation and parole to pre- or
post-adjudication diversions such as drug courts or mental health courts,
are subject to coercion by the array of agents (e.g., parole or probation
officers, diversion program counselors) who monitor their compliance
with program requirements and who may invoke further sanctions for

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program failure or noncompliance. Thus, one can fall within the protections recommended by this committee by virtue of being ordered by the
criminal justice system to reside in a confined setting or, if living in the
community, by virtue of the restrictions on individual decision making
imposed by some part of the criminal justice system. In order to be a
prisoner, there must be some nexus or connection between the setting or
restricted liberty of the person and the action of the criminal justice system. For all individuals who meet this definition, regulations that govern
research with prisoners should be applied. The current statutory or constitutional distinctions between the civil and criminal processes, which
are evolving, are not sufficiently clear to allow an easy determination of
whether the proposed systems of protection should apply. For instance,
juveniles confined under orders of family court (or the equivalent, such
as a juvenile court) likely require additional protections, but an analysis
of their needs is beyond the scope of this report. If, however, they are
transferred from the original jurisdiction of the family court (or the
equivalent, such as a juvenile court) to the jurisdiction of a state or federal criminal court, then they would fall under this definition. Other types
of confinement on the civil/criminal frontier that our definition encompasses include commitment by reason of an acquittal on the grounds of
insanity and commitment as sexual offender (e.g., so-called criminal
sexual psychopaths or violent sexual predators) under various state laws.
However, those persons whose confinement is the result of other civil
proceedings, such as those designed to protect a mentally ill person from
harming self or others, would not be covered by our system of protections. There are substantial ethical issues involved in conducting research
with these populations that go beyond the scope of this report. Parallel
studies, such as the ones undertaken by this committee, may be needed to
explore ethical issues of research involving these groups.
DELINEATION OF SETTINGS
In the interest of clarity, the committee specifies an array of settings
in which regulations governing research with prisoners should apply, as
well as a brief listing of settings for which the recommended regulations
are not considered necessary. Some cases may arise that are not specifically addressed, and these must be decided on a case-by-case basis. Further discussion of research gradation and level of risk, which determine

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the study design and monitoring safeguards required, is provided in
Chapter 6.
When Proposed Regulations Should Apply
Settings/situations in which proposed regulations governing research
with prisoners should apply are as follows:
●
●
●

●

●
●

●

state or federal prisons (including, e.g., camps, farms, boot
camps);
any jail or detention facility (e.g., municipal, city, county, federal);
any community-based criminal justice supervision program such
as bail or bond supervision, parole, or probation; community correctional re-entry centers; work furlough programs; halfway
houses; or similar programs;
any community-based alternative disposition program, including
(but not limited to) restitution programs, community service programs, or participation in other activities deemed to constitute
punishment or other mandatory activities resulting from being
sentenced;
inpatient or outpatient psychiatric treatment settings if an individual is involuntarily committed as a result of a finding of not
guilty by reason of insanity;
treatment settings for any person who, having served a sentence
for a sex offense, is subsequently deemed to meet criteria for involuntary commitment under various criminal sexual psychopath
or violent sexual predator (or equivalent) statutes in a civil proceeding;
placement or participation in a community residential drug, alcohol, or mental health treatment program, day program, or partial-day program if mandated by a criminal court as part of an
order for conditional release or sentencing; and
participation in a drug court, mental health court, or other criminal justice specialty court that functions to divert arrested or
convicted individuals into substance abuse or mental health service programs.

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When Proposed Regulations Should Not Apply
Settings/situation in which proposed regulations governing research
with prisoners would not apply are as follows:
●

●

individuals committed to involuntary inpatient psychiatric or
substance abuse treatment, or to any form of mandated community treatment, by the order of a juvenile, civil, or probate court
(as stated earlier in this chapter, juveniles likely need additional
protections, but this committee was not equipped to address their
specific needs);
individuals living in a noncustodial community setting who meet
the above definition of prisoner but whose status as a prisoner is
not relevant or related to their enrollment in a particular community-based research project. This means that the criminal justice
agent or agency having supervisory jurisdiction over the individual was not involved in the plans for study enrollment, and the
study itself does not include prisoner status as a criterion for participation. This exclusion permits prisoners living in the community to enroll in research that is open to any citizen in the
community (e.g., hospital or medical school-based clinical trials,
survey studies) without imposing the restrictions of the proposed
regulations on those research entities.
WHEN LIBERTY STATUS CHANGES

If the subject’s liberty status changes through arrest or revocation of
probation or parole, and the person is then confined in a custodial setting,
do the provisions of Subpart C become applicable to the subject? The
committee’s answer was yes, regardless of the nature of the research.
Upon entering a custodial setting, that person becomes formally and in
every way a prisoner, subject to the same constraints and concerns that
the committee has expressed in this report, and therefore needs the same
safeguards. There is no ethical justification for providing fewer safeguards for a new entrant into prison than those already in prison.
This does not mean, however, that study participation would be
automatically terminated. It means that continued participation requires a
new review of that prisoner’s participation in the study. The original institutional review board (IRB) should review the impact of the correc-

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tional setting on the procedures, with input from the IRB affiliated with
the correctional setting. It should be done in an expedient manner (e.g.
within 30 to 45 days) to allow for continuation of study participation.
Continuity of care is an important issue, especially for treatment
studies. If terminating prisoner participation would adversely affect the
health of the subject, participation may continue until the IRB review
takes place. The custodial official receiving the prisoner should be informed that the prisoner is enrolled in a research protocol, provided information on the protocol, and explained the potential risks of not
allowing continued participation. The researcher would have an obligation to advocate for providing the appropriate care while seeking to comply with regulations applicable to that setting.
Certain social/behavioral studies that, for example, examine health
and risk behaviors over several years, may see some participants move
into correctional settings. If the researchers wish to continue study involvement for those individuals, review would be necessary to weigh the
risks and benefits within the new setting. If the risks remain low, continuation may be approvable. However, if new risks are foreseen, but
they are still low, the consent may need to be updated for the participant’s continued involvement.
This need for review may not be an issue for many jailed detainees
who are often incarcerated for just a few days if that short period does
not affect participation in the protocol. In a related, but different situation, if a prisoner is participating in a study within a correctional setting
and is transitorily confined to disciplinary segregation, the researcher
will have to evaluate whether or not the potential interruption in access
during the period of segregation would preclude continued participation.
Research studies lose participants for many reasons. There may be
occasions in which participation in the study may not continue for the
research participant who becomes incarcerated. For example:
1. The IRB may determine that the risks outweigh potential benefits to remaining in the study.
2. By statute, some states do not permit biomedical/clinical trials
research in prisons.
3. By Department of Corrections policy, some states do not permit
biomedical/clinical trials research in prisons.

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REFERENCES
BJS (Bureau of Justice Statistics). 2001. Trends in State Parole, 2000. [Online].
Available: http://www.ojp.usdoj.gov/bjs/pub/pdf/tsp00.pdf [accessed December 23, 2005].
BJS. 2004. Probation and Parole in the United States, 2003. [Online]. Available: http://www.ojp.usdoj.gov/bjs/pub/pdf/ppus03.pdf [accessed December
23, 2005].
NCPHSBBR (National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research). 1976. Research Involving Prisoners
(DHEW Pub. No. (OS) 76-131). Washington, DC: U.S. Department of Health,
Education, and Welfare.
Petersilia J. 2000. Challenges to prisoner reentry and parole in California. California Policy Research Center Brief Series http://www.ucop.edu/cprc/parole.
html [accessed April 4, 2006].
U.S. DHHS (U.S. Department of Health and Human Services). 2005. Code of
Federal Regulations: Title 45. Public Welfare. Part 46: Protection of Human
Subjects. Washington, DC: U.S. DHHS.

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5
The Ethical Framework
for Research Involving Prisoners

In 1976, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR) addressed
the ethics of research with prisoners in a document entitled Report and
Recommendations: Research Involving Prisoners. The commission focused on respect for persons and justice as the two key ethical considerations that would guide their recommendations.
The intervening decades have offered few reasons to quarrel with the
commission’s identification of these two factors as fundamental ethical
principles guiding the conduct and regulation of research with prisoners.
The goal of this chapter is to demonstrate that the principles of justice
and respect for persons, although having evolved in meaning over the
past three decades, should still be the basis for determining whether to
conduct research with prisoners.
As part of this ethical evolution, the committee suggests that collaborative responsibility should be added to an updated ethical framework as
a derivative of the principle of justice. The national commission thought
of justice as primarily a matter of the distribution of the benefits and burdens of research, and that is certainly a legitimate understanding. Recent
scholarship has offered reason to elevate some other concerns under the
heading of justice. In particular, attention to distributive justice should be
complemented by attention to the needs and responsibilities of all parties
who will be involved with or affected by a research endeavor.
This focus on collaboration will more effectively facilitate the implementation of ethical research. In order for research to be truly ethical,
it must be tailored to the individual setting; a one-size-fits-all approach is
inadequate. Every research setting and population presents unique challenges and concerns. Ethically appropriate subject protections in one in133

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stitution may be grossly inadequate in another. Only through close cooperation and communication with all relevant parties, in every implicated
setting, can researchers ensure that they are creating ethical conditions
that are favorable for respect and unfavorable for exploitation in any research context.
THE 1976 COMMISSION’S ETHICAL FRAMEWORK
Historical Context
The commission’s deliberations took place against a background that
included the Nazi experiments with concentration camp prisoners followed by the adoption of a stringent standard of voluntary consent in the
Nuremburg Code. Many interpreted the code’s statement that potential
subjects “be so situated as to be able to exercise free power of choice,
without the intervention of any element of force, fraud, deceit, duress,
overreaching, or other ulterior form of constraint or coercion” (U.S.
GPO, 1953, p. 181) as precluding participation by prisoners.
This thinking was reinforced by publicity about the realities of research in prisons. The late 1960s and early 1970s saw a series of exposés
documenting abuses in connection with nontherapeutic research in U.S.
prisons (Mitford, 1973a,b; Rugaber, 1969). Many of those who were
most vocal about the plight of prisoners (i.e., journalists and prisoner
advocacy and civil liberties groups) saw research with prisoners largely
under the twin headings of coercion and exploitation (Mitford, 1973a,b;
Rugaber, 1969). For the most part, these groups pushed for restriction
rather than reform of the prison research enterprise.
Although the commission did not recommend a ban on all research
with prisoners, their work and the subsequent scholarship and regulation
have been described as tending toward that result: “The result of these
regulations has been, as was their goal, the virtual elimination of biomedical research activity in prisons and jails” (Dubler & Sidel, 1989,
p.185) According to one informed estimate, in the late 1990s only about
15 percent of institutions that engaged in clinical research in the United
States included prisoners in their research protocols (Hoffman, 2000). In
1997, New York State had the largest estimated number of HIV-infected
prisoners of any prison system (9,456), but only 8 (less than .001 percent) were enrolled in clinical trials (Lazzarini and Altice, 2000).

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Justice and Respect for Persons
The commission’s emphasis on limiting research involving prisoners
was guided by its choice of ethical framework. Congress’s charge to the
commission concerning research with prisoners identified informed consent as the primary locus of ethical concern. In particular, Congress directed the commission to attend to three components of informed
consent: (1) nature of the consent; (2) adequacy of the information given;
and (3) competence and freedom of the prisoners or their legal representatives to make a choice.1
In carrying out this charge, the commission used elements of a principle-based ethical framework that would be more fully fleshed out in the
Belmont Report. The commission identified two basic ethical dilemmas
arising in connection with the use of prisoners as research subjects and
linked these dilemmas to two basic ethical principles (NCPHSBBR,
1976, p. 5). The first issue was whether prisoners bear a fair share of the
burdens of research and receive a fair share of the benefits. The commission linked this dilemma to the principle of justice, specified as the fair
treatment of persons and groups. The second issue was whether prisoners
could give truly voluntary consent. The commission linked this dilemma
to the principle of respect for persons, specified as involving the protection and promotion of personal autonomy. The principles of beneficence
and non-maleficence (providing benefit and doing no harm) were not
discussed by the commission in its report on prison research; however,
they were prominently featured in the Belmont Report, and both maintain an underlying importance in the ethics of human subjects research.
These concepts have been well developed in other works (Beauchamp
and Childress, 2001).
The commission then reviewed two possible perspectives on prisoner
participation in research involving two very different interpretations of
respect for persons and justice. According to the first perspective, the
principles of respect for persons and justice require that prisoners not be
deprived of the opportunity to volunteer for research. Here the emphasis
is on the freedom of prisoners to decide questions of research participation for themselves and on the possible benefits of research participation.
According to the second perspective, the principles of respect for
persons and justice require (1) that prisoners be protected from exploitation, safeguards be introduced to reduce elements of constraint, and,
1

National Research Act (Public Law 93-348 (1974); 88 Stat. 348), section 202(a)(2).

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when that proves impossible, participation be prohibited; and (2) that
prisoners as a group not bear a disproportionate share of research burdens without a commensurate share of benefits. Here the emphasis is on
structural conditions that create special vulnerabilities in prison populations and the possible burdens of research participation. The commission
adopted the second perspective.
The commission explicitly stated that its stance was influenced by its
understanding of the realities of prison life, including conditions of social
and economic deprivation and the possibility or even likelihood of manipulation or corruption on the part of prison authorities and prisoners in
positions of privilege. Recognizing that they were inclining toward protectionism, the commissioners commented that “should coercion be lessened and more equitable systems for the sharing of burdens and benefits
be devised, respect for persons and concern for justice would suggest that
prisoners not be deprived of the opportunity to participate in research”
(NCPHSBBR, 1976, p. 8).
Flowing from this protectionist perspective, the commission’s ethical
framework and current federal regulations permit therapeutic research2
with prisoners as long as multiple safeguards are in place, but they do not
encourage or provide incentives for therapeutic research with prisoners.
The perception that all forms of research involving prisoners are equally
ethically problematic, or subject to blanket prohibition or to conditions
so onerous that the research is not worth doing, may be responsible for
the dwindling of prisoner research participation to the point that justice
concerns have been expressed about the exclusion of prisoners from
clinical trials.
AN UPDATED ETHICAL FRAMEWORK
The committee developed a new ethical framework that utilizes the
ethical principles applied by the national commission in the 1976, with
several new, important components. The framework builds on the principles of respect for persons and justice by shifting from a categorical approach to review to a risk-benefit analysis approach, and by adding a

The commission thought use of the term “therapeutic research” aided and abetted the
therapeutic misconception and substituted the more precise but more unwieldy expression
“research on practices which have the intent and reasonable probability of improving the
health or well-being of the subject.”

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derivative of justice, called collaborative responsibility to research proposal development.
Ideas about justice and respect for persons have evolved over the
past three decades. To construct a comprehensive ethical framework for
thinking about research in prisons, this chapter explores recent research
ethics scholarship.3 Changes in the way these principles have been conceptualized have influenced the shape of our recommendations. However, before beginning to address how this new ethical framework is
different than that of the original commission, it is important to stress
that it does not deviate from their core ethical principles.
Respect for persons requires that research subjects be treated as
autonomous individuals. As discussed in Chapter 1, it is clear that prisoners are still an extremely vulnerable population, with severely restricted autonomy; thus, this issue requires special attention. Prisoners
still need to be protected from the risk of coercion, undue inducement,
and exploitation. The historical pattern of research abuses in prisons underscores the need to have an ethical framework that, first and foremost,
is concerned with the welfare of prisoners. Similarly, justice still requires
a careful consideration of the fair distribution of burdens and benefits.
Prisoners, as a vulnerable population, are in jeopardy of receiving a disproportionate share of the risk associated with human subjects research.
As stated by the National Bioethics Advisory Commission, “In research
involving human subjects, risk is a central organizing principle, a filter
through which protocols must pass (NBAC, 1998, p. 89). Like the original commission, our recommendations start with a baseline ethical concern for the protection of prisoners.
Respect for Persons

In this section, the committee expresses its support for a broadened view of the principle of respect for persons, to consider more
than a narrow focus on informed consent issues, which are still vital but not the whole picture. It also suggests a shift from a categorical approach to research review to a risk-benefit approach.

Other concepts, such as coercion, undue inducement, exploitation, and choice, remain
important ethical considerations but will not be discussed in this chapter.

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An Expanded View of Respect for Persons
In accord with its emphasis on the principle of respect for persons,
the original commission’s report focused on informed consent. Although
informed consent is still an ethically important means of ensuring respect
for the right of persons to engage in autonomous decision making, recent
scholarship has questioned the myopia caused by such a narrow focus.
Kahn, Mastroianni, and Sugarman (1998) are the editors of a volume
that captures a major research ethics reform agenda in its title: Beyond
Consent: Seeking Justice in Research. One question the editors raise is
whether research ethics has been too concerned with informed consent to
the neglect of other matters. There seems to be agreement from a variety
of perspectives that informed consent forms have consumed too much
time and energy. Critics of the preoccupation with forms are not necessarily interested in shifting attention away from informed consent.
Rather, they may emphasize that documentation should be but a part of
an informed consent process that involves opportunities for questions
and answers and allows time for reflection before a decision is made, and
that more attention should be paid to ameliorating basic power and
knowledge differentials, which may undermine information sharing, understanding, and voluntariness. One proposal for reform advises simply
raising the consciousness of investigators and ancillary personnel. Another suggests the use of external measures such as third-party monitoring to guard against deficiencies. This could be accomplished by the
integration of third-party research subject advocates in the informed consent process, especially for studies that are considered unusually sensitive or risky or that involve subjects with impaired autonomy (see PRSA
discussion in Chapter 6).
A more fundamental question is whether too much weight has been
placed on informed consent in the framework of research ethics and research regulation. As noted previously, the National Research Act charge
to the commission focused on informed consent issues, so the centrality
of consent issues in the report is neither surprising nor necessarily indicative of a judgment on the part of the commissioners that the most compelling issues in research with prisoners are those of consent.
An alternate perspective, discussed by Emanuel et al. (2000), focuses
on directing attention to risks and to risk-benefit analysis. According to
this view, only health-related benefits derived from the research can be
counted as benefits to individual subjects, meaning that extraneous benefits, such as payments or medical services unrelated to the research, are

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excluded in this analysis. Further, although the process of weighing risks
against benefits is inherently subjective, the analysis should be based on
data permitting identification of the types of potential harms and benefits, their probability of occurrence, and their long-term consequences.
For example, a placebo-controlled trial of new antiemitic therapy for patients undergoing chemotherapy could be rejected because the investigators failed to give adequate weight to the discomfort associated with
nausea and vomiting and failed to take steps to minimize this potential
harm by using available antiemitic agents in the control group (Emanuel
et al., 2000).
These questions about an undue focus on informed consent influence
our recommendations. More attention needs to be paid to risks and riskbenefit analysis rather than the formalities of an informed consent document. The ethical risks associated with research involving prisoners cannot be solved by focusing only on the informed consent document.
The Role of Protectionism
A risk-benefit paradigm is necessarily more flexible than the current
categorical approach. Although some might view this flexibility as opening the door for potential abuses, this new approach should actually increase the protection of prisoners involved in research.
This committee, like the original commission, is focused on the protection of prisoners as our core ethical concern. However, there are many
approaches one can take to accomplish this goal, involving different levels of protective oversight mechanisms. One scholar outlines three types
of protectionism:
Weak protectionism is the view that this problem is best resolved
through the judgment of virtuous scientists. Moderate protectionism accepts the importance of personal virtue but does not find it
sufficient. Strong protectionism is disinclined to rely, to any substantial degree, on the virtue of scientific investigators for purposes of subject protection (Moreno, 2001)
The movement over time has been from weaker to stronger forms of
protectionism as a means of addressing a fundamental problem, specifically, the tension between protecting the interests of subjects and promoting scientific progress. Strong protectionism sharply limits
investigator discretion and demands external assurances through meas-

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ures such as third-party monitors of consent, conflict-of-interest committees, and other procedures. These external assurances can be associated
with costs, thus leading to an ethical critique of strong protectionism. For
example, an emphasis on external assurances may weaken the sense of
personal moral responsibility on the part of investigators. Similarly, rigid
external assurances, like those seen in the current regulations, can direct
attention away from an analysis of risks and benefits, where the key ethical issues can be found.
Simultaneously, there has been a countervailing force in the march
toward strong protectionism, exemplified in the push by AIDS activists
for greater access to clinical trials and by progressives for the inclusion
of women and children in research studies. More recently, there has been
a similar movement to ensure that racial/ethnic minority groups are included in research. These tendencies form one basis for a somewhat different reading of the history. This reading indicates a trend away from
viewing certain types of research participation (especially clinical trials)
as mostly risky or burdensome toward viewing them as mostly beneficial.
This represents a change in thinking about distributive justice. The
commission focused on the equitable distribution of risks and worried
that prisoners would bear more than their fair share. However, an equally
valid case can be made for attention to the distribution of benefits. For
example, Mastroianni and Kahn (2001) wrote that, in the 1970s, federal
“policies emphasized the protection of human subjects from the risks of
harm in research, and justice was seen as part of this protection,” but
since the early 1990s “justice as applied in research ethics has emphasized the need to ensure access to the potential benefits that research has
to offer” (Mastroianni and Kahn, 2001).

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Some fundamental changes in the nature of the research conducted
with human subjects provide
During the committee’s October 2005 meeting,
support for this account of the prisoner liaison panel spent a great deal of
the recent history of research time debating the appropriateness of including
prisoners in research, with special concerns for
practices. For example, al- biomedical research.
though the paradigmatic
“We have 275 million people in this country.
studies with prisoners in the We have 2 million in prisons. What is the allure
period leading up to the re- to this population, if it is not the fact that it is a
controlled population?” asked Daniel Murphy,
port were studies in which Ph.D., a former prisoner in the Federal Bureau
investigators induced disease of Prisons and now professor in the Department
to learn more about it, bio- of Political Science and Justice Studies at Appamedical research is more lachian State University. In other words, why
likely now to be discussed in conduct studies with prisoners when there are
many more people outside of prison who are
terms of clinical trials com- potential participants?
paring alternative beneficial
treatments. The last several years have also seen the publication of studies comparing the outcome between patients who participate in clinical
trials and those who receive standard care outside such trials; the results
have tended to favor the former (Agrawal and Emanuel, 2003).
The two accounts can be reconciled in several ways. Increased protectionism is quite visible over the past century, whereas movements
demanding greater access to clinical trials are far more recent. Further,
protectionism as distrust of individual investigators can coexist with a
view that participation in research subject to external oversight can often
offer benefits to individuals and groups. One can simultaneously believe
that the piling on of more rules and oversight bodies at some point becomes counterproductive and that human subjects are presently inadequately protected. Indeed, many modern ethicists seem to hope for a
reawakening of scientific conscience rather than additional fortifications
to the citadel of regulations.

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This committee concurs.
During the committee’s October 2005 meeting,
The critique of strong protec- the prisoner liaison panel spent a great deal of
tionism, combined with a time debating the appropriateness of including
new understanding of re- prisoners in research, with special concerns for
biomedical research.
search as a potential benefit,
“It is so much easier for indiscretions or bad
requires a reexamination of intentions to take place behind those prison walls
the current regulations. Ad- and razor wire. I have seen it in so many cases,
vances in ethical thinking where doctors who were sworn to save lives and
about protectionism suggest do good have become so consumed by that intellectual scientific quest that they forget about the
a new regulatory model. In test subject. It is just so easy to abuse the situaparticular, the committee tion,” stated Allen Hornblum, author of Acres of
rejects strong protectionism Skin (Hornblum, 1998) and former member of
because it discounts the no- the Philadelphia Prison System Board of Trustees.
tion that researchers can be
trusted to act virtuously in the protection of subjects. Researchers have
responsibility for protecting subjects in their studies, especially those
who are most vulnerable. However, given the troubling history of research abuses in prisons, weak protectionism is not an option. The recommendations in this chapter, and throughout this report, reflect a
moderate protectionist stance, acknowledging that robust protections are
needed but that they need not be rigid or absolute.
This position should not be perceived as a call for the relaxation of
prison research ethics. Justice and respect for persons are as vital today
as they were three decades ago; research still must be constrained by
these ethical principles. The prison continues to be a setting in which it
may be difficult to avoid contamination through contact with what will
often be a culture of, at best, deprivation and dysfunction and, at worst,
corruption, brutality, and degradation (Hornblum, 1997, 1998; Murphy,
2005; Rhodes, 2005).
Perhaps some unease is appropriate about removing what prisoners
themselves, given full information and understanding, might regard as
acceptable or even desirable options in light of their circumstances, circumstances that are unlikely to be changed for the better by research
bans. A prisoner’s ability to participate in research need not be completely precluded.
The original commissioners talked to actual prisoner-subjects during
a fact-finding visit to Jackson State Prison on November 14, 1975. The
prison, in southern Michigan, was at the time home to one of the largest
nontherapeutic biomedical research programs in the country. The report
notes that commission members spoke with a representative sample of

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research participants and nonparticipants selected by commission staff
from a master list of all prisoners and found that, overall, participants
valued the opportunity to participate in research and felt they were sufficiently informed and free to enroll or withdraw at will, and nonparticipants did not object to this opportunity being available to others
(NCPHSBBR, 1976).
“My experience has really been that prisThis message continues to be
oners want access to innovative intervention
articulated today. This committee programs. They want to change. They want
visited one prison and one prison to have access to the things that are going
medical facility to discuss ex- to help them, and that is one reason why
perimentation with current pris- people become involved, at least in working
with us,” said Olga Grinstead, Ph.D., adoners and peer educators (see junct associate professor at the University
Appendix A). The prisoners ac- of California, San Francisco’s Center for
tively expressed the desire to AIDS Prevention Studies, when she spoke to
have access to research. They the committee in July 2005. She contined,
stated they would feel they had a “From the issue of equity or the issue of
justice, there are advantages to being inchoice as to whether to partici- volved in research. We need to be aware
pate and that they know their that prisoners are motivated to be in volved
rights when it comes to study in research. They are motivated to give
participation. The prisoners and back, and that should be taken into account
too.”
peer educators at those site visits
also echoed the sentiment that prisoners possess sufficient autonomy to
make informed decisions about whether to participate in a given study.4
This, combined with the myopic emphasis on informed consent, is
why the current categorical reguDoris James, of the Bureau of Justice Stalatory approach should be aban- tistics, added that some studies are very
doned in favor of a risk-benefit specific to the experiences and actions of
prisoners. “Offenders are the only source of
paradigm. The following rec- some of this data, data that are needed to
ommendations strive to acknowl- provide programs, to produce policies to
edge
that,
in
limited help meet their needs.”
circumstances, the potential benefit of a research protocol can justify research involving prisoners. These limited circumstances cannot be captured by a rigid categorical approach but need to be rooted in a riskbenefit analysis that grapples with the balance between a need for protection and access to potentially beneficial research protocols.

Of course, this survey only represents the views of a limited sample of prisoners. Although many inmates might share these opinions, others might feel that their circumstances do not permit the exercise of autonomy. This emphasizes the need for setting
specific collaboration, discussed in detail later.

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Recommendation 5.1 Apply Risk-Benefit Framework to
Research Review
The U.S. Department of Health and Human Services should
revise regulations regarding research with prisoners from a
model based on categories to a system based on weighing of
risks and benefits for the individual human subject, similar
to the approach currently used in Subpart D5.
The risks and benefits of human subjects research are the ethically relevant issues, not the category of the research. The current categorical approach is dependent on stipulated research
categories that are subject to various interpretations. This approach does not provide sufficient or reliable protection for the
human subject. In addition, the present structure does not address
the actual conditions of confinement or the restrictions on liberty
that attach to any prisoner (whether incarcerated or subject to restraints on liberty in connection with community-based alternatives to incarceration) who may consider becoming a research
subject and for whom the regulations are intended to provide
protection. A risk-based approach is preferable because it requires IRBs and the Office for Human Research Protections to
(1) focus on the potential benefits and harms of each suggested
research protocol and (2) identify the particular ethical issues
that each protocol raises in the specific context of the correctional setting.
The general principle holds for all research: Ethically permissible research must offer benefits to prisoners that outweigh the risks. On the
risk side of the equation, it will be important to analyze all potential
risks, even something as seemingly innocuous as an interview. Certain
questions can trigger harmful emotional or psychological responses;
these questions cannot be allowed among prisoners unless there is an
associated benefit.
On the benefit side, there may be research protocols, most likely epidemiological or social/behavioral, that carry very low risks for the prisoner subjects but no personal benefit for the subjects. Instead, the
potential benefits may be for prisoners as a class (e.g., studies to identify
factors that predict recidivism). Application of a risk-benefit analysis
may determine that, because the risks are very low and important knowl5

Details of Subpart D in IOM 2004, pp. 100-103.

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edge or benefits may accrue for prisoners as a class, the research may be
considered ethically acceptable. The same may hold true for epidemiological studies (as distinct from biomedical research) that require analysis
of biomedical samples, such as tissue, blood, or urine, but are not designed to assess outcomes of an intervention.
The idea of benefit can be flexible enough to include minimal risk
protocols where the benefit to prisoners is indirect and/or temporally distant. It will be up to IRB’s to determine whether there is a convincing
affirmative reason for conducting research in a prison setting. When reviewing minimal risk research that does not present a direct benefit to
subjects or prisoners as a class, IRB’s should consider whether the research has the potential to yield important scientific information and the
extent to which that information can only be obtained in a prison setting.
For example, it would be appropriate to allow a prisoners’ continued participation in a minimal risk longitudinal study (i.e. epidemiological
study) that they began before being incarcerated. Such studies may not
benefit either the individual prisoner or prisoners as a class, but may
generate important information about the community to which the participant belonged before incarceration. This would be permissible because the subject was selected for reasons other than incarceration, and
the subject’s decision to participate is unlikely to have been influenced
by the pressures of prison life. However, it should be noted that the
flexible notion of benefit has distinct limits. In the absence of benefit,
either to the prisoner subject or to prisoners as a class, the research
should be conducted in other settings
This balancing framework represents a departure from the way that
decisions are currently made for approving research protocols. The present system utilizes the idea of “minimal risk” to evaluate the dangers
associated with a protocol; studies are often characterized as presenting
either minimal risk, or more than minimal risk. The committee believes
that this categorical approach is problematic and needs to be balanced
with a consideration of benefit . Under a new risk-benefit framework,
studies should be evaluated through a dynamic process of balancing risks
and benefits, thus removing the need to rely on static definitions and
categories. Nonetheless, as discussed in Chapter 6, the idea of minimal
risk can be a useful tool for evaluating the risk side of a risk-benefit
analysis. IRBs are accustomed to this starting point in their analyses, but
should also move beyond strict reliance on this specific term in favor of a
consideration of the balance between risks and benefits. Moreover, given
the particularities of being a prisoner, the committee believes that the

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definition of “minimal risk” presently in Subpart C should be replaced by
a slightly modified version of the definition, as follows:
“…the probability and magnitude of physical or psychological harm that
is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons living outside the
correctional setting.”
This definition reflects the fact that prisoners are faced with a high baseline level of daily risk, thus making prison life an inappropriate reference
point for determining whether a research protocol presents more than
minimal risk.
Guidance on biomedical research The following guidance suggests
how the risk-benefit framework should be applied to biomedical research. Specific direction is being supplied for this area because of the
history and controversy surrounding medical and pharmacological studies in prisons. For other types of research (i.e. epidemiological, behavioral, etc.), these very specific limitations are not relevant.
There are two narrow circumstances in which biomedical research
might be ethically acceptable:
1. In normal circumstances, a biomedical research study may be
ethically acceptable if:
●

●

for research on new therapies or preventive measures, there
is already some evidence of safety and efficacy, as in Phase
3 testing for new drugs, as defined by the Food and Drug
Administration (FDA); and
the ratio of prisoner to non-prisoner subjects does not exceed
50 percent.

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perts, who, in a public process, consider the ethical acceptability of the
protocol (as is the process for Subpart D [45 C.F.R. § 46.407]), and make
recommendations to the responsible government authority (Office for
Human Research Protections) regarding the special circumstances that do
or do not provide a basis for research and the safeguards that must apply.
Rationale This approach starts with the presumption that biomedical research should be severely restricted and is allowable only in limited
circumstances. Biomedical research involving prisoners as subjects is
only permitted when the potential benefit to the prisoner-participants
outweighs the risk to which the subjects are exposed. Under this framework, studies that offer no benefit to potential subjects would be precluded (eg., testing of cosmetic products).The goal of the risk-benefit
analysis is to prevent prisoners from being burdened by more than their
fair share of risk, while allowing access to research that has potential
benefits. This is especially relevant in circumstances in which effective
treatments have not been developed to address a life-threatening or lifealtering condition.
The guidelines articulated above illustrate how these principles
would be applied in practice. The first allowable situation involves a
treatment that appears to be safe and effective based on small-scale trials.
The potential benefit of an experimental intervention must be established
before engaging in a risk-benefit analysis. As such, Phase 1 and Phase 2
studies, as defined by the FDA to determine safety and toxicity levels,
would not be allowable. Since these trials are principally designed to
study a drug’s safety and efficacy, potential benefits are not yet clear. In
these cases, risks to the prisoner might well overshadow the uncertainty
of unproven benefits. Only Phase 3 studies would be allowed, since basic
efficacy would already have been demonstrated.
This approach reflects the growing view that research presents not
only burdens but can also present benefits that should be fairly distributed to prisoners. However, the distribution of burdens must still be considered – thus the requirement that the ratio of prisoner to non-prisoner
subjects does not exceed 50 percent. Biomedical research should involve
prisoners only to provide a benefit to individual prisoner participants,
not because they are a convenient source of subjects. This 50 percent
limit represents the committee’s strongly held view that prisoners should
not comprise the majority of a biomedical study’s enrollment when nonincarcerated subjects are available. The just distribution of risks and the

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potential for abuse require that researchers not be permitted to unnecessarily rely on prisoners as subjects.
It should be noted that the 50 percent limit is a ceiling that should
only be approached when extensive use of prisoners as subjects can be
justified by potential benefit. If a disease is less common in prisons, ethical guidelines would suggest a lower proportion of prisoner subjects. Inmates should only be part of the subject pool to the extent that the
disease affects the prisoner population. A study that extensively enrolls
prisoners when non-prisoner subjects are available should be examined
closely to ensure that benefit to the prisoner population, and not convenience, is the true justification.
Under guideline 2, the 50 percent ceiling can be exceeded in exceptional circumstances, such as for conditions that solely or almost exclusively affect prisoners (Example repetitive sexual assault, see Example 7,
Chapter 6, page 194). Due to the inherent risks associated with research
involving prisoners, increased oversight is needed when a biomedical
study enrolls a high proportion of prisoners, or when the potential benefits are expected but not yet established. Thus, the second exception requires more stringent safeguards. In this instance, the protocol would
need to be submitted to an expert panel of medical and ethical scholars,
whose opinions would be collected by the supervising agency and published on the agency’s Web site. The agency would then need to publicly
post an opinion regarding its acceptance or rejection of the expert testimony and the reasons for either. This process is analogous to the process
used under Subpart D § 407 (IOM, 204).
The preceding discussion should not be construed as an abandonment of the commission’s “primarily protective framework.” The goal of
a risk-benefit framework is to maximize the safety and well-being of
prisoners. As the commission emphasized, respect for persons requires
that the risk of coercive practices and research abuses be negated (or at
least minimized) by the use of protective measures. The commission’s
approach stressed the prevention of deleterious research protocols, but it
did not properly account for potential that research can offer positive
benefits to prisoner-subjects. A risk-benefit framework is still primarily
concerned with preventing harm, but does so in a manner that allows for
participation in research when the potential for benefit to prisoners
greatly outweighs potential risks.
Risk-benefit analyses of the type illustrated here provide the bases
for the kinds of specific safeguards discussed and described in greater
detail in Chapter 6.

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Justice
In this section, the committee lays out its expansion of the principle
of justice in two ways: To include: 1) collaborative responsibility for research proposals and setting a research agenda and 2) enhancing the welfare of prisoner population.
Collaborative Responsibility
The conceptualization of justice has expanded since the original
commission’s work. They primarily thought of justice in terms of the
distribution of risks and benefits. Although this is still a legitimate concern, some recent scholarship suggests elevating collaborative responsibility under the rubric of justice.
Specifically, Eckenwiler (2001) develops a proposal for incorporat“We need to emphasize and re-emphasize
ing particularity into the research review process that re- the voluntary nature of research in our collaborations with community based agencies,
flects
the
interest
in with the Department of Corrections, with the
subjectivities and participatory prisoners themselves. We need to be sure we
justice in contemporary feminist are getting input from the incarcerated comscholarship. She notes that munity,” said Olga Grinstead, Ph.D., Unianalyses of potential harms and versity of California, San Francisco Center
for AIDS Prevention Studies, at its July 2005
benefits, and trade-offs between meeting that. Dr. Grinstead has been develthem, can vary considerably oping and evaluating HIV, STD, and hepatidepending on personal charac- tis prevention programs for incarcerated
teristics and on the social, eco- men and their female partners since 1993.
nomic, and institutional contexts. A determination to be impartial or to
put oneself in the shoes of a particular kind of research subject will be
inadequate in many circumstances: “When differences between the social
positions of the deliberators and the targeted beneficiaries involve relations of privilege and oppression attempts to ignore one’s own situation
or imagine the perspectives of others are especially unlikely to be successful. Furthermore, as most IRB [institutional review board] members
are health care providers and scientists, they are less disposed to question
features of research that collude in perpetuating inequalities…[and may
also be] acutely aware of the financial environment in which they operate
and of the importance of clinical research in their institutions’ economic
viability” (Eckenwiler , 2001). Eckenwiler recommends that, among
other things, efforts be undertaken to enhance the participation of affected or interested groups. This involves acknowledging that groups are

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not monolithic and are themselves subject to a range of problems that
should be addressed in the consultation process. This recommendation
has two aspects: (1) including more laypeople who match the local population and common subject groups in key respects; and 2) shaping IRBs
so they are hospitable places for lay members.
This committee agrees with this perspective. Thus, a new risk-benefit
approach needs to be accompa“I would like to know more about how we
nied by an emphasis on collabocould have a liaison between the inmates and
ration. The ethical problems the researchers. I really think that that is an
associated with research involv- important issue,” stated Debra Breuklander
ing prisoners will manifest at the committee’s October 2005 meeting.
themselves differently in each Ms. Breuklander is a former prisoner who is
a nurse consultant at MECCA, a resicorrectional setting. The one- now
dential inpatient substance abuse treatment
size-fits-all approach character- program in Des Moines, Iowa, and a member
ized by a focus on informed of the committee’s prisoner liaison panel.
consent cannot adequately address the unique concerns presented by each setting. Thus, all relevant
parties should be involved (prisoners, correctional officers, medical staff,
administrators) when creating and implementing a research protocol.
This effort, combined with a more specific focus on risks and benefits,
can lead to research practices that better incorporate justice and respect
for persons.
Recommendation 5.2 Use a Collaborative Research
Approach
Under an ethic of collaborative responsibility, investigators
should find ways to obtain input from prisoners and other
stakeholders on the design and conduct of any research protocol involving prisoners.
To satisfy the spirit of the Belmont Report principles in
modern correctional settings requires recognition of an additional ethical imperative. Collaborative responsibility is a necessary ethical underpinning for research in correctional settings.
Collaborative responsibility is a phrase intended to convey the
idea that, to the extent feasible, all aspects of research (design,
planning, and implementation) should include the active participation of relevant institutional stakeholders (prisoners, correctional officers, medical staff, administrators). Efforts should be
made to consult with major stakeholders within the local institution, particularly prisoners as well as former prisoners and prison

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staff, to particularize the protocol to local conditions. A focus on
collaboration would help cope with the reality that each institution has its own unique conditions and also may facilitate openness of the research environment. With collaborative input,
research design and implementation could be tailored to the issues, needs, and capacities of a given setting. Prisoners have an
interest in being consulted as part of the collaborative process.
The responsibility for collaboration lies with investigators, who
need to make the effort to engage prison administration and prisoners themselves for their input, and with the human research
participant protection program, which must determine that the
effort was made.
A valuable model can be found in Responsible Research: A Systems
Approach to Protecting Research Participants (IOM, 2003), which sets
forth the phases of human research (see Figure 5-1). Most of these
phases provide an opportunity for collaboration that can facilitate the
conduct of research in accordance with the principles of justice and respect for persons.
At the outset, a researcher must construct a research question. Collaboration with prisoners and prison staff at this stage can be a productive means of addressing topics that will have the most benefit for the
prison population. Representatives from within the prison system can
encourage study of the most pressing problems or discourage protocols
that address insignificant issues. It is at this first stage that prisoners in
particular can voice their thoughts on whether a given research question
provides benefits that outweigh the risks.
Collaboration during protocol development is important because
each correctional setting presents unique strengths and weaknesses. This
is an opportunity to assess a specific prison’s infrastructure (e.g., to determine what is feasible). In particular, collaboration during protocol development can reveal setting-specific characteristics that will make it
significantly more difficult to conduct ethical research (i.e., presence of
gangs, mistrust of outsiders, inadequate medical infrastructure). When
such barriers exist, the researcher, in collaboration with prisoners, correctional officers, medical staff, and administrators, must consider whether
it is even appropriate to perform human subject research in that setting,
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FIGURE 5-1 The phases of human research.
SOURCE: IOM, 2003, Figure 1.1, p. 41.
Recruitment and enrollment make up a third area of potential collaboration. Involving prisoners in the recruitment process can go a long
way toward minimizing potential coercion or undue inducement. If prisoners have a voice in how subjects are enrolled, they can help protect
themselves from inappropriate recruitment practices that infringe on their

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autonomy (respect for persons) or unfairly distribute risks and benefits
within the prison population (justice).
This model and discussion are not meant to provide a comprehensive
list but merely to illustrate that collaboration can and should occur at
every level of the research process. There is no objective way to say collaboration occurred. However, the HRPPP can ask if all relevant people
were consulted and determine that the process was transparent and fair.
As long as all parties are consulted fully and fairly, given an opportunity
to be heard, the goal is met.
The committee acknowledges that this will generally be a new model
to many researchers and within most correctional settings, and, thus will
require a significant commitment to implement.

Welfare of the Prisoner Population
Recent decades have seen an explosion in writing on justice, specifically in the context of research. As discussed previously, this has involved a change in the way we view distributive justice. The commission
thought of distributive justice as requiring the fair distribution of research
risks and burdens. However, much of the recent philosophical work argues that, although justice requires the protection of vulnerable subjects
from exploitative research, sometimes it also mandates that research be
done to improve the welfare of these populations. This perspective focuses on the idea that justice requires the fair distribution not only of
risks but also of benefits.
In this area, the volume Beyond Consent: Seeking Justice in Research has synthesized and extended prior work on justice. In the chapter
“Race, Justice, and Research,” King (1998, p. 102) argues that justice
should take us beyond purely distributive concerns to the evaluation and
modification of “institutional arrangements” and structures of “decision
making and other procedural aspects of research.” Another chapter,
“Convenient and Captive Populations,” provides a history of the regulation of research with prisoners, institutionalized persons, military personnel, and students in the United States. It concludes by endorsing a
protectionist stance toward these populations, based on histories of
abuse, while noting that “there are circumstances in which justice may
permit, or even require, access to research” for these populations, such as
“the prevalence of a disease that poses a particular threat” to its members

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and “cannot be studied as effectively with other subjects”(Moreno, 1998,
p. 127).
Similarly, two other philosophers have also thought about the idea
that justice requires more than the protection of subjects from exploitation; in order to be truly ethical, research must actively consider what is
best for a population. London, in his work on international research, argues that the permissibility of clinical research should rest in part on its
contribution to “filling the gaps between the most important health needs
in a community and the capacity of its social structures to meet
them”(London, 2005, p. 33). Even if a particular research project is not,
strictly speaking, exploitative, it may still be ethically problematic if it is
not the project that has the greatest potential to address the health problems and concerns of the community. Powers (1998, p. 150) argues that
“freedom of choice is important, but the availability of choice-worthy
options also is important.” He calls for a complex, comprehensive concept of justice in research that not only synthesizes elements of the various norms (e.g., adopting a dual focus on individuals and groups,
benefits and burdens, and upstream and downstream) but also considers
the connections between research and other realms of health (or, for that
matter, social) policy.
The committee believes that this expanded concept of justice is an
important ethical development. Justice requires more than the protection
of prisoners from harm caused by the research itself. Ethical research
carries with it a responsibility to grapple with the fact that potential harm
is ubiquitous in everyday prison life, creating an environment for research in which the choice to participate in a study can be inherently coercive and potentially dangerous. Thus, in order for research to be
ethical, justice requires that it must be done in a setting in which there is
an adequate standard of health care in place.
How to assess the adequacy of a correctional health care system?
The committee acknowledges that the vast majority of researchers and
IRBs do not have the expertise to directly measure health care quality in
correctional settings. Certain indirect measures, however, may help with
this determination. For example, has the specific correctional system’s
health care services been found to be unconstitutional by a court? Is it
under a consent decree, settlement agreement, or a similar process relevant to the adequacy of the healthcare services? Such situations create a
presumption that the system was inadequate at that time. Research in a
correctional facility that involves subject matter addressed under a court
order/settlement/consent decree should be presumptively disapproved.

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(The concern is primarily biomedical research, but behavioral research
could be implicated under the standards proposed here if the underlying
mental health support is seriously lacking in the institution and if the proposed research project has mental health as an integral component of the
behavioral research.)
To allow biomedical research under such circumstances, the IRB
must apply the risk/benefit analysis the committee proposes in a heightened form and find that the research proposed is permissible only after
reviewing the specific components of the research and its interaction
with the specific components of the system presumed to be deficient.
This risk/benefit application should address the theoretical aspects of the
proposed research, as well as its administration and monitoring, including the informed consent. The IRB must assure itself that no prisoner is
choosing to be a research subject in order to bypass the presumptively
deficient system.
Other factors, which would be useful though not definitive, include:
1. Is the system accredited by a third party, such as NCCHC, ACA,
or JCAHO?
2. Have any recent internal or external assessments been made of
the health care system?
3. Do relevant QI studies exist?
4. Do other relevant assessments exist?

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Recommendation 5.3 Ensure Adequate Standards of Care
Human research participant protection programs,6 together
with the prison administration and prison health care professionals, are responsible for ensuring that research with prisoners occurs in an environment that is appropriate to the
health and well-being of prisoners, including access to existing medical and mental health care that is adequate, protection from inmate attempts to coerce or manipulate
participation or nonparticipation in research, and prompt
access to decent health care services in case the research
causes physical or mental harm.
Ethical research requires an environment that is humane and
provides reasonable access to supportive care, particularly when
human subjects are exposed to physical or psychological risks.
Without adequate medical or psychological care, subjects may
be vulnerable to undue inducements to participate in research
such that they would consent in order to gain access to medical
care or other benefits they would not normally have. Finally, researchers have an ethical obligation, if they expose subjects to
risk, to rapidly and professionally remedy any harms caused by
the research.
HRPPPs can meet their obligations under Recommendation 5.3 by
engaging in due diligence and going through a careful process to discover whether adequate heath care exists within the correctional setting,
including analysis of the factors described above and any others that
might reflect on the quality of the correctional setting. Obtaining answers
to these questions would likely require visitng the setting, speaking to
health care staff, and reviewing relevant court cases.
Lastly, if research is to be done in prisons, there is an ethical responsibility to devote much of this research effort to determine how best to
achieve all of the legitimate purposes of the criminal justice system.

The term human research participant protection program is used throughout this report to mean the network of entities with direct responsibility for the safety of those enrolled in the studies carried out under its purview. The HRPPP most often includes the
research organization, the study sponsor, investigator, IRB, and, when relevant, the data
safety monitoring board (IOM, 2003). In the contexts described in this report, prison
research subject advocates would be an important part of this network as well.

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Recommendation 5.4 Support Critical Areas of Correctional Research
Government agencies should fund and researchers should
conduct research to identify needed supports to facilitate
prisoners’ successful reentry into society, reduce recidivism,
and inform policy makers about the most humane and effective strategies for the operation of correctional systems.
Society creates a correctional system for clear purposes, such as
deterrence to future crime and rehabilitation of those who are
convicted of committing offenses. It is of utmost social importance to better understand how best to achieve the purposes of
incarceration, including reduction of recidivism and successful
introduction back into the community. Perhaps unavoidably, the
criminal justice system inflicts some harm on those it punishes.
As ethical people, we constantly strive to develop and use corrective measures that are effective and humane, without causing
unnecessary physical or mental harm to prisoners. However,
prisoners are a vulnerable population subject to abuse and exploitation. Indeed, several subclasses of prisoners make up some
of society’s most vulnerable populations, such as young people,
persons with mental disabilities, racial minorities, women, and
people with diseases (addiction, hepatitis, HIV, hypertension,
diabetes) that may or may not be treated during imprisonment. It
is, therefore, especially important to better understand how to
protect and promote the welfare and well-being of this large and
growing segment of our society. Scientific knowledge and information about “best practices” gained from high-quality research is critically important to understanding how best to
achieve all of the legitimate purposes of the criminal justice system.
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the arguments and data. Journal of the American Medical Association
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Beauchamp TL, Childress JF. (2001). Principles of Biomedical Research Ethics.
4th ed. New York: Oxford University Press.
Dubler NN, Sidel VW. 1989. On research on HIV infection and AIDS in correctional institutions. Milbank Quarterly 67(2):171–207.

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Eckenwiler L. 2001. Moral reasoning and the review of research involving human subjects. Kennedy Institute of Ethics Journal 11(1):37–69.
Emanuel EJ, Wendler D, Grady C. 2000. What makes clinical research ethical?
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Hoffman S. 2000. Beneficial and unusual punishment: an argument in support of
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Hornblum AM. 1997. They were cheap and available: prisoners as research subjects in twentieth century America. British Medical Journal 315:1437–1441.
Hornblum AM. 1998. Acres of Skin: Human Experiments at Holmesburg
Prison. New York: Routledge.
IOM (Institute of Medicine). 2003. Responsible Research: A Systems Approach
to Protecting Research Participants. Washington, DC: National Academy
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IOM. 2004. The Ethical Conduct of Clinical Research Involving Children.
Washington, DC: National Academies Press.
Kahn JP, Mastroianni AC, Sugarman J, eds. 1998. Beyond Consent: Seeking
Justice in Research. New York: Oxford University Press.
King PA. 1998. Race, justice, and research. In: Kahn JP, Mastroianni AC,
Sugarman J, eds. Beyond Consent: Seeking Justice in Research. New York:
Oxford University Press. Pp. 88–110.
Lazzarini Z, Altice FL. 2000. A review of the legal and ethical issues for the
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Moreno JD. 1998. Convenient and captive populations. In: Kahn JP, Mastroianni AC, Sugarman J, eds. Beyond Consent: Seeking Justice in Research.
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Moreno JD. 2001. Goodbye to all that: the end of moderate protectionism in
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Murphy D. 2005. Health care in the federal bureau of prisons: fact or fiction.
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NBAC (National Bioethics Commission). 1998. Research Involving Persons
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NCPHSBBR (National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research). 1976. Report and Recommendations:
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Powers M. 1998. Theories of justice in the context of research. In: Kahn JP,
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6
Systems of Oversight, Safeguards,
and Protections

Participation in human subjects research has often been thought of as
a burden, which suggests that the barriers to participation were significant. Although it is important to be vigilant to avoid unwarranted burdens, there is also an increasing awareness that research participation can
sometimes afford benefits. Thus, when thinking about research involving
prisoners, potential benefits and risks must be carefully considered. This
chapter focuses on the systems of oversight, safeguards, and protections
that would enable human research participant protections programs to
weigh the potential benefits and risks and then apply important safeguards and monitoring processes, based on level of risk, to approved research. It includes a discussion of how prisoner research should be
defined and how it should be reviewed (when, what, and by whom).
Recommendations regarding the use of a prison research subject advocate (PRSA) and stronger national oversight of prisoner research are also
discussed. The chapter ends with the committee’s suggestions to modify
the risk-benefit approach used in Subpart D of 45 C.F.R. § 46 for application to apply it to research involving prisoners.Relevant examples are
provided.
OVERARCHING PRINCIPLE
In considering a system of oversight, safeguards, and protections under the broader proposed definition of “prisoner,” the committee weighed
the current system in view of the locus of specific threats to ethical research with prisoners and perceived need for concrete responses to those
specific threats. In doing so, the committee considered (1) alternative
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conceptual frameworks for defining and reviewing permissible research
with prisoners, (2) the substantial variability in threats to ethical research
(e.g., the potential and likelihood for coerced participation; the degree of
openness to outside review, and remediation of emergent researchrelated problems) across the expanded array of research settings (i.e.,
community settings as well as traditional institutions), (3) differing types
and magnitudes of potential risks posed by specific types of research
(i.e., biomedical as distinct from social/behavioral), and (4) specific
safeguards related to research design and implementation monitoring that
might facilitate safe and ethical research across these diverse settings.
To correct the inadequacies and lack of complete coverage of current
regulations, as described in Chapter 3, the systems recommended by the
committee are meant to apply to all research with prisoners to ensure that
the same protections are afforded to every prisoner-subject. Prisonersubjects are currently being enrolled in a broad spectrum of research on
various topics at many different institutions and by many different researchers. To achieve the objective of adequately protecting prisonersubjects, the system of oversight must cover all research involving this
vulnerable population regardless of the funding source, the federalwide
assurance (FWA) status of the institution conducting the research, the
correctional setting in which the research will take place, or the type of
research being conducted. Additionally, the oversight system should
cover research involving individuals meeting the definition of prisoner
set forth in Chapter 4, which includes persons at all custody levels, from
those who reside in prisons or jails to those who are under supervision in
detention centers or other types of community placements.
DEFINING AND REVIEWING PRISONER RESEARCH
For the tasks of defining and reviewing permissible research with
prisoners, the committee considered the current framework of the U.S.
Department of Health and Human Services (DHHS) regulations at 45
C.F.R. § 46 Subpart C (Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects)1. This
regulation requires that a duly constituted institutional review board
(IRB), with at least one prisoner representative as a voting member, re1

Revised November 13, 2001.

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view and approve the study, with consideration of the special circumstances inherent in conducting the research with prisoner-subjects. Subpart C defines permitted research using a combination of substantive
research categories and risk levels and for certain types of research. All
studies involving prisoners within this framework are subject to certification by the DHHS Office for Human Research Protections (OHRP),
which verifies that (1) the IRB has appropriately reviewed the study and
(2) the study falls into one of the categories of permissible research (see
Chapter 3 for details). This subpart also requires federal-level review (in
consultation with a panel of experts) and published notice in the Federal
Register for certain categories of research.
On close inspection and in light of the experiences of committee
members who have served on IRBs, the Subpart C provisions appear
problematic. The substantive categories are not mutually exclusive, and a
study that might be permitted without secretarial review in one category
(e.g., a study of drug addiction as a cause of criminal behavior) might
require secretarial review in another (e.g., drug addiction as a condition
particularly affecting prisoners). The classification and OHRP certification process for such studies can be lengthy and contentious, often resulting in (sometimes prolonged) delays, which may discourage
investigators from conducting valuable research. The value added by the
certification and review process, as it currently operates, is not clear. Further, OHRP has reported receiving for review and certification studies
that were designed to yield potentially important and useful information
but could not be approved because they did not fall into one of the approvable substantive categories.
The committee considered whether a modified version of the framework provided under 45 C.F.R. § 46 Subpart D might be preferable for
the review of research involving prisoners. The Subpart D framework is
structured primarily in terms of level of risk posed to the subject (minimal or greater than minimal) and whether the research presents the prospect of direct benefit to individual subjects (for a more detailed
description, see IOM, 2004, pp. 100-103). With modifications that either
(1) specify particular research categories that would be impermissible
with prisoners or (2) delineate specific kinds of design and monitoring
safeguards necessary for IRB approval of permissible research, the
committee judged that greater protections could be afforded prisonersubjects by the use of a modified Subpart D framework (see page 186,
“Applying Safeguards for Particular Kinds of Research”).

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What Is Reviewed
All research that involves prisoners must be reviewed by an independent body before it begins. Under 45 C.F.R. § 46, research is defined
as “a systematic investigation, including research, development, testing
and evaluation, designed to develop or contribute to generalizable knowledge.” This definition is subject to varying interpretations both inside
and outside the prisoner research context. The main distinction between a
research activity and a nonresearch activity is the primary intent of the
activity: Research aims to test hypotheses and/or generate new knowledge, whereas nonresearch aims to control a disease or other condition or
to improve a program or service. Clinical or epidemiological studies that
are intended to reveal new information about a disease, behavior, or
treatment are clearly research. In contrast, data collection efforts that are
intended solely to aid in evaluating an internal system or in quality improvement (QI) initiatives may not be research.
There is little dispute that correctional health care systems should
have an ongoing system in place to monitor and evaluate health care services from quality assurance/improvement perspectives. In general,
measurable components of care include accessibility, appropriateness,
continuity, effectiveness, efficacy, efficiency, patient perspective issues,
safety of the care environment, and timeliness (Joint Commission on Accreditation of Healthcare Organizations, 1992). Such internal program
assessments are central to policy makers and organization executives for
management purposes, especially in the context of limited financial resources and increasing demand for services (Council of State Governments, 2002). These evaluation systems have a variety of different labels,
including QI, comprehensive QI, total QI, and quality assurance (QA). In
more mature systems, QA is an element of a more comprehensive QI
process. Outcome QI studies examine whether expected outcomes of
patient care were achieved. Process QI studies examine the effectiveness
of the health care delivery process.
Under the current federal regulations, only research activities that involve human subjects (or data from or about human subjects) require
IRB review and approval. However, state-level Departments of Corrections (DOCs) have different rules and are not consistent in what they
consider to be research and nonresearch (see Chapter 2). For example,
●

in some states internal evaluations are not considered research,
whereas similar activities undertaken by outside researchers are;

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in-house activities require fewer approvals or reviews than external activities;
unless results are to be published, IRB review may not be required.

Because either type of activity (research or nonresearch, in-house or
external) may involve the collection of private or sensitive information,
there is a chance that prisoners who participate may be put at risk. Thus,
to afford the greatest protection to prisoners, both activities may need
outside scrutiny, especially in view of the heightened vulnerability of
prisoners. If there is doubt about whether an activity requires review, it
should be resolved in favor of providing additional protection to the human subjects through independent review and oversight. However, some
activities (e.g., review of information from medical records to determine
what therapies are most effective in a given correctional facility) are
clearly designed to give clinicians and prison administrators information
needed to provide quality care. Likewise, some activities are designed to
improve the operations of the facility (i.e., QI processes) and are not intended to be disclosed outside that facility. These activities, as well as
external surveys for accreditation purposes, would not require review by
an IRB because they do not constitute research.
Who Reviews
Current regulations state that research involving prisoners must be
reviewed by an independent review committee, such as IRB, before any
prisoner-subjects are contacted or any information about prisonersubjects is accessed by the researcher. This independent committee
should include members with diverse demographic (e.g., gender and
race/ethnicity) and technical (e.g., scientific and nonscientific) backgrounds. In addition, the committee should include at least one prisoner
representative who has experience with the prison setting, but is not an
employee of the setting. This person should have particular knowledge of
the correctional setting and should be able to represent the interests of the
prisoners. The prisoner representative, who is a voting member on the
committee, could be a person who works with prisoners (e.g., an attorney, a service provider, or a chaplain who is not an employee of the correctional institution or agency), a family member of an inmate, or an exoffender. The committee should not include any individuals who have a

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conflict of interest in reviewing the study, such as the researchers themselves, representatives from a sponsor, or the prison staff. In the case of
multisite studies, it may be necessary to obtain input from more than one
prisoner representative, because local conditions are likely to vary from
site to site
Two implementation issues require specific discussion. First, it is vital that the prisoner representatives on the IRB have sufficient opportunity to be heard, independent from the people who work in prisons
(correction officers, medical staff, and administrators). Prison staff can
provide valuable input concerning the institutional needs and capacities.
However, their institutional perspective may make it difficult for them to
appreciate or articulate an accurate or sensitive assessment of the actual
risk to prisoner subjects. As such, the prisoner representative must have
the independence to freely express prisoner concerns, even when they
may come in conflict with the institutional issues.
Second, it will be important to diligently seek out and train prisoner
representatives. If a representative is an ex-offender or prisoner advocate
from outside of the institution, he or she must be familiar enough with
the characteristics of the particular setting in question to provide relevant
comments. Representatives from inside or outside the correctional setting
should be given access to the prisoners so that individual concerns can be
expressed. To ensure sufficient understanding of the risks and potential
benefits of a protocol, the prisoner representatives should receive adequate training on human subjects protections to understand the risks and
potential benefits of protocols.
Currently, prisoner research that falls under 45 C.F.R. § 46 Subpart
C must be reviewed by a properly constituted IRB that is registered with
OHRP and operates under an FWA. This IRB may be the same committee that reviews nonprisoner research, or it may be a distinct committee
convened to review studies involving prisoner-subjects. Presently, research involving prisoners that is not governed by 45 C.F.R. § 46 Subpart C may or may not be reviewed by an IRB. Instead, it may be
reviewed by another, independent prison review committee, such as a
research committee that reviews research conducted at a specific prison.
Although a prison review committee may review a study, theirs should
not be the only review because of their close ties to the prison. According
to the committee’s survey of DOC representatives (Chapter 2), IRB review is not consistent, and DOC IRBs do not universally include prisoner
representatives. Other DOC IRBs may include people designated as prisoner representatives who may lack sufficient detachment and objectivity

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to perform that function (e.g., health care professionals employed by the
prison). Under the recommended oversight paradigm, review by an IRB
(or other independent review committee) would be required for all research involving prisoners regardless of whether review by a prison review committee is also done. For studies conducted at more than one
facility, reviews may be required by a local IRB or review committee for
each facility.
It should be noted that the IRB is only one component of an institution’s human research participants protection program (HRPPP).2 The
HRPPP is a broader organizational structure in which the responsibility
for protecting research participants is shared among the sponsor, the larger research organization, the investigators, and the IRB (IOM, 2003).
Components of the HRPPP, in addition to the IRB, may entail additional
levels of review and monitoring for prisoner studies, depending on the
type and the risk level of the research.
How Reviews Are Conducted
The committee determined that the way in which IRB reviews of
prisoner studies are conducted need not vary substantially from how
these reviews are done currently, except for an increased emphasis on
assessing risks and benefits. (Biomedical research, compared with other
types of research, remains a critically important area of concern.) This
accounts for the committee’s recommendation to replace the current
Subpart C framework, which requires categorization of the research
study, with a modified Subpart D framework, which focuses on risks and
individual benefits, to guide the IRB in reviewing research involving
prisoners.
Prisoner studies should be reviewed by a fully convened (and properly constituted) IRB or other independent review committee, as is presently done and recommended by OHRP. One or more prisoner
representatives must be in attendance at this review. The committee re2

The term human research participant protection program is used throughout this report to mean the network of entities with direct responsibility for the safety of those enrolled in the studies carried out under its purview. The HRPPP most often includes the
research organization, the study sponsor, investigator, IRB, and, when relevant, the data
safety monitoring board (IOM, 2003). In the contexts described in this report, prison
subject research advocates would be an important part of this network as well.

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views the study protocol and all associated study materials (e.g., letters,
consent forms, questionnaires, experimental protocols, drug information,
and monitoring procedures). Committee members discuss the procedures
in detail, with particular emphasis on potential risks to the prisonersubjects and whether proper protections are proposed to mitigate these
risks. They also evaluate other issues that are unique to performing the
research with prisoners in a correctional setting:
●

●
●
●

●

Is it necessary to involve prisoners in the study? This first question addresses the concerns expressed by several prisoner liaison
panel members (Chapter 5). There are many more nonprisoners
than prisoners in this country. Why are prisoners an appropriate
source of subjects for the study?
Will prisoners constitute a majority of the study subjects? The
committee determined that, for most biomedical research, no
more than 50% of the subjects may be prisoners.
How will the prisoners be recruited for the study, and how will
prison staff be involved in this process?
How will informed consent be obtained from the prisonersubjects? Voluntary informed consent is difficult to ensure in
prison settings because of the inherently coercive environment.
Thus, this evaluation by the IRB will include a full review of the
consent process. With regard to the consent form itself, are all
elements of consent included and explained in lay language and
translated into a language the prisoner can understand if he or
she is not English speaking? For prisoners with poor reading
skills, is the informed consent process modified to accommodate
their needs, perhaps including a test of comprehension? Just as
critical is the IRB’s review of the procedures that will be followed to obtain consent: Who will obtain consent? How will the
information be presented to the potential subject to ensure full
comprehension? How will the prisoner’s questions be answered?
Will the prisoner be informed of any special implications related
to participation in the research study in a given facility (e.g., in
some facilities, testing positive for HIV may lead to transfer to a
different facility, limitations on work opportunities and family
visits, or specific medical treatments)? The consent must address
the policies and practices of the correctional setting in which the
study is conducted; it is the investigator’s responsibility to be-

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come informed about these issues before presenting the study
procedures to the IRB.
Will the prisoner-subject be paid for participation in the study? If
so, how will this payment be made (e.g., into a spending account,
as a noncash item)? What assurances have been given that such
payments are both allowed by the facility and appropriate?
Will the prisoner-subject feel that participation is truly voluntary
and feel free from coercion (either to participate or not)? Is it
possible to hold in confidence the prisoner’s decision whether or
not to participate? The IRB must also be assured, and the prisoner-subject informed, that neither parole nor the confinement
situation will be affected by the decision to participate or not in
the research.
How will privacy be maximized? The interview setting is of particular concern, including the physical location of the room and
the location of officers while the interview is underway. Officers
need to be out of earshot, but it may also be important to make
provisions to conduct the interview out of sight or with the prisoner facing away from officers and passersby. Computerized
data collection methods (e.g., audio-assisted self-interviewing in
which the respondent hears the questions through earphones and
then types responses into the computer) can provide extra privacy protection for especially sensitive interview topics. Clinical
studies under FDA’s purview require that a copy of the written
informed consent, which contains details on the protocol, be
placed in the participant’s medical record. However, for other
studies, such as those of social/behavioral nature, unless the correctional setting has a policy that requires the same, a copy of the
consent form need not be entered into the file ,and perhaps need
not be left with the prisoner-subject. (There are circumstances
under which possession of the consent form itself could compromise privacy.) The IRB could waive that requirement, while
ensuring informed consent occurs. The IRB could also assign a
unique study number to a research protocol (e.g., USF#12.344).
Since IRBs (and correctional agencies) may both require evidence that the prisoner gave written informed consent, it could
be arranged that the final/signature page of the consent form include only the following language, plus signature blocks: “I have
had an opportunity to read and discuss the consent form that explains research study Number USF12.344. I have had ample time

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to discuss this study with a member of the research staff and
have received satisfactory information to allow me to decide
about taking part in the study. By my signature below, I do voluntarily consent to participate in this study.” The prisoner could
keep a copy of this consent form which, if discovered by corrections staff or other prisoners, would not disclose anything substantive about the nature of the research; similarly, if the
corrections agency required evidence that the prisoner consented
to and/or participated in the study, a copy of this in the file also
would not violate confidentiality concerns beyond the fact of
participation (which the agency almost inevitably and unavoidably knows because of movement control).
Will a prisoner’s status
“You have to know what the perception is
as a research subject going to be, not just the exact design, but
have social or other con- how it is going to be perceived in the populace and by staff. Does involvement say the
sequences (either posi- participant is a snitch? Will it reveal HIV
tive or negative) for the status or sexual preference? That is a preprisoner?
cursor to doing the risk-benefit analysis,”
What arrangements will said Jack Beck, director of the Prison Visitbe made for prisoners to ing Project at the Correctional Association
of New York, and a member of the commitvoice complaints about tee’s prisoner liaison panel, at the committhe study or concerns tee’s October 2005 meeting.
about their rights as subjects, and how will these communications be facilitated in the
correctional setting? (Access to telephones is commonly restricted in correctional facilities, so this too must be considered.)
How will the confidenti“The research on women in the prison is
ality of the study data be very touchy for me,” explained Jean Scott,
maintained? The IRB deputy regional director of New York City
will assess whether ade- Correctional Treatment Programs, Phoenix
and a prisoner liaison panel member.
quate plans are in place House
“I see a lot of researchers going in to [get
to prevent breaches of the women to] ‘tell your story.’ This woman
confidentiality, including bears her soul, and that’s it, she goes down
how hard copy forms are as another number. She’s left feeling bad,
handled by the study somebody else now knows her story. Now
what do we do? They send these research
staff within the correc- teams in to start opening up all these
tional setting and how wounds with these women, and it is not a
electronic data are pro- good thing. [We need] to have a program
tected. Unless names of that is going to spend the time that is needed
prisoners are critical to for the women.”

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the study (i.e., the study involves continuing treatment, future
follow-up, or linkage to other records), the link between names
and study data should be destroyed at the earliest possible time.
Different types of confidentiality provisions will be required for
different types of data (e.g., How are HIV results or other lab results protected? What happens when a prisoner reports an illegal
behavior or a parole violation? Who is informed when a prisoner-subject requires follow-up care?). The limits of confidentiality that can be ensured may also vary by location (i.e., related
to individual state laws or facility rules), and prospective prisoner-subjects must be informed of these limits during the consent process (e.g., some jurisdictions require reporting of child
abuse or threats to harm oneself or others).
● How will the research subjects access adequate health care if participation in the research leads to the need for medical or psychological services?
● How will follow-up care be provided to prisoners who may need
it? Will it be possible for prison health care providers to be informed of a person’s participation without informing other
prison authorities?
● How will study procedures be adapted to fit different settings in
multisite studies? The researcher must present information about
each research site to assure the committee that local conditions
have been considered in the fashioning of responsive and appropriate study procedures. Gathering this facility-specific information and customizing the study procedures are likely to require
substantial effort by the investigator, depending on the number
of participating study sites, as well as approval by a local IRB
that had the benefit of participation by a prisoner advocate familiar with the particular facility.
The IRB needs as much insight into the correctional setting as possible. To optimize a collaborative research relationship between correctional agencies, investigators, and prisoners to answer the questions
listed above, some institutional initiative will be required. In addition to
including a prisoner representative on the IRB and consulting with prison
staff at each study site, it may be desirable for researchers to convene a
prison advisory group to assist them in developing appropriate and feasible procedures for each study site. This group should be composed of
current prisoners who can inform the researchers about unique factors to

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consider at their particular institution. For example, they could provide
suggestions about how to publicize the study, the best times and locations for recruitment, and how to minimize outside influences on a prisoner’s participation decision. This information will also be critical to the
IRB as it decides whether adequate protections are in place to allow the
study to go forward. It may also be advisable for an individual who is
monitoring related or other studies within the same setting (termed a
PRSA for prison research subject advocate by the committee (described
on page 179) and/or prison staff to attend IRB meetings relevant to research within their institutions). Investigators could consider scheduling
periodic (e.g., annual or semiannual) meetings with correctional agencies. With such exchange, investigators may be able to broaden their research protocols to address issues of concern in the correctional setting
that would “host” their study, even if the original or primary focus of the
investigation is derived from the investigators’ own research program.
Similarly, corrections staff may get a preview of the kinds of issues and
proposals that the investigators intend to pursue and contribute at the
early (and later) stages of study design and implementation.
During the deliberation phase of the review, the IRB will decide
whether prisoners can be involved in the research study at all in view of
the risks and benefits affecting this special population. The IRB may vote
to approve the study, approve with modifications, defer, disapprove the
study, or it may determine that the study requires a federal-level review.
Two elements of research discussed previously—informed consent
and privacy—are so integral to high-quality, ethical research that they
require special attention. As such, the committee formulated recommendations regarding both issues.
Recommendation 6.1 Ensure Voluntary Informed Consent
Human research participant protection programs should ensure voluntary informed consent is obtained from subjects in
all research involving prisoners
Informed consent is vital to autonomous decision making and respect for persons and is considered a bedrock of ethical research—whether it involves prisoners or non-prisoners.
Informed consent is an interactive and ongoing process to ensure
that participants are voluntarily participating in research and that
they understand the level and nature of the risks and the uncertainty of potential benefits. The written consent form—one part
of the process—is the mechanism for documenting that commu-

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nication with the participant regarding relevant considerations to
enrollment in a protocol has taken place. The informed consent
process must help the prisoner to exercise autonomous decision
making. The process poses special challenges in the correctional
setting, where autonomy may be inconsistent with institutional
order and judicially imposed limitations on liberty. In a correctional setting, a prisoner’s capacity to exercise independent
judgment may have atrophied. The consent process and discussion must include a focus on the risks and benefits of the research in the context of confinement or the manner in which
liberty has been restricted.This would include the impact of any
research data on a prisoner (e.g., how would testing positive for a
communicable disease impact housing, work opportunities,
medical treatment, family visiting). There is no question that,
within correctional settings, it is more difficult to provide integrity to the process of informed consent, but this does not remove
the obligation. If it is determined that voluntary informed consent is not obtainable, then a research proposal should not go forward.
Some researchers would argue that obtaining informed consent may
impede some types of research, for example, studies of social phenomena
via participant observation. Informing the subjects that they are being
watched would undermine the research. For non-prisoner research, studies may not require informed consent under two sections of the Common
Rule:
(1) Some research can be deemed exempt from IRB review, including: “Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or
observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly
or through identifiers linked to the subjects; and (ii) any disclosure of the
human subjects' responses outside the research could reasonably place
the subjects at risk of criminal or civil liability or be damaging to the
subjects' financial standing, employability, or reputation.” (45 CFR
46.101(b)(2))
(2) An IRB could also waive the requirement for informed consent
under 46.116: “An IRB may approve a consent procedure which does not
include, or which alters, some or all of the elements of informed consent
set forth in this section, or waive the requirements to obtain informed

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consent provided the IRB finds and documents that: (1) The research
involves no more than minimal risk to the subjects; (2) The waiver or
alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver
or alteration; and (4) Whenever appropriate, the subjects will be provided
with additional pertinent information after participation.”
However, the committee believes that neither of these justifications
apply to prisoner subjects. Questions of autonomy and liberty are so different in correctional settings that the IRB should always be required to
examine the ethical implications and require voluntary informed consent.
In the first case, the committee feels that no research involving prisonersubjects should be deemed exempt from IRB review because the second
condition ((ii) above) cannot be met. It is conceivable that even just observation of a prisoner's behavior, if that is disclosed to prison officials,
could put the prisoner at risk. In the second case, it is not possible to say
with certainty that the first two conditions ((1) and (2) above) will be met
for prisoner subjects, regardless of the stated objective of the study.
Even a seemingly benign study could pose more than minimal risk to the
prisoner subjects. For example, prisoners might be observed selling
drugs in the yard in a study whose purpose was simply to observe how
different racial or ethnic groups interacted with each other in the yard. If
so, a waiver of informed consent could adversely affect their rights and
welfare (if the prison officials learned of this observation and took action
against the prisoner). The prisoner would need to be informed of these
risks before the study began.
Recommendation 6.2 Protect the Privacy of Prisoners Engaged in Research
Human research participant protections programs should
collaborate with prison officials, probation officers, and
other staff relevant to the correctional setting to protect the
privacy of subjects in prisoner research.
Privacy is considered one of the necessary prerequisites for ethical research. In most circumstances, this means nondisclosure of
the identity of the research subject and ensuring confidentiality
of the specific data collected. Privacy is exceedingly difficult to
attain in prison settings, however, because of the inherently coercive and institutionalized contexts and the controlled and public nature of physical movement. Maximizing privacy within a
correctional setting will require collaborative planning efforts

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that involve potential subjects and staff from the correctional setting to consider the impact of participation on privacy issues.
Given that it may not be possible to guarantee absolute privacy in some situations, researchers, IRBs, and other human research participant protection programs should consider the extent
to which core privacy issues can be protected from disclosure
through realistic and practical approaches. For instance, it may
be clear to prisoners and staff that research is being conducted,
but the specific nature of the study or the characteristics common
to human subjects need not be generally known or discernible.
These measures, and their limits, should be discussed in detail
with prospective participants in the context of the consent process.
In determining whether to approve or to continue research,
HRPPPs should balance the effectiveness of measures designed
to protect participant privacy, the extent of confidence that human subjects understand and willingly accept the risks in view of
possible benefits, and the anticipated value of the research.
The committee investi- Allen Hornblum, a member of the committee’s
gated whether the Health In- prisoner liaison group, recalled the lack of
surance
Portability
and prison privacy he witnessed as a member of
Accountability Act (HIPAA) the board of trustees of an 8,000-person prison
system. “I would go through the rolodexes of
of 1996 (Pub. L. No. 104-191) the inmates. There were inmates who had on
afforded any special privacy their cards that they were HIV positive, which
protections to prisoners in- absolutely was not supposed to be known to
volved in research and found anybody in the institution except the doctor
the inmate. But on every cell block I could
that it does not. This law pro- and
find it. And if the guards know it, the inmates
tects medical information for know it.”
all research participants, not
just prisoner participants. In addition, not all medical information is covered; only protected health information (PHI) falls under HIPAA. PHI
includes any medical data that contain uniquely identifiable information,
such as a Social Security number, address, or fingerprint [45 C.F.R. §
160.103, 2003] and that is held by a health care provider (or other “covered entity”). Thus, HIPAA would apply only to information collected in
the course of medical service provision. Researchers could not obtain
and analyze this PHI unless they comply with specific privacy protec-

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tions that are provided under the HIPAA research provisions.3 However,
researchers, assuming they are not themselves a covered entity, could
collect their own data directly from prisoner research subjects without
concern for these regulations.
When Reviews Are Done
As is the case for research that involves persons in the community
(i.e., the free world), the review by an IRB or other ethics review committee for research involving prisoners should be conducted at the following times:
●

●
●
●

initial review: before any subjects are contacted or any information about them is accessed. The elements of this review and the
types of issues to be discussed during this review were detailed
previously.
amendment review: any time the researcher wants to change a
procedure, consent process, or data collection form.
adverse events or unexpected problems: at the time they occur.
continuing review: at an interval specified by the IRB at initial
review and dependent on the risk level for the study (e.g.,
monthly or quarterly, but no less often than once per year).

Depending on the nature of an amendment or adverse event, and at
the discretion of the IRB, it may be acceptable to use an expedited IRB
review procedure for these types of reviews. Expedited reviews can be
done by an IRB chair or experienced IRB member (rather than by the full
committee), but they must include consultation with the prisoner representative. No research involving prisoner-subjects should be deemed exempt from IRB review. Even a low-risk questionnaire involving
prisoner-subjects requires an IRB review.
There are other situations for which IRB review is required. A preliminary review can be conducted before funding has been obtained for
the study. During this review, the IRB will assess at the most fundamental level whether prisoners can be ethically involved in the proposed re3

Otherwise protected data may be used and disclosed for research if (1) it has been
deidentified; (2) the individual has given written authorization; (3) without authorization,
in limited circumstances such as for activities involved in preparing for research or for
research on decedents; or (4) without authorization, if a waiver has been obtained.

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search. If so, the adequacy of the protections will be assessed and suggestions offered to the researcher about how to strengthen the protections. However, the preliminary review does not substitute for the initial
review. No subjects can be contacted and no information can be accessed
based on a preliminary IRB review. IRB review would also be needed
when an investigator wants to use for research purposes data collected
during an activity initially classified as treatment or QI (i.e., not research).
SYSTEMATIC OVERSIGHT OF RESEARCH
WITH PRISONERS
Although approval of research by the IRB or other independent review committee is a critical first step in protecting research subjects, it is
not sufficient. Research involving prisoners, like other types of research,
must be monitored throughout the course of the study to verify that study
procedures are being conducted as approved and to detect adverse events
or unexpected problems in a timely manner. Ongoing monitoring, then,
is another key issue that must be considered in the new oversight requirements. The monitoring process may need to differ depending on the
setting or type of study. For example, studies that take place in closed
institutions that restrict subjects’ access to investigators or advocates
may require more proactive (inside the institution) monitoring than those
that take place in the community, where subjects are more at liberty to
pick up the phone and call someone. Similarly, higher risk or more intrusive studies (e.g., research that involves medical, pharmaceutical, or biological agents or interventions) probably require more intrusive
monitoring, whereas social/behavioral studies (e.g., involving questionnaires) and program evaluations may require less stringent monitoring.
Highly coercive environments, such as higher security jails and prisons, pose well-documented challenges to conducting ethical research
with prisoners. Specific threats to principles of individual autonomy
(e.g., voluntary consent) and justice (e.g., not bearing disproportionate
weight of research risks) are more likely to occur in such closed environments, and it is these environments to which the national commission’s recommendations and the current Subpart C regulations were most
responsive.
The committee has proposed broadening the definition of prisoner to
apply to a much larger number of individuals in a broader array of envi-

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ronments (see chapter 4). This expanded definition of prisoner was developed in view of the committee’s awareness that the types of threats
(i.e., coercion, undue inducement, lack of access to the outside) observed
in these traditional institutional settings exist to some degree in other,
less traditional settings as well. However, there are also quantitative differences in the extent to which these threats exist and in the likelihood
that they will arise in less restrictive prisoner settings. There continues to
be a power differential between criminal justice-involved individuals and
agents of the justice system (e.g., parole or probation officers or staff in
community agencies, such as residential treatment programs and halfway/transition houses where prisoners reside or receive services). Of
course, the level of day-to-day control and scrutiny is likely reduced in
these community settings, and there is likely a greater degree of openness
in such settings. As the level of restrictiveness and external control decreases (e.g., from closed residential facility to probation or house arrest), individuals are likely to have greater opportunities for unmonitored
communications with others, including telephone or visitation access to
friends, family, or other third parties who may have the prisoner’s interests at heart. Depending on individual resources, increased access and
individual choice in health care services are also likely.
As a consequence of the broader proposed definition of prisoner and
the expanded array of settings in which regulations governing research
with prisoners as subjects may apply, it follows that IRBs responsible for
reviewing and approving research with prisoners must consider the variety of settings and associated features of those settings vis-à-vis the level
of scrutiny/control, openness, and, particularly in the case of medical
research protocols, quality of agency health care services and prisonersubjects’ access to alternatives. In this expanded definition of prisoner
and the broader landscape of settings in which research with prisoners
may be conducted, research protections must be tailored to some degree
to particular types of research (e.g., social and behavioral as compared
with biomedical [broadly conceived] and the features of the particular
setting).
In the context of this greater need for local identification and scrutiny
of the nuances of research settings vis-à-vis the potential for control and
coercion, openness, and access, the committee considered an array of
specific research design controls and research monitoring practices that
IRBs should consider imposing as a function of the research setting.
These controls and practices were derived from the ethical analysis described in Chapter 5. It was the committee’s view that, in most instances,

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such judgments and determinations could not likely be made easily or
effectively by a remote, centralized review entity that had little firsthand
knowledge of local circumstances. Thus, the safeguards proposed in the
following section provide for federal-level administrative oversight of
particular research protocols in only limited circumstances. Instead, federal-level oversight would focus on making determinations about sensitive research proposals that require federal-level review; enforcing
compliance with regulations, investigating problems, intervening to curtail abuses, and applying sanctions for noncompliance; serving as a national resource for HRPPPs; and maintaining a national registry of all
research involving prisoners (see later discussion). Various options for
monitoring, including the use of a PRSA, the IRB itself, and a national
oversight group, are discussed next.

Prison Research Subject Advocate
A PRSA would be assigned to monitor prisoner research of certain
risk levels. The scope and intensity of monitoring would be determined
by the IRB with input from the investigator and correctional setting staff.
The PRSA concept is, in part, modeled on the research subject advocate
position now in place in clinical research centers at medical research institutions around the country. However, the PRSA is distinct from a
clinical research associate, who is employed by a research sponsor or
contract research organization in clinical trials strictly to monitor regulatory compliance at sites participating in clinical trials. Another model for
the PRSA concept comes from the European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment
(Council of Europe, 1987). The intent of the convention is to strengthen
the protection of persons deprived of liberty. The convention establishes
a committee that visits places where persons are deprived of their liberty,
including prisons and hospitals where patients are subject to detention,
and writes a report of findings to the government with recommendations.
The report and recommendations may be made public only at the government’s request.
Recommendation 6.3 Strengthen Monitoring of Research
Involving Prisoners
Institutional Review Boards that review and approve research involving prisoners should establish an on-site, ongo-

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ing monitoring function through a prison research subject
advocate.
A prison research subject advocate (PRSA) helps provide assurance, via ongoing onsite monitoring, such that research subjects
within a specific facility or program are protected.The PRSA
must be local to the correctional facility in which the research is
being conducted to enable frequent visits to the facility, to establish trust among the prisoners, and to respond quickly to any adverse events. The IRB should have free access to the PRSA and
be able to meet with the PRSA separate from the investigator
and correctional setting staff. The extent of monitoring should be
calibrated to the level of restrictions imposed on prisoners in the
particular correctional setting and the degree of risk involved in
participation, regardless of whether this research is biomedical or
social/behavioral in nature.
The PRSA’s responsibilities would be to:
1. Monitor compliance with the protocol and full implementation of
any IRB-approved research.
2. Monitor adverse events, including how these events are tracked,
the submission of timely adverse event reports to the IRB and appropriate federal agencies, and IRB review of these reports.
3. Monitor compliance with all relevant regulatory requirements.
4. Determine that research is conducted only on current, approved
protocols and with current, valid informed consent.
5. Monitor the consent process by investigators and study coordinators to verify that the prisoners are able to make informed—and uncoerced—decisions about participation.
6. Provide a mechanism for receiving and responding to any participant or staff-generated questions regarding participation of human
subjects in the research. The PRSA should be able to receive complaints
and questions from individual prisoner-subjects, so there must be mechanisms in place to ensure that prisoner-subjects have timely access to the
PRSA.
7. Assess the implementation of arrangements to protect the privacy and confidentiality of research participants, particularly in connection with personal health information.

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The PRSA should be an individual who has formal training in the
human research participant protections system and human research ethics. Study sponsors may be required to provide all or a reasonable portion of the PRSA’s salary as an overhead expense of the study. Among
various candidates for the PRSA position discussed by the committee,
the following were considered viable and adequate:
●
●
●
●

an ombudsman,
a person employed by the IRB,
a person affiliated with a national entity, an independent contractor hired by the study (if this is the only way to pay the PRSA
using grant funding), and
a QI director if the QI program at the facility is adequate.

To help ensure the PRSA’s independence and credibility with prisoner-subjects, the PRSA should not be an employee of the correctional
facility.
The QI option proposed “I don’t think that a person who worked for
above is considered secondary to the Department of Corrections would be the
the other options because of con- ideal person to go in and monitor. I think it
cern that an individual who is an would have to be somebody that has no
vested interest,” said Jean Scott, at the
employee of the correctional set- committee’s October 2005 meeting. Ms.
ting would not be able to provide Scott is deputy regional director of New
the kind of impartial monitoring York City Correctional Treatment Prothat would be required to keep grams, Phoenix House, and a member of the
prisoner-subjects as the top pri- committee’s prisoner liaison panel.
ority. If every effort is made to identify a PRSA from outside the correctional facility and none can be found, the PRSA functions could be performed by a QI director already in place at the facility, under the
following conditions:
1. The IRB approves the procedures that will be used by the QI director for monitoring the study.
2. The QI process has written protocols for auditing/reviewing the
responsibilities previously listed for the PRSA.
3. The IRB receives and reviews the reports generated by the QI director relevant to the pertinent research activities and has the right to
have the QI director revise/redo audits if they are not adequate for monitoring purposes.
4. The QI director reports directly to the IRB.

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The activities of the PRSA go beyond the routine annual reviews that
IRBs currently conduct. The PRSA’s activities are study specific (although a single person could be a PRSA for more than one study) and are
“on the ground” activities, involving varying degrees (depending on the
type & risk level of the research) of direct observation of specific research activities. The requirement of PRSA monitoring does create an
additional expense, which should be borne by the institution conducting
the research as an inherent cost of ethical research.
IRB Postapproval Monitoring
Most IRB’s have some mechanism for monitoring studies after they
are initially approved. These vary by IRB and type of study but may include audits of study records, contact with subjects, and sometimes even
direct observation of interviews. For studies involving prisoners, the type
of monitoring required will depend on the nature of the correctional setting, the extent of restrictions imposed on prisoners in that setting, and
the degree to which the proposed research poses risk to the health or
well-being of the prisoner-subjects. At minimum, there should be some
mechanism whereby prisoner-subjects can contact the IRB to report
problems or ask questions. Guidance and support should be provided to
IRBs to allow them to be more proactive in their approach to monitoring
of research involving prisoners.
Recommendation 6.4 Modify IRB Considerations for Independent Ethical Review of Research Protocols
Institutional Review Boards (IRBs) should focus on the particular ethical issues that each protocol raises in the specific
context of the correctional setting. IRBs would no longer be
required to forward research proposals to OHRP for certification, except for those rare proposals that require federallevel review.
IRBs should:
1. review studies at the local level, make the initial assessments
of risk and potential benefits, and approve or reject individual
studies based on detailed information about the protocol and correctional setting;
2. determine if a study requires federal-level review;

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3. evaluate investigator efforts to obtain input from prisoners
and other stakeholders on the design and conduct of the protocol;
4. evaluate the proposed research environment in terms of adequacy of existing health services;
5. calibrate the extent of safeguards and monitoring to the level
of restrictions imposed upon prisoners in the particular correctional setting and the degree of risk involved in study participation;
6. receive monitoring reports directly from PRSAs and researchers, at a scope and frequency determined during study review.
National Oversight
Monitoring by IRBs is not sufficient to provide the level of protection needed for research involving prisoners. It may be difficult for IRBs
to engage in the kind of self-reflection necessary to rethink how a protocol, which they themselves approved, might go awry. The committee
recommends that, although IRBs should retain the bulk of the approval
and monitoring functions to keep these at a local level, a national independent body is also needed as an additional safeguard (see following
discussion). Recommendation 6.5 first deals with enhancing the capacities of the oversight system under DHHS jurisdiction. A further expansion to cover all research involving prisoners follows later in this chapter.
Recommendation 6.5 Enhance OHRP’s Capacity to Provide
Systematic Oversight of Research Involving Prisoners
The Department of Health and Human Services should
strengthen the capacity of the Office for Human Research
Protections to provide systematic oversight of research involving prisoners that is within its purview.
Four necessary functions that are currently lacking in whole or in
part in oversight of research involving prisoners:
1. maintain a national registry of all prisoner research that
is conducted;
2. make determinations about studies that require federallevel review;

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3. enforce compliance with the regulations, investigate reports of possible problems, intervene to curtail abuses,
and impose sanctions for noncompliance; and
4. serve as a national resource for HRPPPs to promote a
uniform understanding and consistent application of the
regulations.
For research under DHHS jurisdiction, OHRP is currently designed
to perform three of the four functions listed in Recommendation 6.5.
However, OHRP does not have the funding or personnel to adequately
carry out the tasks. The universe of research involving prisoners is larger
than that covered by the current regulations. Furthermore, there are vast
inconsistencies in how research is defined, who reviews it, and how it is
monitored. OHRP needs to be revitalized and refocused to carry out the
three functions already within its purview. As a fourth, new function, the
national registry should be housed within OHRP as well.
IRBs or other independent review committees would still review
studies at the local level, making the initial assessments of risk and approving or rejecting individual studies based on detailed information
about the study. A revitalized OHRP would be more involved in investigating and intervening when problems occur and promoting consistency
on a nationwide basis, thus filling critical voids in the current oversight
system. To ensure that research involving prisoners is conducted in an
ethically responsible way, OHRP needs greater resources and broader
powers than presently exist. The enforcement division of OHRP, for example, presently consists of fewer than four full-time positions, and its
responsibilities encompass all research (not just prisoner research) conducted under existing regulations.
Because there is no central repository for the collection of data regarding research involving prisoners, it is difficult or impossible to quantify the number of such studies underway at any given time, the number
of prisoners involved, the types of studies being conducted, the subject of
inquiry in this research, the incidence of protocol deviations, or the occurrence of adverse outcomes (see Chapter 2). A national registry would
help OHRP provide technical assistance and training as well. With this
registry, the OHRP and others would have access to valuable information
about the kinds of research being conducted, problems and adverse
events that have been identified, and the types of protections appropriate
for different research projects in various correctional settings. Addition-

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ally, as the national body charged with the enforcement of the governing
regulations, OHRP could provide authoritative interpretations of the
regulations and their application in various circumstances. In its charge
to enforce governing regulations, when less formal procedures prove inadequate, OHRP must have the authority to initiate legal action to compel compliance, including discovery and subpoena power to uncover
abuses and enforce regulations. Anyone should be able to report alleged
violations of prisoner-subject rights to OHRP without fear of retaliation
(the OHRP would have to be able to invoke whistle-blower protection
for people who disclose problems), substantially improving the safeguards to prisoners who agree to participate in research.
Revitalizing OHRP to take on these four oversight functions would,
however, leave a gaping hole in the national oversight structure that must
be acknowledged and remedied. OHRP’s jurisdiction regarding research
involving prisoners is limited to studies funded by DHHS, Social Security Administration, and Central Intelligence Agency. The remaining
federal agencies and nonfederal and private entities are not required to
submit to OHRP oversight. According to the committee’s review of current research involving prisoners (see Chapter 2), only 11 percent of all
of the studies reviewed were funded by DHHS, indicating that the vast
majority of research involving prisoners does not fall within OHRP
overview jurisdiction. Therefore, to ensure the ethical conduct of all research involving prisoners, the enhanced OHRP oversight model must be
replicated for all research involving prisoners, regardless of funding
source, so that research supported by any federal agency, all nonfederal
agencies, and the private sector is subjected to the same systematic oversight.
Recommendation 6.6 Establish Systematic Oversight of All
Research Involving Prisoners
To expand prisoner protections beyond the narrow jurisdiction of DHHS, Congress should establish a national system of
oversight that is applied uniformly to all research involving
prisoners, performing all of the functions listed in Recommendation 6.5. The vast majority of research involving prisoners does not fall within OHRP overview jurisdiction.
Strengthening the safeguards provided for all prisoners involved in research, regardless of funding source, will facilitate safe and ethical research across the full range of
prisoner-involved research.

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These functions could be performed by the revitalized and properly
funded OHRP if its jurisdiction were extended to the entire range of research involving prisoners regardless of funding source: federal or nonfederal, public or private. An alternative is to compose a national entity
to perform the necessary oversight functions. Placing the functions
within OHRP may be more feasible and less disruptive, but it must be
done with serious attention to the extra support needed within OHRP to
undertake those tasks fully and much more broadly than its current limits
to Common Rule agencies. The committee is calling for substantial improvements to the existing system of oversight; if a new entity is necessary to make it happen, then it should be created.
Finally, for reasons similar to those underlying the committee’s recommendation for establishing systematic oversight, the research process
needs to be characterized by transparency and accountability.
Recommendation 6.7 Ensure Transparency and Accountability in the Research Enterprise
Human research participant protections programs and
prison administrations conducting human subject research
should be open, transparent, and accountable.
A sound, ethical protection program involves an open, transparent research process. It requires that the mechanisms used to protect participants from undue harm and to respect their rights and
welfare must be apparent to everyone involved. This transparency requires open communication and interaction with the local
community, research participants, investigators, and other stakeholders in the research enterprise. Accountability entails maintaining fidelity to the methodology stipulated in the protocol as
well as accountability to ensure the quality and performance of
the protection program itself.
APPLYING SAFEGUARDS FOR PARTICULAR
KINDS OF RESEARCH
As noted earlier, the committee recommends that the current Subpart
D framework, with modifications for application with prisoner-subjects,
be utilized to define permissible research. The modifications necessary

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for such research to be approvable include (a) a risk-benefit analysis to
ascertain whether participation carries potential benefits that outweigh
risks, and (b) the utilization of special design and monitoring safeguards4, which would vary as a function of the type of research, the risks
it poses, and the nature of the research setting. The greater the restrictions upon liberty in a particular correctional setting, the greater the need
for safeguards and protections of prisoner-subjects.
The guidance and examples in this section are intended to be illustrative of the ethical framework presented in chapter 5. Specifically, it
demonstrates the importance and application of the risk-benefit approach
with appropriate safeguards and monitoring based on the level of risk
and the restrictions of the correctional setting. The framework respects
the principle of justice and provides adequate protection and potential
benefit for prisoners involved in research.
As stated in Chapter 5, a risk-benefit analysis would normally prohibit certain types of biomedical research involving prisoners because
potential risks outweigh potential benefits:
1. Phase 1 and Phase 2 studies of experimental treatments, as defined by the Food and Drug Administration, because of insufficient
evidence of prospect of direct benefit at this early stage of testing
(Example 7 provides a rare, specific circumstance in which Phase 1
and Phase 2 studies might be permissible, and in which case, federallevel review and high-level safeguards and monitoring would be required).
2. Studies that involve exposing subjects to potentially noxious biological or chemical agents merely for the purpose of determining
and/or evaluating human reactions to such agents.
3. Biomedical studies that would enroll more prisoners than nonprisoners, unless a federal-level review authorizes the study.
Once the IRB determines that a study involving prisoners offers
more potential benefits than risks and does not fall within one of the
categories of impermissible research noted above, it must determine the
appropriate safeguards and monitoring. The types and levels of safeguards and monitoring required will depend on the nature of the correctional setting, the extent of restrictions imposed on prisoners in that
4

Special safeguards mean those safeguards above and beyond the usual safeguards routinely considered necessary for the approval of research protocols.

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setting, and the degree to which the proposed research poses risk to the
health or well-being of the prisoner-subjects.
Box 6-1 presents the kinds of special design and implementation
safeguards and special monitoring safeguards that an IRB might mandate
for particular research protocols. In the examples that follow, research
involving low risk and conducted in less restrictive settings may be approvable without the IRB imposing any special safeguards; however,
additional special safeguards from Box 6-1 may be necessary for prisoner research that involves greater risk and is planned for more restrictive settings. Stronger safeguards would also be needed in those
extremely limited circumstances when it would be ethically permissible
to utilize a greater proportion of prisoners than non-prisoners.
BOX 6-1
Special Study Design and PRSA Monitoring Safeguards
Special Study Design Safeguards (D1-D7)
D1.
Investigator should obtain a federal certificate of confidentiality to protect
against the disclosure of prejudicial, confidential, or personal information.
D2.
The proportion of prisoner-subjects to non-prisoner-subjects may not
exceed 50 percent.
D3.
Neither the PI nor any member of the research team or staff member of
the institution/agency at which the study is conducted may receive financial or
other incentives for meeting recruitment quotas.
D4.
In clinical trials of medications in which some study arms provide for the
administration of standard-of-care treatment, those same medications must be
available to prisoners diagnosed with the same disease who are not recruited for,
or if recruited decline to participate in, the clinical trial.
D5.
The PI must demonstrate to the satisfaction of the IRB that the research
setting is sufficiently open to permit regular, prompt, and proactive monitoring of
prisoner-subjects’ clinical status by research staff or PSRA staff
required by the research protocol.
D6.
The PI must demonstrate, to the satisfaction of the IRB, that the quality
of physical/mental health services in the particular correctional setting is adequate to respond in a timely and professionally responsible manner to complaints, problems, and side effects that may emerge from prisoners’ participation
in a research study5.
D7.
The researcher must present to the IRB how the research is proceeding
after the first 30 days that subjects are enrolled.
Special PRSA Monitoring Safeguards (M1-M6)

See Chapter 5, page 154 for indirect measures for assessing adequacy of health care
services.

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M1.
Periodic observation (spot-checking) of informed consent dialogues at
recruitment.
M2.
Soon after enrollment, test randomly selected subjects for comprehension of the consent disclosure6.
M3.
Periodic debriefing of subjects to determine whether they experienced
any pressure or coercive actions by investigators or correctional personnel regarding the prisoner-subject’s participation.
M4.
Periodic observation (spot-checking) of protocol administrations to ensure fidelity to and compliance with the approved protocol.
M5.
Periodic debriefing of subjects regarding personal reactions to research
stimuli (e.g., interviews, questionnaires, medications, or devices)
M6.
Periodic debriefing of subjects regarding timeliness and adequacy of
investigator responses to any problems or complaints that the subjects associate
by with study participation (e.g., side effects or adverse reactions to medications
or devices; adverse psychological reactions).
NOTE: PI, principal investigator.

The safeguards in Box 6-1 are designed to be responsive to specific
ethical (and in some instances, practical) considerations in research with
prisoners. The obvious general principle is that, as the level of research
risk increases and as greater restrictions on liberty appear in a particular
correctional setting, additional safeguards should be used. With respect
to design safeguards, D1 (federal certificates of confidentiality) is responsive to the concern that correctional settings may pose greater challenges to privacy and confidentiality. D2 (50 percent ceiling) is designed
to prevent investigators from capitalizing on prisoners as a captive population and to ensure that prisoners do not bear an undue share of the burdens of research in higher risk studies. D3 (prohibiting incentives for
recruitment quotas), D4 (availability of control-arm standard-of-care
medications and treatments to nonresearch participants), and D6 (adequate prison health services) are viewed as protections against potentially
coercive conditions. D5 (openness of the research setting) is responsive
to the concern that, compared with non-prisoner research subjects, prisoners may generally be at greater risk of experiencing harmful effects of
research because of limited access to researchers. D7 (30-day review
6
The PRSA needs to determine that the person understands, or has access to information that enables them to understand, the basic study parameters. This should not be a
“memory test” of the consent disclosure. Subjects could display comprehension of the
basic study parameters by retrieving their copy of the consent disclosure and “explaining”
to the PRSA the information therein. A problem would exist, however, if a subject did
not appear to understand the study parameters even with access to and opportunity to
review the disclosure.

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presentation to IRB) provides an extra safeguard to evaluate high-risk
studies once they have begun.
Monitoring safeguards generally permit IRBs to obtain information
about recruitment and protocol administration that is independent of the
investigator or correctional setting. These safeguards are justified on the
principle that research activities should be open and that investigators
should be accountable for the proper administration of their protocols.
M1, M2, and M3 provide independent checks on the validity of the informed consent process, which may face various threats because of the
potentially coercive nature of correctional settings. M4 provides for an
independent check of the protocol implementation, which protects
against protocol deviations that have not been approved by the IRB. M5
and M6 provide for an independent assessment of subjects’ reactions to
protocol stimuli and the appropriateness and timeliness of investigators’
intervention to remedy or ameliorate untoward adverse reactions.
Sample Situations
The following vignettes are provided as exemplars of the kinds of
considerations that might arise in IRB deliberations about particular
types of studies. The vignettes are clearly not exhaustive, nor are the particular hypothetical “solutions” embedded in them intended to be prescriptive. IRBs encounter a wide variety of prisoner research proposals
that vary in the intrusiveness of the experimental stimuli, the restrictiveness of the correctional setting, the level and extent of risks and benefits
to prisoner participants as individuals or as a class, and in other study
parameters. The current Subpart D framework, with modifications for
application to research with prisoners, provides a better conceptual
scheme for evaluating such proposals. However, IRBs should impose
special study safeguards, such as those indicated in Box 6-1, when levels
of restrictiveness and/or risk require them. At the highest level of risk,
federal-level review becomes an added requirement, as in Subpart D (45
C.F.R.§ 46.407).
It is beyond the scope of this committee’s charge to prescribe extensive and highly detailed requirements that would accommodate any foreseeable study design; the judgment of the IRB will be required to
implement special safeguards in any given case. However, this discussion of IRBs imposing special safeguards should not be read as a mere
suggestion; the committee is unanimous in asserting the need for regula-

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tions that expressly require IRBs to proactively impose special safeguards when needed to adequately protect prisoner-subjects. Moreover, it
is anticipated that regulations based on the committee’s deliberations will
ensure adequate protection for prisoner-subjects in all research settings.
Example 1: A psychologist administers a measure of general personality traits, such as impulsivity, extraversion, and anxiety sensitivity,
to prisoners as they prepare for discharge from prison to a community half-way house. This is a non-interventional study that does not
elicit any sensitive or prejudicial information7; the questions on these
measures are of the type usually encountered in routine psychological
evaluations and thus meet the conventional and historical definitions of
“minimal risk.” The investigator obtains a report of disciplinary infractions for each inmate in the study. Correlational analyses are conducted
to determine the extent to which these general personality traits predict
the subsequent disciplinary problems. Based on these analyses, suggestions are made to the prison staff responsible for discharge planning
about the potential utility of these kinds of measures for identifying prisoners more or less likely to adjust successfully in this particular type of
placement. The study has the potential to benefit prisoners as a class by
informing the placement decisions that DOC officials make when prisoners are transitioned to the community, potentially increasing the likelihood of a successful return to the community. Thus the study is
considered low enough risk that the IRB might opt not to impose any
special safeguards. Informed consent can be obtained in the usual way
without requiring PRSA monitoring/spot-checking, and there is no apparent reason to require the investigator to seek a Certificate of Confidentiality. At minimum, there should be some mechanism whereby

7
Prejudicial information includes the personal information that, if disclosed to or discovered by certain third parties, might result in formal consequences for the individual.
Examples include self-reporting of (1) having previously abused children or the elderly
(potentially subject to state mandatory reporting laws), (2) medical conditions or vulnerabilities that might be stigmatizing or adversely affect ability to obtain or retain medical
insurance, (3) prior criminal activity (only if described in sufficient detail to render the
subject a suspect in a particular crime), or (4) conduct that violates institutional or program rules or conditions of probation or parole, the revelation of which could result in the
imposition of punitive or disciplinary measures (e.g., drug use). Sensitive information is
that which might be potentially embarrassing if revealed to third parties (e.g., sexual habits) even if such disclosure might not put the person at risk for formal sanctions.

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prisoner-subjects can contact the IRB to report problems or ask questions.
Example 2: An investigator is interested in the personality correlates
of risky behavior. With the cooperation of a probation services office,
she recruits voluntary participants from individuals living in the community who come in for monthly probation supervision. Her protocol includes self-report questionnaires that assess general personality features;
she also conducts a semi-structured interview that queries the individual
about risky behaviors, such as participating in unprotected sex, illicit
drug use, reckless or fast driving, and other kinds of risky behaviors. Although the protocol may meet traditional and historical criteria for
“minimal risk,” the dependent measure (risky behavior questionnaire)
solicits information (e.g., contemporary drug use or law violations) that,
if revealed to the probation officer, could result in violation of probation;
the questionnaire also solicits information (e.g., sexual activity) that
might be potentially embarrassing under some circumstances. The study
does have the potential to benefit prisoners as a class by identifying personality features that may lead to a risky lifestyle, and this information
could potentially form the basis for interventions that target the reduction
of such behaviors in other prisoners in the future.
When a protocol will solicit sensitive or prejudicial information, the
IRB should consider requiring safeguards and monitoring procedures of
the type indicated in Box 6-1. For research in a relatively lower security
setting (e.g., a probational services office), the investigator might be required to obtain a Federal Certificate of Confidentiality; a PRSA might
also be assigned to periodically de-brief randomly selected subjects to
determine whether they had experienced any untoward actions by investigators or their probation officers, such as coercion. In higher-security
settings (e.g., a jail or prison), additional and stronger safeguards and
monitoring might be deemed necessary. For example, the PRSA might
be assigned to spot-check protocol administration to ensure that the protocol was administered within the institution in a way that protected the
prisoner’s privacy. And of course, in any study that elicits sensitive or
prejudicial information, the potential prisoner-participant must be advised in clear terms of the risks associated with disclosure of such information. The potential participant must also be advised that he may refuse
to answer any questions, and that he may discontinue his participation in
the study at any time without adverse consequence to his personal circumstances or the conditions of his confinement.

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Example 3: Phase 3 study that plans to enroll more prisoners than
non-prisoners comparing an experimental treatment for hepatitis C
with an existing therapy. This research involves greater than minimal
risk, but presents the prospect of direct benefit to the individual participants (Currently § 46.405 Subpart D). The study is not approvable, however, unless it reduces the percentage of prisoner-subjects to no more
than 50 percent. If prisoner enrollment is reduced, safeguards and monitoring should still be extensive. They might include all of the safeguards
listed in Box 6-1, plus M3-6 of the PRSA monitoring safeguards.
Example 4: If a Phase 3 study were comparing an experimental
treatment to placebo for a condition for which no standard therapy
exists. Placebo-controlled studies are not allowable if there is a standard
therapy for the condition. Current standard therapy would have to be the
comparator to the experimental therapy in order for the study to provide
potential benefits to the individual prisoner-subjects. If there is no standard therapy and placebo control is proposed, concerns regarding use of
placebo are sufficient for the committee to determine that federal-level
review would be necessary. Exceptional safeguards would need to be put
in place as well. The PRSA should attend informed consent dialogues to
ensure prisoners understand that they may be receiving a placebo. Also
appropriate are M5 and M6 from Box 6-1, which provide for reactions to
study medications and subjects’ experiences with the responsiveness of
the prison staff and investigators to adverse events that they may have
experienced. In addition, M7, should be used, requiring researchers to
present the study’s status to the IRB after the first 30 days that the subjects were enrolled.
Example 5: A study of posttraumatic stress disorder in which participants are queried in depth about prior traumas and associated
reactions, but which does not involve investigation of treatments for
such conditions. In-depth explorations of traumatic events and the deliberate uncovering of associated feelings and emotions might result in a
degree of psychological discomfort that increases potential risk to some
participants. In addition, this study provides no potential benefit for the
individual, but may benefit prisoners as a class if the investigation aims
to understand the impact of trauma on crime or recidivism after release
from prison, or serves as a potential basis for developing therapeutic interventions.

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The research may be approvable if benefits to prisoners as a class
can be ascertained. However, level of risk is greater than minimal, therefore the IRB may deem necessary a higher frequency, extent, and type of
PRSA monitoring (as described in Box 6-1) than would be needed for a
study that delved only superficially into past traumatic experiences (e.g.,
some research questionnaires include only one or two cursory questions
about whether the respondent believes that he or she has ever been
abused or experienced trauma, without exploring any details of such experiences). For example, M4 (PRSA monitoring, spot-checking administration of the protocol) might reveal the extent to which the investigator
evaluated the immediate impact of the protocol on the subject and took
appropriate action (e.g., crisis intervention; referral to services) when
subjects became upset as a consequence of participation.
Example 6: A study that utilizes functional magnetic resonance imaging to study brain activity during subjects’ responses to visual or
verbal stimuli that invoke feelings of anger and aggression. This
study is an example of a behavioral study in that the outcomes involve
monitoring of brain activity (behavior). It does not provide direct benefit
to prisoner-subjects, but it might benefit prisoners as a class if methods
to reduce anger could be developed based on the MRI results. Because
MRI is considered an invasive monitoring procedure, the study would
involve somewhat greater than minimal risk. Safeguards and monitoring
must be correspondingly more stringent. In addition, safeguards and
monitoring would need to be more stringent if the study were taking
place in a high-security correctional setting than if it were in a lessrestrictive setting.
Example 7: A Phase 1 study of a medication that may reduce repetitive sexual assaults. Research that presents an opportunity to understand, prevent, or alleviate a serious problem that solely or almost
exclusively affects the health or welfare of prisoners is a narrow category
that the committee expects will be used in only rare cases. The committee recommends that proposals for this type of research be permissible
only under the added scrutiny of federal-level review and approval. Such
studies may not proceed until after the secretary has consulted with the
appropriate experts, such as an ad hoc committee as used for Subpart D
(§ 46.407 Subpart D), and published notice in the Federal Register of the
intent to approve such research. It includes studies seeking to develop
medications for the treatment or management of certain behaviors that

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are unique to, or almost exclusively found in, prisoner populations. For
example, repetitive violence or repetitive sexual assault are behaviors not
widely distributed in the general population. Individuals who exhibit
these behaviors are confined for long periods of time with little prospect
for release unless methods are developed to manage their deviant behavior. Insofar as the committee has recommended against permitting prisoners to participate as research subjects in Phase 1 and Phase 2 clinical
trials of medications, in the case of such conditions an exception is necessary as there are no alternative candidate research populations to draw
from. Due to the potential risks (prisoners make up more than 50 percent
of the study population and phase 1 testing is early testing with little data
on benefit), this study would require the most stringent design safeguards
and PRSA monitoring , some of which is described in the Box 6-1.
Example 8: Research to understand segregation or other isolated
settings and its effects. There would be significant problems gaining
reliable voluntary consent from individuals within the isolated confines
of segregation or who face the bleak future of death row. Approval of
any studies within these settings would require a federal-level review
process, including consultation with the appropriate experts, such as an
ad hoc committee as used for Subpart D (§ 46.407 Subpart D), and published notice in the Federal Register of the intent to approve such research. Studies proposed within these settings would have to establish a
clear potential benefit to the prisoner-subjects and would likely be limited to studies designed to measure the adverse effects of segregation on
mental or physical health or well being. Extraordinary safeguards must
be in place to minimize coercive forces and maximize the likelihood that
prisoner participation is voluntary. Monitoring should be extensive as
well, including PRSA attendance at every enrollment interview to ensure
and reinforce disclosure that participating (or not) in the research does
not affect how long the person may remain in his/her current special
status/setting.
Example 9: A study is proposed to compare drug X with drug Y to
treat impulse control disorders. Clinicians currently use drug Y to
treat such disorders, however, it is not on the prison’s formulary due
to its cost. Available instead is the lower-cost generic form, which is
more likely to cause gastric side effects than drug Y. The study would
not be approvable because of standard of care and consent issues. Some
prisoners may be willing to expose themselves to unknown risks of tak-

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ing drug X in the hope of receiving drug Y, which is considered a useful
drug for impulse control disorders, but is not available, except through
this research project.
Example 10. A person sentenced to probation is released from jail
and resumes living at home and makes monthly visits for probation
supervision. This prisoner reads in the newspaper that the local university medical school is conducting a Phase 2 study of a drug to
treat adult attention deficit disorder (ADHD). Having previously been
diagnosed with ADHD, he calls the university and makes an appointment
to meet with the study coordinator and eventually enrolls in the study.
This is an example of the situation described in Chapter 4, in which the
prisoner is voluntarily participating in a study that has no necessary connection to his status as a prisoner; no criminal justice agent (e.g., his probation officer) is involved in the identification or recruitment process,
and his status as a “prisoner” is of no interest or consequence to the investigators – they are simply interested in adults with ADHD. The proposed regulations/guidelines in this report pertaining to “prisoner
research” would not apply to this individual because there is no criminal
justice nexus to his study participation.
Example 11: A study to compare the effectiveness of two in-prison
education programs for prisoners with HIV. The study would assess
prisoner actions after release from prison. Many DOCs have recently
instituted “transitional case management programs” for prisoners with
HIV, diabetes, tuberculosis, or mental health issues as a standard of care
when prisoners are released from custody. Researchers are trying to better understand the impact of this new case-management model and how
to improve it and compare it with other models. This research would involve recruiting prisoners and starting the health education and/or behavioral intervention pre-release, then following prisoners post- released to
determine if they followed up with their treatment, for example, or if
they are using condoms post-release. The risks are low, and potential
benefits exist for prisoners as individuals and as a class. Regarding important safeguards, the researchers would need to 1) obtain a Federal
Certificate of Confidentiality to protect the confidentiality of the information the prisoner provides for the study, 2) convince the IRB that financial or other incentives are not provided for meeting recruitment
quotas, 3) and find that the setting is sufficiently open to conduct the research (D1, D3, and D5). Although risks are considered low, the IRB

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will still want to be convinced that participants know what they are getting into, and that the researchers are adhering to the protocol. Periodic
monitoring (spot-checking), as described in Box 6-1 should accomplish
this goal. And of course, in any study that elicits sensitive or prejudicial
information, the potential prisoner-participant must be advised in clear
terms of the risks associated with disclosure of such information. The
potential participant must also be advised that he may refuse to answer
any questions, and that he may discontinue his participation in the study
at any time without adverse consequence to his personal circumstances
or the conditions of his parole.
Example 12: A study to compare the effect of standard diet plus a
dietary supplement versus standard diet alone on violent behavior
among prisoners8. Non-prisoner research has shown a correlation between high intake of omega-3 fatty acids (fish) and lower murder rates.
A researcher proposes to enroll 231 volunteers in a prison. Half would
receive omega-3 fatty acids and other supplements; half would receive
placebo. Placebo is used so that the study subjects and others do not
know who is receiving the supplement and who is not. Reports of antisocial behavior (assaults and other violations) would be measured before
and during the intervention. Approval or disapproval of this study would
depend on whether the IRB views it as behavioral or biomedical. The
researchers are measuring behavior, but what is the supplement considered—a behavioral intervention or a biomedical intervention? No diagnosed condition is being “treated” and the supplement is not a drug
controlled by the FDA. This may be a case in which fitting a study into a
clear category is less helpful than doing a straightforward risk/benefit
analysis. If viewed as biomedical, the study would be unapprovable because of the 50 percent rule. The placebo question is tricky as well. If a
standard of care exists, it should be provided as the comparator arm.
There is no standard of care in terms of dietary supplements, but both
groups are getting the same standard diet. If considered a behavioral
study, it would likely be approvable. What safeguards and monitoring
would be necessary? If the study is approvable, since prisoners will be
8
Interesting note: This study was actually published in 2002 in the United Kingdom
(Mihm, 2006). Antisocial behavior (assaults and other violations) dropped by a third
(relative to previous records) in the group that received the supplements. There was no
behavior change in the control group. The investigator is planning a larger study and
similar trials are underway in Holland and Norway.

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ingesting a substance, it is worth putting special safeguards in place, including D1, D3, D5, and D6. The PRSA should periodically attend informed consent dialogues to ensure prisoners understand that they may
be receiving a placebo. Also appropriate are M5 and M6 from Box 6-1,
which provide for reactions to study medications and subjects’ experiences with the responsiveness of the prison staff and investigators to adverse events that participants may have experienced.
OTHER CATEGORIES AND TYPES OF RESEARCH
INVOLVING PRISONERS PROHIBITED
Because of the history of abuse in prisoner research and the continuing existence of powerful incentives to exploit this vulnerable population, the committee encourages a conservative approach to the approval
of any research involving prisoners. Those studies that are approved
should incorporate safeguards necessary and appropriate to ensure the
safety of prisoner-subjects in view of the correctional setting in which
the study will be conducted. The committee unanimously recommends
against the conduct of any research involving prisoners that is not specifically permitted under this report.
IMPACT OF COMMITTEE RECOMMENDATIONS ON
STAKEHOLDER RESPONSIBILITIES
The recommendations offered in this report are intended to support
the development of a uniform system that provides critically important
protections for prisoners involved in research. Strengthening the systems
of oversight and requiring collaboration at every level of the research
process will require substantial commitments from every stakeholder
(Table 6-1). The committee acknowledges, for example, that the collaboration model will be new within most correctional settings and among
many researchers. However, if research is to be supported to improve the
welfare of prisoner populations, it must be done with rigorous safeguards
and under a comprehensive HRPPP.

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TABLE S-1 Impact of Committee Recommendations on Stakeholder
Responsibilities
Stakeholders
Congress

Current Duties

DHHS/OHRP

1. DHHS agencies
follow Sub-part C,
OHRP also has oversite for research involving prisoners for
two other agencies
(CIA, SSA) that
signed on to Subpart
C.
2. For above mentioned studies involving prisoners, OHRP
must certify that IRB
has followed Subpart
C.
3. If a protocol does
not fit within one of
five catargories, regardless of risk benefit, it is not approved.

Proposed Duties Based on
Committee Recommendations
1. Mandate uniform guidelines
2. Adequately fund OHRP to
strengthen its capacity to provide uniform oversight
3. Establish national oversight entity (OHRP or other) to
provide same OHRP oversight
functions for the larger universe of research involving
prisoners that is not within
DHHS jurisdiction.
1. Expand definition of prisoner.
2. Support critical areas of
correctional research.
3. Revise Subpart C regulations to reflect a risk benefit
approach to research review
similar to Subpart D.
4. Establish a system of safeguards to be applied uniformly.
5. Revitalize OHRP to enhance its capacity to provide
uniform oversight.
6. Maintain a national registry
of all prisoner research.
7. OHRP no longer certifies
all studies, although it still
oversees process of “exceptional” study review.
8. OHRP focus shifts to national oversight, data collection, compliance, enforcement,
and technical assistance role.

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Proposed Duties Based on
Committee Recommendations
1. All federal agencies follow
Subpart C.
2. Support critical areas of
correctional research.

Stakeholders
Other federal agencies

Current Duties
Only CIA, SSA follow
Subpart C.

Nonfederal and
private sponsors

Not required to follow
Subpart C.

Must follow revised Subpart C.

Correctional settings 1. No clear, standard
expectations for providing input in design
or access for onsite
monitoring.
2. May or may not
require IRB review for
research at their facility.

1. Protocol review is
based on categories.
2. For DHHSsupported research
involving prisonersm
submit to OHRP for
certification, and if
necessary, federallevel review.
3. Wait for OHRP
certification before
study can be approved.
4. Ensure informed
consent.
5. Protect subject
privacy.
6. Include prisoner

1. Review shifts from category-based to risk-benefit approach, with focus on the
particular ethical issues that
each protocol raises in the specific context of the correctional setting.
2. Only “exceptional” studies
are submitted to OHRP for
federal-level review.
3. Evaluate investigator efforts to obtain input from prisoners and other stakeholders
on the design and conduct of
research protocols involving
prisoners.
4. Evaluate the proposed re-

HRPPP/IRB

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SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS

Stakeholders
HRPPP/IRB
(con’t)

201

Proposed Duties Based on
Current Duties
Committee Recommendations
representative as voting search environment in terms of
adequacy of existing health
member of IRB
services to ensure that prisoner
participation is truly voluntary
and assess existing capacity to
provide for timely and adequate medical response to adverse events experienced by
the research subjects.
5. Ensure informed consent.
6. Protect subject privacy.
7. Include prisoner representative as voting member of IRB
8. Be open, transparent, and
accountable.

Investigators

1. Present studies to
IRB and await IRB
approval and OHRP
certification.
2. No standards for
getting input or ensuring adequate medical
response.
3. Obtain informed
consent.

1. Present study to IRB for
approval. Only requires OHRP
review for “exceptional” studies
2. Demonstrate efforts to obtain input on study design and
implementation from stakeholders, including prisoners.
3. Demonstrate to the IRB
that the proposed research
environment provides for
timely and adequate medical
response to adverse events
experienced by the research
subjects.
4. Obtain informed consent.
5. Be open, transparent, and
accountable.

PRSAs

Do not exist.

Provide assurance, via ongoing, onsite monitoring, such
that research subjects within a
specific facility or program are
protected.
Multisite studies would likely
have more than one PRSA.

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Stakeholders
PRSAs (con’t)

Current Duties

Prisoners

1. Provide informed
consent.

Proposed Duties Based on
Committee Recommendations
Duties expand as potential
risks to participants increase.
1. Provide informed consent.
2. Provide input, on request,
on study design and implementation.

REFERENCES
Council of Europe. 1987. European Convention for the Prevention of Torture
and Inhuman or Degrading Treatment or Punishment. Available:
http://conventions.coe.int/Treaty/EN/Reports/HTML/126.htm [accessed December 26, 2005].
Council of State Governments. 2002. Criminal Justice/Mental Health Consensus
Project. New York: Council of State Governments.
IOM (Institute of Medicine). 2003. Responsible Research: A Systems Approach
to Protecting Research Participants. Washington, DC: National Academies
Press.
IOM. 2004. The Ethical Conduct of Clinical Research Involving Children.
Washington, DC: National Academies Press.
Joint Commission on Accreditation of Healthcare Organizations. 1992. The
Transition from QA to QI: Performance-Based Evaluation of Mental Health
Organizations. Oakbrook Terrace, IL: Joint Commission on Accreditation of
Healthcare Organizations.
Mihm, S. 2006. Does eating salmon lower the murder rate? New York Times
Magazine. April 16. [Online] Available: http://www.nytimes.com/2006/04/16/
magazine/16wwln_idealab.html?ex=1146110400&en=2528d21f31d15f30&e
=5070 (Accessed April 25, 2006).

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A
Data Sources and Methods

To comprehensively address the committee’s overarching task of reviewing ethical considerations for protection of prisoners involved in
research, the committee cast a broad net for the collection and assessment of information. These sources included commissioned papers (Box
A-1), open sessions and workshops, telephone interviews and e-mail surveys to the state Departments of Corrections, a survey of recent literature
(to assess basic characteristics of research with prisoners), and two site
visits to the correctional facilities.
In addition, a liaison panel of former prisoners and prisoner advocates was assembled for the committee to consult with throughout the
project (Box A-2). The committee organized two meetings with the liaison panel to receive their expert advice and guidance in framing the issues, identifying important sources of information, and ensuring a
comprehensive analysis. A summary description of the committee’s evidence gathering activities and results follows.

203

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ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS

BOX A-1
Commissioned Papers

Ethical Issues Regarding HIV/AIDS Research Among Prisoners
Theodore M. Hammett, Ph.D., Abt Associates Inc.

10 Years of HIV/AIDS Research Behind Bars: Time for Change

Jason Farley, PhD(c), MPH, CRNP, The Johns Hopkins University

Rethinking the Ethics of Research Involving Prisoners
Alex London, Ph.D., Carnegie Mellon University

Research with Prisoners: A Reexamination of Ethical Foundations

Mary Anderlik Majumder, J.D., Ph.D., Center for Medical Ethics and Health
Policy

Current Status of the Process of Mental Health Research and
Substance Abuse Research with Prisoners: Practical Burdens
and Benefits of the Current System

Robert Trestman, Ph.D., M.D., University of Connecticut Health Center
BOX A-2
Former Prisoners/Prisoner Advocates
Liaison Group
Edward Anthony, Philadelphia, PA
Jack Beck, Esq., Correctional Association of New York
Debra Breuklander, MECCA
James J. Dahl, Ph.D., Phoenix House
Allen Hornblum, M.A., M.P.A., Temple University
Daniel S. Murphy, Ph.D., Appalachian State University
Barry Nakell, Esq., North Carolina Prisoner Legal Services, Inc.
Osvaldo Rivera, LADC I, Span, Inc.
Jeffrey Ian Ross, Ph.D., University of Baltimore
Jean Scott, Phoenix House

OPEN SESSIONS AND WORKSHOPS
Over the course of the study, the committee sought and received input from former prisoners, representatives of the prisoner advocacy
community, bioethics researchers, health professionals, prison services
researchers, and other organizations involved with research in prisons.
To help accomplish this, the committee held three open meetings. The
first was part of the first committee meeting on March 16, 2005. Staff

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205

from the Office for Human Research Protections (OHRP) discussed the
current federal regulations and their goals for this Institute of Medicine
(IOM) project. Perspectives on the current federal regulation and needed
changes were also provided by representatives of the prisoner advocacy
community, bioethics researchers, prison services researcher, and a representative from the federal Bureau of Prisons (BOP). The second was a
workshop in Washington, DC, on May 4, 2005. This public workshop
focused on the ethical and legal/regulatory frameworks that underlie research involving prisoners. The committee also heard from representatives of the corrections industry about the practicalities of conducting
research in correctional settings. A panel of former prisoners/prisoner
advocates talked about needed protections for research involving prisoners. The third workshop was held in San Francisco on July 18, 2005. This
workshop focused on topical research areas and methodological issues
related to conducting research with correctional populations. Former
prisoners and prisoner advocates also presented their views of needed
protections. The organizations and individuals that addressed the committee in these open sessions are listed in Box A-3. In addition, many
other individuals attended and participated in the three public meetings
(Box A-4).

BOX A-3
Individuals and Organizations that Addressed the Committee
Elizabeth Alexander, J.D., National Prisoner Project of the American Civil Liberties Union (ACLU)
Edward Anthony, Philadelphia, PA
Larry Bench, Ph.D., Utah Department of Corrections
Jessica Berg, J.D., Case Western Reserve University
Joseph Bick, M.D., California Medical Facility
Debra Breuklander, MECCA
Alvin J. Bronstein, J.D., ABA Task Force on Legal Status of Prisoners, ACLU
National Prison Project
James Childress, Ph.D., University of Virginia
Gwendolyn C. Chunn, M.A., American Correctional Association
Hazel D. Dean, Sc.D., M.P.H., Centers for Disease Control and Prevention
Nancy Dubler, LL.B., Montefiore Medical Center
Bernice Elger, Ph.D., Timothy Harding University of Geneva, Switzerland
Gerald Gaes, Ph.D., National Institute of Justice
Julia Gorey, J.D., Office for Human Research Protections
Olga Grinstead, Ph.D., M.P.H., University of California, San Francisco
Alison Hardy, J.D., Prison Law Office
Edward Harrison, CCHP, National Commission on Correctional Health Care

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Allen Hornblum, M.A., M.P.H., Temple University
Doris J. James, M.A., Bureau of Justice Statistics
Denise Johnston, M.D., Center for Children of Incarcerated Parents
Patricia King, J.D., Georgetown University
Peter Leone, Ph.D., University of Maryland at College Park
Phillip Lyons, J.D., Ph.D., Sam Houston State University
Philip Magaletta, Ph.D., Federal Bureau of Prisons
Monika Markowitz, MSN, RN, M.A., Virginia Commonwealth University
Mary Faith Marshall, Ph.D., University of Minnesota
Nena Messina Ph.D., University of California, Los Angeles
Daniel S. Murphy, Ph.D., Appalachian State University
David Paar, M.D., University of Texas Medical Branch, Galveston
Darrel A. Regier, M.D., M.P.H., American Psychiatric Association
Bernard Schwetz, DVM, Ph.D., Department of Health and Human Services
Vera Hassner Sharav, M.L.S., Alliance for Human Research Protection
Christopher Slobogin, J.D., LL.M., University of Florida School of Law
Susan Sniderman, M.D., IRB Chair, UCSF
Irene Stith-Coleman, Office for Human Research Protections
T. Howard Stone, J.D., LL.M., University of Louisville
David Thomas, M.D., Nova Southeastern University College of Medicine
Dan Wikler, Ph.D., Harvard University
Gary Zajac, Ph.D., Pennsylvania Department of Corrections

BOX A-4
Public Meeting Participants
Sue Allison, Federal Bureau of Prisons
Susan Bankowski, Johns Hopkins School of Public Health
Jessica Baumann, Bureau of National Affairs
Francis Beylotte, American Psychological Association
Laura Bishop, Kennedy Institute of Ethics
Kristina Borror, Office for Human Research Protections
Bret Bucklen, Pennsylvania Department of Corrections
Scott Camp, Federal Bureau of Prisons
Michael Carome, Office for Human Research Protections
Erika Check, Nature
Michael D. Cohen, New York State Office of Children and Family Services
Jennifer Couzin, Science
Joyce Cutler, Staff Correspondent Bureau of National Affairs
Pamela Diamond, University of Texas School of Public Health
Erik Dietz, Federal Bureau of Prisons
Glen Drew, Office for Human Research Protections
Jessica Ebert, Nature
David Egilman, Brown University
Bernice Elger, University of Geneva and National Institutes of Health (NIH)
Patricia El-Hinnawy, Office for Human Research Protections
Julie Falk, CorrectHELP
Christine Fornwalt, Johns Hopkins Bloomberg School of Public Health
Gerald Gaes, National Institute of Justice

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207

Doreen Geiger, Washington State Department of Corrections
Harold Goldstein, American Psychiatric Institute for Research and Education
Te Guerra
Erica Hall, KPFT Pacifica Radio, Houston News
Shirley Hicks, Office for Human Research Protections
Terry Hill, Lumetra
Sally Hillsman, American Sociological Association
Bill Holman, Gilead Sciences, Inc
Craig Hutchinson, University of California, San Francisco (UCSF), Center for
AIDS Prevention Studies
Victoria Joseph, Bureau of Prisons
Julie Kaneshiro, Office for Human Research Protections
Alexa Kasdan, San Francisco AIDS Foundation
Steven Krosnick, NIH/Center for Scientific Review
Dan Landrigan, Report on Research Compliance
Molly Lang, The Blue Sheet
Elizabeth Mendelsohn, UCSF Office of Research
Leah Mendelsohn, Johns Hopkins Bloomberg School of Public Health
Virginia Morrison, Health Care Mediations, Inc.
Janet Myers, UCSF Medicine
Edward Opton, Jr.
Sangeeta Panicker, American Psychological Association
Kevin Prohaska, Office for Human Research Protections
Mercedes Rubio, American Sociological Association
William Ruby, Gilead Sciences, Inc.
Sandra Sanford , George Mason University
Jeffrey Schomisch, Guide to Good Clinical Practice
Angela Sharpe, Consortium of Social Science Associations
Barbara Solt, Institute for the Advancement of Social Work Research
Anne Spaulding , Medical College of Georgia/
Georgia Correctional Health Care, Infectious Disease
Mary Sylla, Centerforce
Sara Tobin, Stanford University Center for Biomedical Ethics
Christie Visher, The Urban Institute
Cheryl Crawford Watson, National Institute of Justice
Donna Willmott, Legal Services for Prisoners with Children

LITERATURE SURVEY TO ASSESS GENERAL
CHARACTERISTICS OF RESEARCH WITH PRISONERS
To help characterize the landscape of published research with prisoners (i.e., who is doing what type of research in what type of prisoner
settings), the committee conducted an assessment of prisoner research
published in peer-reviewed journals. The preliminary search consisted of
English language articles published since 1990, using the following databases: MedLine, PsychLit, Sociological Abstracts, Cumulative Index to

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Nursing & Allied Health Literature, Criminal Justice Abstracts, Education Resources Information Center, National Technical Information Service, and Excerpta Medica Database. Search terms used included IRB
composition, multisite study/studies, risk-benefit, informed consent, undue influence, vulnerable populations, payment, biomedical research,
behavioral research, environment, clinical trials, medication development, FDA, data storage, record keeping, privacy, placebo-control trials,
standard of care, follow-up care, follow-up monitoring, data monitoring,
HIV/AIDS, tuberculosis, infectious diseases, substance abuse, mental
health, women, females, juveniles, adolescents, and mental illness. These
search terms were cross-matched with the following subject terms: inmate(s), prisoner(s), incarcerate(d), jail(s). The preliminary search resulted in more than 14,000 articles. The search was then limited to the
past 5 years, which resulted in a selection of 1,870 articles.
A random sampling of 20 percent of the 1,870 articles was selected
as the final sample. Of these 374 studies, a total of 327 were studies that
included human subjects. The remaining 47 included the following types
of articles: review articles, commentaries, introductions to special editions, letters to the editor, position pieces, editorials, theory articles, news
articles, legal reviews, opinion pieces, discussion pieces, and news type
articles.
All of the articles were reviewed and coded using the standard criteria. The results follow.
Results
The results of the survey to assess the general characteristics of published research with prisoners are summarized in the following figures.
Funding Sources
Funding stemmed from a variety of sources, including the federal
government, state agencies, universities, and the private sector (Figures
A-1, A-2).

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APPENDIX A

Prison System
4%
Meta Analysis
(No Funding)
1%

Joint
4%

Foundation
5%

Other
29%

National Institute
of Justice
5%

Centers for Disease
Control
3%
National Institutes
of Health
8%

Did Not Specify
20%

Other, Federal
10%
State
11%

FIGURE A-1 Source of funding.
7

Number of Studies

6
5
4
3
2

1
0
n
ty
nt
nt
nt
rd
ss
irs
es
ns
l Gra inistratio llege Gra rsity Gra sota Pre Associat ans Affa
Quali rch Awa of Priso
a
r
and
e
choo
e
o
u
e
e
dm
T
S
n
iv
t
h
s
a
C
A
l
B
c
n
e
in
e
e
r
a
r
A
s
V
U
a
R
u
ic
of M
Med d Service
Rese illy Pilot ederal B
ersity
L
n
care
F
Univ
ealth hiatry/Eli
ces a
r
H
u
r
o
o
s
syc
cy f
h Re
Agen lescent P
Healt
Ado
d
n
hild a
y of C
adem
c
A
rican
Ame

FIGURE A-2 Number of studies with other or other federal sources of
funding.

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ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS

Mechanism of Approval
Most studies (66%) did not report the mechanism by which they
were approved (Figure A-3). Fifteen per cent indicated institutional review board approval; other entitiy review was 19%.

Institutional
Review Board,
15%

No Approval
Mentioned,
66%

Other Entity
Review,
19%

FIGURE A-3 Mechanism of approval.
Study Design
As shown in Figure A-4, epidemiological studies were the most
common (39%). Other common study designs included correlational
studies (27%) and those assessing behavioral outcomes (14%).

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APPENDIX A

Medical
Outcome,
5%
Non-medical
Experiment,
1%

Case Study,
6%
Other,
8%

Epidemiological
(e.g., surveys),
39%

Behavioral
Outcome,
14%

Correlational
Study,
27%

FIGURE A-4 Study design.
Type of Study
Most of the studies (41%) in the sample had a sociobehavioral focus,
lacked a therapeutic purpose, and had minimal risk to participants (Figure A-5). Program evaluations (26%) and record reviews (21%) were
also common.

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ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS
Medical, Therapeutic, No
Standard of Care,
Medical, Therapeutic,
Biomedical,
1%
Standard of Care Exists,
Nontherapeutic,
2%
1%
Other, 2%

Social/Behavioral, Nontherapeutic, Greater than
Minimal Risk,
0%

Social/Behavioral,
Therapeutic,
6%

Social/Behavioral, Nontherapeutic, Minimal Risk,
41%

Administrative
Records Review,
21%
Department of Corrections
Program Evaluation,
26%

FIGURE A-5 Type of study. (Same as Figure 2-3).
NOTE: Greater than minimal risk included any biomedical (nontherapeutic)
study; any medical therapeutic study (regardless of the existence of a standard of
care); any social/behavioral therapeutic study; and any nontherapeutic study
involving a manipulation that the research assistant judged to involve potentially
serious physical or emotional stress (e.g., long sleep deprivation). Not greater
than minimal risk included any study based on review of administrative records;
any program evaluation study; any nontherapeutic social/behavioral study that
either involved no manipulation (e.g., innocuous questionnaires/surveys) or involved a manipulation that the research assistant judged did not involve potentially serious physical or emotional stress (e.g., long sleep deprivation).

Studies were largely focused on health status (43%) and personality
characteristics (19%) (Figure A-6).

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APPENDIX A

Other,
8%
No Relationship
with Being in
Prision,
9%

Being Confined,
10%

Personality
Characteristics,
19%

Health Status,
43%

Re-Entry,
11%

FIGURE A-6 Categories of research.
Facilities/Locations
More than half of the studies (53%) were conducted in prisons or
jails (Figure A-7). Another large proportion of the studies (37%) were
conducted in alternate settings, such as treatment programs or postincarceration settings (Figures A-7, A-8).
Other,
10%
Alternatives to
Incarceration,
37%
Prisons, Jails,
53%

FIGURE A-7 Facilities/location of studies.

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Day Treatment,
0%

Boot Camps,
1%

Home
Confinement,
1%
Residential Drug
Treatment, 4%

Halfway
Houses,
0%

Community
Corrections,
4%

Juvenile
Detention
Center,
12%
Mental Health
Facilities,
4%

Probation,
7%
Parole,
4%

FIGURE A-8 Alternatives to incarceration research settings.
NOTE: This graph corresponds to the “Alternatives to Incarceration” slice in
Figure A-7. Juvenile detention centers were included in this analysis because the
committee decided to limit its focus to adults after this literature assessment was
conducted.

Number and Demographics of Research Participants
The number of participants in a published article ranged from 1 to
336,668. Most studies (272) included 1,000 or fewer participants (Figure
A-9).

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APPENDIX A

Number of Participants

>100,000

10,001-100,000

1,001-10,000

182

101-1,000
90

<100
0

100

150

200

Number of Studies

FIGURE A-9 Number of research participants.
Gender More studies included male participants than female participants
(Figure A-10).
300
262

Number of Studies

250

227

200
150
100
43

50
0
Male

Female

Did Not Specify

FIGURE A-10 Number of studies by gender of participants.
Age Most studies included adult participants; few included participants
younger than 18 years (Figure A-11).

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ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS

188

Number of Studies

200
150

101

100

50
15

0
Under 18 Years
of Age

Over 18 Years
of Age

Other

Did Not Specify

FIGURE A-11 Number of studies by age of participants.
Race/Ethnicity Most studies included participants of white/European
American race/ethnicity, closely followed by black/African American,
and Latino/Hispanic (Figure A-12). Other racial/ethnic groups were represented to a lesser extent (Figures A-13, A-14).

Number of Studies

300
250

229

242
191

200

161

150
100
50
0
Black/African
American

White/Euro
American

Latino/Hispanic

Other

FIGURE A-12 Number of studies by race/ethnicity of research participants.

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APPENDIX A
140

122

100
80
60

40
20

ia
l
/O
th
er

ify

-w

on
N

al
in

an
di
In

an
Am
er
ic
an
La
tin
a
H
ai
tia
n

e
iv

er
ic

N
ka

as
N

at
iv

fic

Is
l

ab
Ar

tir
ac

Number of Studies

120

FIGURE A-13 Number of studies with participants of “other”
race/ethnicity.

Number of Studies

5
4

4
3

3
2

Bicultural

Mulatto

0
Bi-racial

Minority

Multiracial

Mixed

Nonblack

FIGURE A-14 Number of studies with nonwhite participants.
SITE VISITS
The committee conducted two site visits to correctional facilities. On
July 20, 2005, the committee visited San Quentin Prison in San Francisco and the California Medical Facility (CMF) at Vacaville, California.
During their site visits, the committee had guided tours of both facilities
and unstructured discussions with peer educators (i.e., inmates who are

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trained to be peer educators) about research experiences and needed protections when participating in research.
SURVEY OF STATE DEPARTMENTS OF CORRECTIONS
As part of its data collection activities, the committee collected information from state DOCs regarding research policies and practices.
The committee conducted telephone interviews with six states, and sent a
survey to the remaining states and District of Columbia by email.
Telephone Interviews
The committee collected information from DOCs in six states via
telephone interviews: New York, California, Iowa, Texas, Florida, and
Utah. The interviews covered the following:
●
●
●
●
●
●
●
●

types of research that are conducted,
number of studies that have been undertaken in recent years,
requirements for informed consent,
degree of risk to which research subjects are subjected,
procedures for processing research proposals,
credentials and qualifications of the people charged with the responsibility of approving research,
problems or concerns that have arisen in connection with such
research, and
impact of laws and regulations on proposed or actual research
projects.

Chapter 2 includes summary results of those telephone interviews.
E-Mail Survey
In the interest of reaching all 50 states and the District of Columbia,
similar information to that which was collected by telephone interviews
was requested from the DOCs of the remaining 44 states and Washington, DC in an email survey. The purpose of this survey was to poll the
states’ DOCs about their research activities and practices. All but three
(Delaware, Illinois, Wyoming) DOCs responded, bringing to 48 the total

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number of DOCs about which the committee had information (6 from
telephone interviews, 42 from e-mail survey). Table A-1 presents the
survey questions and a summary of DOC responses.

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TABLE A-1 Summary of Results from Department of Corrections
(DOC) Survey
Question

Yes

For questions 1-8, is this type of research permitted in your DOC?
40
1. Purely DOC records review, typically descriptive studies
(e.g., demographics of prison population) or correlational studies (e.g., association of prisoner characteristics with type of
index crime, number/type of disciplinary infractions) based on
information routinely gathered by DOC outside the framework
of a specific research protocol.

Other

2. Evaluation studies of DOC programs. Evaluate the process or
outcomes of an internal DOC program such as an educational
program (e.g., impact of new classroom technique on GED test
performance), or health or mental health treatment program
(e.g., drug/substance abuse education; sex offender treatment).

3. Nontherapeutic social/behavioral studies involving minimal
risk such as administration of interviews and/or questionnaires
to assess personality features and personal history for development of a risk assessment measure; reaction time studies (e.g.,
how quickly inmates respond to different visual stimuli presented on a computer screen).

1/case by case
1/yes-noa

4. Nontherapeutic social/behaviors studies involving greater
than minimal risk (e.g., evaluate the effects of prolonged sleep
deprivation).

1/not likely
2/case by case
1/yes-nob

5. Evaluation of behavioral clinical interventions developed and
administered by outside agencies (e.g., university researchers
implement and evaluate a group therapy treatment protocol for
PTSD that is not part of DOC standard services).

2/case by case
1/yes-noa

6. Medical research–therapeutic studies (e.g., AIDS, hepatitis
C, breast/prostate cancer, reproductive medicines/devices) in
which study involvement permits inmates to have access to
experimental treatments that would not be otherwise available.

1/case by case
1/yes-noa

7. Medical research–therapeutic studies of diseases for which
there is an established standard of care (e.g., new asthma medications).

1/case by case
1/yes-noa

8. Biomedical studies of a nontherapeutic nature. Examples
include studies that involve exposure to a biological or chemical
agent to assess the effects on and reactions of humans (e.g.,
effects of cosmetic or cleaning agents on skin).

1/not likely

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Question

Yes

Other

9. If you answered “no” to any of the questions above, is it
31
8
3/NA
the case that some of these types of research are explicitly
prohibited by your DOC policy or by legislation?
Answer the following questions only if at least one of the types of research
described above is permitted in your DOC.
To ensure the safety of research subjects, in many research settings any study
that involves human beings as research participants must be evaluated and approved by an institutional review board (IRB) before the study can commence.
Please answer each of the questions below regarding IRB involvement in research at your organization.
10. Does your DOC require IRB approval before research can
29
10
3/NA
commence?
11a. Does your DOC have its own IRB within the organization? 13
26
3/NA
11b. If you answered YES to Question 11a: Are there prisoner
5
13
24/NA
representatives on the DOC’s IRB?
12. Does your DOC have an adverse events reporting proc18
20
4/NA
ess/procedure?
NOTE: DOC, Department of Corrections; IRB, institutional review board; NA, not applicable.
a
Vermont stated that the DOC is part of an umbrella Agency of Human Services
(AHS). The AHS operates an IRB for review of all research, including DOC-related studies. No research involving minimal or greater risk to participants may proceed without
IRB approval.
b
Only with IRB approval.

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B
The National Commission’s
Deliberations and Findings

NATIONAL RESEARCH ACT
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research (NCPHSBBR) was created in 1973
by the National Research Act (Pub. L. No. 93-348) and charged with
submitting periodic reports to the President, Congress, and Secretary of
the Department of Health, Education and Welfare (DHEW) about protecting humans involved in research. The commissioners were specifically charged to look into protections for certain classes of research subjects that included children, the “institutionally mentally infirm,” and
prisoners. Title II of the act, which applies to prisoners, is presented in
Box B-1.
The commission was further required by Section 202(a)(3) to make
recommendations to Congress for developing laws that could be implemented at other agencies that would protect persons involved in biomedical and behavioral research, including research on prisoners that
may have been supported by those non-DHEW agencies.
In its charge to the commission concerning research with prisoners,
Congress identified informed consent as the locus of ethical concern. In
particular, Congress directed the commission to attend to three components of informed consent: (1) the nature of the consent; (2) the adequacy
of the information given; and (3) the competence and freedom of the
prisoners or their legal representatives to make a choice.1
In carrying out this charge, the commission used elements of a principle-based ethical framework that would be more fully fleshed out in the
1

National Research Act, § 202(a)(2).

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Belmont Report (NCPHSBBR, 1976), a response to its charge to identify
the relevant ethical principles that relate to and support research with
human subjects. This 20-page document discussed the line to be drawn
between practice of biomedical and behavioral therapy and research in
those areas. It identified three philosophical principles or general prescriptive judgments that were particularly relevant to research with human subjects: respect for persons, beneficence, and justice.
The first principle—respect for persons—“incorporates at least two
ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are
entitled to protection” (p. 4 NCPHSBBR, 1979). The second principle—
beneficence—demands that persons be “treated in an ethical manner not
only by respecting their decisions and protecting them from harm, but
also by making efforts to secure their well-being” (p. X). The concerns
of the final principle—justice—are found in the answer to the question
that the report poses: “Who ought to receive the benefits of research and
bear its burdens?” (pgs. 4-5 NCPHSBBR, 1979). It is clear that the concerns raised by the report remain central to the analysis of this document.
NATIONAL COMMISSION METHODOLOGY
The national commission determined that research involving prisoners was so complex that a special section of regulations was needed to
(1) provide severe restraints on the sorts of research that could be performed to protect the rights and interests of inmates and (2) impose specific rules and procedures for institutional review boards reviewing protocols for correctional settings. The current inquiry, almost 30 years
later, asks whether that special set of regulations is still sufficient and
valid. The national commission noted that research in correctional settings presented problems largely relating to coercion and challenges to
autonomous consent and refusal.
The national commission conducted a number of informationgathering activities as part of the development of its report on prisoners.
Commission members made site visits to four prison facilities that conducted research with their inmate populations and two research facilities
that were not penal institutions but that used prisoners as research subjects. During these visits, commission members and staff talked with inmates who did and did not participate in research projects, with prison

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225

administrators who had oversight responsibilities, and with directors of
the research programs at the facilities.
When the National Commission visited the Jackson State Prison
in Michigan on November 14, 1975, they met with a group of
highly articulate prisoners. The leader of the group greeted them
with the following opening statement: “ ‘Ladies and gentlemen:
You are in a place where death at random is a way of life. We
have noticed that the only place in this prison that people don’t
die is in the research unit. Just what is it that you think you are
protecting us from?’” (p. 186 Dubler and Sidel, 1989, quoting
Alan Bronstein).
In addition, commission members held hearings to allow for comment by those who would be most affected by any proposed protections.
Groups represented at these hearings included members of the scientific
community, advocates for the rights of prisoners, attorneys who provided
legal services to prisoners, representatives from the pharmaceutical industry, and members of the general public. A National Minority Conference on Human Experimentations was also held to allow for groups representing minority concerns to receive a more in-depth hearing.
In addition to these activities, members of the commission staff authored papers, completed surveys, and wrote other reports that helped to
inform the commission’s deliberations. Papers were written by others as
well. Topics for these papers were (1) alternatives to the use of inmates
as research subjects; (2) a review of foreign practices on developing new
pharmaceutical medications with prison subjects; (3) a review of philosophical, sociological, and legal views of the use of inmates in research; (4) behavioral perspectives on using inmate subjects; and (5) a
survey of research review procedures, principal investigators, and inmate
subjects at five facilities.
The state of the art, as reported to the commissioners, was unsettled
and unsettling. The pharmaceutical industry and various stakeholders,
other than prisoners, were crafting the research agenda in correctional
settings. Inmates often agreed to participate, with the hope of improving
their living conditions or their chances for probation or parole.

Finally, members of the national commission held a series of public hearings that began in January 1976. During these hearings,
commissioners discussed findings and identified and developed

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recommendations that were included in the final report, which was
released in October 1976 (NCPHSBBR, 1976).
NATIONAL COMMISSION DELIBERATIONS, FINDINGS,
AND CONCLUSIONS
The national commission began its report by acknowledging some of
the history of research with prisoners and noting that sensitivities to
abuses in the United States and other countries had led to a generally
growing concern about the propriety of research in prisons.
It then noted that there were two specific sets of concerns that were
directly relevant to the report and recommendations: first, a set of general
concerns about the “serious deficiencies in living conditions and health
care that generally prevail in prisons” (p. 5 NCPHSBBR, 1976b) and,
second, a set of ethical concerns asking
Do prisoners bear a fair share of the burdens and receive a fair
share of the benefits of research?
Are prisoners, in the words of the Nuremberg Code (1949) “so
situated as to be able to exercise free power of choice” (p. 181).
That is, can prisoners give truly voluntary consent to participate
in research?
These two dilemmas relate to two of the basic ethical principles: justice, which requires that persons and groups be treated fairly, and respect
for persons, which requires that the autonomy of persons be promoted
and protected. In discussing these issues, the commission noted that in its
judgment the “appropriate expression of respect consists in protection
from exploitation” (p. 7 NCPHSBBR, 1976b). On the issue of justice, it
stated that the concern is
To ensure the equitable distribution of the burdens of research no
matter how large or small those burdens may be. The Commission is concerned that the status of being a prisoner makes possible the perpetration of certain systemic injustices. For example,
the availability of a population living in conditions of social and
economic deprivation makes it possible for researchers to bring
to these populations types of research which persons better situated would ordinarily refuse. It also establishes an enterprise

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227

whose fair administration can be readily corrupted by prisoner
control or arbitrarily manipulated by prison authorities. And finally, it allows an inequitable distribution of burdens and benefits, in that those social classes from which prisoners often come
are seldom full beneficiaries of improvements in medical care
and other benefits accruing to society from the research enterprise. (Pp. 7-8 NCPHSBBR, 1976b)
Chapter 2 of this report makes clear that today’s correctional environments have the same characteristics that were of concern to the commission 30 years ago plus new, important features as well.
The commission completed its deliberations with five recommendations, which largely, although not entirely, became the guiding elements
for 45 CFR 46, Subpart C. They are listed in Box B-2.
The commission’s deliberations came after the late 1960s and early
1970s saw a series of exposés documenting abuses in connection with
nontherapeutic research in U.S. prisons (Mitford, 1973a,b; Rugaber,
1969). Many of those who were most vocal about the plight of prisoners,
journalists and the staff of prisoner advocacy and civil liberties groups,
saw research with prisoners largely under the twin headings of coercion
and exploitation (Mitford, 1973a,b; NCPHSBBR, 19762; Rugaber, 1969).
For the most part, these groups pushed for restriction rather than reform
of the prison research enterprise. Although the commission did not recommend a ban on all research with prisoners, its work and the aftermath
have been described as tending toward that end: “The result of these
regulations has been, as was their goal, the virtual elimination of biomedical research activity in prisons and jails” (Dubler and Sidel, 1989, p.
185). According to one informed estimate, in the late 1990s only about
15 percent of institutions engaged in clinical research in the United
States included prisoners in their research protocols (Hoffman, 20003). In
2
See the summaries of presentations made to the commission (pp. 44-48) by Gabe
Kaimowitz, a senior staff attorney for Michigan Legal Services; Matthew L. Myers, from
the National Prison Project of the American Civil Liberties Foundation; Allan H. Lawson, executive director of the Prisoners’ Rights Council of Pennsylvania; and the Rev.
Americus Roy of the Prisoners Aid Association of Maryland, at a public hearing held on
January 9, 1976.
3
Hoffman was citing a 1998 estimate by Paula Knudson, executive coordinator of the
University of Texas Health Science Center Committee for the Protection of Human Subjects. One factor to be considered may be state bans on biomedical research with prisoners; Hoffman cites a survey from the American Correctional Health Services Association
finding that 22 states have such total bans.

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1997, New York State had the largest estimated number of HIV-infected
prisoners of any prison system (9,456), but only 8 (< 0.001 percent) were
enrolled in clinical trials (Lazzarini and Altice, 2000, pp. 112-113).

BOX B-1
National Research Act Section 202(a)(2)
The Commission shall identify the requirements for informed consent to participation in biomedical and behavioral research by…prisoners…The Commission
shall investigate and study biomedical and behavioral research conducted or
supported under programs administered by the Secretary [DHEW] and involving
prisoners…to determine the nature of the consent obtained from such persons or
their legal representatives before such persons were involved in such research;
the adequacy of the information given them respecting the nature and purpose of
the research, procedures to be used, risks and discomforts, anticipated benefits
from their research, and other matters necessary for informed consent; and the
competence and the freedom of the persons to make a choice for or against involvement in such research. On the basis of such investigation and study the
Commission shall make such recommendations to the Secretary as it determines
appropriate to assure that biomedical and behavioral research conducted or supported under programs administered by him meets the requirements respecting
informed consent identified by the Commission.

BOX B-2
National Commission Recommendations
1. Recommended that studies of the possible causes, effects, and processes
of incarceration and studies of prisons as institutional structures or of prisoners
as incarcerated persons may be conducted or supported provided that (A) they
present minimal or no risk and no more than mere inconvenience to the subjects and (B) the requirements under Recommendation 4 are fulfilled.
2. Research on practices both innovative and accepted, which have the intent
and reasonable probability of improving the health or well-being of the individual
prisoner, may be conducted or supported provided the requirements under Recommendation 4 are fulfilled.
3. Discussed the need for a national ethical review body to determine that the
research fulfills an important social and scientific need, that the involvement of
the prisoners satisfies conditions of equity, and that a high degree of voluntariness is required. This recommendation led to requirements for certain sorts of
secretarial review in the actual regulations but did not mirror the commission’s
list of mandatory characteristics of the prison, which included many requirements for conditions of confinement, such as adequate living space, existence
of single occupancy cells, operable toilets, access to clean and working showers, existence of good-quality medical facilities in the prison that are adequately

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staffed and equipped and approved by an outside medical accrediting organization, among others. This requirement for the specifics of prison existence did not
become part of the regulations.
4. This recommendation had two parts:
• The head of the responsible federal department or agency should determine that the competence of the investigators and the adequacy of the research
facilities involved are sufficient for the conduct of any research project in which
prisoners are to be involved.
• All research involving prisoners should be reviewed by at least one human subjects review committee.
5. A grandfathering provision that permitted research in existence to continue
for at least 1 year.

REFERENCES
Dubler N, Sidel V. 1989. On research on HIV infection and AIDS. The Milbank
Quarterly 67(2):171-207.
Hoffman S. 2000. Beneficial and unusual punishment: An argument in support
of prisoner participation in clinical trials. Indiana Law Review 33:475.
Lazzarini Z, Altice FL. 2000. A review of the legal and ethical issues for the
conduct of HIV-related research in prisons. AIDS and Public Policy Journal
15(3/4):105-135.
Mitford J. 1973a. Experiments behind bars: Doctors, drug companies, and prisoners. Atlantic Monthly 23:64-73.
Mitford J. 1973b. Kind and usual punishment: The prison business. New York:
Alfred A. Knopf.
NCPHSBBR. (National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research) . 1976. The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research.
Washington, DC: U.S. Department of Health, Education, and Welfare.
NCPHSBBR. 1976b. Report and Recommendations: Research Involving Prisoners. DHEW Publication No. (OS) 76-131.
Nuremburg Code. 1949. Trials of War Criminals Before the Nuremburg Military
Tribunals Under Control Council Law No. 10, Vol. 2. Washington, DC: U.S.
Government Printing Office.
Rugaber W. 1969, July 29. Prison drug and plasma projects leave fatal trail. New
York Times, p. 20.

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C
Report of the SACHRP Subcommittee and
Human Subjects Protections

In 2003, the Secretary’s Advisory Committee on Human Research
Protections (SACHRP) asked its Subpart C Subcommittee to review the
text and application of Subpart C primarily to determine whether the current Department of Health and Human Services (DHHS) interpretation
and application of Subpart C’s requirements should be modified.1
Among the topics the subcommittee addressed were the following:
the definition of prisoner under Subpart C;
the application of research protections to those who become incarcerated after agreeing to participate in a nonprisoner study;
• issues with identifying a prisoner representative for prisoner research institutional review boards (IRBs) and particularly in multisite
studies;
• conduct of expedited review in prisoner research;
• the definition of “minimal risk” under Subpart C (which is different from the Subpart A definition); and
• the requirement of secretarial review when prisoners in the control
group are merely provided the standard of care.
•
•

These topics and the subcommittee’s recommendations for further
consideration by the Institute of Medicine are discussed in more detail
below.

The full report of the subcommittee’s findings is available at http://www.hhs.gov/
ohrp/sachrp/mtgings/present/SubpartC.htm.

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ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS

DEFINITION OF PRISONER
The subcommittee recommended that a modified Subpart A analysis
apply when a subject who is enrolled in a study may not be fully within
the definition of prisoner for the duration of the study. First, the subcommittee affirmed that the interpretation of prisoner should remain defined by the words of the regulation and not expanded to include other
subjects whose liberty is restricted, such as those in community correctional facilities or on probation or parole. Although those subjects deserve heightened protection, the subcommittee recommended that DHHS
rely on Subpart A’s protections for subjects “vulnerable to coercion or
undue influence” without including those subjects as prisoners under
Subpart C. Likewise, when a subject is incarcerated after becoming enrolled in a study, the concerns about coercion and undue influence are
not as great; at the same time, it may be difficult to modify the research
protocol to comply with Subpart C. Therefore, the subcommittee suggested that Subpart A’s general requirement of heightened protection
apply instead. The subcommittee recommended that an IRB should review a researcher’s request to continue the research when a subject subsequently becomes incarcerated, taking into account the new conditions
of incarceration but without fully engaging in a new Subpart C approval
process.
PRISONER IRB REPRESENTATIVE
The subcommittee discussed a variety of problems with identifying a
representative who would be skilled and knowledgeable enough to be
effective but not so unlike the rest of the IRB as to be marginalized. The
subcommittee recommended that the Office of Human Research Protections (OHRP) assist IRBs in searching for an appropriate prisoner representative, which might include family members of prisoners, former
prisoners (especially people in recovery from substance addiction who
have also had experience as prisoners), and service providers who assist
in the correctional process. It was recommended that OHRP should provide functional criteria that might help IRBs (and investigators, who are
also responsible for the composition of an IRB that will properly evaluate ethical issues) identify persons who can be an effective voice for
prisoners within the IRB. With respect to multisite studies, the subcommittee recommended that, although Subpart C only requires one prisoner

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representative on a central IRB for multisite research, the IRB must nevertheless consider the individual circumstances of each prison site, which
can vary widely. In addition, with respect to expedited review, the subcommittee recommended that, if expedited review of a protocol is required, a prisoner representative should be one of the reviewers.
DEFINING MINIMAL RISK AND BENEFIT TO
PARTICIPANT
The subcommittee considered two issues regarding the distinction
between using as the ethical baseline other healthy prisoners as opposed
to other healthy persons generally. First, the subcommittee affirmed that
the different definition of minimal risk in the Subpart C regulations compared with Subpart A regulations was appropriate. The Subpart C regulations specify that the determination of minimal risk must be in
comparison to the ordinary experience of a healthy person, which the
subcommittee interpreted as referring to a healthy person outside the
prison environment. The subcommittee cautioned that the greater situational risk in the prison setting should not influence the baseline for the
IRB’s decision; rather, the minimal risk should be compared with the risk
to a healthy person in a safe environment. OHRP should provide guidance, using examples, of how the minimal risk might be viewed in different protocols.
At the same time, the subcommittee viewed the current OHRP interpretation of when a protocol does not provide a benefit to the participant
as overly restrictive. OHRP’s position is that using standard of care as a
control arm does not provide any benefit to the participant and thus requires secretarial review and expert panel consideration. The subcommittee’s view is that, because the participant receives the standard of care
and does ultimately benefit from the results of the research, even if not
immediately, such a control arm should not require heightened review.
The subcommittee recommended that only when the control group is
placebo only (and thus deviating from the standard of care) should the
protocol be considered to include an arm not benefiting from the research.
The subcommittee also pointed out the problems with the jurisdiction
of Subpart C. Because it has been adopted by so few agencies, it has
limited application to federally funded research. In addition, it does not
automatically apply to institutions that have signed a federal-wide assur-

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ance (FWA) unless they specifically request that it be part of their obligation. Because of these two enormous gaps in coverage, most research
involving prisoners does not fall under the special protections of Subpart
C.
RECOMMENDATIONS FOR FURTHER CONSIDERATION
BY THE INSTITUTE OF MEDICINE
In addition to its recommendations on the issues discussed previously, the subcommittee noted with approval that the Institute of Medicine (IOM) had been charged with studying the human research
protections for prisoners. The subcommittee recommended the IOM
committee’s consideration of the following:
• the need for a requirement that research only be conducted in prisons providing standard of care to the general population (and how best to
get such services in place);
• the interpretation of the requirement that follow-up care be provided when the prisoner has been released from confinement; and
• the limited jurisdiction of Subpart C (i.e., to DHHS-supported research only).

OTHER FEDERAL HUMANSUBJECTS
PROTECTIONS
The full panoply of DHHS protections for prisoners in Subpart C
presently only apply to research funded by DHHS, the Central Intelligence Agency, and the Social Security Administration. Some of the
other 14 departments and agencies that have adopted the Common Rule
accept the OHRP-approved FWA as assurance of compliance with ethical regulations regarding human research subjects. However, those departments and agencies have not adopted Subpart C, so the assurance
will only require certification of compliance with the Common Rule
(Subpart A).2 Although institutions holding an FWA and engaging in
research funded by one of the other departments or agencies may voluntarily extend their protections to include those under the other subparts
2

One exception is the Department of Education, which has adopted Subpart D but has
not adopted Subparts B or C of the DHHS regulations.

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(including Subpart C)—OHRP estimates that this applies to approximately 60 percent of institutions holding an FWA—they are not required
to do so.
Moreover, prisoner research that is funded by another department or
agency (other than DHHS) falls outside of the protections of OHRP
oversight even if the institution has requested in its FWA that Subpart C
apply because OHRP does not monitor the institution’s compliance with
a voluntary assurance regarding Subpart C. Additionally, an organization that does not receive its funding from any of these sources will generally not hold an FWA and would not be required to comply with the
Common Rule or any of the subparts (see Table C-1).
At the same time, certain federal departments or agencies that have
adopted a form of the Common Rule have also adopted their own additional rules protecting certain categories of human research subjects
other than Subpart C. Of particular interest are the Department of Justice, because it includes the Bureau of Prisons, and the Food and Drug
Administration, because its regulations govern a majority of biomedical
research (regardless of whether the subjects of the study are prisoners).
TABLE C-1 Overview of Regulations Applicable to Research Involving
Prisoners as Subjects, Independent of Funding Source
Federal—Adult

Federal–
Juvenile

State–
Juvenile

State– Adult

Medical
Treatment–
nontherapeutic/
cosmetic

Not permitted

FDA Subpart A, FDA Subpart A,
state policy
FDA Subpart D,
state policy

Pharmaceutical/
medical device–
therapeutic (for
specific inmate’s
condition)

DOJ Subpart A,
FDA Subpart A,
DHHS
(Subpart C)

DOJ Subpart A, FDA Subpart A, FDA Subpart A,
FDA Subpart A, FDA Subpart D, FDA Subpart D,
DHHS (Subpart Cstate policy
state policy
FDA Subpart D

Non-FDA
Regulated
Medical
treatment–
therapeutic

DOJ Subpart A,
DHHS
(Subpart C)

DOJ Subpart A, Varies by state
DHHS (Subpart C)

Varies by state

Nonmedical
research

DOJ Subpart A,
BOP research
policy

DOJ Subpart A, Varies by state
BOP research
policy

Varies by state

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D
Code of Federal Regulations

TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 46
PROTECTION OF HUMAN SUBJECTS
**
Revised June 23, 2005
Effective June 23, 2005
***
Basic HHS Policy for Protection of Human Research
Subpart A -Subjects
Sec.
46.101

To what does this policy apply?

46.102

Definitions.

46.103

Assuring compliance with this policy--research conducted
or supported by any Federal Department or Agency.

46.10446.106

[Reserved]
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46.107

IRB membership.

46.108

IRB functions and operations.

46.109

IRB review of research.

46.110

Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor
changes in approved research.

46.111

Criteria for IRB approval of research.

46.112

Review by institution.

46.113

Suspension or termination of IRB approval of research.

46.114

Cooperative research.

46.115

IRB records.

46.116

General requirements for informed consent.

46.117

Documentation of informed consent.

46.118

Applications and proposals lacking definite plans for involvement of human subjects.

46.119

Research undertaken without the intention of involving human subjects.

46.120

Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal Department or Agency.

46.121

[Reserved]

46.122

Use of Federal funds.

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46.123

Early termination of research support: Evaluation of applications and proposals.

46.124

Conditions.

Subpart B -- Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Sec.
46.201

To what do these regulations apply?

46.202

Definitions.

46.203

Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

46.204

Research involving pregnant women or fetuses.

46.205

Research involving neonates.

46.206

Research involving, after delivery, the placenta, the dead
fetus or fetal material.

46.207

Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.

Subpart C -- Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Sec.
46.301

Applicability.

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46.302

Purpose.

46.303

Definitions.

46.304

Composition of Institutional Review Boards where prisoners
are involved.

46.305

Additional duties of the Institutional Review Boards where
prisoners are involved.

46.306

Permitted research involving prisoners.

Subpart D Additional Protections for Children Involved as Subjects in
Research
Sec.
46.401

To what do these regulations apply?

46.402

Definitions.

46.403

IRB duties.

46.404

Research not involving greater than minimal risk.

46.405

Research involving greater than minimal risk but presenting
the prospect of direct benefit to the individual subjects.

46.406

Research involving greater than minimal risk and no prospect
of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.

46.407

Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children.

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APPENDIX D

46.408

Requirements for permission by parents or guardians and for
assent by children.

46.409

Wards.

Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
Editorial Note: The Department of Health and Human Services issued a notice
of waiver regarding the requirements set forth in part 46, relating to protection
of human subjects, as they pertain to demonstration projects, approved under
section 1115 of the Social Security Act, which test the use of cost--sharing, such
as deductibles, copayment and coinsurance, in the Medicaid program. For further information see 47 FR 9208, Mar. 4, 1982.
Note: As revised, Subpart A of the HHS regulations incorporates the Federal
Policy for the Protection of Human Subjects (56 FR 28003). Subpart D of the
HHS regulations has been amended at Section 46.401(b) to reference the revised
Subpart A.
The Federal Policy for the Protection of Human Subjects is also codified at

7 CFR Part 1c

Department of Agriculture

10 CFR Part 745

Department of Energy

14 CFR Part 1230 National Aeronautics and Space Administration
15 CFR Part 27

Department of Commerce

16 CFR Part 1028 Consumer Product Safety Commission
22 CFR Part 225

International Development Cooperation Agency,
Agency for International Development

24 CFR Part 60

Department of Housing and Urban Development

28 CFR Part 46

Department of Justice

32 CFR Part 219

Department of Defense

34 CFR Part 97

Department of Education

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38 CFR Part 16

Department of Veterans Affairs

40 CFR Part 26

Environmental Protection Agency

45 CFR Part 690

National Science Foundation

49 CFR Part 11

Department of Transportation

***
Subpart A Basic HHS Policy for Protection of Human Research Subjects
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v1(b).
Source: 56 FR 28003, June 18, 1991; 70 FR 36325, June 23,
2005.
§46.101 To what does this policy apply?
(a) Except as provided in paragraph (b) of this section, this policy applies
to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which
takes appropriate administrative action to make the policy applicable to
such research. This includes research conducted by federal civilian employees or military personnel, except that each department or agency
head may adopt such procedural modifications as may be appropriate
from an administrative standpoint. It also includes research conducted,
supported, or otherwise subject to regulation by the federal government
outside the United States.
(1) Research that is conducted or supported by a federal department or
agency, whether or not it is regulated as defined in §46.102(e), must
comply with all sections of this policy.
(2) Research that is neither conducted nor supported by a federal department or agency but is subject to regulation as defined in §46.102(e) must
be reviewed and approved, in compliance with §46.101, §46.102, and
§46.107 through §46.117 of this policy, by an institutional review board

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(IRB) that operates in accordance with the pertinent requirements of this
policy.
(b) Unless otherwise required by department or agency heads, research
activities in which the only involvement of human subjects will be in one
or more of the following categories are exempt from this policy:
(1) Research conducted in established or commonly accepted educational
settings, involving normal educational practices, such as (i) research on
regular and special education instructional strategies, or (ii) research on
the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the
research could reasonably place the subjects at risk of criminal or civil
liability or be damaging to the subjects' financial standing, employability,
or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of
this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will
be maintained throughout the research and thereafter.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these
sources are publicly available or if the information is recorded by the
investigator in such a manner that subjects cannot be identified, directly
or through identifiers linked to the subjects.

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(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives are consumed or (ii) if a food is
consumed that contains a food ingredient at or below the level and for a
use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the
Food Safety and Inspection Service of the U.S. Department of Agriculture.
(c) Department or agency heads retain final judgment as to whether a
particular activity is covered by this policy.
(d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise
subject to regulation by the department or agency but not otherwise covered by this policy, comply with some or all of the requirements of this
policy.
(e) Compliance with this policy requires compliance with pertinent federal laws or regulations which provide additional protections for human
subjects.
(f) This policy does not affect any state or local laws or regulations
which may otherwise be applicable and which provide additional protections for human subjects.
(g) This policy does not affect any foreign laws or regulations which may
otherwise be applicable and which provide additional protections to human subjects of research.

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(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect
human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent
with the World Medical Assembly Declaration (Declaration of Helsinki
amended 1989) issued either by sovereign states or by an organization
whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a department or agency
head determines that the procedures prescribed by the institution afford
protections that are at least equivalent to those provided in this policy,
the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this
policy. Except when otherwise required by statute, Executive Order, or
the department or agency head, notices of these actions as they occur will
be published in the FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures.
(i) Unless otherwise required by law, department or agency heads may
waive the applicability of some or all of the provisions of this policy to
specific research activities or classes or research activities otherwise
covered by this policy. Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office,
and shall also publish them in the FEDERAL REGISTER or in such
other manner as provided in Department or Agency procedures.1
1
Institutions with HHS-approved assurances on file will abide by provisions of Title 45 CFR part 46 subparts A-D. Some of the other departments and agencies have incorporated all provisions of Title 45 CFR Part
46 into their policies and procedures as well. However, the exemptions at
45 CFR 46.101(b) do not apply to research involving prisoners, subpart
C. The exemption at 45 CFR 46.101(b)(2), for research involving survey
or interview procedures or observation of public behavior, does not apply
to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in
the activities being observed.
[56 FR 38012, 28022, June 18, 1991; 56 FR 29756, June 28, 1991; 70
FR 36325, June 23, 2005]

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§46.102 Definitions.
(a) Department or agency head means the head of any federal department or agency and any other officer or employee of any department or
agency to whom authority has been delegated.
(b) Institution means any public or private entity or agency (including
federal, state, and other agencies).
(c) Legally authorized representative means an individual or judicial or
other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved
in the research.
(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute
research for purposes of this policy, whether or not they are conducted or
supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
(e) Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or
agency has specific responsibility for regulating as a research activity,
(for example, Investigational New Drug requirements administered by
the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency
solely as part of the department's or agency's broader responsibility to
regulate certain types of activities whether research or non-research in
nature (for example, Wage and Hour requirements administered by the
Department of Labor).
(f) Human subject means a living individual about whom an investigator
(whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

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Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the
subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior
that occurs in a context in which an individual can reasonably expect that
no observation or recording is taking place, and information which has
been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a
medical record). Private information must be individually identifiable
(i.e., the identity of the subject is or may readily be ascertained by the
investigator or associated with the information) in order for obtaining the
information to constitute research involving human subjects.
(g) IRB means an institutional review board established in accord with
and for the purposes expressed in this policy.
(h) IRB approval means the determination of the IRB that the research
has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
(i) Minimal risk means that the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
(j) Certification means the official notification by the institution to the
supporting department or agency, in accordance with the requirements of
this policy, that a research project or activity involving human subjects
has been reviewed and approved by an IRB in accordance with an approved assurance.
§46.103 Assuring compliance with this policy -- research conducted or
supported by any Federal Department or Agency.
(a) Each institution engaged in research which is covered by this policy
and which is conducted or supported by a federal department or agency

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shall provide written assurance satisfactory to the department or agency
head that it will comply with the requirements set forth in this policy. In
lieu of requiring submission of an assurance, individual department or
agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for federalwide use by that office. When the existence of an HHS-approved
assurance is accepted in lieu of requiring submission of an assurance,
reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human
Research Protections, HHS, or any successor office.
(b) Departments and agencies will conduct or support research covered
by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to
continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include:
(1) A statement of principles governing the institution in the discharge of
its responsibilities for protecting the rights and welfare of human subjects
of research conducted at or sponsored by the institution, regardless of
whether the research is subject to Federal regulation. This may include
an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement
does not preempt provisions of this policy applicable to department- or
agency-supported or regulated research and need not be applicable to any
research exempted or waived under §46.101 (b) or (i).
(2) Designation of one or more IRBs established in accordance with the
requirements of this policy, and for which provisions are made for meeting space and sufficient staff to support the IRB's review and recordkeeping duties.
(3) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications,
licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relation-

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ship between each member and the institution; for example: full-time
employee, part-time employee, member of governing panel or board,
stockholder, paid or unpaid consultant. Changes in IRB membership
shall be reported to the department or agency head, unless in accord with
§46.103(a) of this policy, the existence of an HHS-approved assurance is
accepted. In this case, change in IRB membership shall be reported to the
Office for Human Research Protections, HHS, or any successor office.
(4) Written procedures which the IRB will follow (i) for conducting its
initial and continuing review of research and for reporting its findings
and actions to the investigator and the institution; (ii) for determining
which projects require review more often than annually and which projects need verification from sources other than the investigators that no
material changes have occurred since previous IRB review; and (iii) for
ensuring prompt reporting to the IRB of proposed changes in a research
activity, and for ensuring that such changes in approved research, during
the period for which IRB approval has already been given, may not be
initiated without IRB review and approval except when necessary to
eliminate apparent immediate hazards to the subject.
(5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any
unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or
determinations of the IRB; and (ii) any suspension or termination of IRB
approval.
(c) The assurance shall be executed by an individual authorized to act for
the institution and to assume on behalf of the institution the obligations
imposed by this policy and shall be filed in such form and manner as the
department or agency head prescribes.
(d) The Department or Agency head will evaluate all assurances submitted in accordance with this policy through such officers and employees
of the department or agency and such experts or consultants engaged for
this purpose as the department or agency head determines to be appropriate. The department or agency head's evaluation will take into consideration the adequacy of the proposed IRB in light of the anticipated scope of
the institution's research activities and the types of subject populations
likely to be involved, the appropriateness of the proposed initial and con-

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tinuing review procedures in light of the probable risks, and the size and
complexity of the institution.
(e) On the basis of this evaluation, the department or agency head may
approve or disapprove the assurance, or enter into negotiations to develop an approvable one. The department or agency head may limit the
period during which any particular approved assurance or class of approved assurances shall remain effective or otherwise condition or restrict approval.
(f) Certification is required when the research is supported by a federal
department or agency and not otherwise exempted or waived under
§46.101 (b) or (i). An institution with an approved assurance shall certify
that each application or proposal for research covered by the assurance
and by §46.103 of this Policy has been reviewed and approved by the
IRB. Such certification must be submitted with the application or proposal or by such later date as may be prescribed by the department or
agency to which the application or proposal is submitted. Under no condition shall research covered by §46.103 of the Policy be supported prior
to receipt of the certification that the research has been reviewed and approved by the IRB. Institutions without an approved assurance covering
the research shall certify within 30 days after receipt of a request for such
a certification from the department or agency, that the application or proposal has been approved by the IRB. If the certification is not submitted
within these time limits, the application or proposal may be returned to
the institution.
(Approved by the Office of Management and Budget under control number 0990-0260.)
[56 FR 38012, 28022, June 18, 1991; 56 FR 29756, June 28, 1991; 70
FR 36325, June 23, 2005]
§§46.104--46.106 [Reserved]
§46.107 IRB membership.

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(a) Each IRB shall have at least five members, with varying backgrounds
to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural
backgrounds and sensitivity to such issues as community attitudes, to
promote respect for its advice and counsel in safeguarding the rights and
welfare of human subjects. In addition to possessing the professional
competence necessary to review specific research activities, the IRB
shall be able to ascertain the acceptability of proposed research in terms
of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews
research that involves a vulnerable category of subjects, such as children,
prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with
these subjects.
(b) Every nondiscriminatory effort will be made to ensure that no IRB
consists entirely of men or entirely of women, including the institution's
consideration of qualified persons of both sexes, so long as no selection
is made to the IRB on the basis of gender. No IRB may consist entirely
of members of one profession.
(c) Each IRB shall include at least one member whose primary concerns
are in scientific areas and at least one member whose primary concerns
are in nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family
of a person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(f) An IRB may, in its discretion, invite individuals with competence in
special areas to assist in the review of issues which require expertise be-

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yond or in addition to that available on the IRB. These individuals may
not vote with the IRB
§46.108 IRB functions and operations.
In order to fulfill the requirements of this policy each IRB shall:
(a) Follow written procedures in the same detail as described in
§46.103(b)(4) and to the extent required by §46.103(b)(5).
(b) Except when an expedited review procedure is used (see §46.110),
review proposed research at convened meetings at which a majority of
the members of the IRB are present, including at least one member
whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those
members present at the meeting
§46.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered
by this policy.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that
information, in addition to that specifically mentioned in §46.116, be
given to the subjects when in the IRB's judgment the information would
meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may
waive documentation in accordance with §46.117.
(d) An IRB shall notify investigators and the institution in writing of its
decision to approve or disapprove the proposed research activity, or of
modifications required to secure IRB approval of the research activity. If
the IRB decides to disapprove a research activity, it shall include in its

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written notification a statement of the reasons for its decision and give
the investigator an opportunity to respond in person or in writing.
(e) An IRB shall conduct continuing review of research covered by this
policy at intervals appropriate to the degree of risk, but not less than once
per year, and shall have authority to observe or have a third party observe
the consent process and the research.
(Approved by the Office of Management and Budget under control number 0990-0260.)
§46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved
research.
(a) The Secretary, HHS, has established, and published as a Notice in the
FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
be amended, as appropriate, after consultation with other departments
and agencies, through periodic republication by the Secretary, HHS, in
the FEDERAL REGISTER. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.
(b) An IRB may use the expedited review procedure to review either or
both of the following:
(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
(2) minor changes in previously approved research during the period (of
one year or less) for which approval is authorized.
Under an expedited review procedure, the review may be carried out by
the IRB chairperson or by one or more experienced reviewers designated
by the chairperson from among members of the IRB. In reviewing the
research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in §46.108(b).

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(c) Each IRB which uses an expedited review procedure shall adopt a
method for keeping all members advised of research proposals which
have been approved under the procedure.
(d) The department or agency head may restrict, suspend, terminate, or
choose not to authorize an institution's or IRB's use of the expedited review procedure.
§46.111 Criteria for IRB approval of research.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) By using procedures which are
consistent with sound research design and which do not unnecessarily
expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment
purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if
any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should
consider only those risks and benefits that may result from the research
(as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the
research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB
should take into account the purposes of the research and the setting in
which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled
persons, or economically or educationally disadvantaged persons.

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(4) Informed consent will be sought from each prospective subject or the
subject's legally authorized representative, in accordance with, and to the
extent required by §46.116.
(5) Informed consent will be appropriately documented, in accordance
with, and to the extent required by §46.117.
(6) When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women,
mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to
protect the rights and welfare of these subjects.
§46.112 Review by institution.
Research covered by this policy that has been approved by an IRB may
be subject to further appropriate review and approval or disapproval by
officials of the institution. However, those officials may not approve the
research if it has not been approved by an IRB.
§46.113 Suspension or termination of IRB approval of research.
An IRB shall have authority to suspend or terminate approval of research
that is not being conducted in accordance with the IRB's requirements or
that has been associated with unexpected serious harm to subjects. Any
suspension or termination of approval shall include a statement of the
reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency
head.
(Approved by the Office of Management and Budget under control number 0990-0260.)

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§46.114 Cooperative research.
Cooperative research projects are those projects covered by this policy
which involve more than one institution. In the conduct of cooperative
research projects, each institution is responsible for safeguarding the
rights and welfare of human subjects and for complying with this policy.
With the approval of the department or agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar
arrangements for avoiding duplication of effort.
§46.115 IRB records.
(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if
any, that accompany the proposals, approved sample consent documents,
progress reports submitted by investigators, and reports of injuries to
subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show
attendance at the meetings; actions taken by the IRB; the vote on these
actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and
a written summary of the discussion of controverted issues and their
resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in
§46.103(b)(3).
(6) Written procedures for the IRB in the same detail as described in
§46.103(b)(4) and §46.103(b)(5).

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(7) Statements of significant new findings provided to subjects, as required by §46.116(b)(5).
(b) The records required by this policy shall be retained for at least 3
years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records
shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable
manner.
(Approved by the Office of Management and Budget under control number 0990-0260.)
§46.116 General requirements for informed consent.
Except as provided elsewhere in this policy, no investigator may involve
a human being as a subject in research covered by this policy unless the
investigator has obtained the legally effective informed consent of the
subject or the subject's legally authorized representative. An investigator
shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider
whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or
the representative shall be in language understandable to the subject or
the representative. No informed consent, whether oral or written, may
include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal
rights, or releases or appears to release the investigator, the sponsor, the
institution or its agents from liability for negligence.
(a) Basic elements of informed consent. Except as provided in paragraph
(c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
(1) A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

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(2) A description of any reasonably foreseeable risks or discomforts to
the subject;
(3) A description of any benefits to the subject or to others which may
reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to
whether any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist of,
or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions
about the research and research subjects' rights, and whom to contact in
the event of a research-related injury to the subject; and
(8) A statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(b) Additional elements of informed consent. When appropriate, one or
more of the following elements of information shall also be provided to
each subject:
(1) A statement that the particular treatment or procedure may involve
risks to the subject (or to the embryo or fetus, if the subject is or may
become pregnant) which are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation
may be terminated by the investigator without regard to the subject's
consent;

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(3) Any additional costs to the subject that may result from participation
in the research;
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course
of the research which may relate to the subject's willingness to continue
participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study.
(c) An IRB may approve a consent procedure which does not include, or
which alters, some or all of the elements of informed consent set forth
above, or waive the requirement to obtain informed consent provided the
IRB finds and documents that:
(1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed
to study, evaluate, or otherwise examine: (i) public benefit or service
programs; (ii) procedures for obtaining benefits or services under those
programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of payment for
benefits or services under those programs; and
(2) The research could not practicably be carried out without the waiver
or alteration.
(d) An IRB may approve a consent procedure which does not include, or
which alters, some or all of the elements of informed consent set forth in
this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

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(3) The research could not practicably be carried out without the waiver
or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional
pertinent information after participation.
(e) The informed consent requirements in this policy are not intended to
preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be
legally effective.
(f) Nothing in this policy is intended to limit the authority of a physician
to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
(Approved by the Office of Management and Budget under control number 0990-0260.)
§46.117 Documentation of informed consent.
(a) Except as provided in paragraph (c) of this section, informed consent
shall be documented by the use of a written consent form approved by
the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
(b) Except as provided in paragraph (c) of this section, the consent form
may be either of the following:
(1) A written consent document that embodies the elements of informed
consent required by §46.116. This form may be read to the subject or the
subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
(2) A short form written consent document stating that the elements of
informed consent required by §46.116 have been presented orally to the
subject or the subject's legally authorized representative. When this
method is used, there shall be a witness to the oral presentation. Also, the
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or the representative. Only the short form itself is to be signed by the
subject or the representative. However, the witness shall sign both the
short form and a copy of the summary, and the person actually obtaining
consent shall sign a copy of the summary. A copy of the summary shall
be given to the subject or the representative, in addition to a copy of the
short form.
(c) An IRB may waive the requirement for the investigator to obtain a
signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the
consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether
the subject wants documentation linking the subject with the research,
and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally
required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may
require the investigator to provide subjects with a written statement regarding the research.
(Approved by the Office of Management and Budget under control number 0990-0260.)
§46.118 Applications and proposals lacking definite plans for involvement of human subjects.
Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that
subjects may be involved within the period of support, but definite plans
would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in
which the activities involving subjects remain to be selected; and projects
in which human subjects' involvement will depend upon completion of
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applications need not be reviewed by an IRB before an award may be
made. However, except for research exempted or waived under §46.101
(b) or (i), no human subjects may be involved in any project supported
by these awards until the project has been reviewed and approved by the
IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency.
§46.119 Research undertaken without the intention of involving human
subjects.
In the event research is undertaken without the intention of involving
human subjects, but it is later proposed to involve human subjects in the
research, the research shall first be reviewed and approved by an IRB, as
provided in this policy, a certification submitted, by the institution, to the
department or agency, and final approval given to the proposed change
by the department or agency.
§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
(a) The department or agency head will evaluate all applications and
proposals involving human subjects submitted to the department or
agency through such officers and employees of the department or agency
and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained.
(b) On the basis of this evaluation, the department or agency head may
approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.
§46.121 [Reserved]
§46.122 Use of Federal funds.

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Federal funds administered by a department or agency may not be expended for research involving human subjects unless the requirements of
this policy have been satisfied.
§46.123 Early termination of research support: Evaluation of applications and proposals.
(a) The department or agency head may require that department or
agency support for any project be terminated or suspended in the manner
prescribed in applicable program requirements, when the department or
agency head finds an institution has materially failed to comply with the
terms of this policy.
(b) In making decisions about supporting or approving applications or
proposals covered by this policy the department or agency head may take
into account, in addition to all other eligibility requirements and program
criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether
the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the
judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).
§46.124 Conditions.
With respect to any research project or any class of research projects the
department or agency head may impose additional conditions prior to or
at the time of approval when in the judgment of the department or
agency head additional conditions are necessary for the protection of
human subjects.
Subpart B Additional Protections for Pregnant Women, Human Fetuses
and Neonates Involved in Research
Source: 66 FR 56778, Nov. 13, 2001, unless otherwise
noted.

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§46.201 To what do these regulations apply?
(a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant women, human fetuses, neonates
of uncertain viability, or nonviable neonates conducted or supported by
the Department of Health and Human Services (DHHS). This includes
all research conducted in DHHS facilities by any person and all research
conducted in any facility by DHHS employees.
(b) The exemptions at §46.101(b)(1) through (6) are applicable to this
subpart.
(c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in §46.101(f) is
intended to include the laws of federally recognized American Indian and
Alaska Native Tribal Governments.
(d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
§46.202 Definitions.
The definitions in §46.102 shall be applicable to this subpart as well. In
addition, as used in this subpart:
(a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous
respiratory activity, spontaneous movement of voluntary muscles, nor
pulsation of the umbilical cord.
(b) Delivery means complete separation of the fetus from the woman by
expulsion or extraction or any other means.
(c) Fetus means the product of conception from implantation until delivery.
(d) Neonate means a newborn.

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(e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
(f) Pregnancy encompasses the period of time from implantation until
delivery. A woman shall be assumed to be pregnant if she exhibits any of
the pertinent presumptive signs of pregnancy, such as missed menses,
until the results of a pregnancy test are negative or until delivery.
(g) Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human Services to whom authority has been delegated.
(h) Viable, as it pertains to the neonate, means being able, after delivery,
to survive (given the benefit of available medical therapy) to the point of
independently maintaining heartbeat and respiration. The Secretary may
from time to time, taking into account medical advances, publish in the
FEDERAL REGISTER guidelines to assist in determining whether a
neonate is viable for purposes of this subpart. If a neonate is viable then
it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.
§46.203 Duties of IRBs in connection with research involving pregnant
women, fetuses, and neonates.
In addition to other responsibilities assigned to IRBs under this part, each
IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all applicable sections of this
subpart and the other subparts of this part.
§46.204 Research involving pregnant women or fetuses.
Pregnant women or fetuses may be involved in research if all of the following conditions are met:
(a) Where scientifically appropriate, preclinical studies, including studies
on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;

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(b) The risk to the fetus is caused solely by interventions or procedures
that hold out the prospect of direct benefit for the woman or the fetus; or,
if there is no such prospect of benefit, the risk to the fetus is not greater
than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other
means;
(c) Any risk is the least possible for achieving the objectives of the research;
(d) If the research holds out the prospect of direct benefit to the pregnant
woman, the prospect of a direct benefit both to the pregnant woman and
the fetus, or no prospect of benefit for the woman nor the fetus when risk
to the fetus is not greater than minimal and the purpose of the research is
the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the
informed consent provisions of subpart A of this part;
(e) If the research holds out the prospect of direct benefit solely to the
fetus then the consent of the pregnant woman and the father is obtained
in accord with the informed consent provisions of subpart A of this part,
except that the father's consent need not be obtained if he is unable to
consent because of unavailability, incompetence, or temporary incapacity
or the pregnancy resulted from rape or incest.
(f) Each individual providing consent under paragraph (d) or (e) of this
section is fully informed regarding the reasonably foreseeable impact of
the research on the fetus or neonate;
(g) For children as defined in §46.402(a) who are pregnant, assent and
permission are obtained in accord with the provisions of subpart D of this
part;
(h) No inducements, monetary or otherwise, will be offered to terminate
a pregnancy;

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(i) Individuals engaged in the research will have no part in any decisions
as to the timing, method, or procedures used to terminate a pregnancy;
and
(j) Individuals engaged in the research will have no part in determining
the viability of a neonate.
§46.205 Research involving neonates.
(a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
(1) Where scientifically appropriate, preclinical and clinical studies have
been conducted and provide data for assessing potential risks to neonates.
(2) Each individual providing consent under paragraph (b)(2) or (c)(5) of
this section is fully informed regarding the reasonably foreseeable impact
of the research on the neonate.
(3) Individuals engaged in the research will have no part in determining
the viability of a neonate.
(4) The requirements of paragraph (b) or (c) of this section have been
met as applicable.
(b) Neonates of uncertain viability. Until it has been ascertained whether
or not a neonate is viable, a neonate may not be involved in research
covered by this subpart unless the following additional conditions have
been met:
(1) The IRB determines that:
(i) The research holds out the prospect of enhancing the probability of
survival of the neonate to the point of viability, and any risk is the least
possible for achieving that objective, or

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(ii) The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there
will be no added risk to the neonate resulting from the research; and
(2) The legally effective informed consent of either parent of the neonate
or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of
either parent's legally authorized representative is obtained in accord
with subpart A of this part, except that the consent of the father or his
legally authorized representative need not be obtained if the pregnancy
resulted from rape or incest.
(c) Nonviable neonates. After delivery nonviable neonate may not be
involved in research covered by this subpart unless all of the following
additional conditions are met:
(1) Vital functions of the neonate will not be artificially maintained;
(2) The research will not terminate the heartbeat or respiration of the
neonate;
(3) There will be no added risk to the neonate resulting from the research;
(4) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
(5) The legally effective informed consent of both parents of the neonate
is obtained in accord with subpart A of this part, except that the waiver
and alteration provisions of §46.116(c) and (d) do not apply. However, if
either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a
nonviable neonate will suffice to meet the requirements of this paragraph
(c)(5), except that the consent of the father need not be obtained if the
pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate
will not suffice to meet the requirements of this paragraph (c)(5).

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(d) Viable neonates. A neonate, after delivery, that has been determined
to be viable may be included in research only to the extent permitted by
and in accord with the requirements of subparts A and D of this part.
§46.206 Research involving, after delivery, the placenta, the dead fetus
or fetal material.
(a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus,
shall be conducted only in accord with any applicable federal, state, or
local laws and regulations regarding such activities.
(b) If information associated with material described in paragraph (a) of
this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
§46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the
health or welfare of pregnant women, fetuses, or neonates.
The Secretary will conduct or fund research that the IRB does not believe
meets the requirements of §46.204 or §46.205 only if:
(a) The IRB finds that the research presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of pregnant women, fetuses or neonates;
and
(b) The Secretary, after consultation with a panel of experts in pertinent
disciplines (for example: science, medicine, ethics, law) and following
opportunity for public review and comment, including a public meeting
announced in the FEDERAL REGISTER, has determined either:
(1) That the research in fact satisfies the conditions of §46.204, as applicable; or

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(2) The following:
(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the
health or welfare of pregnant women, fetuses or neonates;
(ii) The research will be conducted in accord with sound ethical principles; and
(iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.
Subpart C

Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Source: 43 FR 53655, Nov. 16, 1978, unless otherwise
noted.

§46.301 Applicability.
(a) The regulations in this subpart are applicable to all biomedical and
behavioral research conducted or supported by the Department of Health
and Human Services involving prisoners as subjects.
(b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred
by applicable State or local law.
(c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
§46.302 Purpose.
Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and
uncoerced decision whether or not to participate as subjects in research,
it is the purpose of this subpart to provide additional safeguards for the

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protection of prisoners involved in activities to which this subpart is applicable.
§46.303 Definitions.
As used in this subpart:
(a) Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human Services to whom authority has been delegated.
(b) DHHS means the Department of Health and Human Services.
(c) Prisoner means any individual involuntarily confined or detained in a
penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals
detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration
in a penal institution, and individuals detained pending arraignment, trial,
or sentencing.
(d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
§46.304 Composition of Institutional Review Boards where prisoners are
involved.
In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out responsibilities under this part with
respect to research covered by this subpart, shall also meet the following
specific requirements:
(a) A majority of the Board (exclusive of prisoner members) shall have
no association with the prison(s) involved, apart from their membership
on the Board.

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(b) At least one member of the Board shall be a prisoner, or a prisoner
representative with appropriate background and experience to serve in
that capacity, except that where a particular research project is reviewed
by more than one Board only one Board need satisfy this requirement.
[43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8366, Jan. 26, 1981]
§46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
(a) In addition to all other responsibilities prescribed for Institutional Review Boards under this part, the Board shall review research covered by
this subpart and approve such research only if it finds that:
(1) The research under review represents one of the categories of research permissible under §46.306(a)(2);
(2) Any possible advantages accruing to the prisoner through his or her
participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to
weigh the risks of the research against the value of such advantages in
the limited choice environment of the prison is impaired;
(3) The risks involved in the research are commensurate with risks that
would be accepted by nonprisoner volunteers;
(4) Procedures for the selection of subjects within the prison are fair to
all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board
justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners
who meet the characteristics needed for that particular research project;
(5) The information is presented in language which is understandable to
the subject population;
(6) Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions re-

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garding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and
(7) Where the Board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate
provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
(b) The Board shall carry out such other duties as may be assigned by the
Secretary.
(c) The institution shall certify to the Secretary, in such form and manner
as the Secretary may require, that the duties of the Board under this section have been fulfilled.
§46.306 Permitted research involving prisoners.
(a) Biomedical or behavioral research conducted or supported by DHHS
may involve prisoners as subjects only if:
(1) The institution responsible for the conduct of the research has certified to the Secretary that the Institutional Review Board has approved the
research under §46.305 of this subpart; and
(2) In the judgment of the Secretary the proposed research involves
solely the following:
(i) Study of the possible causes, effects, and processes of incarceration,
and of criminal behavior, provided that the study presents no more than
minimal risk and no more than inconvenience to the subjects;
(ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk
and no more than inconvenience to the subjects;

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(iii) Research on conditions particularly affecting prisoners as a class (for
example, vaccine trials and other research on hepatitis which is much
more prevalent in prisons than elsewhere; and research on social and
psychological problems such as alcoholism, drug addiction, and sexual
assaults) provided that the study may proceed only after the Secretary
has consulted with appropriate experts including experts in penology,
medicine, and ethics, and published notice, in the FEDERAL
REGISTER, of his intent to approve such research; or
(iv) Research on practices, both innovative and accepted, which have the
intent and reasonable probability of improving the health or well-being
of the subject. In cases in which those studies require the assignment of
prisoners in a manner consistent with protocols approved by the IRB to
control groups which may not benefit from the research, the study may
proceed only after the Secretary has consulted with appropriate experts,
including experts in penology, medicine, and ethics, and published notice, in the FEDERAL REGISTER, of the intent to approve such research.
(b) Except as provided in paragraph (a) of this section, biomedical or
behavioral research conducted or supported by DHHS shall not involve
prisoners as subjects.
Subpart D Additional Protections for Children Involved as Subjects in
Research
Source: 48 FR 9818, March 8, 1983, unless otherwise noted.
§46.401 To what do these regulations apply?
(a) This subpart applies to all research involving children as subjects,
conducted or supported by the Department of Health and Human Services.
(1) This includes research conducted by Department employees, except
that each head of an Operating Division of the Department may adopt
such nonsubstantive, procedural modifications as may be appropriate
from an administrative standpoint.

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(2) It also includes research conducted or supported by the Department
of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (i) of §46.101 of
subpart A, waive the applicability of some or all of the requirements of
these regulations for research of this type.
(b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable
to this subpart. The exemption at §46.101(b)(2) regarding educational
tests is also applicable to this subpart. However, the exemption at
§46.101(b)(2) for research involving survey or interview procedures or
observations of public behavior does not apply to research covered by
this subpart, except for research involving observation of public behavior
when the investigator(s) do not participate in the activities being observed.
(c) The exceptions, additions, and provisions for waiver as they appear in
paragraphs (c) through (i) of §46.101 of subpart A are applicable to this
subpart.
[48 FR 9818, Mar.8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757,
June 28, 1991.]
§46.402 Definitions.
The definitions in §46.102 of subpart A shall be applicable to this subpart as well. In addition, as used in this subpart:
(a) Children are persons who have not attained the legal age for consent
to treatments or procedures involved in the research, under the applicable
law of the jurisdiction in which the research will be conducted.
(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement,
be construed as assent.
(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

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(d) Parent means a child's biological or adoptive parent.
(e) Guardian means an individual who is authorized under applicable
State or local law to consent on behalf of a child to general medical care.
§46.403 IRB duties.
In addition to other responsibilities assigned to IRBs under this part, each
IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all applicable sections of this
subpart.
§46.404 Research not involving greater than minimal risk.
HHS will conduct or fund research in which the IRB finds that no greater
than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the
permission of their parents or guardians, as set forth in §46.408.
§46.405 Research involving greater than minimal risk but presenting the
prospect of direct benefit to the individual subjects.
HHS will conduct or fund research in which the IRB finds that more than
minimal risk to children is presented by an intervention or procedure that
holds out the prospect of direct benefit for the individual subject, or by a
monitoring procedure that is likely to contribute to the subject's wellbeing, only if the IRB finds that:
(a) The risk is justified by the anticipated benefit to the subjects;
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches;
and
(c) Adequate provisions are made for soliciting the assent of the children
and permission of their parents or guardians, as set forth in §46.408.

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§46.406 Research involving greater than minimal risk and no prospect of
direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
HHS will conduct or fund research in which the IRB finds that more than
minimal risk to children is presented by an intervention or procedure that
does not hold out the prospect of direct benefit for the individual subject,
or by a monitoring procedure which is not likely to contribute to the
well-being of the subject, only if the IRB finds that:
(a) The risk represents a minor increase over minimal risk;
(b) The intervention or procedure presents experiences to subjects that
are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or
condition; and
(d) Adequate provisions are made for soliciting assent of the children and
permission of their parents or guardians, as set forth in §46.408.
§46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the
health or welfare of children.
HHS will conduct or fund research that the IRB does not believe meets
the requirements of §46.404, §46.405, or §46.406 only if:
(a) The IRB finds that the research presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children; and
(b) The Secretary, after consultation with a panel of experts in pertinent
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following opportunity for public review and comment, has determined
either:
(1) That the research in fact satisfies the conditions of §46.404, §46.405,
or §46.406, as applicable, or (2) the following:
(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the
health or welfare of children;
(ii) The research will be conducted in accordance with sound ethical
principles;
(iii) Adequate provisions are made for soliciting the assent of children
and the permission of their parents or guardians, as set forth in §46.408.
§46.408 Requirements for permission by parents or guardians and for
assent by children.
(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are
made for soliciting the assent of the children, when in the judgment of
the IRB the children are capable of providing assent. In determining
whether children are capable of assenting, the IRB shall take into account
the ages, maturity, and psychological state of the children involved. This
judgment may be made for all children to be involved in research under a
particular protocol, or for each child, as the IRB deems appropriate. If
the IRB determines that the capability of some or all of the children is so
limited that they cannot reasonably be consulted or that the intervention
or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is
available only in the context of the research, the assent of the children is
not a necessary condition for proceeding with the research. Even where
the IRB determines that the subjects are capable of assenting, the IRB
may still waive the assent requirement under circumstances in which
consent may be waived in accord with §46.116 of Subpart A.

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(b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to
the extent that consent is required by §46.116 of Subpart A, that adequate
provisions are made for soliciting the permission of each child's parents
or guardian. Where parental permission is to be obtained, the IRB may
find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §46.406
and §46.407 and permission is to be obtained from parents, both parents
must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
(c) In addition to the provisions for waiver contained in §46.116 of subpart A, if the IRB determines that a research protocol is designed for
conditions or for a subject population for which parental or guardian
permission is not a reasonable requirement to protect the subjects (for
example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section,
provided an appropriate mechanism for protecting the children who will
participate as subjects in the research is substituted, and provided further
that the waiver is not inconsistent with federal, state, or local law. The
choice of an appropriate mechanism would depend upon the nature and
purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and
condition.
(d) Permission by parents or guardians shall be documented in accordance with and to the extent required by §46.117 of subpart A.
(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
§46.409 Wards.
(a) Children who are wards of the state or any other agency, institution,
or entity can be included in research approved under §46.406 or §46.407
only if such research is:

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(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not
wards.
(b) If the research is approved under paragraph (a) of this section, the
IRB shall require appointment of an advocate for each child who is a
ward, in addition to any other individual acting on behalf of the child as
guardian or in loco parentis. One individual may serve as advocate for
more than one child. The advocate shall be an individual who has the
background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the
guardian organization.

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E
Acronyms

AE
AIDS

Adverse Events
Acquired Immunodeficiency Syndrome

BJS
BOP
BRRB

Bureau of Justice Statistics
Bureau of Prisons
Bureau Research Review Board

CDC
CDCR
CIA
CMF
CQI
CRA
CRC
CYA

Centers for Disease Control and Prevention
California Department of Correction and Rehabilitation
Central Intelligence Agency
California Medical Facility
Comprehensive Quality Improvement
Clinical Research Associate
Clinical Research Center
California Youth Authority

DHHS
DOC
DOJ
DHEW

Department of Health and Human Services
Department of Corrections
Department of Justice
Department of Health, Education and Welfare

FBP
FDA
FWA

Federal Bureau of Prisons
Food and Drug Administration
Federalwide assurance

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GAO
GED

General Accounting Office
General Equivalency Degree

HIV
HIPAA
HRPPP

Human Immunodeficiency Virus
Health Insurance Portability and Accountability
Act
Human Research Participant Protection Program

IRB
IOM

Institutional Review Board
Institute of Medicine

JPI

Justice Policy Institute

LRRB

Local Research Review Board

National Commission

NIC
NIH
NIJ
NFCMH

The National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research
National Commission on Correctional Health
Care
National Institute of Corrections
National Institutes of Health
National Institute of Justice
New Freedom Commission on Mental Health

OHRP
ORE
OSI

Office for Human Research Protections
Office of Research and Evaluation
Open Society Institute

PHI
PRSA

Protected Health Information
Prison Research Subject Advocate

QA
QI

Quality Assurance
Quality Improvement

Research Assistant

SACHRP

Secretary's Advisory Committee on Human Research Protections

NCCHC

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APPENDIX E

SAMHSA
SSA

Substance Abuse and Mental Health Services
Administration
Social Security Administration

TB
TQI

Tuberculosis
Total Quality Improvement

United States

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F
Committee, Liaison Panel, and Staff
Biographies

COMMITTEE
Lawrence O. Gostin, J.D., L.L.D. (Hon.) Chair (Georgetown University School of Law and The Johns Hopkins University School of Public
Policy), is an internationally recognized scholar in law and public health.
He is an elected member of the Institute of Medicine of the National
Academies and an elected fellow of the Hastings Center. At the National
Academy of Science, he currently serves on the Board on Health Promotion and Disease Prevention, is a member of the Committee to Enhance
the Effectiveness of CDC Quarantine Station Expansion Plan for U.S.
Points of Entry, and recently served as chair of the Committee on Genomics and the Public’s Health in the 21st Century. Professor Gostin is
the Health Law and Ethics Editor of the Journal of the American Medical
Association and serves on the editorial boards of many other scholarly
journals. His recent books include The AIDS Pandemic: Complacency,
Injustice, and Unfulfilled Expectations (2004), The Human Rights of
Persons with Intellectual Disabilities: Different But Equal (2003, with S.
S. Herr, H. H. Koh, eds.), Public Health law and Ethics: A Reader
(2002), and Public Health Law: Power, Duty, Restraint (2000). Professor
Gostin is the John Carroll Research Professor of Law at the Georgetown
University Law School. He also directs the Centers for Disease Control
and Prevention’s Collaborating Center Promoting Health Through Law.
Hortensia Amaro, Ph.D., is distinguished professor of health sciences at
the Bouve College of Health Sciences at Northeastern University (NEU)
and director of the Institute on Urban Health Research at NEU. She re285

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ceived her doctoral degree from the University of California at Los Angeles in 1982 and was awarded an honorary doctoral degree in humane
letters by Simmons College in 1994. Over the last 20 years, Dr. Amaro’s
work has focused on improving the connections between public health
research and public health practice. Her research has focused on epidemiological and community-based studies of alcohol and drug use among
adolescents and adults, on the effectiveness of HIV/AIDS prevention
programs, and on substance abuse and mental health treatment issues for
women. In 1996, Dr. Amaro was appointed to the Board of the Boston
Public Health Commission by Mayor Thomas Menino. She currently
serves as vice chair of the board. She has recently served as an appointed
member of the National Advisory Council of the National Institute on
Drug Abuse. Dr. Amaro has also served on several committees at the
National Research Council related to social and behavioral research; substance abuse, mental health and AIDS; and legal and ethical issues for
women in clinical studies.
Patricia Blair, Ph.D., J.D., is vice president and university counsel at
the University of Texas Health Center in Tyler, Texas and adjunct associate professor in the School of Nursing. She is also university compliance office and university ethics officer. Her research has focused on
nursing ethics, law and policy; legal and ethical issues related to correctional health care; and the provision of health care services in prison settings. Dr. Blair is a member of the board of directors of the American
Association of Nurse Attorneys. She received her M.S.N. from the University of Texas Medical Branch at Galveston, J.D. from Texas Southern
University, L.L.M. in Health Law and Policy from the University of
Houston Law School, and Ph.D. from the University of Texas Medical
Branch in Clinical Sciences Health Services Research with a focus on
health disparities research.
Steve Cambra, Jr. is co-owner of Cambra, Larson & Associates, a
criminal justice consulting firm that advises prison facilities on compliance with federal and state regulations. He has spent 35 years working in
the corrections industry. Mr. Cambra began as a corrections officer in
1970 at the California Men’s Colony and was gradually promoted
through management and administrative ranks. He served as warden of
Pelican Bay State Prison for almost 3 years before being promoted to
chief deputy director for field operations with the California Department
of Corrections. Mr. Cambra also served as director of the California De-

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partment of Corrections. In this position, he was responsible for approximately 122,000 parolees and 160,000 inmates in a system that included 33 prisons, 38 conservation camps, 16 community correctional
facilities, 35 work furlough and prisoner mother community-based programs, and more than 100 parole offices statewide. He currently advises
the California Youth Authority. Mr. Cambra earned a B.A. in social science at Stanislaus State College.
G. David Curry, Ph.D., is an ex-prisoner. He is a professor in the Department of Criminology and Criminal Justice at the University of Missouri—St. Louis. He is currently conducting outcome evaluations of a
number of St. Louis programs designed to reduce youth violence. Dr.
Curry is coauthor of Confronting Gangs: Crime and Community (2002)
and author of Sunshine Patriots: Punishment and the Vietnam Offender
(1985) as well as book chapters and research articles. He is a member of
the American Society of Criminology, American Association for the Advancement of Science, and Academy of Criminal Justice Sciences. He
has received the Boys and Girls Club of America Advocacy Award
(2001) and his university’s Chancellor’s Award for Excellence in Service
(2004). Dr. Curry received his Ph.D. in sociology from the University of
Chicago. He also completed postdoctoral studies there with a specialization in evaluation research methods. Dr. Curry served as chair of a university IRB committee (2 years) and as a prisoner representative on an
IRB (6 years).
Cynthia A. Gómez, PhD, is the founding director of Health Equity Initiatives at San Francisco State University where she leads efforts to enhance and integrate campus research, curricula, community service and
training programs that address health disparities and/or promote health
equity in the United States. She previously served as co-director of the
Center for AIDS Prevention Studies (CAPS) at the University of California at San Francisco where she was also an associate professor in the
Department of Medicine and leading scientist in HIV prevention research
since 1991. She received her master’s degree in psychology from Harvard and her PhD in Clinical Psychology from Boston University. Prior
to her work with CAPS, Dr. Gómez spent 12 years working in community health settings, including five as director of a child and family mental health center in Boston. Dr. Gómez is considered a pioneer in the
areas of cultural determinants in sexual behaviors among Latinos, in the
role of power dynamics in sexual risk among women, and in the devel-

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opment of HIV prevention interventions, including interventions for
people living with HIV. Dr Gómez is a nationally renowned speaker and
an expert in the field of HIV prevention and sexual health. She has
served on several national committees including the Center for Disease
Control’s HIV and STD Advisory Council, National Institute on Drug
Abuse’s (NIDA) National Hispanic Science Network, and the Substance
Abuse and Mental Health Services Administration’s (SAMHSA) Advisory Committee on Women’s Services. She is a member and past chair
of the board of directors of the Guttmacher Institute. She serves on several other boards of directors including: the National AIDS Fund, Public
Responsibility in Medicine & Research, and the Pacific Institute for
Women’s Health. Dr Gómez was also an appointed member to the
Presidential Advisory Council on HIV/AIDS under both WJ Clinton and
GW Bush administrations.
Bradford H. Gray, Ph.D., is a principal research associate at the Urban
Institute and editor of The Milbank Quarterly, a journal of population
health and health policy. He was formerly a study director at the Institute
of Medicine, a faculty member at Yale University, and director of the
health policy division at the New York Academy of Medicine. He earlier
served on the staff of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research and was a consultant on institutional review boards to the President’s Commission for
the Study of Ethical Problems in Medicine and Research. He has published extensively on matters pertaining to the ethics of human experimentation, for-profit and nonprofit health care, and the changing conditions of medical professionalism. His books include Human Subjects in
Medical Experimentation: The Conduct and Regulation of Clinical Research (1975) and The Profit Motive and Patient Care: The Changing
Accountability of Doctors and Hospitals (1991). Dr. Gray
holds bachelor’s and master’s degrees from Oklahoma State University
and a Ph.D. in sociology from Yale University. He is a fellow of The
Hastings Center, AcademyHealth, and the New York Academy of Medicine. Dr. Gray is a member of the Institute of Medicine.
Michael S. Hamden, J.D., is executive director of North Carolina Prisoner Legal Services, Inc., a public service, nonprofit organization for
prisoners and others detained in the criminal justice system in North
Carolina. He also serves as a prisoner representative for the Research
Triangle Institute’s institutional review boards. Mr. Hamden is a member

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of the North Carolina Bar Association, where he currently serves as chair
of the Section on Constitutional Rights and Responsibilities. He is also a
member of the North Carolina Academy of Trial Lawyers and served as
Chair of the North Carolina Legal Services Planning Council. Mr.
Hamden is a member of the American Bar Association, serving as cochair on the Corrections and Sentencing Committee and as liaison to the
American Correctional Association (ACA). In the ACA, Mr. Hamden is
a member of the Standards Committee and the Commission on Accreditation for Corrections, both as commissioner and as a member of the Executive Committee. He has written extensively on the provision of legal
services to prison populations, most recently coediting The Law and Policy of Sentencing and Corrections (7th ed., 2005) with law professor
Lynn S. Branham. Hamden earned a J.D. at the University of Tennessee
College of Law and a bachelor of music degree at Berklee College of
Music.
Jeffrey L. Metzner, M.D., is clinical professor in the Departments of
Psychiatry and Pediatrics at the University of Colorado School of Medicine and associate director of the Forensic Psychiatry Fellowship Program. He is a member of the American Psychiatric Association and immediate past chair of its Council on Psychiatry and the Law. He also
holds memberships with the American Academy of Psychiatry and Law,
American Academy of Forensic Sciences, American College of Legal
Medicine, and American Correctional Association. Dr. Metzner has written extensively on the psychiatric care of prison populations. He received
his M.D. from the University of Maryland Medical School.
Jonathan Moreno, Ph.D., is the Emily Davie and Joseph S. Kornfield
Professor of Biomedical Ethics and director of the Center for Biomedical
Ethics at the University of Virginia. Dr. Moreno is an elected member of
the Institute of Medicine, a bioethics consultant for the Howard Hughes
Medical Institute, a senior fellow at the Center for American Progress, a
faculty affiliate of the Kennedy Institute of Ethics at Georgetown University, and a fellow of the Hastings Center. He was a member of the
National Human Research Protection Advisory Committee and during
1994-1995 was senior policy and research analyst for the President’s
Advisory Committee on Human Radiation Experiments. He is currently a
member of the Health Sciences Policy Board of the Institute of Medicine
and served as cochair for the Committee on Guidelines for Human Embryonic Stem Cell Research. Among his books are Is There an Ethicist in

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the House: On the Cutting Edge of Bioethics (2005) and Undue Risk:
Secret State Experiments on Humans (2001).
Larry Palmer, L.L.B., is the endowed chair in urban health policy at the
University of Louisville, with appointments in the Department of Family
and Community Medicine, Institute for Bioethics, Health Policy and
Law, and School of Public Health and Information Sciences. Before joining the University of Louisville, he was a professor at Cornell University
Law School in Ithaca, New York. Professor Palmer is the author of Law,
Medicine, and Social Justice (1989), Endings and Beginnings: Law,
Medicine and Society in Assisted Life and Death (2000), and numerous
articles dealing with law, medicine, and health policy. Professor Palmer
is also the executive producer and author of the study guide of the prizewinning educational video Susceptible to Kindness: Miss Evers’ Boys
and the Tuskegee Syphilis Study. He is a member of the board of directors of the Hastings Center in Garrison, New York. Previously, Professor
Palmer served as a director of the National Patient Safety Foundation
(1997-2002) and a trustee of the Phillips Exeter Academy (1990-2000).
He was a member of the Committee on Establishing a National Cord
Blood Stem Cell Bank Program with the Institute of Medicine.
Norman Poythress, Ph.D., is professor in the Department of Mental
Health Law and Policy at the Florida Mental Health Institute at the University of South Florida. He received his Ph.D. in clinical psychology
from the University of Texas at Austin in 1977. Dr. Poythress has previously worked at the Center for Forensic Psychiatry in Ann Arbor, Michigan, and the Taylor Hardin Secure Medical Facility in Tuscaloosa, Alabama. He is a past president of the American Psychology-Law Society
(Division 41 of the American Psychological Association) and was the
recipient in 1990 of the American Academy of Forensic Psychology’s
Award for Distinguished Contributions to Forensic Psychology. Dr.
Poythress was a consultant to the MacArthur Foundation Research Network on Mental Health and the Law from 1989 to 1996. He is coauthor
of Psychological Evaluations for the Courts: A Handbook for Mental
Health Professionals and Lawyers, and his current research interests include forensic evaluation, psychopathy, and risk assessment. He is a
member of the American Psychological Association and the International
Association for Forensic Mental Health Services.

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William J. Rold, J.D., C.C. H.P.-A., is a practicing civil rights attorney
in New York City. A substantial part of his practice involves representing prisoners in lawsuits concerning health care and other rights. He also
publishes, lectures, and consults with correctional health care officials
throughout the United States and abroad. He was a staff attorney for the
Prisoners’ Rights Project in New York for 10 years. Mr. Rold represents
the American Bar Association on the board of directors of the National
Commission on Correctional Health Care and has served on the institutional review board of the New York City Department of Health for research involving prisoner subjects. Mr. Rold earned his juris doctor in
1977 from Georgetown University Law Center and holds his advanced
certification as a correctional health care professional. He serves on the
editorial board of the Journal of Prison Health. He was honored with the
Bernard P. Harrison Award of Merit for his service to correctional health
care by the National Commission on Correctional Health Care in St.
Louis in 2000. Mr. Rold was recently appointed a vice chair of the Corrections Committee of the American Bar Association.
Janette Y. Taylor, Ph.D., is associate professor in the College of Nursing at the University of Iowa. She is a certified women’s health care
nurse practitioner with specialization in obstetrics, gynecological and
neonatal nursing. Dr. Taylor’s research has focused on race/ethnicity as
variables in nursing research, African American women’s experience of
domestic violence, the health of women prisoners, reconnecting incarcerated women with their children, and using narrative art therapy with incarcerated abused women. She completed her Ph.D. at the University of
Washington.
Wendy Visscher, Ph.D., is director of RTI International’s Office of Research Protection and Ethics. RTI is an independent, nonprofit organization that conducts research and development projects for
government and commercial clients worldwide. Dr. Visscher oversees
the operation of RTI’s three institutional review boards (IRBs) and chairs
one of these committees. The IRBs review, approve, and monitor all human subjects research conducted by RTI, including both biomedical and
sociobehavioral research. Dr. Visscher maintains RTI’s federal-wide assurance with the U.S. Department of Health and Human Services’
(DHHS) Office for Human Research Protections. She has expertise in
DHHS and Food and Drug Administration human subjects protection
regulations, the Health Insurance Portability and Accountability Act and

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other privacy laws, and international guidelines and state laws that relate
to research. She provides guidance and training for researchers and legal
and regulatory staff on human subjects and privacy issues and earned
her certified IRB professional (CIP) rating in 2002. Dr. Visscher is
also an experienced researcher and holds a master’s of public health and
a Ph.D. in epidemiology from the University of Minnesota.
Barry Zack, MPH, is Executive Director of Centerforce, a nongovernment organization working with prisoners, their families and persons recently released from jails and prisons in Northern and Central
California. He is also an associate clinical professor at the University of
California, San Francisco, in the Department of Community Health Systems at the School of Nursing. He has been direct service provider and
community researcher working with incarcerated populations since 1986.
Mr. Zack has published research and presented at professional conferences
on
behavioral
intervention
strategies
to
prevent
HIV/Hepatitis/STDs and reduce risk behavior among prisoners; he has
consulted with many Department of Corrections’ on “Effective Bahavioral Interventions in the Correctional Setting.” He is on the editorial
board of Infectious Diseases in Corrections Report (formerly HEPP Report) and the Journal of Correctional Health Care. Mr. Zack was an external consultant for the Centers for Disease Control and Prevention’s
“Prevention and Control of Infections with Hepatitis Viruses in Correctional Settings” as well as the Surgeon General’s “Call to Action on Corrections and Community Health.”
EXPERT ADVISER
Nancy Neveloff Dubler, LL.B., is the Director of the Division of Bioethics, Department of Epidemiology and Population Health, Montefiore
Medical Center and Professor of Epidemiology and Population Health at
the Albert Einstein College of Medicine. She received her B.A. from
Barnard College and her LL.B. from the Harvard Law School. Ms. Dubler directs the Bioethics Consultation Service at Montefiore Medical
Center (founded in 1978) as a support for analysis of difficult clinical
cases presenting ethical issues in the health care setting; this service uses
mediation as its process. She lectures extensively and is the author of
numerous articles and books on termination of care, home care and longterm care, geriatrics, prison and jail health care, and AIDS. She is Co-

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Director of the Certificate Program in Bioethics and the Medical Humanities, conducted jointly by Montefiore Medical Center/Albert Einstein College of Medicine with Cardozo Law School of Yeshiva University. Her most recent books are: Ethics On Call: Taking Charge of Lifeand Death Choices in Today’s Health Care System, with David Nimmons, Vintage Press, (1993); Bioethics Mediation: A Guide to Shaping
Shared Solutions, co-author, Carol Liebman, United Hospital Fund, New
York, New York, (2004); The Ethics and Regulation of Research with
Human Subjects, Carl Coleman, Jerry Menikoff, Jesse Goldner and
Nancy Dubler, LexisNexis, Newark, NJ, (2005). She consults often with
federal agencies, national working groups and bioethics centers.
LIAISON PANEL: FORMER
PRISONERS/PRISONER ADVOCATES
Edward Anthony was an inmate in Philadelphia’s Holmesburg Prison in
the 1960s. During that time he took part in a series on medical experiments that included patch tests, diet studies, and psychotropic drug experiments for the U.S. Army. Since becoming fully aware of how he and
other former prisoners were used and misused as experimental material
in the book Acres of Skin, Mr. Edwards has become an activist on the
subject of ethical research and has spoken at numerous colleges, including Brown, Pennsylvania State, and Holy Family Universities. Mr. Edwards is currently working on a book with Allen Hornblum of Temple
University concerning his life as a human guinea pig.
Jack Beck has been the director of the Prison Visiting Project at the Correctional Association (CA) of New York since October 2004. The CA
has statutory authority to inspect prisons in New York State and to report
findings to the legislature and public. In addition, the project has issued
major reports on prison health care, disciplinary segregation, and treatment of inmates with mental illness. Before his association with CA, Mr.
Beck was a senior supervising attorney at the Prisoners’ Right Project of
the Legal Aid Society, where he worked for 23 years. He specialized in
medical care issues, with particular focus on HIV/AIDS and hepatitis C.
Mr. Beck is also a member of several statewide coalitions concerned
with medical and mental health care in prisons that have been advocating
for legislation to improve care of inmates. Mr. Beck has been a member
of the New York Academy of Medicine institutional review board as the
prisoner representative for 6 years. From 2003 to 2005, he was a member

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of the Department of Health and Human Services Secretary’s Advisory
Committee on Human Research Protections, Subcommittee on Subpart
C: Prisoners Research.
Debra Breuklander is a nurse consultant at MECCA, a residential inpatient substance abuse treatment program in Des Moines, Iowa. She previously worked as therapeutic community mentor and staff assistant
while incarcerated at the Iowa Correctional Institution for Women. Ms.
Breuklander has presented on child abuse prevention, reentry programs,
and family transition in prison populations. She is currently vice president of the Iowa Correctional Institution for Women Therapeutic Community Advisory Board and a member of the Friends of Iowa Women
Prisoners.
James Dahl is a clinical psychologist and sociologist focused on research development, field implementation of evidence-based treatment,
and collaborative community projects. He is currently directing research
development for the largest substance abuse treatment organization in the
United States, Phoenix House, managing a portfolio of competitive research grants in applied research related to therapeutic community and
related treatment strategies for substance abuse. Dr. Dahl formerly
served as director of Research Development, Research Foundation of
City University of New York, driving a strategic research development
program in biomedical and other bio-based technology, photonics, and
aquaculture for the 20-campus system, which supports $250 million in
research annually. He also served as vice president of Washington-based
University Research Corporation for more than 6 years, specializing in
federally sponsored research to application of evidence-based programs
through training and site development. Dr. Dahl has held positions as a
university professor at the State University of New York at Stony Brook
(School of Medicine/Psychiatry and School of Social Work) and Hofstra
University. He was a senior grants officer for a private foundation and a
consultant for Washington-based WESTAT and Macro International,
delivering technical assistance to state drug treatment programs for Substance Abuse and Mental Health Services Administration
(SAMHSA)/Center for Substance Abuse Treatment as well as Atlanta
University, Crime and Justice Institute, and Howard University, Center
for Drug Abuse Research. He also served for 6 years as vice president of
the University Research Corporation in Bethesda, Maryland, conducting
federal research and practice dissemination projects for the National In-

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stitute of Justice, Office of Juvenile Justice and Delinquency Prevention,
and Department of Education. He is currently a review panelist for
SAMHSA (U.S. Department of Health and Human Services), U.S. Department of Justice, and National Institute of Drug Abuse Clinical Trials
Network (CTN) Concept Wave Reviews. Dr. Dahl is a current member
of the American Psychological Association, American Psychological
Society, and the New York Academy of Sciences. He is board certified
in cognitive-behavioral therapy and hypnotherapy.
Allen Hornblum has spent many years in government and has an extensive background working in the criminal justice system. He has served as
chief of staff of the Philadelphia Sheriff’s Office and on the boards of the
Pennsylvania Crime Commission, Pennsylvania Commission of Crime
and Delinquency, and Philadelphia Prison System Board of Trustees. Mr.
Hornblum’s book Acres of Skin is the leading work on the subject of
America’s use of prison inmates as test subjects for medical experiments
He has recently completed a documentary on the Holmesburg experiments. Mr. Hornblum has also lectured on the subject at an array of institutions of higher learning, including Brown and Columbia Universities,
National Institutes of Health, and British Medical Association. Mr.
Hornblum has also written Philadelphia City Hall (2003), a photographic
history of Philadelphia’s City Hall and Confessions of a Second Story
Man: Junior Kripplebauer and the K&A Gang, which is scheduled for
release in May 2005. He is currently working on two books, one of
which will document the life of a former inmate test subject and his lasting resentment toward the medical establishment.
Daniel Murphy is currently a professor in the Department of Political
Science and Justice Studies at Appalachian State University. He is also
author of “Aspirin Ain’t Gonna Help the Kind of Pain I’m In: Health
Care Delivery in the Federal Bureau of Prison,” which appears in Convict Criminology. Dr. Murphy’s research is based on his personal experience, having been imprisoned in the Federal Bureau of Prisons for 5
years. He is also an active member of the Convict Criminologists group.
Dr. Murphy is cochair of the Federal Citizens United for the Rehabilitation of Errants’ (FedCURE) Legislative Action Committee. He also
serves as a member of FedCURE’s Board of Directors.
Barry Nakell, Esq., is a former professor of law and an attorney who
has been an advocate for the rights of prisoners over the last 30 years.

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Mr. Nakell represented the prisoner class in the seminal case, Bounds v.
Smith, which established that prisoners have a right of access to the
courts. After his victory in that case, in 1978 Mr. Nakell was the moving
force in the creation of North Carolina Prisoner Legal Services, Inc., and
has continuously served as a member of its board of directors.
Osvaldo Rivera is a 50-year-old Latino, born and raised in Puerto Rico.
He has worked in the field of human services for approximately 10 years.
Mr. Rivera was a member of the Consumer Advisory Board for the Massachusetts Department of Public Health. He currently serves on the Ryan
White Planning Council. For the last 5 years, Mr. Rivera’s work consisted of providing re-integration services to offenders and ex-offenders.
He is affiliated with Span Inc., which specializes in providing reintegration services in the greater Boston, Massachusetts, area. Mr. Rivera’s
main focus is HIV/AIDS-positive men and those who are at high risk for
acquiring and transmitting HIV/AIDS, hepatitis, and other sexually
transmitted infections. After a long battle with addiction and many years
spent in and out of prisons, Mr. Rivera committed to work with people
like himself. He went to school to further his education and became a
certified addiction specialist and a licensed alcohol and drug counselor.
He earned respect and a good reputation within his community as a positive role model and leader. Mr. Rivera’s desire is to continue his positive
work in order to empower and strengthen others in need.
Jeffrey Ian Ross is an associate professor in the Division of Criminology, Criminal Justice, and Social Policy and a research fellow at the Center for Comparative and International Law at the University of Baltimore. He has conducted research, written, and lectured on national
security, political violence, political crime, policing, and corrections for
more than 15 years. His work has appeared in many academic journals
and books as well as popular magazines. He is the author of Making
News of Police Violence (Praeger, 2000), coauthor (with Stephen C.
Richards) of Behind Bars: Surviving Prison (Macmillan, 2002), editor of
Controlling State Crime (2nd ed., Transaction Books, 2000), Violence in
Canada: Sociopolitical Perspectives (Oxford University Press, 1995),
Cutting the Edge: Current Perspectives in Radical/Critical Criminology
and Criminal Justice (Praeger, 1998), Varieties of State Crime and Its
Control (Criminal Justice Press, 1999), and coeditor, with Stephen C.
Richards, of Convict Criminology (Wadsworth, 2002). In 1986 Ross was
the lead expert witness for the Senate of Canada’s Special Committee on

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Terrorism and Public Safety. He received his Ph.D. in political science
from the University of Colorado and was a social science analyst with
the National Institute of Justice, a division of the U.S. Department of Justice before coming to the University of Baltimore.
Jean Scott is the Deputy Regional Director of the New York City and
Correctional Treatment Programs at Phoenix Houses of New York, the
largest substance abuse treatment organization in the United States. Ms.
Scott first joined Phoenix House in 1970; subsequently served as Manager of Purchasing and Corporate Relations; Senior Director/Assistant to
the Associate Director of Phelan Place; Regional and Facility Director at
the Hart Island complex; and Assistant Director of the Far Rockaway
facility. From 1983 to 2000 she served as Vice President, Director of
Adult Programs and in 2000, she was promoted to Deputy Regional Director, New York City and Correctional Treatment Programs for Phoenix
Houses of New York, where she oversees budgets in excess of $10 million for residential programs. She was also responsible for development,
coordination, and implementation of a joint initiative with the New York
State Department of Corrections, providing drug treatment for incarcerated offenders. She has served on the OASAS Credentialing Board; the
Argus Community, Inc., ACT I, Private Sector Advisory Board; and the
Board of Trustees at St. Francis College. In 1993, she received the 9th
Fannie Lou Hamer award and in 1996 the 7th Annual Founders award
from the Black Agency Executives. Ms. Scott is a credentialed alcohol
and substance abuse counselor (CASAC), a certified addictions specialist
(CAS) and a certified criminal justice addictions specialist (CCJAS); and
she currently sits on the OASAS Appeals Board.
STAFF
Andrew Pope, Ph.D., is director of the board on Health Sciences Policy
in the Institute of Medicine. With a Ph.D. in physiology and biochemistry, his primary interests are in science policy, biomedical ethics, and the
environmental and occupational influences on human health. During his
tenure at the National Academies and since 1989 at the Institute of Medicine, Dr. Pope has directed numerous studies on topics that range from
injury control, disability prevention, and biologic markers to the protection of human subjects of research, National Institutes of Health prioritysetting processes, organ procurement and transplantation policy, and the

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role of science and technology in countering terrorism. Dr. Pope is the
recipient of the National Academy of Sciences President’s Special
Achievement Award and the Institute of Medicine’s Cecil Award.
Adrienne Stith Butler, Ph.D., is a senior program officer in the Board
on Health Sciences Policy of the Institute of Medicine (IOM). She is currently study director for the IOM Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Previously, Dr. Stith Butler
served as study director for the IOM report, Preparing for the Psychological Consequences of Terrorism: A Public Health Strategy conducted
within the Board on Neuroscience and Behavioral Health. She has also
served as a staff officer for IOM reports, In the Nation’s Compelling Interest: Ensuring Diversity in the Health-Care Workforce and Unequal
Treatment: Confronting Racial and Ethnic Disparities in Health Care,
conducted within the Board on Health Sciences Policy. Before working
at the IOM, Dr. Butler served as the James Marshall Public Policy
Scholar, a fellowship cosponsored by the Society for the Psychological
Study of Social Issues and the American Psychological Association
(APA). In this position, based at the APA in Washington, DC, she engaged in policy analysis and monitored legislative issues related to ethnic
disparities in health care and health research, racial profiling, and mental
health counseling provisions in the reauthorization of the Elementary and
Secondary Education Act. Dr. Butler, a clinical psychologist, received
her doctorate in 1997 from the University of Vermont. She completed
postdoctoral fellowships in adolescent medicine and pediatric psychology at the University of Rochester Medical Center in Rochester, New
York.
Susan McCutchen is a research associate for this study. She has been on
staff at the National Academies for nearly 25 years, assisting committees
focused on a wide variety of subjects, including studies for the Agency
for International Development, technology transfer, aeronautics and
space research, various kinds of natural disasters, HIV and needle exchange, human factors and engineering, the polygraph, poison control
centers, education and testing issues (e.g., “No Child Left Behind”), ethics in research, and Social Security (i.e., representative payees, disability
determinations). She has a B.A. in French from Miami University in
Ohio and an M.A. in French with a minor in English from Kent State
University.

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Eileen Santa, M.A., is a research associate working with the premature
birth and the prisoner research ethics committees. She earned her master’s degree in clinical psychology from the University of Massachusetts,
where she is currently a doctoral candidate. Her research focuses on the
cultural factors that contribute to healthy outcomes for Latina mothers
and children.
Vilija Teel works as the senior project assistant for this study, providing
administrative support for the project. Mrs. Teel plans and coordinates
logistical arrangements for committee meetings, including coordinating
travel and lodging for committee members, overseeing the attendee registration process during open sessions, and providing support throughout
the committee meeting. She also provides support for the project’s financial management, including processing payment requests and ensuring
timely reimbursement of travel and incidental expenses. Mrs. Teel
earned a B.A. in English/Linguistics from Vilnius University and has
taken additional course work in finance and management areas. She is
proficient in all of the major office-environment software programs. In
addition to English, she has a good grasp of many other languages.
Jason Farley is currently working as an intern for this study. Mr. Farley
is completing a Ph.D. in the School of Nursing at The Johns Hopkins
University. He holds a bachelor’s degree in nursing from the University
of Alabama, a master’s degree in public health from the University of
Alabama, Birmingham, and a master’s degree in nursing from The Johns
Hopkins University School of Nursing. He is certified as an adult nurse
practitioner with a clinical practice both in infectious disease and emergency medicine. His doctoral study was recently funded by a National
Research Service Award by the National Institute of Health. His research
will investigate the molecular epidemiology of methicillin-resistant
Staphylococcus aureus in the Baltimore City jail system.

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