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Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

THE NATIONAL ACADEMIES PRESS

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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Award No. N01-OD-4-2139, TO #149 (DHHS-5294-249) between the National Academy of Sciences and the DHHS (Office for Human Research Protections)/National Institutes of Health and by a grant from The Greenwall Foundation. Any opinions, findings, or conclusions expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

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Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

“Knowing is not enough; we must apply.

Willing is not enough; we must do.”

—Goethe

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine


The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.


The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.


The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.


The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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

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

Jonathan Moreno,

University of Virginia, Charlottesville

Larry I. Palmer,

University of Louisville, Louisville, KY

Norman G. Poythress, Jr.,

University of South Florida, Tampa

William J. Rold,

New York

Janette Y. Taylor,

University of Iowa, Iowa City

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

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

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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 Maryland, Baltimore

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 Staff

Andrew Pope, Director

David Codrea, Financial Associate

Amy Haas, Board 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.

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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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

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

Preface

The Committee’s task—to review the ethics regarding research in volving 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

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

nonprisoners, (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 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 policy makers 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 and deter-

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

mined 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. Part 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 the term 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 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 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 devising 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

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

3

 

FEDERAL REGULATORY LANDSCAPE

 

73

   

 Adoption of DHHS Human Subjects Protection Regulations,

 

74

   

 The Common Rule,

 

76

   

 Subpart C: Prisoners as Research Subjects,

 

79

   

 Report of the SACHRP Subcommittee,

 

81

   

 Other Federal Human Subjects Protections,

 

84

   

 Subpart D,

 

85

   

 Other DHHS Agencies: FDA Regulations,

 

86

   

 DOJ Regulations,

 

89

   

 Analysis,

 

94

   

 Existing Authority for Broader Regulation,

 

95

   

 Can the DHHS Be Guaranteed Broader Authority?,

 

96

   

 Alternatives to Comprehensive Regulation,

 

99

4

 

DEFINING PRISONERS AND CORRECTIONAL SETTINGS

 

101

   

 Ethical Foundations of Current Research Regulations,

 

101

   

 Current Regulations Pertinent to Places of Prisoner Research,

 

102

   

 Correctional Settings Encompass More than Prisons and Jails,

 

103

   

 Definition of Prisoner,

 

105

   

 Delineation of Settings,

 

109

   

 When Proposed Regulations Should Apply,

 

109

   

 When Proposed Regulations Should Not Apply,

 

110

   

 When Liberty Status Changes,

 

110

5

 

THE ETHICAL FRAMEWORK FOR RESEARCH INVOLVING PRISONERS

 

113

   

 The 1976 Commission’s Ethical Framework,

 

114

   

 Historical Context,

 

114

   

 Justice and Respect for Persons,

 

115

   

 An Updated Ethical Framework,

 

116

   

 Respect for Persons,

 

117

   

 Justice,

 

127

6

 

SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS

 

137

   

 Overarching Principle,

 

137

   

 Defining and Reviewing Prisoner Research,

 

138

   

 What Is Reviewed,

 

139

   

 Who Reviews,

 

141

   

 How Reviews Are Conducted,

 

143

   

 When Reviews Are Done,

 

150

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

Acronyms

AE adverse events

AIDS acquired immunodeficiency syndrome

BJS Bureau of Justice Statistics

BOP Bureau of Prisons

BRRB Bureau Research Review Board

CDC Centers for Disease Control and Prevention

CDCR California Department of Correction and Rehabilitation

CIA Central Intelligence Agency

CMF California Medical Facility

CQI comprehensive quality improvement

CRA clinical research associate

CRC clinical research center

CYA California Youth Authority

DHHS Department of Health and Human Services

DOC Department of Corrections

DOJ Department of Justice

DHEW Department of Health, Education, and Welfare

FBP Federal Bureau of Prisons

FDA Food and Drug Administration

FWA federal-wide assurance

Page xvii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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GAO General Accounting Office

GED General Equivalency Development (test)

HIV human immunodeficiency virus

HIPAA Health Insurance Portability and Accountability Act

HRPPP Human Research Participant Protection Program

IRB institutional review board

IOM Institute of Medicine

JPI Justice Policy Institute

LRRB local research review board

National Commission The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

NCCHC National Commission on Correctional Health Care

NIC National Institute of Corrections

NIH National Institutes of Health

NIJ National Institute of Justice

NFCMH New Freedom Commission on Mental Health

OHRP Office for Human Research Protections

ORE Office of Research and Evaluation

OSI Open Society Institute

PHI protected health information

PRSA prison research subject advocate

QA quality assurance

QI quality improvement

RA research assistant

SACHRP Secretary’s Advisory Committee on Human Research Protections

SAMHSA Substance Abuse and Mental Health Services Administration

SSA Social Security Administration

TB tuberculosis

TQI total quality improvement

U.S. United States

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In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, 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, have limited privacy, and often receive 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 contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections:

• expand the definition of "prisoner";

• ensure universally and consistently applied standards of protection;

• shift from a category-based to a risk-benefit approach to research review;

• update the ethical framework to include collaborative responsibility; and

• enhance systematic oversight of research involving prisoners.

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