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

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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 Board on Health Sciences Policy Lawrence O. Gostin, Cori Vanchieri, and Andrew Pope, Editors THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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THE NATIONAL ACADEMIES PRESS • 500 FIFTH STREET, N.W. • Washington, DC 20001 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. International Standard Book Number-10: 0-309-10119-0 International Standard Book Number-13: 978-0-309-10119-6 Library of Congress Control Number: 2006937620 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http:// www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2007 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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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 Acad- emy 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 engi- neers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is presi- dent 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 Coun- cil 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

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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 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 v

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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 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. vi

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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 proce- dures 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, evi- dence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the delibera- tive 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 vii

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viii INDEPENDENT REPORT REVIEWERS 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, Pennsyl- vania 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 con- sidered. 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 in volving prisoners—was as challenging as it was important. Research is critically important in providing knowledge needed for informed and en- lightened 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 illus- trations of unconscionable abuses. Getting the balance right between scien- tifically 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 Protec- tion of Prisoners Involved in Research, was to explore whether the conclu- sions reached in 1976 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research remain appropri- ate 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 ix

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x PREFACE 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 prison- ers is conducted ethically, and (4) identify issues and needs for future con- sideration and study. Past abuse in biomedical research in prisons has engendered deep dis- trust 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 mark- edly 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 chil- dren are also incarcerated in American prisons today. Prisoners are particu- larly vulnerable to exploitation not only because of their low socioeco- nomic status, but also due to the realties of prison life. Although conditions are widely variable, overall prisoners are subjected to high levels of coer- cion (explicit and implicit). The prison environment makes it difficult to assure even minimal standards for ethical research such as voluntary in- formed 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 Com- mittee 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 correc- tional 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 ben- efit 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 vulnerabil- ity. Our answer, after an exhaustive study, was an emphatic “no.” Al- though 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-

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xi PREFACE 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 re- search 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 pro- tection 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 estab- lished 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, en- hance 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 execu- tive 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 appar- ently 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

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xii PREFACE 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 ACRONYMS xvi SUMMARY 1 1 INTRODUCTION 21 Why Now?, 22 Committee’s Task and Approach, 24 Methods and Approach, 26 Organization of This Report, 27 2 TODAY’S PRISONERS: CHANGING DEMOGRAPHICS, HEALTH ISSUES, AND THE CURRENT RESEARCH ENVIRONMENT 29 Changing Demographics and Health Issues, 30 Descriptions of Prisons, Jails, and Other Correctional Settings, 30 The Prisoner Population, 31 Summary of Findings on Changing Demographics and Health Issues, 58 Current Research Environment, 59 Current Status of Prisoner Research, 59 Results from the Surveys with Key DOC Personnel, 59 Published Literature: A Review of Selected Prisoner Studies, 61 Data Retrieval Needs Improving, 64 Summary of Findings on Current Research Environment, 66 xiii

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xiv CONTENTS 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

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xv CONTENTS Systematic Oversight of Research with Prisoners, 151 Prison Research Subject Advocate, 153 IRB Postapproval Monitoring, 156 National Oversight, 157 Applying Safeguards for Particular Kinds of Research, 160 Sample Situations, 162 Other Categories and Types of Research Involving Prisoners Prohibited, 170 Impact of Committee Recommendations on Stakeholder Responsibilities, 170 APPENDIXES A Data Sources and Methods 175 B The National Commission’s Deliberations and Findings 191 C Report of the SACHRP Subcommittee and Human Subjects Protections 199 D Code of Federal Regulations Title 45: Public Welfare, Part 46: Protection of Human Subjects 205 E Committee, Expert Advisor, Liaison Panel, and Staff Biographies 239 INDEX 253

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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 xvi

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xvii ACRONYMS 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 The National Commission for the Protection of Human Commission 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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