Ethical Considerations FOR Research Involving Prisoners
Lawrence O. Gostin, Cori Vanchieri, and Andrew Pope, Editors
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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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
Northeastern University, Boston, MA
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
University of Virginia, Charlottesville
Larry I. Palmer,
University of Louisville, Louisville, KY
Norman G. Poythress, Jr.,
University of South Florida, Tampa
William J. Rold,
Janette Y. Taylor,
University of Iowa, Iowa City
RTI International, Research Triangle Park, NC
Centerforce, San Quentin, CA
Expert Advisor and Liaison, Board on Health Sciences Policy
Montefiore Medical Center, Bronx, NY
Georgetown University Law Center, Washington, DC
Bondurant, Mixson, & Elmore, LLP, Atlanta, GA
Silver Spring, MD
Jason E. Farley,
The Johns Hopkins University, Baltimore, MD
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
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
Perlegen Sciences, Mountain View, CA
Lynn R. Goldman,
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
University of Pittsburgh, PA
Martha N. Hill,
Johns Hopkins University School of Nursing, Baltimore, MD
American Association for the Advancement of Science, Washington, DC
Vanderbilt University Medical Center, Nashville, TN
University of Virginia, Charlottesville
E. Albert Reece,
University of Maryland, Baltimore
National Health Council, Washington, DC
Michael J. Welch,
Washington University School of Medicine, St. Louis, MO
Owen N. Witte,
University of California, Los Angeles
Research!America, Alexandria, VA
Andrew Pope, Director
David Codrea, Financial Associate
Amy Haas, Board Assistant
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
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.
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
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-
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
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
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
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
TQI total quality improvement
U.S. United States