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Date: July 12, 2006
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FOR IMMEDIATE RELEASE
Greater Oversight and Rigorous Safeguards Needed to Ensure
That all Research Involving Prisoners Meets High Ethical Standards
WASHINGTON -- More comprehensive safeguards and oversight measures are needed to ensure that the participation of prisoners in scientific research meets the highest ethical standards and aims to improve the well-being of prisoners, says a new report from the Institute of Medicine of the National Academies.
Most research with prisoners now takes place outside the scope of federal regulations and often without the scrutiny of institutional review boards (IRBs). Congress should mandate uniform guidelines for all human research participant protection programs regarding studies that enroll prisoners and create a national system of oversight that applies to this research, the report says. At the same time, the federal government should maintain a detailed public database that tracks all studies involving prisoners.
These added protections should cover not only research participants who are confined in prisons or jails, but also those who are on parole, probation, or in community-based alternatives to incarceration. Federal research regulations define prisoners solely as people who are incarcerated, but that view is too narrow, the report says. In 2004, for example, only 30 percent of adults under the supervision of the criminal-justice system were actually imprisoned. The U.S. Department of Health and Human Services and other agencies that write, implement, or enforce rules governing the use of prisoners in studies should expand protection to this broader population, which also faces restrictions on autonomy.
"Humane, respectful treatment of all prisoners is a hallmark of decent society," said Lawrence Gostin, associate dean and professor of law, Georgetown University Law Center, Washington, D.C., and chair of the committee that wrote the report. "Our goal should be to promote rigorous, responsible research that has the potential to improve the well-being of prisoners and the general public, while taking great care to protect the health and human rights of study participants. Given prisoners' limited privacy, inherently coercive living arrangements, and often inadequate health care, they are among the most vulnerable human subjects of research."
History of Exploitation and Gaps in Protection
Research involving prisoners has a tainted history. In the past, some scientific investigators used prisoners to study a variety of illnesses and toxins when human experimentation in free society was not allowed, and many who participated did not give voluntary, informed consent or fully understand the risks or possible benefits of research protocols. In the late 1970s, the U.S. government implemented federal legislation to protect human subjects in scientific research; the section dealing with prisoners is commonly referred to as Subpart C of the Common Rule. Since then, the total population of the U.S. correctional system -- including inmates and people on probation or parole -- has increased almost fivefold, and prisoners' access to adequate health care has not always kept pace with this growth. In addition, an increasingly large number of people from disadvantaged groups, such as racial minorities and people who have mental illnesses or communicable diseases, are under the supervision of the criminal justice system. These changes make clear the need for stronger ethical safeguards in research involving a rapidly expanding segment of society, the report says.
Currently, the Office for Human Research Protections (OHRP) in HHS oversees research that is funded by three of 17 relevant federal agencies -- but not research funded by the Bureau of Prisons in the U.S. Department of Justice and other federal, state, and private organizations that support studies with prisoners. This patchwork approach to protecting the rights and health of prisoners enrolled in research is unjustified, the committee said.
Federal regulations should be revised so that all research involving prisoners is held to uniform ethical standards and guidelines -- regardless of the source of funding or support, or the type of correctional facility or program. And each of these studies should fall under OHRP's oversight, the report says.
The Office for Human Research Protections needs major reinforcement, since it lacks adequate funding and personnel to carry out its work for the three agencies already within its purview, much less any expanded responsibilities, the report says. HHS should strengthen OHRP's capacity to fulfill its existing mission, which includes rule enforcement and outreach to programs designed to protect research participants. OHRP would then be in a better position to provide comprehensive, national oversight of all research involving prisoners -- a charge that would likely require even more resources. If OHRP cannot effectively carry out the broader assignment, Congress should create a new entity to do so.
HHS also should revise regulations so that all proposals for research that enlists prisoners are reviewed based on the risks and benefits for individual human subjects, an approach similar to one now taken for child participants in research. Generally speaking, Subpart C says that only research that fits within certain categories is permitted in prisoner populations, but the categories are poorly defined, the report says.
Whether prisoners can exercise independent choice about participating in scientific research has long been a controversial issue. The report says that voluntary, informed consent is a prerequisite, and that human research participant protection programs must ensure it. Otherwise, research proposals should not be approved. Officials from the protection programs also should work with prison administrators, probation officers, and other relevant professionals to safeguard the privacy of prisoners enrolled in studies.
To be ethically permissible, research must offer prisoners potential benefits that outweigh risks, the committee emphasized. Biomedical research in particular should be severely limited because the safety and efficacy of such studies are seldom clear in their early stages.
A national database is needed to bring clarity to this murky area of research, the report says. DOJ and a stronger OHRP should work together to maintain a public registry of all research involving prisoners. The database should include details about the groups conducting the research and being tested; the sponsors; ethical standards employed; the quality of research oversight; and related issues.
Also, research protection programs must be transparent and accountable. There should be open communication and interaction among research participants, investigators, and other stakeholders, the report says. Monitoring should be improved at the local level, too. Currently, institutional review boards evaluate research proposals involving prisoners and make decisions on whether they should be conducted, but IRB approval alone is insufficient in this area. The boards should install independent, on-site "prison research subject advocates" to verify that procedures are being carried out as approved and to quickly detect and report any problems. And IRBs should focus on the particular ethical issues each study raises in a given correctional setting, the report adds.
Collaborative Approaches Are Key
Scientific investigators should get input from prisoners and other stakeholders on the design and conduct of studies, the report says. Using this kind of collaborative approach at every step of the research process would allow the unique circumstances of local correctional facilities to be taken into account, and it could foster more openness in the research enterprise.
Programs that protect research participants also should work with prison administrators and health care officials to make sure that test subjects have immediate access to health care services that are adequate and already in place. This is especially critical if studies result in physical or mental harm, the report says. Furthermore, measures should be taken to protect research participants from fellow inmates who may want to sway their decisions about taking part.
High-quality research involving prisoners can inform criminal justice policies, the report points out. With government funding, investigators should study ways to effectively run correctional systems, reduce recidivism, and help former prisoners thrive in society.
The study was sponsored by the Office for Human Research Protections in the U.S. Department of Health and Human Services, and the Greenwall Foundation. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, evidence-based advice to policymakers, health professionals, industry, and the public. A committee roster follows.
Copies of the pre-publication version of Ethical Considerations for Research Involving Prisoners are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
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[ This news release is available at http://national-academies.org ]
vv: Science Policy, Health Policy, Social and Behavioral Science, Medicine
INSTITUTE OF MEDICINE
Board on Health Sciences Policy
COMMITTEE ON ETHICAL CONSIDERATIONS FOR REVISIONS TO DHHS
REGULATIONS FOR PROTECTION OF PRISONERS PARTICIPATING AS SUBJECTS IN RESEARCH
LAWRENCE O. GOSTIN, J.D. (CHAIR)
Professor of Public Health
Johns Hopkins University, and
Professor of Law and Director
Center on Law and the Public's Health
Georgetown University Law Center
HORTENSIA AMARO, PH.D.
Distinguished Professor of Health Sciences
Bouve College of Health Sciences
Northeastern University, and
Vice Chair of the Board
Boston Public Health Commission
PATRICIA BLAIR, PH.D., J.D.
Office of Legal Affairs, and
Adjunct Associate Professor
School of Nursing
University of Texas Health Center
STEVE CAMBRA JR., B.A.
Cambra, Larson & Associates, and
California Youth Authority
G. DAVID CURRY, PH.D.
Department of Criminology and Criminal Justice
University of Missouri
CYNTHIA P. GOMEZ, PH.D.
Co-Director and Interim Division Chief
Center for AIDS Prevention Studies, and
Department of Medicine
University of California
BRADFORD H. GRAY, PH.D.
Principal Research Associate
Urban Institute, and
MICHAEL HAMDEN, J.D.
North Carolina Prisoner Legal Services Inc., and
Institutional Review Board
Research Triangle Park
JEFFREY L. METZNER, M.D., P.C.
Departments of Psychiatry and Pediatrics
School of Medicine, and
Forensic Psychiatry Fellowship Program
University of Colorado
JONATHAN D. MORENO, PH.D.
Howard Hughes Medical Institute;
Emily Davie and Joseph S. Kornfield Professor of Biomedical Ethics; and Director
Center for Biomedical Ethics
University of Virginia
LARRY I. PALMER, LL.B.
Endowed Chair in Urban Health Policy
Institute for Bioethics, Health Policy, and Law
University of Louisville
NORMAN POYTHRESS, PH.D.
Department of Mental Health Law and Policy, and
Florida Mental Health Institute
University of Florida
WILLIAM J. ROLD, J.D.
Private Practice Attorney at Law
New York City
JANETTE TAYLOR, PH.D.
College of Nursing
University of Iowa
WENDY VISSCHER, PH.D.
Office of Research Protection and Ethics
Research Triangle Park, N.C.
BARRY ZACK, M.P.H.
ANDREW POPE, PH.D.