RTI International - News Release - 7.12.2006
Panel Recommends Additional Oversight, Safeguards for Research Involving Prisoners
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RESEARCH TRIANGLE PARK, N.C. -– More comprehensive safeguards and oversight measures are needed to ensure that the rights of prisoner participants in scientific research are protected, according to a new report from the Institute of Medicine of the National Academies.
The report was written by members of the Institute's Committee on Ethical Considerations for Revisions to the Department of Health and Human Services Regulations for Protection of Prisoners Involved in Research.
Director of RTI International’s Office of Research Protection, Wendy Visscher, Ph.D., who served as a member of the panel that wrote the report, said that enhanced protections are needed to ensure that research involving prisoners is conducted in an ethical fashion, and that the same protections are afforded to all prisoner participants.
"Ensuring that the proper protections are provided is an important ethical consideration for all studies involving prisoners because of the inherent vulnerability of this group," Visscher said. "Researchers, prison officials and oversight bodies have a shared responsibility to make sure prisoner participants are able to provide informed consent, that the benefits of the study outweigh the risks, and that strict measures are in place to safeguard their privacy and confidentiality."
Visscher said the report identifies specific safeguards that might apply to different types of research with prisoners, and also provides some recommendations for how the regulations might be changed to emphasize risks and benefits, rather than category of research.
The committee members reported that most research conducted with prisoners takes place outside the scope of federal regulations and often without the scrutiny of Institutional Review Boards (IRBs). To combat this problem, the committee members recommend that Congress establish uniform guidelines for the review of all research studies that enroll prisoners; create a national system of oversight that applies to research involving prisoners; and maintain a detailed public database that tracks all studies in which prisoners participate.
The authors also suggest that the protection guidelines for prisoners should include research participants who are confined in prisons or jails as well as those who are on parole, probation or in community-based alternatives to incarceration. Current federal research regulations apply only to people who are incarcerated.
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.
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 the National Academies Press Web site.