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Fall 2006 Vol. 6 No. 3

Table of Contents

Research Involving Prisoners

Greater Oversight Needed to Ensure Humane, Respectful Treatment

©Thinkstock/Jupiterimages Prisoners are considered particularly vulnerable participants in scientific research projects. Federal guidelines specify that great care be taken when they are enrolled in studies so that they are not unduly influenced to join. But most research involving them takes place outside the scope of federal regulations and often without the scrutiny of institutional review boards (IRBs), which monitor how well studies comply with various rules.

In the past, some scientific investigators used prisoners to study illnesses and toxins when human experimentation in free society was not allowed. Many who participated did not give voluntary, informed consent or fully understand research protocols. This legacy of unethical treatment led the federal government in the late 1970s to implement regulations to protect all human subjects in research. Since then, however, the total population of the U.S. correctional system -- including inmates and people on probation or parole -- has increased almost fivefold. Plus, more people from disadvantaged groups, such as racial minorities and people who have mental illnesses, are under the supervision of the criminal justice system.

A new Institute of Medicine report says greater oversight and more safeguards are needed to ensure that research involving this growing segment of society meets the highest ethical standards and seeks to improve the well-being of prisoners. To that end, Congress should mandate uniform guidelines for all human research participant protection programs regarding studies that enroll prisoners -- regardless of the source of funding or the type of correctional program. Additionally, the federal government should maintain a detailed public database that tracks these studies.

The improved safeguards 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 now define prisoners solely as people who are incarcerated, the report points out. The U.S. Department of Health and Human Services and other agencies that write, implement, or enforce rules governing the use of prisoners as subjects in studies ought to expand protection to this broader population, which also faces restrictions on autonomy.

These studies should fall under the oversight of the Office for Human Research Protections (OHRP) in HHS, the report says. However, HHS needs to give this office more muscle to carry out its current mission, which includes rule enforcement. OHRP would then be in a better position to provide national oversight of all research involving prisoners, a charge that would likely require more resources. If OHRP cannot effectively handle the broader assignment, Congress should create a new entity to do so.

The committee that wrote the report emphasized that research must offer prisoners potential benefits that outweigh risks. Furthermore, human research participant protection programs must guarantee that prisoners have given voluntary, informed consent.

Monitoring should be improved at the local level, too, the report says. IRBs 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. Likewise, scientific investigators should get input from prisoners and other stakeholders on the design and conduct of studies. Test subjects also must have immediate access to adequate health care services, in case studies result in physical or mental harm.

Humane, respectful treatment of all prisoners, the report says, is a hallmark of decent society.   -- Vanee Vines

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, Institute of Medicine (2006, approx. 316 pp.; ISBN 0-309-10119-0, available from the National Academies Press, tel. 1-800-624-6242; $44.00 plus $4.50 shipping for single copies).

The committee was chaired by Lawrence Gostin, professor of law, Georgetown University Law Center, Washington, D.C. 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.

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Copyright 2006 by the National Academy of Sciences