late on what that movement means. For example, an inmate’s trip to a medical clinic that is investigating acquired immune deficiency syndrome (AIDS) or hepatitis C makes quite clear what the inmate’s visit portends.

Third, ethical research involves ensuring, as a prerequisite for research, that the standard of medical health care available in the correctional setting permits the inmate to have a meaningful choice between the existing care that is available and the experimental intervention. In addition, other matters that generally are not complex issues in research outside of correctional settings appear as ethical dilemmas in the prison or jail. For example, in a correctional setting it may be difficult to distinguish between a refusal of care and a denial of care. Likewise, there can be difficulties in distinguishing between compliance and noncompliance in the research protocol. For example, if an inmate does not appear for a scheduled research meeting, which may also provide access to health care, it may not be clear whether the inmate has (1) decided not to come, (2) been barred or precluded from coming, (3) been taken to court for an unanticipated appearance, or (4) been presented with an unscheduled family visit.

These concerns are readily apparent in the context of research involving prisoners. However, what about questions of justice and fairness? How much of the burden of research should prisoners be asked to bear? How many of the potential benefits of research will be directed toward the prisoners? The acne medication Retin-A was basically developed in the Philadelphia prison system, with serious harms and few benefits afforded the prisoners who were involved in the research (Hornblum, 1998). Alternatively, many inmates would choose to live and work in a research unit if they could, regardless of the risks and benefits associated with research participation. Should that be encouraged, permitted, or, as it is now, barred from the prison setting? What if the burdens of research are actually experienced by inmates as benefits to be coveted in the deprived and stark setting of the prison? Should that overcome the current stance of the regulations in the U.S. Department of Health and Human Services (DHHS, 2005a) 45 C.F.R. Part 46 (see Appendix D)?

WHY NOW?

In response to a request from the Office for Human Research Protections (OHRP), the Institute of Medicine (IOM) formed the Committee on Ethical Considerations for Protection of Prisoners Involved in Research to address ethical considerations for protecting prisoners involved in research. The broad purpose was to examine whether the conclusions reached in 1976 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (see Appendix B) remain appropriate today. The national commission’s report (NCPHSBBR, 1976) was the basis



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