threats. In doing so, the committee considered (1) alternative conceptual frameworks for defining and reviewing permissible research with prisoners; (2) the substantial variability in threats to ethical research (e.g., the potential and likelihood for coerced participation; the degree of openness to outside review, and remediation of emergent research-related problems) across the expanded array of research settings (i.e., community settings as well as traditional institutions); (3) differing types and magnitudes of potential risks posed by specific types of research (i.e., biomedical as distinct from social/behavioral); and (4) specific safeguards related to research design and implementation monitoring that might facilitate safe and ethical research across these diverse settings.

To correct the inadequacies and lack of complete coverage of current regulations, as described in Chapter 3, the systems recommended by the committee are meant to apply to all research with prisoners to ensure that the same protections are afforded to every prisoner-subject. Prisoner-subjects are currently being enrolled in a broad spectrum of research on various topics at many different institutions and by many different researchers. To achieve the objective of adequately protecting prisoner-subjects, the system of oversight must cover all research involving this vulnerable population regardless of the funding source, the federal-wide assurance (FWA) status of the institution conducting the research, the correctional setting in which the research will take place, or the type of research being conducted. Additionally, the oversight system should cover research involving individuals meeting the definition of prisoner set forth in Chapter 4, which includes persons at all custody levels, from those who reside in prisons or jails to those who are under supervision in detention centers or other types of community placements.

DEFINING AND REVIEWING PRISONER RESEARCH

For the tasks of defining and reviewing permissible research with prisoners, the committee considered the current framework of the U.S. Department of Health and Human Services (DHHS) regulations at 45 C.F.R. Part 46 Subpart C (Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects).1 This regulation requires that a duly constituted institutional review board (IRB), with at least one prisoner representative as a voting member, review and approve the study, with consideration of the special circumstances inherent in conducting the research with prisoner-subjects. Subpart C defines permitted research using a combination of substantive research categories and risk levels and for certain

1

Revised November 13, 2001.



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