• for research on new therapies or preventive measures, there is already some evidence of safety and efficacy, as in Phase 3 testing for new drugs, as defined by the FDA; and

  • the ratio of prisoner to nonprisoner subjects does not exceed 50 percent.

  1. In exceptional circumstances, a biomedical research study may be ethically acceptable even if the benefit of an intervention has not been completely established, or if the research population is disproportionately comprised of prisoners. These two criteria may be waived if the research addresses a condition or behavior that is solely or almost exclusively found in incarcerated populations (e.g., repetitive sexual assaults). Studies of this nature could only proceed, however, with a federal-level review. The protocol must be submitted to a national, specially convened panel of experts, who, in a public process, consider the ethical acceptability of a particular protocol and make recommendations to the responsible government authority (OHRP) regarding the special circumstances that do or do not provide a basis for research and the safeguards that must apply. This review would be very similar to the process outlined under Subpart D (45 C.F.R. § 46.407) that requires DHHS secretarial consultation for studies that are not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of prisoners (rather than children), except that the panel of experts could be convened by an entity outside DHHS if appropriate.

This approach comports with the committee’s risk-benefit approach. Given the history of and continued potential for prisoner exploitation, biomedical research should be permitted only if there is a strongly favorable benefit-risk ratio for the prisoner. The distribution of burdens should also be considered, thus the requirement that at least half of the research subjects must come from nonprisoner populations. Research should only involve prisoners to provide a benefit to prisoners, not because they are a convenient source of subjects. This approach would enable fair distribution of potential benefits and burdens to prisoners.

To provide extra protections in the area of biomedical intervention research, which likely carries the greatest risks for subjects, the only benefits that should be considered are the benefits to the subjects themselves. Benefits to prisoners as a class are not a strong enough justification for a biomedical intervention study to proceed. These biomedical inquiries may include drug studies and surgical, radiological, or any interventional study in which the outcome of the biomedical intervention is the question of interest.

There may be research proposals, most likely within social/behavioral

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