quires secretarial review and expert panel consideration. The subcommittee’s view is that, because the participant receives the standard of care and does ultimately benefit from the results of the research, even if not immediately, such a control arm should not require heightened review. The subcommittee recommended that only when the control group is placebo only (and thus deviating from the standard of care) should the protocol be considered to include an arm not benefiting from the research.

The subcommittee also pointed out the problems with the jurisdiction of Subpart C. Because it has been adopted by so few agencies, it has limited application to federally funded research. In addition, it does not automatically apply to institutions that have signed an FWA unless they specifically request that it be part of their obligation. Because of these two enormous gaps in coverage, most research involving prisoners does not fall under the special protections of Subpart C.

Recommendations for Further Consideration by the IOM

In addition to its recommendations on these issues, the subcommittee noted with approval that the IOM had been charged with studying the human research protections for prisoners. The subcommittee recommended the IOM committee’s consideration of:

  • the need for a requirement that research only be conducted in prisons providing standard of care to the general population (and how best to get such services in place);

  • the interpretation of the requirement that follow-up care be provided when the prisoner has been released from confinement; and

  • the limited jurisdiction of Subpart C (i.e., to DHHS-supported research only).


The full panoply of DHHS protections for prisoners in Subpart C presently apply only to research funded by the DHHS, the CIA, and the SSA. Some of the other 14 departments and agencies that have adopted the Common Rule accept the OHRP-approved FWA as assurance of compliance with ethical regulations regarding human research subjects. However, those departments and agencies have not adopted Subpart C, so the assurance will only require certification of compliance with the Common Rule (Subpart A).25 Although institutions holding an FWA and engaging in re-


One exception is the Department of Education, which has adopted Subpart D but has not adopted Subparts B or C of the DHHS regulations.

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