The subcommittee recommended that a modified Subpart A analysis apply when a subject who is enrolled in a study may not be fully within the definition of the term prisoner for the duration of the study. First, the subcommittee affirmed that the interpretation of prisoner should remain defined by the words of the regulation and not expanded to include other subjects whose liberty is restricted, such as those in community correctional facilities or on probation or parole. Although those subjects deserve heightened protection, the subcommittee recommended that the DHHS rely on Subpart A’s protections for subjects “vulnerable to coercion or undue influence” without including those subjects as prisoners under Subpart C. Likewise, when a subject is incarcerated after becoming enrolled in a study, the concerns about coercion and undue influence are not as great; at the same time, it may be difficult to modify the research protocol to comply with Subpart C. Therefore, the subcommittee suggested that Subpart A’s general requirement of heightened protection apply instead. The subcommittee recommended that an IRB should review a researcher’s request to continue the research when a subject subsequently becomes incarcerated, taking into account the new conditions of incarceration but without fully engaging in a new Subpart C approval process.
The subcommittee discussed a variety of problems with identifying a representative who would be skilled and knowledgeable enough to be effective but not so unlike the rest of the IRB as to be marginalized. The subcommittee recommended that the Office of Human Research Protections (OHRP) assist IRBs in searching for an appropriate prisoner representative, which might include family members of prisoners, former prisoners (especially people in recovery from substance addiction who have also had experience as prisoners), and service providers who assist in the correctional process. It was recommended that the OHRP should provide functional criteria that might help IRBs (and investigators, who are also responsible for the composition of an IRB that will properly evaluate ethical issues) identify persons who can be an effective voice for prisoners within the IRB. With respect to multisite studies, the subcommittee recommended that, although Subpart C only requires one prisoner representative on a central IRB for multisite research, the IRB must nevertheless consider the individual circumstances of each prison site, which can vary widely. In addition, with respect to expedited review, the subcommittee recommended that, if expedited review of a protocol is required, a prisoner representative should be one of the reviewers.