researcher’s request to continue the research when an individual 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 OHRP should 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. 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. With respect to expedited review, the subcommittee recommended that, if expedited review of a protocol is required, a prisoner representative be one of the reviewers.
The subcommittee considered two issues regarding the distinction between using other healthy prisoners as the ethical baseline as opposed to other healthy persons generally. First, the subcommittee affirmed that the different definition of minimal risk in the Subpart C regulations compared with Subpart A regulations was appropriate. The Subpart C regulations specify that the determination of minimal risk must be in comparison to the ordinary experience of a healthy person, interpreted as meaning a healthy person outside the prison environment. The subcommittee cautioned that the greater situational risk in the prison setting should not influence the baseline for the IRB’s decision; rather, the minimal risk should be compared with the risk to a healthy person in a safe environment. The OHRP should provide guidance, using examples, of how the minimal risk might be viewed in different protocols.
At the same time, the subcommittee viewed the current OHRP interpretation of when a protocol does not provide a benefit to the participant as overly restrictive. The OHRP’s position is that using standard of care as a control arm does not provide any benefit to the participant and thus re-