U.S. Department of Health & Human Services
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Can subpart C be applied to research in anticipation of some subjects being or becoming prisoners?
Yes, if investigators anticipate that some of the subjects in a planned research study population are likely to be prisoners or become prisoners during the course of the study (for example, subjects in substance abuse treatment studies) the IRB may review the research prospectively for prisoner involvement in accordance with the requirements of subpart C of 45 CFR part 46. When an IRB reviews a research proposal in which the subjects are not prisoners, but in anticipation of the likelihood that some of the subjects will become prisoners during the course of the research, some of the seven findings required by 45 CFR 46.305(a) may not be applicable. As examples, if subjects are not recruited from within a prison, the finding under 45 CFR 46.305(a)(4) would not be applicable; and, if there is no particular parole board involved yet, the finding under 45 CFR 46.305(a)(6) would not be applicable. The IRB should document these findings accordingly, and must certify the research to OHRP. The IRB must wait for OHRP to authorize the research study prior to initiating any interaction or intervention with, or obtaining identifiable private information about, prisoners.
IRBs should use their discretion in deciding whether to apply the additional requirements of subpart C to research in anticipation of some subjects being or becoming prisoners. In some cases, the involvement of subjects who may be prisoners or become prisoners can be anticipated in ways that make the additional protections of subpart C meaningful. In other cases there may be insufficient information available at that time to make the seven findings required by 45 CFR 46.305(a) (for example, the IRB may not know the specific penal institutions where subjects will be prisoners and therefore will lack important information about the local research context), and the IRB may have to wait until more specific information becomes available. In these instances, the IRB would need to conduct the subpart C review after research subject(s) have become incarcerated.
Last Reviewed: 01/20/2011
Related Questions:
- Are there additional regulatory considerations for research involving prisoners?
- Can research involving prisoners be approved under expedited review?
- How do the regulations define “minimal risk” for research involving prisoners?
- Can informed consent be waived or altered in research involving prisoners?
- What happens if a human subject becomes a prisoner during the course of a research study?
