Are there additional regulatory considerations for research involving prisoners?
Yes. In addition to the requirements of subpart A, subpart C of the HHS regulations at 45 CFR part 46 identifies more requirements for research involving prisoners. In summary, the major additional considerations are: • the exemptions that generally apply to certain types of research involving human subjects do not apply to research involving prisoners (45 CFR 46.101, footnote 1); • in order to approve research involving prisoners, the IRB must find that the proposed research falls into one of the permissible categories of research, and make six other findings; • the institution must certify to OHRP that an IRB has reviewed the proposal and made seven required findings, and receive OHRP authorization prior to initiating any research involving prisoners; (45 CFR 46.305(c)) • the IRB must include a prisoner or prisoner representative, (45 CFR 46.304(b)) and meet a membership requirement concerning the number of IRB members not associated with a prison involved in the research; (45 CFR 46
