If multiple institutions are engaged in the same research study involving prisoners, do all institutions need to certify to OHRP?
Each institution engaged in a multicenter research study involving prisoners must certify to OHRP in accordance with the requirements of HHS regulations at 45 CFR 46.305(c) and 46.306(a)(1), unless (a) an institution relied upon the review of an IRB operated by another institution engaged in the research; and (b) that IRB or the other institution certified to OHRP on behalf of both institutions.
Related Questions
- If multiple institutions are engaged in the same research study involving prisoners, do all institutions need to certify to OHRP?
- If a study involving prisoners previously authorized by OHRP is amended, does the institution need to recertify?
- What happens if an IRB chooses the wrong category of research involving prisoners in its certification to OHRP?
