What materials and information should be sent to OHRP for certification of research involving prisoners?

The institution's certification must indicate that the IRB reviewed the research under subpart C and made the seven findings as required by the regulations (45 CFR 46.305(a)). Under its authority at 45 CFR 46.115(b), OHRP also requires the responsible institution to submit a copy of the research proposal so OHRP can determine whether the proposed research involves one of the categories of research permissible under 45 CFR 46.306(a)(2), and if so, which one. The term “research proposal” includes: • the IRB-approved protocol;any relevant HHS grant application or proposal; • any IRB application forms required by the IRB; • and any other information requested or required by the IRB to be considered during initial IRB review.

OHRP also encourages the institution to include the following information in its prisoner research certification letter to facilitate processing: • the OHRP Federalwide Assurance (FWA) number; • the IRB registration number for the designated IRB; and • the date(s) of ...

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