The institution responsible for conducting research involving prisoners that is supported by DHHS shall certify to the Secretary through the Office of Human Research Protections (OHRP) that the IRB has made the seven findings required under the regualations (45 CFR 46.305(a)). The institution must send to OHRP a certification letter to this effect, which should also include the name and address of the institution and specifically identify the research protocol in question and any relevant DHHS grant application or protocol. DHHS conducted or supported research involving prisoners as subjects may not proceed until OHRP issues its approval in writing to the institution on behalf of the Secretary under 45 CFR 46.306(a)(2).

Under its authority at 45 CFR 46.115(b), OHRP requires that the institution responsible for the conduct of the proposed research also submit to OHRP a copy of the research proposal so that 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.