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Office for Human Research Protections (OHRP)PrisonersSee also OHRP Guidance on the Involvement of Prisoners in Research Prisoner Certification Letter to OHRPAn institution that intends to conduct HHS-supported research involving prisoners as subjects must certify to the Secretary (through OHRP) that the IRB has made the seven findings required under 45 CFR 46.305(a), including the finding that the proposed research represents one of the permissible categories of research under 45 CFR 46.306(a)(2). The institution must send OHRP a certification letter, to that effect, which should include the name and address of the institution and specific identification of the research protocol, including the relevant grant number. Under its authority at 45 CFR 46.115(b), OHRP requires the responsible institution to also submit to OHRP 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:
OHRP also encourages the institution to include the following information in its prisoner research certification letter, to facilitate processing:
Epidemiological Waiver [PDF - 41KB] For questions related to prisoners in research, please contact Julia Gorey, or at 240-453-8141. |
Last revised: December 12, 2007