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Prisoner Research Certification

How to Prepare a Prisoner Certification Letter to OHRP

An 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.  OHRP encourages the electronic submission of Subpart C certifications requests.  Requests should be sent to subpartc@hhs.gov

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:

  • 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:

  • OHRP Assurance #
  • IRB # for Designated IRB
  • Date(s) of IRB Meeting(s) in which protocol was considered, including a brief chronology that encompasses:
    • Date of initial IRB review
    • Date of Subpart C review

Epidemiological Waiver [PDF - 41KB]

For questions related to prisoners in research, please contact Julia Gorey, or via phone at 240-453-8141.

Content created by Office for Human Research Protections
Content last reviewed on March 18, 2016