Subpart C Certification Request 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) or meets the criteria for the Epidemiological Waiver. Epidemiological Waiver. To send a subpart C certification request to OHRP, the institution must submit this submission form: https://oash.force.com/ohrpwebforms/s/prisoner-web-form in conjunction with a copy of the research proposal. The term “research proposal” includes:

• the IRB-approved protocol, including consent forms;
• any IRB application forms required by the IRB; and
• any other information requested or required by the IRB to be considered during IRB review.

Note: If an IRB considers the grant application during its review of the study, only submit portions of the grant application relevant to subpart C review.

Questions regarding Subpart C and certification should be sent to subpartc@hhs.gov