Subpart C Research Certification Form

The Office for Human Research Protections (OHRP) is requesting approval of the Department of Health and Human Services (HHS) Subpart C Research Certification Form. This form will facilitate collection of information relevant to an institutional request for OHRP authorization of research involving prisoners; the information in the form will be entered into OHRP’s prisoner research database, and will be used by OHRP to draft a response certification letter back to the institution. This is a new information collection request. The respondents for this collection are institutions or organizations operating Institutional Review Boards (IRBs) that have approved enrollment, or are planning to approve enrollment, of prisoners in human subjects research conducted or supported by HHS.

The latest form for Subpart C Research Certification Form expires 2023-07-31 and can be found here.