An institution that intends to conduct HHS-supported research involving prisoners as subjects must certify that an IRB has made the seven (7) 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).
On July 31, 2020 the Office for Human Research Protections (OHRP) released a new Subpart C Certification Submission Form. This form is intended to standardize the information submitted by institutions and reduce administrative delays caused by insufficient submissions. The institution must send OHRP a completed Subpart C Certification Form (OHRP encourages the electronic submission of such requests), which includes the name and address of the institution and the relevant grant number.
Institutions should submit the completed form as part of a Subpart C certification request for the inclusion of prisoners in HHS conducted or supported research, along with other required materials.
The Subpart C Certification Submission Form is approved for use through July 31, 2023, under Control Number 0990-047. If you have questions regarding the certification process for your research, please contact Pearl IRB today.