Subpart C Research Certification Form

The Office for Human Research Protections (OHRP) is requesting a three-year extension of OMB No. 0990-0473, the HHS Subpart C Research Certification Form, currently approved through July 31, 2023. This information collection request includes three new information elements (Name(s) of Institutions Relying on the IRB of Record; Program Officer’s Email Address; and the IRB Determination Regarding the Risk Level of the Study) and clarification in two information elements (Name and address of the IRB of Record Institution; and Contact information for the IRB of record) on the current Subpart C Research Certification Form. The purpose of the Subpart C Research Certification Form is to provide a simplified, standardized procedure for institutions to submit subpart C research certifications to OHRP in order to meet the regulatory requirements for including prisoners in non-exempt human subjects research that is conducted or supported by HHS. The form also simplifies the internal process used by OHRP to review and record such certifications, resulting in faster processing while reducing unnecessary and burdensome staff time. Respondents for this information collection are institutions or organizations which operate the IRB of record that approved the research, or the non-institutional IRBs that serve as the IRB of record.

The latest form for Subpart C Research Certification Form expires 2026-10-31 and can be found here.

Subpart C Research Certification Form

Federal Enterprise Architecture: Health - Health Care Services

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