The Council on Governmental Relations (COGR), representing over 200 U.S. research universities and affiliated medical centers, submitted detailed feedback to the Office for Human Research Protections (OHRP) regarding the July 2022 draft guidance on the use of a Single Institutional Review Board (sIRB) for cooperative research. COGR commends the OHRP for addressing the complexities of sIRB implementation but emphasizes the need for further clarity and flexibility in the draft guidance. Their letter highlights the practical experiences of institutions since the sIRB mandate took effect, including reliance on platforms like SMART IRB, and encourages OHRP to recognize such models explicitly as compliant with federal requirements.
COGR requests the harmonization of OHRP’s guidance with that of other federal agencies to avoid conflicting requirements and calls for consideration of additional exceptions to the sIRB mandate—particularly for small, expedited studies, research involving substantial local variation, and ongoing longitudinal studies transitioned due to new funding. The letter also suggests clearer delineation of responsibilities between sIRBs and local Human Research Protection Programs (HRPPs), particularly concerning the identification and application of state and local laws, as well as local standards of care and community attitudes. COGR recommends that local HRPPs, rather than the sIRB, should primarily provide site-specific regulatory information, and that this partnership is essential for ensuring participant protections specific to local contexts. Overall, the organization stresses the importance of balancing the efficiencies of sIRB review with the need for meaningful consideration of local factors, and requests that OHRP revise its guidance to more fully reflect these operational and ethical realities.
