The Council on Governmental Relations (COGR), representing over 190 research-focused institutions, submitted comments regarding the Interim Final Rule that delayed the revisions to the Federal Policy for the Protection of Human Subjects, also known as the Common Rule. COGR expressed concern that the last-minute postponement of both the effective and compliance dates created significant challenges for institutions that had worked to prepare for timely implementation of the revised rule. They advocated for a decoupling of the effective and compliance dates, suggesting that while the effective date should remain July 19, 2018, the compliance date should be set to July 19, 2019. COGR argued that this approach would give institutions flexibility to implement certain provisions while allowing time for essential guidance to be developed with community input, particularly on complex issues such as excluding certain activities from the Common Rule and expanding exempt research activities.
COGR emphasized that timely and collaborative development of guidance from the Office for Human Research Protections (OHRP) would facilitate smoother transitions for research institutions and enhance compliance with the new requirements. They suggested prioritizing the creation of guidance on key aspects, including benign behavioral interventions, limited IRB review, and data security criteria, to support effective and practical implementation. Overall, COGR’s recommendations aim to balance regulatory compliance with institutional readiness, ensuring that research activities involving human subjects continue without unnecessary administrative disruption while safeguarding participant protections.
