The letter, jointly authored by the Association of American Medical Colleges, Association of American Universities, Association of Public and Land-grant Universities, and the Council on Governmental Relations, addresses concerns regarding the interpretation and implementation of compliance dates for cooperative research under the revised Common Rule. The organizations express particular unease about recent communications from the Office for Human Research Protections (OHRP) suggesting that ongoing cooperative research approved after January 21, 2019, but before January 20, 2020, would need to be paused, identified, and transitioned to a single Institutional Review Board (IRB) review as of the 2020 compliance date. The letter argues that this interpretation is contrary to the preamble’s stated purpose of providing a transitional phase for adjustment to the new requirements, noting that no previous public guidance or presentations had indicated that already-approved multisite studies would require such a transition.
The authors contend that enforcing this interpretation would create unnecessary administrative burden, increase costs, and disrupt federally funded research without advancing participant protections. They urge the OHRP and related agencies to issue clear and timely guidance clarifying that studies approved by multiple IRBs prior to the cooperative research compliance date are not subject to retroactive single IRB requirements. The letter further references a provision in the rule allowing federal agencies to exempt certain research from the single IRB mandate where it is deemed inappropriate, and suggests issuing a formal statement to that effect for impacted studies. The organizations reiterate their commitment to collaborative discussion and stress that prompt clarification is necessary to support compliance and minimize negative impacts on the research enterprise.
