The letter, jointly authored by the leadership of the Council on Governmental Relations (COGR), Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and the Association of American Medical Colleges (AAMC), addresses the National Institutes of Health (NIH) concerning the impending implementation of the NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research, which is set to take effect on May 25, 2017. The organizations request a one-year extension of the policy’s implementation, extending the compliance deadline to May 25, 2018, citing the complex logistical, administrative, and financial challenges institutions face in transitioning to the new requirements. They highlight deficiencies in current guidance, particularly around costing and budgeting for IRB-related expenses, and emphasize uncertainties about the infrastructure and operational changes needed, including IT upgrades and personnel adjustments.
The letter notes that proposed changes to federal human subject protection policies (the Common Rule) provide institutions with a longer adjustment period, contrasting with the NIH’s relatively short 11-month implementation window. The authors express concern that many details, specifically regarding cost recovery and budgeting within NIH grant proposals, remain unresolved. They urge NIH to clarify guidance on allowable costs, consider providing additional funding or IT infrastructure grants to support compliance, and discuss mechanisms to prevent a reduction in funds available for actual research. The signatories underline that these unresolved issues hinder institutions’ ability to make informed decisions about whether to serve as reviewing IRBs or to rely on commercial IRBs, as well as how to manage associated costs and logistical complexities. Ultimately, they stress the need for a deliberate and well-resourced transition to ensure successful and effective implementation of the sIRB policy.
