The document provides a detailed overview of the NIH Single Institutional Review Board (sIRB) policy, particularly focusing on its costing perspective as outlined by the Division of Grants Compliance and Oversight and the Office of Policy for Extramural Research Administration. Issued on June 21, 2016, and effective for applications submitted on or after September 25, 2017, the policy mandates the use of a single IRB for domestic sites participating in multi-site studies involving non-exempt human subjects research. Provisions for exceptions are included when compliance with sIRB review is barred by legal or policy constraints.
In terms of costing, the policy allows flexibility, permitting institutions to decide whether sIRB-related costs are treated as direct or indirect, as long as practices are consistent with federal cost principles and Uniform Guidance. Primary sIRB activities—such as ethical review of study protocols—can be charged as direct costs if appropriately distinguished from indirect costs and treated consistently across similar circumstances. The guidance assures that such charging practices do not require changes to accounting methods and have been validated by consultations with the Office of Management and Budget (OMB) and HHS Cost Allocation Services (CAS). Various implementation options are suggested, including fee structures, recharge or service center models, and the use of independent IRBs. The document concludes by providing resources and guidance notices to facilitate policy compliance and implementation.
