The document outlines the implementation of the NIH Single Institutional Review Board (sIRB) Policy for multi-site studies, as discussed in a 2017 panel at the Council on Governmental Relations meeting. The policy requires that domestic sites participating in NIH-funded, non-exempt multi-site studies using the same protocol must designate a single IRB of record, enhancing consistency and streamlining ethical review processes. Applicants are required to submit a comprehensive sIRB plan with their grant application, detailing the selection of the IRB, adherence procedures, communication strategies, and anticipated reliance agreements; although these formal agreements and IRB approvals can be finalized after the award is made, initiation of human subjects research is restricted until all are in place. The panel discussed the scope, costing mechanisms, legal exceptions, and practical challenges of this policy, emphasizing the balance between direct and indirect costs, workflow integration, and resource allocation, as well as institutional readiness and communication.
The discussion included perspectives from leading research institutions, each addressing unique implementation strategies, staffing adaptations, and the complexities of budgeting sIRB-related expenses. Major themes included the decision process between using local versus commercial IRBs, the impact on institutional operations, and challenges in harmonizing reliance agreements and cost recovery models. Commercial IRB providers like WIRB (Western Institutional Review Board) were highlighted for their robust infrastructure, regulatory compliance, and the ability to facilitate rapid, coordinated review across institutions. Exception criteria were discussed, particularly in cases involving conflicting state, federal, or tribal laws, and the nuanced approach NIH will take to granting policy exceptions. The meeting underscored the significant operational, cultural, and administrative adjustments necessitated by the sIRB mandate, and the ongoing need for clear guidance and collaboration among participating research sites to ensure compliance and maintain research efficiency.
