IRB: Ethics & Human Research

A Federated Model of IRB Review for Multisite Studies: A Report on the National Children’s Study Federated IRB Initiative

When institutional review boards (IRBs) review protocols for multisite studies, the default practice is for iterative, often sequential independent reviews to take place by an IRB at each site engaged in the same study. This approach is criticized for being inefficient and costly, for adding unnecessary variation to the IRB review process, and for generally not adding meaningful protections for study participants. The National Children’s Study has implemented an innovative approach to centralized IRB review of multisite studies, a federated model of IRB review, and is currently piloting and evaluating this model. The federated model incorporates three options for IRB review of multisite studies: 1) reliance on a lead IRB, 2) shared IRB review, and 3) local IRB review at each study site with access to IRB submissions approved by a lead IRB. All options include a commitment to sharing IRB submissions and determinations among study sites. The federated model incorporates a mechanism for establishing a shared set of principles, processes, and performance metrics for the review of protocols at participating institutions. The model gives institutions maximum flexibility to choose an IRB review process and reduces the potential for duplicative review of protocols by IRBs across sites.

Slutsman J, Hirschfeld S. A federated model of IRB review for multisite studies: A report on the National Children’s Study federated IRB initiative. IRB: Ethics & Human Research 2014;36(6):1-6.