Using a single institutional review board (sIRB) for multisite trials can improve the quality and efficiency of multicenter clinical trials—and beginning Jan. 25, 2018, the National Institutes of Health (NIH) is requiring use of an sIRB for NIH-funded multicenter clinical research.
To help drive adoption of sIRB review, CTTI has developed several recommendations, resources, and tools for use by the research community, and recently convened an expert meeting to discuss further actions that CTTI, the U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and NIH can take to ease the transition. The expert meeting included representatives from academia, government agencies, IRBs, pharmaceutical and device companies, contract research organizations, and patient groups, with the goal of identifying remaining gaps in knowledge and potential solutions to implementing a sIRB model.
Meeting participants highlighted the need for clarity around language and procedures, and emphasized that early collaboration among parties can mitigate the challenges. Participants felt that the time is right to learn from each other by sharing successful models of sIRB review among the private sector, academia, and government research organizations. Next steps from CTTI will involve new projects and committees to develop additional supportive tools and strategies for implementing sIRB review.