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Ohio CTSAs Implement a Reliant IRB Model for Investigator‐Initiated Multicenter Clinical Trials

Effective clinical and translational research is an essential component of improving human health as delineated in the National Institutes of Health (NIH) roadmap, 1,2 yet efficiently conducting that research remains problematic. 3,4 Challenges include the high costs of conducting research, a shortage of qualified investigators, 5 low subject enrollment rates, 6,7 slow dissemination of results, 8 reduced funding, 3 lagging IT systems, 9 and increased regulatory burden. 10,11 A priority for the National Center for the Advancement of Translational Science (NCATS), and its Clinical Translational Science Award (CTSA) Consortium, is to address this last concern regarding regulatory burden. Specifically the focus is on the improvement of Institutional Review Board (IRB) processes; especially novel models for regulatory review of multicenter clinical and translational research studies. The three Ohio CTSA sites, housed at Case Western Reserve University (CWRU) in Cleveland, The Ohio State University (OSU) in Columbus, and the University of Cincinnati (UC), have collaborated to create a novel IRB review concept with the hopes of addressing this concern and achieving a more effective and efficient IRB review of multicentered clinical research studies.