Utilizing the traditional IRB review process—individual IRB approval at each study site—has been shown to be duplicative; cause significant delays in study initiation; and result in varying IRB determinations across study sites. In response, the National Institutes of Health and the Department of Health and Human Services in 2016 and 2017, respectively, released new policies requiring the use of a single IRB review for multi-site studies.
In alignment with the recent policy changes, the Trial Innovation Network established three Network Central IRBs (CIRBs): Johns Hopkins University School of Medicine, The University of Utah, and Vanderbilt University Medical Center. The CIRBs are charged with promoting faster, more consistent IRB determinations for multi-site studies, as well as developing shared CIRB processes, tools and operating guidelines for investigators and institutions implementing single IRB review. The Network CIRBs are a vanguard in using the SMART IRB Authorization Agreement and will leverage the current SMART IRB efforts to onboard all the CTSA Programs to the SMART IRB reliance agreement.
The Trial Innovation Network CIRBs are piloting processes and tools on early-phase Network projects to gain firsthand knowledge about how to improve and innovate the CIRB System.
Development is currently underway, and key documents are provided here to ensure that CTSA Program Hubs and study teams are up-to-date on the latest processes and instructions for using the CIRB System. These documents will change and improved overtime, and updates will be announced and described on this page.
[This section will include dated announcements about changes, new features, etc.]
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