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.

 

CIRB System Materials

 

  • CIRB Workflow: an over of how the CIRB processes is established for each study.
  • IRB Guidance Documents:
    • SMART IRB reliance agreement (here)
    • SMART IRB Addendum Template (here)
    • SMART IRB Exchange (here)
    • Consent form guidance (here)
    • HIPAA guidance (here)
    • Local Context Review Guidance (here)
    • COI guidance (under development)
    • Personnel Changes Guidance (under development)
    • Problem Reporting Guidance (under development)
    • QI Monitoring Plan Guidance (under development)
  • Investigator and Study Team Materials:
    • Initiating the CIRB process as the Lead Site investigator (here)
    • CIRB Workflow Guidance (under development)
    • Finalizing a Protocol for CIRB Review Guidance (under development)
    • Amendment and Annual Review Guidance (under development)

CIRB  System Announcements

[This section will include dated announcements about changes, new features, etc.]