1 | Application

  • Describe the Institution’s IRB operations
  • Summarize its key characteristics
  • Review and complete the ‘Terms of Application’ and ‘Terms of Membership’

2 | IRB Written Procedures Self-Assessment

  • Complete the IRB Written Procedures Self-Assessment*
    • CARE-Q Review Team will review along with the Institution’s IRB standard operating procedures and other documentation (e.g., guidance documents, website) to evaluate Institution’s compliance with OHRP/FDA regulations

 3 | Institutional Visit & IRB meeting observation conducted by CARE-Q Review Team

  • Interviews with key stakeholders (e.g., IRB staff, IRB Chairs and Members, Researchers & Institutional Officials)
  • Observation of at least one IRB meeting
  • Follow the ‘lifecycle’ of several IRB applications from submission to approval
  • Review another subset of IRB files

*Adapted from the OHRP/FDA Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (May 2018)

After the Visit

After the Visit


  • Five-year term
    • Recertification
  • Requirement to Submit Annual Report
    • IRB portfolio, IRB metrics
  • Ongoing CARE-Q Member Engagement | 3X/Year
    • Foster efficiency, share best practices & address issues of common interest
  • Contribution of Reviewers
    • Provide qualified senior staff to participate as Review Team Members
  • Dedicated In-Person IRB Evaluation Visit
    • IRBs with 4+ registered IRBs require 1/3 of IRBs assessed within a membership term |