THE PROCESS

 

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

Certification

• 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