Frequently Asked Questions (FAQs)

Link to a PDF version

A quality assurance initiative for IRB programs developed by University of California and Stanford University

• Process is low-cost, peer-driven, collegial, and pragmatic
• Developed to satisfy SMART IRB quality assessment requirements
• Focused specifically on IRB regulations; no shadow or made-up requirements

• Ensure that IRB’s written procedures follow current regulatory requirements
• Ensure that IRBs follow their written procedures via IRB meeting observation
• Identify potential for greater efficiency in IRB office workflow
• Document compliance with regulatory requirements
• Document quality assessment for reliance purposes
• Receive a report on best practices recommendations
• Become integrated into a collegial peer network with continuing education and support
• Support regular engagement to learn how other institutions address common issues

IRB offices that have not recently undergone a complete review of  their policies and procedures will derive significant benefit from this  comprehensive review and ongoing engagement with IRB colleagues at peer  institutions. Additionally, IRB offices planning to sign on to SMART IRB or an updated version of the SMART IRB agreement can undergo CARE-Q certification to meet the SMART IRB requirement for quality assessment.

We can accept applications from any organization. Contact us to discuss your organization's interest.

Any IRB office is eligible to apply

Each CARE-Q certified institution will make qualified senior staff available to conduct at least two reviews of other applicant institutions as in-kind effort. On-going engagement and participation in Consortium activities is required in accordance with membership agreement. The first annual fee is one year following certification.

*A large program is defined as an NIH Clinical & Translational Science Award Hub or NCI Designated Cancer Center

View the table at the bottom of the page for a full cost breakdown.

• Contact the CARE-Q team at info@careq.org to discuss application
• Review CARE-Q membership terms and application for certification
• Submit signed membership agreement and application
• Complete CARE-Q Form A (written procedures self-assessment)
• Submit Form A with supporting documents

• CARE-Q selects a team of 2-3 reviewers from CARE-Q community and member institutions
• CARE-Q reviewers assess application, Form A, and documentation
  • May provide feedback and queries
• CARE-Q team initiates and conducts assessment visit
  • IRB meeting observation(s) and minutes review
  • Interviews with staff, IRB members, faculty, and other stakeholders
  • Review selected IRB applications
• CARE-Q team prepares report summarizing strengths, makes suggestions for improvement and if appropriate, provides recommendation to Board of Governors for certification
• CARE-Q Board of Governors reviews report and issues certification, if appropriate

The time it takes depends on a number of factors including the maturity of the IRB program and the sophistication and breadth of written procedures; typically this takes 6-12 months from the submission of the completed application

• IRB office is expected to participate in regular CARE-Q meetings and engagement workshops
• IRB office is expected to provide qualified staff for CARE-Q assessments as learning and sharing opportunities
• IRB office submits brief annual report to maintain certification
• IRB office re-certifies every 5 years which includes another program visit