Collegial, Peer-Driven IRB Quality Assurance
CARE-Q was developed by the University of California and Stanford University to provide external, independent evaluation of IRB offices. Our goal is to assure that each IRB office has clearly written procedures for human research participant protection that conform to regulatory requirements and are being followed consistently.
Overview
Read an introductory overview about CARE-Q's history and objectives.
CARE-Q Application Process
The CARE-Q process includes a self-assessment by the applicant IRB office followed by an assessment visit from the CARE-Q review team. The process ends with a written summary of the IRB office strengths and weaknesses, suggestions for improvement, and if appropriate, a recommendation for formal certification.
Self-Assessment
To begin the process, the applicant completes a written procedures self-assessment (Form A) based on the checklist incorporated in the OHRP/FDA Written Procedures Guidance for Institutions and IRBs.
Review Team Visit
A team of qualified IRB professionals initiates a 2-3 day assessment visit, including convened IRB committee meeting observation(s) and discussions with IRB staff, researchers, IRB members, and other key stakeholders.
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