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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.

Introductory Overview Slides

FAQs

Learn more about CARE-Q by reviewing the FAQs.

CARE-Q FAQs

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.

Sample Form A

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.

Sign up for CARE-Q Mailing List

Sign up to receive CARE-Q email updates to stay current on news about certified institutions, educational offerings, current job postings, and more.  Email CARE-Q if you have any questions.

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