The Consortium for Applied Research Ethics Quality (CARE-Q) is a quality assurance program developed at 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 protecting human research participants that accurately conform to regulatory requirements and are being followed consistently.

As part of the CARE-Q process, applicants complete a written procedures self-assessment (Form A) based on the checklist incorporated in the OHRP/FDA Written Procedures Guidance for Institutions and IRBs.  Following our initial review, we initiate a 2- to 3-day assessment visit that includes observation of one or more convened IRB committee meetings and discussions with office staff, board members, faculty researchers and other stakeholders.  To help identify inefficiencies, shortcomings and errors, the review team also track several types of IRB applications through the system – from the initial application to final approval.

This process ends with a written summary of the IRB office strengths and weaknesses, suggestions for improvement, and if appropriate, a recommendation for formal certification.

This CARE-Q Introductory Overview and CARE-Q FAQs provide more information about CARE-Q.

 

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Email CARE-Q at: info@care-q.org