ABOUT CARE-Q

Mission

To build an effective, straight-forward, collegial, member-driven process that certifies the operational quality of human research ethics committees;

Target

Institutional Review Boards / Human Research Protection Programs

Goals

  • Support the practical application of the human research regulations
  • Ensure policies and procedures are consistent with regulatory requirements
  • Strengthen the institution’s IRB/HRPP quality assurance oversight

Founders

University of California; Stanford University

Overview

Anyone familiar with IRB operations in the US is aware of the great inconsistencies across institutions in how federal human research regulations and guidance documents are implemented.  One way to harmonize institutional practices is to ensure that each IRB follows a set of formalized or standard written procedures that are based on federal regulations and guidance documents, and that are used to guide their day-to-day operational and decision-making processes.

The IRB leadership at the University of California and Stanford University have worked together to develop CARE-Q – a program that systematically reviews the policies, procedures, and operations of institutions’ IRB offices, identifies each IRB’s strengths and weaknesses, and formally certifies those that are in compliance with federal regulations and policies. 

CARE-Q – the Consortium for Applied Research Ethics Quality – is a member-driven, peer review program that has 3 major components:

  • Reviews the IRB’s written materials to ensure that they are consistent with the Guidance on Institutional Review Board Written Procedures developed by the Office of Human Research Protections and the Food and Drug Administration.
  • Conducts a site visit that observes 1 or more IRB Committee meetings, follows the course of selected IRB submissions in a stepwise fashion from the point of entry to final approval, and meets with office personnel to obtain first-hand information on specific processes (e.g., administrative or ‘expedited’ reviews; reliance agreements).
  • Supports ongoing engagement activities in which Consortium members participate in periodic webinars and other educational programs that permit the ready exchange of best practices and new information in a collegial manner.

Value

  • Cost-effective way for institutions to ensure that their IRB office has been systematically reviewed and found to meet current federal standards. 
  • Provides an interactive peer network comprised of Consortium members who can serve as sources for best practices as well as support the continuing quality improvement of all members.
  • Provides foundation for reliance relationships.
  • Innovation, flexibility and excellence are encouraged.

care-q.org