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Value of CARE-Q Evaluation & Certification

  • Ensures that the IRB’s standard operating procedures follow current regulations and guidance – i.e., are complete, accurate, comprehensible and readily available to both staff and researchers
  • Determines whether the IRB office workflow is optimally efficient, and suggests improving those processes consistent with the institution’s needs and resource
  • Increases the likelihood that the rights and welfare of human subjects are being protected because CARE-Q provides external, independent evidence that the institution’s IRB has developed, and has implemented, clear written procedures as recommended by OHRP and FDA
  • Provides documentation for research sponsors and other research institutions that the IRB office complies with current regulatory requirements
  • Provides documentation for reliance purposes (e.g., SMART IRB agreement) that the IRB has undergone an assessment of quality
  • Integrates each CARE-Q certified institution into a collegial peer network with periodic educational programs and opportunities to address questions together