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