Learn More about CARE-Q Certification

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

Who should consider certification?

IRB offices that have not recently undergone a complete review of their policies and procedures will derive significant benefit from this comprehensive review and ongoing engagement with IRB colleagues at peer institutions. Additionally, IRB offices planning to sign on to SMART IRB or an updated version of the SMART IRB agreement can undergo CARE-Q certification to meet the SMART IRB requirement for quality assessment.

We can accept applications from any organization. Email us at info@care-q.org to discuss your organization's interest.

Cost Considerations

Each institution will make qualified senior staff available to conduct at least two reviews of other applicant institutions as in-kind effort. On-going engagement and participation in Consortium activities is required in accordance with membership agreement. The first annual fee is one year following certification.

*A large program is defined as an NIH Clinical & Translational Science Award Hub or NCI Designated Cancer Center

Responsibilities of Certified IRB Offices

Recertification is required every 5 years
A brief report summarizing IRB metrics and any substantive changes to policies or procedures must be submitted annually
Each certified office is expected to provide qualified senior staff to participate as a CARE-Q review team member, to have a presence at the monthly CARE-Q executive meetings and to actively participate in our ongoing CARE-Q member engagement webinars.

Certified Institutions

These IRB offices have successfully completed CARE-Q certification. The links for each certified site take you to the institution's procedures, guidance documents, or other resources.