Collegial, Peer-Reviewed IRB Quality Assurance
External, independent evaluation of IRB offices
CARE-Q was developed by 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 human research participant protection that conform to regulatory requirements and are being followed consistently.
Click below to read an introductory overview about CARE-Q's history and objectives
To prepare for CARE-Q certification, we held several sessions for both our staff and our IRB members to familiarize ourselves with newly revised policies and procedures. This prompted lively discussions to further improve the clarity of our policies and effectiveness of our program. We found the certification process to be a positive educational experience.
Participating in the CARE-Q HRPP interview process was a positive, friendly, and collegial experience. The interview was a conversation among colleagues and sparked a larger discussion surrounding quality improvement initiatives. The experience was both enriching and useful for our program.
The CARE-Q accreditation process is something that our Human Research Protections Program (HRPP) looked forward to. We already had HRPP policies in place, however some required updating per current practices and the accreditation process provided an opportunity to revisit these. Additionally, we revitalized some of our outdated website guidance and documents as a result. Using the CARE-Q provided checklist, our team completed the self-assessment process in a couple of months as a part-time project. During this process, CARE-Q helped us to re-phrase policy to read more accurately using succinct language. In addition, they provided feedback on and allowed us to showcase our very best work in stellar protocol review and unique protocol efficiencies. Isn't it the most meaningful feedback when it comes from those in the field, your peers? Perhaps their findings can be what you need to further elevate your HRPP. If you are looking for a quality assessment of your HRPP from kindhearted, well experienced people who know IRB regulations, CARE-Q is the answer!
The CARE-Q process of review and accreditation was an excellent opportunity for our team to organize, and trouble shoot our processes for potential regulatory assessments. By happenstance we were audited by the FDA shortly thereafter and went into the process feeling confident that we had re-reviewed our procedure documents and minutes, that our rosters were current and that our records were in good shape. Additionally, the accreditation and annual review credibly meets auditing requirements for SMART IRB (generic – national SIRB) participation. Lastly, participating as a CARE-Q auditor allows for additional insights into national best practices and keeps me informed.
Consortium for Applied Research Ethics-Quality (CARE-Q)
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