CARE-Q selects a team of 2 or 3 reviewers who are highly experienced IRB staff drawn from the members of the CARE-Q community – including those from CARE-Q certified institutions.
Team members independently review responses to items in the IRB written procedures self-assessment (Form A) and then, during a consensus conference, evaluate each response (including SOPs, IRB-prepared guidance documents, and web-based materials) for accuracy, completeness, and readability. Written feedback is provided, as needed, to ensure all materials comply with OHRP/FDA regulations.
Following the applicant’s response to this feedback, including revisions to the self-assessment document, a site assessment is scheduled by the review team.
The site assessment and IRB meeting observation are conducted over a 2 to 3 day period and include:
Individual and/or group interviews with key stakeholders, including IRB staff, IRB chairs and members, researchers, and other institutional officials, as appropriate
Observation of at least one IRB committee meeting, followed by discussion with board members. For those IRBs with 4 or more registered IRB Committees, a second committee must be observed prior to certification.
Examination of the ‘lifecycle’ of several types of IRB protocol submissions (e.g., pediatric; drug trial; observational research) from submission to approval. Our focus is on the multiple steps each protocol undergoes to identify potential problem areas
A ‘closeout’ discussion of findings with IRB office leadership; this is followed by a more formal written summary that details program strengths and weakness, and recommendations for improving processes. This final report is forwarded to the CARE-Q Board of Governors, who review all materials and make the final certification decision.
