Process

Contact us at info@care-q.org to ensure that your institution is eligible and that CARE-Q is a good fit for your office.  After discussing your interest, we will provide you with the CARE-Q terms of membership and CARE-Q application form.  Once CARE-Q receives your application, you will complete the IRB written procedures self-assessment (Form A) while you:

• Review your current policies and procedures, identifying any gaps and revising or developing new procedures, if needed, to address all items in the self-assessment*
• Ensure that all IRB-related materials on your web site are internally consistent and accurately reflect your policies and procedures
• Respond to each of the required items in the self-assessment form by identifying the sections of your supporting documents that address the item, and include a reference to that item for the CARE-Q reviewer.
• Compile copies of all supporting documents into an indexed PDF for submission to CARE-Q

*Consider reviewing materials developed by other successful applicants (see Resources) and you may also contact CARE-Q for a preliminary review of your application, as needed.

CARE-Q enlists a team of 3 experienced, qualified reviewers from the members of the CARE-Q community, including those from CARE-Q certified institutions.  Review team members independently review the Form A and all submitted materials.  The review team meets to evaluate the submission, reviewing SOPs, IRB-prepared guidance documents, and web-based materials, to ensure it is accurate, complete, and readable.  Written feedback is provided, as needed, to ensure all materials comply with OHRP/FDA regulations.  The applicant responds to the written feedback and provides any necessary revisions. 

The review team then performs a site assessment visit over a 2-3 days period.  The site assessment includes:

• Individual and/or group interviews with key stakeholders, including IRB staff, IRB chairs and members, researchers, and other institutional personnel, as appropriate
• Observation of at least one IRB convened committee meeting, followed by discussion with board members.  For 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 with a focus on the multiple steps each protocol undergoes.
• A "closeout" discussion of findings with IRB office leadership, followed by a more formal written summary that details program strengths and weaknesses, with recommendations to improve processes. 

The final report is forwarded to the CARE-Q Board of Governors, who review all materials and make the final certification decision.