The Qualification process is fully described in the CTO REB Qualification Manual (located on the Tools and Resources page); the process was designed to be transparent and educational for all involved.
The review is conducted by a Qualification Team consisting of an Auditor with specific training in reviewing REBs, a CTO representative, and two members from the CTO College of Reviewers who bring expertise from the research ethics community.
REBs wishing to undergo the Qualification process should contact CTO 6-8 weeks prior to the desired on-site visit. CTO can also arrange to conduct a preparation meeting prior to formally initiating the Qualification review, should the REB choose so.
Once a date has been agreed upon for the two-day on-site visit, CTO will develop a Site Visit Plan (SVP), which acts as the agenda for the visit. At least two weeks prior to the on-site visit, the REB must provide the completed preliminary materials, including copies of written Standard Operating Procedures (SOPs) and other supporting documents.
The on-site visit starts with an entrance interview, during which the Site Visit Plan is reviewed, and the Qualification process is described; the Qualification Team can also address any questions that the REB may have. The entrance meeting is typically followed by a brief facilities tour. During the on-site visit, the Qualification Team will request copies of certain REB materials (as outlined in the Qualification Manual) and may follow-up with questions for the REB operations team. Interviews will be held with the Lead REB operations personnel and the REB Chair(s)/Vice-Chair(s). The on-site component concludes with an exit meeting, during which time the REB is provided with preliminary feedback including identification of potential findings.
Following the on-site visit, the REB is provided with a Qualification Report. This report will describe the Qualification process, including materials reviewed, and will identify any areas where the REB did not satisfy the criteria outlined in the Qualification checklist (called ‘findings’). The report may also include recommendations – these are suggestions or observations from the Qualification team that may be helpful to the REB. If no findings are identified, the REB will be designated a CTO Qualified REB. REBs with minor or major findings will be provided with the opportunity to submit a Corrective Action Plan (CAP). The Qualification Team will review the CAP and, upon acceptance of the plan, the REB will be designated as a CTO Qualified REB.
The Qualification will remain in effect for three years from the date of issuance, with Annual Reporting to document changes in REB membership or other substantive changes (e.g., procedures, oversight responsibilities).
Prior to the expiration of the REB’s qualification status, CTO will initiate the Re-Qualification process.