Streamlined Research Ethics

REB Qualification Program

CTO’s REB Qualification Program promotes a high level of trust by ensuring that research ethics boards (REBs) meet a minimum standard for clinical trials and observational health studies in Ontario and Canada. During the qualification process, CTO reviews the operations, documentation, personnel and facilities to ensure the REB meets the applicable regulations and standards. Obtaining CTO REB Qualification allows institutions and REBs to feel confident delegating ethics review and oversight to one other.

Qualification Process

To become Qualified by CTO, an REB must successfully undertake and complete the qualification process. Undergoing the CTO REB Qualification is voluntary, however, any REB that intends to act as the REB of Record for a study using CTO Stream must be Qualified. There are no fees associated with the CTO REB Qualification Program, nor are there any fees associated with maintaining Qualification status. Upon Qualification, the REB leadership will be invited to join the CTO REB Council, which informs and advises on the ongoing development of CTO Stream.

1 Preparation

REB uses the appropriate Qualification Checklist to review their Standard Operating Procedures (SOPs).

2 Request Qualification

REB contacts CTO when they’re ready to begin the qualification process, generally 6-8 weeks prior to the desired on-site visit. 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.

3 On-site Review

The on-site review consists of:

Entrance interview
Brief facilities tour (if applicable)
Submission of materials outlined in the Qualification Manual
Interviews with lead REB operations personnel & REB
Chair(s)/Vice-Chair(s)
Exit meeting & preliminary feedback

4 Report and REB Qualification

CTO will provide the REB Chair(s) and the REB contact person with a Qualification Report. If the Qualification Report does not contain any findings, the REB will be designated as a CTO Qualified REB. If findings are identified, the REB will have the opportunity to submit a Corrective Action Plan (CAP).

5 Duration & Re-Qualification

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). Approximately 6 months prior to the expiry of the REB’s Qualification status, CTO will contact the REB to schedule a Re-Qualification visit. The visit will occur prior to the qualification expiry date.

CTO Qualified REBs

Baycrest Research Ethics Board
Centre for Addiction and Mental Health Research Ethics Board
Comité d’éthique de la recherche de l’Hôpital Montfort
Children’s Hospital of Eastern Ontario Research Ethics Board
Hamilton Integrated Research Ethics Board
Health Sciences North Research Ethics Board
Holland Bloorview Research Ethics Board
Mount Sinai Hospital Research Ethics Board
Ontario Cancer Research Ethics Board
Ottawa Health Science Network Research Ethics Board/Conseil d’éthique de la recherche du réseau de science de la santé d’Ottawa
Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board
Royal Victoria Hospital Research Ethics Board
Southlake Regional Health Centre Research Ethics Board
Sunnybrook Health Sciences Centre Research Ethics Board
The Hospital for Sick Children (SickKids) Research Ethics Board
Unity Health Toronto Research Ethics Board
University Health Network Research Ethics Board
Western University Health Sciences Research Ethics Board
Women’s College Hospital Research Ethics Board

Qualification Program Types

CTO REB Qualification Program

The CTO Research Ethics Board (REB) Qualification Program provides Ontario REBs that are planning to participate in the CTO Streamlined Research Ethics Review System, with a review of their operations, documentation, personnel, and facilities. The review is with respect to regulations, standards, and policies applicable to the conduct of clinical trials and health research in Ontario and Canada.

CTO OHR REB Qualification Program

The CTO Observational Health Research (OHR) Research Ethics Board (REB) Qualification Program is intended for Ontario REBs who are planning to participate in the CTO Streamlined Research Ethics Review System, that specifically review observational health and other non-regulated research. The CTO OHR REB Qualification process provides assurances that REBs meet a minimum standard for REB governance, membership, operations, and procedures.