The CHEO REB was designated a Clinical Trials Ontario (CTO) Qualified REB in January 2017.
The CTO review process is available for use on Full Board and minimal risk studies, where a minimum of two CTO participating sites are taking part in the study.
CHEO-OCTC & CHEO RI CTO process (See Figure 1 below)
1.The lead CTO participating site submits a provincial application and provincial consent/assent forms & participant documents to CTO using CTO Stream (a web-based electronic platform). The application and consent/assent form(s) are meant to apply to all participating sites.
2. CTO selects the most appropriate CTO Qualified REB to be the REB of Record for the entire life of the study; this means that all research ethics submission (e.g., modifications and annual renewals) will be submitted to the selected REB of Record using CTO Stream.
3. All studies, for which CHEO is a participating centre with CTO, are required to submit an administrative application through ROMEO (CTO administrative application). This application includes the submission of CHEO centre consent forms and signature page. This process is an administrative review performed to capture research activity, as well as ensure the appropriate qualifications and departmental impacts are obtained for a research project. Acknowledgement of the completion of the administrative process will signal for the Institutional Approver, to indicate approval of the centre application for submission in CTO stream.
4. Once a decision is made on the provincial application (i.e., approval), each participating centre submits a centre application including centre specific consent forms (a modified version of the provincially approved consent form which includes site-specific information, logos, etc.) and a board of record agreement using CTO Stream. The REB of Record for the study will make a decision upon review of each centre application.
5. For ongoing ethics review (i.e., modifications, annual renewals, study closure, AEs), the provincial lead will submit a provincial event to the REB of Record using CTO Stream. Once the decision is received from the REB of Record, each centre will submit a centre event including site-specific versions of the documents. The REB of Record for the study will make a decision upon review of the centre events. (see figure 2 & 3 below)
Figure 1: New Study Application
Figure 2: Events after initial approval that effect all study sites (i.e., major modifications, minor modifications, annual renewals)
Figure 3: Events that are centre specific (i.e., local SAE, annual renewals)
Frequently Asked Questions (FAQ)
1. How do I submit to CTO? Who do I contact at CTO?
Please contact the CTO Program manager(s) to discuss the study submission process and obtain an account for CTO Stream.
2.Do I still have to submit to CHEO REB if the study has received provincial approval in CTO Stream?
Yes, you will still have to apply at CHEO for administrative approval through ROMEO. This application does not include an ethics review.
A CHEO centre specific application will need to be submitted through CTO Stream for an ethics review and approval. This centre specific application must include any CHEO - specific versions of documents modified from the provincially approved documents. Please see the CHEO Documented Institutional Ethics Requirements document (DIER) for a listing of the pre-approved changes.
CHEO has entered into an agreement with CTO allowing other pediatric specific CTO qualified REBs within the CTO Stream system to be an accepted ethical review, negating the requirement to have ethics review completed by CHEO REB for research involving humans.
3. If another REB has approved the study, do I have to submit to my REB?
Yes. Review by another Ontario REB that is not CTO qualified or is submitted outside of the CTO Stream process is not an accepted ethical review at CHEO. Currently, the only approved REBs of record for CHEO-OCTC/CHEO RI are CHEO REB, OCREB and CTO Qualified REBs through CTO Stream.
4. What is and who signs the Board of Record (BOR)?
The Board of Record agreement (BOR) is an agreement between CTO & CHEO-OCTC that allows for the CTO selected Qualified REB to render decisions on
research studies. The institutional representative is Mr. Bruce Squires. He will sign the Board of Record agreement. Please contact the CHEO REB office staff to begin the process of obtaining his signature at extension 2128 or 3350.