In an effort to streamline the ethical review of multi-site clinical research, there are alternative approaches to obtaining ethical approval. Using an REB/IRB of Record allows a single qualified REB to provide ethical review and oversight for multiple participating sites.
A Research Ethics Board of Record, also known as an REB of Record or Board of Record, provides research ethics review and oversight for a study with multiple participating sites. This means, only one Research Ethics Board (REB) reviews and approves the ethics of a study for more than one site.
The CTO Streamlined Research Ethics Review System (CTO Stream) is a streamlined approach to research ethics review that supports a single, qualified REB (the REB of Record) in providing research ethics review and oversight for multiple participating sites. All studies use the same interface and REB application forms, irrespective of which REB is pending oversight.
When to Use CTO Stream?
Any multi-centre clinical trial or observational study involving two or more academic institutions/public health care institutions (academic hospitals, community hospitals, universities) in Ontario.
- List of participating sites posted on CTO website
- Call CTO if there is a site you do not see on the website
- Private clinics/physician offices are not currently part of the CTO system
Terms at a Glance:
Observational Study - In an observational study, researchers assess health outcomes in groups of participants according to a research plan or protocol. Participants are not prospectively assigned to receive specific interventions by the researcher (as in a clinical trial). For example, in an observational study, researchers may observe a group of adults to learn more about the effects of different lifestyles on cardiac health.
Clinical Trial - In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the researchers.
For a complete list of participating institutions, please click here.
- OCREB Studies Using CTO
The Ontario Cancer Research Ethics Board (OCREB) is a central, expert oncology REB serving the hospitals/cancer centres in Ontario that conduct oncology clinical trials.
All OCREB studies have been transferred from O2 to Clinical Trials Ontario Stream (CTO Stream) and new studies and their follow-on/post-approval applications must be submitted in CTO Stream.
For more information about OCREB studies where the UHN reseach team is the Provincial or Centre Applicant, please contact ClinicalTrials-PMH@uhn.ca.
- Resources and Training Material for UHN Research Teams Using CTO
- UHN's Institutional Requirements when Using CTO
When using an REB of Record model like CTO, it is important to note that each centre's institution will have additional review and/or approval requirements. These institutional requirements will change based on the nature of the study and structure of the organization. At UHN, these non-REB reviews and approvals must be obtained by submitting a CAPCR application. A complimentary CAPCR application is required for all studies submitted in CTO Stream to obtain approval from UHN's non-REB reviewers (e.g. Grants and Contracts Services, Research Quality Integration, Laboratory Medicine Program, etc.).
There are 3 things required before you may begin study activities at UHN:
1. CTO REB of Record (ethics) Approval for the UHN Centre
2. Fully Executed (signed) CTO REB of Record Agreement (only required if the REB of Record is not the UHN REB)
3. Study Granted Institutional Authorization (IA) in CAPCR
Q1. I am completing a UHN Provincial/Centre Initial Application and need to include information for UHN's Primary Institution Rep - who is this?
First Name: Paul
Organization: University Health Network
Address: 700 University Avenue, 10th Floor North Room 1056
The Secondary Institution Rep section should remain blank.
Q2. I have submitted a Centre Initial Application (CIA) in CTO which requires UHN's Institution Rep's signature. The request has gone out but I am still waiting for them to sign - what's the hold up?
As Institution Rep for UHN, Paul MacPherson must sign-off on the CIA in CTO Stream before it can be submitted for review by the REB of Record. Before the Institution Rep will sign, the following has to be completed:
- UHN Centre PI credentials confirmed (eligible to be a PI at UHN)
- CAPCR application submitted
- Department Head in CIA and CAPCR must match
- Centre Applicant must sign in CTO Stream
If you are waiting for a signature for the UHN Institution Rep, please contact email@example.com
Q3. When should you submit the CAPCR Application?
If there is a Centre Initial Application (CIA) for UHN in CTO Stream, the UHN Centre PI is responsible for completing and submitting an application through CAPCR.
You can create and submit the initial application in CAPCR at anytime so long as you understand study activities cannot begin at UHN until your receive Institutional Authorization (IA) in CAPCR. You may submit as soon as the Provincial Initial Application (PIA) for the study has been created in CTO Stream.
Q4. I am the Provincial Applicant - when should I create/submit the Centre Initial Applications in CTO Stream?
A Centre Initial Application (CIA) must be created and submitted for each site (including the Provincial Applicant site). When the Provincial Application is created, research teams should immediately create the CIAs for any known Centre (right after creating the PIA). When the CIA is created for UHN, two things happen:
- The UHN Institution Reps and Admins will automatically be tagged to the study.
- One of the UHN Institution Reps will reach out to the UHN Centre PI to guide them through the process of obtaining Institutional Authorization (IA) at UHN.
Q5. I received an REB of Record Study Agreement from CTO with instructions for my PI to sign. What do I do with the Agreement once my PI has signed?
Fully executed CTO REB of Record Study Agreements are required to start study activities at the site. These are the steps for obtaining the necessarily signatures for the CTO REB of Record Study Agreement:
- CTO will send the REB of Record Study Agreement to the PI for signature.
- The PI/delegate will send a scanned copy of the Agreement (signed by the PI and witness) to firstname.lastname@example.org who will obtain the necessary signature from the UHN signing authority.
- The scanned copy of the Agreement will be sent back to CTO (email@example.com), who will obtain the necessary signatures from the REB Host Institution.
- Fully executed Agreements will be circulated via the correspondence feature in CTO Stream and by email after the CIA is submitted.
Q6. What fo I need to start study activities at UHN?
There are 3 things required before you may begin study activities at UHN if you are the Provincial or Centre Applicant:
- CTO REB of Record (ethics) Approval for the UHN Centre
- Fully Executed (signed) CTO REB of Record Agreement (only required if the REB of Record is not the UHN REB)
- Study Granted Institutional Authorization (IA) in CAPCR
Q7. I will be submitting an Amendment/Continuing Review/Reportable Event/Centre Closure in CTO Stream - do I also need to submit a corresponding CAPCR application?
There are Provincial-level and Centre-level submissions in CTO Stream but not every submission needs a corresponding submission in CAPCR.
Amendment – submission required in CAPCR if the CTO amendment would impact a new or existing service provider/impact assessment reviewer triggered to the study
Centre Continuing Review – submission required in CAPCR to confirm the study continues to maintain ethiccal oversight
Centre Completion/Termination/Suspension – submission required in CAPCR to inform all existing service providers/impact assessment reviewers are aware of the completion/termination/suspension