Decisions as to which panel reviews each proposal are made by the Co-Chairs of the REB in consultation with REB Coordinators.  

All submissions (new studies, renewals, amendments, unanticipated event forms etc.) must be submitted via CAPCR. 

• Research involving only the use of published or publicly available information or materials
• Assessment activities such as quality assessment studies, performance reviews, or testing within normal educational requirements do not generally require REB review and approval

If you cannot determine whether an intended investigation constitutes research, contact the Chair of the REB or an Ethics Coordinator for assistance.

You can close the study if you no longer need access to the participants’ medical records. Once the study is closed, you can still use the collected data, including continue analysis as per protocol, but you cannot access the medical records any longer.

Remote monitoring could be performed using the established UHN permitted process (please see Remote Monitoring of Clinical Research @ UHN - Home).

Participants should provide consent for remote monitoring (please see "UHN REB Guidance document for consent form writing" for suggested language). Participants who are already enrolled in a study should be provided with the "Research Participant Letter". Please see the Documents and Forms page for these supporting documents.

It is the nature of research that answers often lead to more questions and the REB review element of research is no different.
 
An REB review is an iterative process between the PI and the REB which continues until such time as all elements have been satisfactorily addressed.
 
In the course of review, information provided by the study team may result in requests from the REB:
a) to modify elements of the study
b) for more information
 
At the conclusion of the review, the REB will provide one of the following decisions concerning the study:
a) Approved
b) Not Approved
c) Approval Not Required

Consent is an ongoing process and participants should be provided with any and all new information that may influence their consent.
 
New information may be provided, verbally or otherwise, to participants prior to receiving REB approval if the Principal Investigator:

• determines it to be in the best interests of already consented participants (i.e. to eliminate or reduce any apparent immediate hazards to study participants)
• documents the process
• submits all new information and documentation to the REB for confirmation of agreement as soon as possible within seven days.

When revising documents that have been reviewed by the REB, the requested revisions should be tracked and made on a clean copy the REB reviewed document. Please ensure that the version dates of the document are updated. Once all the revisions have been completed, send both a ‘tracked’ copy and a ‘clean’ copy of the document back to the REB. Please note that the REB will not accept documents that include both new revisions and the revisions that were previously reviewed by the REB.

A consent form for pregnancy follow up must be submitted in the event of pregnancy.

Considering it is rare that research participants (or their partners) become pregnant while participating in a clinical research study, to facilitate review and approval process, the REB does not recommend submitting a consent form for pregnancy follow with the initial submission, unless required by the study objectives.

The REB fee is levied and collected by Research Solutions and Services through Grant and Contract Services and is used to partially offset the costs incurred by Research Solutions and Services in providing support to the REB. For more information, please contact crss-help@uhn.ca.

Mailing/Office Address:
700 University Avenue
4th Floor
Toronto, Ontario M5G 1Z5

Inquiries about whether the REB has received your submission, status updates and administrative inquiries should be directed to reb@uhn.ca or to the REB mainline at 416 581-7849. 

The REB examines the budgets of clinical trials in accordance with Tri-Council Policy Statement (TCP) Article 7.3 which states that "REBs shall examine the budgets of clinical trials to assure that ethical duties concerning conflict of interest are respected" and does so from the perspective of :

• Feasibility
• Coercion
• Conflict of Interest

The REB is comprised of four panels. The panel to which proposals are directed for review depends on:

• The subject of the research proposed
• The scientific expertise of  the panel
• In the case of the two multidisciplinary panels (A and B), the current workload of each panel is considered

The decision to delegate a research project is made by the Co-Chairs of the REB. Some criteria by which research may qualify for delegated review are:

• Protocols involving minimal risk or protocols where there are minimal incremental risks over standard procedures
• Minimal risk protocols where data are collected non-invasively such as questionnaires or direct/indirect observation
• Protocols primarily using previously-collected data such as chart reviews and database information
• Protocols using previously-collected tissue or other samples