The definition of research is outlined in the Tri-Council Policy Statement. In summary, research involving humans is considered to include any of the following:

• if the researcher will administer a drug, take a blood sample, do a test or perform any procedure, clinical, therapeutic, or otherwise, upon the person of himself/herself or someone else, for research rather than treatment
• if the researcher will ask people information whether by telephone, letter, survey, questionnaire or interview
• if the researcher will review information from patient charts (even their own patients' charts) for research rather than clinical purposes
• if the researcher will use material derived from people (tissue samples, blood, DNA)
• if the researcher will be using non-public records (e.g. not the telephone book) which contain identifying information about anyone either directly or indirectly
• if the researcher will use information previously gathered about anyone, even if anonymized (secondary data analysis)
• if the researcherwill be observing anyone's responses or behaviour, either directly or indirectly

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

• 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.

In accordance with the Tri-Council Policy Statement, the UHN REB conducts a proportionate review of research protocols: that is, the scale of the review is in accordance with the type of research proposed and with the potential for harm that the research may pose

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

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

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

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

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

Mailing Address:
700 Bay Street
LuCliff Place, 17th Floor, Suite 1700-1
Toronto, Ontario M5G 1Z6

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 see the Grant and Contract Services (link is external) FAQ.

New study applications must be submitted via CAPCR (link is external).

Currently, all other submissions (e.g. renewals, amendments, unanticipated event forms etc.) must be submitted directly to the REB at rebsubmissions@uhnresearch.ca for review.

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.

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.

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.