Ethical Review Guidelines

Please note that all theses, Research Papers (MRP and QRP), and class research projects involving human subjects must receive approval from the Office of Research Ethics (ORE).

Research has been defined as activities “which involve a systematic investigation to establish facts, principles or generalized knowledge.”(Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans, 1998, page 1.1)

No process for data collection, including recruitment or scheduling of appointments, can occur before receiving the final approval from the ORE.

Visit the Office of Research Ethics webpage for application forms, deadlines, and an introduction to the ethical review process. http://www.research.utoronto.ca/for-researchers-administrators/ethics/human/

The Steps to be Taken

1. The Protocol Submission Form

The ORE uses one Protocol Submission Form. It is a fillable Word document. Helpful instructions can be found on the Applications Page under the Supervised and Sponsored Research heading.

Also, download this informed consent check-list (pdf) provided by the ORE to aid in your preparation.

2. Supervisor's Signature

In preparing the materials, work closely with your research thesis supervisor to complete the Protocol Submission Form. Your thesis supervisor is ultimately responsible to assist you in the ethics review process. Be sure to include all appendices, such as recruitment letters, consent forms, and surveys.

3. Department Designate Signature

After your supervisor has signed off on your Protocol Submission Form, make an appointment with your program liason. In person meetings are best. The submission will be reviewed looking particularly closely at issues of informed consent. It is best to book an appointment well in advance of the submission deadline date to the Office of Research Ethics. This will provide enough time to make any revisions necessary.

4. Submission Deadlines at the Office of Research Ethics

For DELEGATED reviews (i.e. non-vulnerable research populations), the application deadline at the ORE is every Monday by 4:00 pm to appear on the agenda for the weekly Thursday review meeting.

For FULL reviews (i.e. vulnerable research populations), please note the submissions dates for FULL reviews.

For HIV REB, please note the submission date deadlines.

Submission Procedure:

E-mail one electronic copy of your protocol and appendices as a single Word document to your program coordinator.

After any revisions necessary have been completed, your coordinator will submit your protocol to the Office of Research Ethics on your behalf, cc'd to you and your supervisor.

All other submissions which are not new (e.g., revisions and annual renewal form), as well as general inquiries should be sent to ethics.review@utoronto.ca

For contact information:

Office of Research Ethics
McMurrich Building, 2nd Floor
12 Queen's Park Crescent West
University of Toronto
Toronto, ON M5S 1A1
416-946-3273

5. Notification of Review

Approximately 3-4 weeks after your submission, the Ethics Review Office will notify you by email about the decisions of the committee regarding your submission. It is possible that further clarification / revisions will be requested. These changes can be emailed to the Ethics Review Office as per their instructions.

Once approval has been given, your study is approved for one year. If you wish to continue your research past the one year date, you must submit a renewal form.

Your supervisor will be copied on your approval notice. However, it is your responsibility to notify the department of the approval so it can be indicated on your student record.

Helpful Hints

Once the ethics protocol leaves the department, we do not have authority over the approval process. Please contact the Office of Research Ethics at 416-946-3273 or ethics.review@utoronto.ca
Pay attention to all dates, especially for FULL reviews.
Answer every question on the protocol form. Indicate 'N/A' for Not Applicable.
Attach all the relevant appendices, such as all invitation letters and consent forms, and copies of survey instruments.
Make sure the protocol form is signed by your supervisor and program coordinator, on behalf of the dept. Chair.
For a thorough explanation of the process go to
http://www.research.utoronto.ca/for-researchers-administrators/ethics/.
Make sure you have the most current forms and instructions.