Clinical Epidemiology Yellow Book
3.7 Submission of Thesis Project for Ethics Review
All students must obtain University of Toronto research ethics approval for their research in addition to any approvals required at their home institutions or those of their supervisors. Applications for approval can only be submitted after the proposal has been approved by the CECHR director. Students must be listed as a researcher or investigator with the relevant Research Ethics Boards. While the University of Toronto sometimes exempts student research from full ethics review, students must apply for such exemptions and supply the appropriate documentation to the IHPME graduate office. Students must never assume that their research is exempt from ethics approval. Students who do not have documented University of Toronto ethics approval will not be allowed to proceed to their defense.
Guidelines for Studies Using Data Held by ICES
ICES is a prescribed entity under section 45 of Ontario’s Personal Health Information Protection Act. Section 45 is the provision that enables ICES to conduct analysis related to the management, evaluation and monitoring of the health system. Section 45 authorizes health information custodians – like physicians, hospitals and long-term care homes – to disclose personal health information to a prescribed entity, like ICES, without consent for such purposes. Studies conducted wholly under section 45, by definition, do not require approval of a research ethics board (REB).
When students at UofT conduct studies (in connection with supervised undergraduate or graduate course work or supervised thesis or non-thesis based graduate analysis) within ICES they do so under the auspices, and as “agents”, of ICES. As such, their studies are legally exempt from REB approval so long as the studies use only personal health information and include specific and substantive objectives to conduct analysis related to the management, evaluation and monitoring of the health system. This also means that the UofT REB does not need to review and approve the study.
In some cases – infrequently – REB approval may be legally required. This is the case if a study’s objectives fall outside section 45 parameters or use ICES data holdings governed by different laws or by data sharing agreements that specifically require REB approval.
All studies carried out within ICES are subject to a privacy impact assessment and approval from ICES’ Privacy & Legal Office prior to launch. The privacy impact assessment is the mechanism that ICES uses to confirm the legal authority for use of the data. If a study requires REB approval, ICES will identify and communicate this requirement. The student is then responsible for obtaining approval of the UofT REB in accordance with its guidelines: REB Guidelines
For questions, please contact the UofT REB at firstname.lastname@example.org or 416 946 3273
TCPS 2 Certificate
IHPME students are required to take the online tutorial TCPS 2: CORE (Course on Research Ethics), an introduction to the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). Upon completion, you will be able to print or email a Certificate of Completion to be submitted to the IHPME graduate office.
The office of Research Ethics at the University of Toronto has launched an online application process. Here is the landing page to submit an application: My Research
Students and faculty should review the following links:
School of Graduate Studies
UofT Research and Innovation
- Humans in Research
- Forms – TAHSN Application Cover Sheet – [word.doc]
- Guidelines and Practices Manual for Research Involving Human Subjects – [PDF]
For more information on Ethics, or if you have questions about submission, please contact:
Daniel Gyewu (email@example.com)
Research Ethics Coordinator