Please refer to the Education and Resources section of Quality Assurance and Education.
Health Canada Submission Review
Sunnybrook Research Institute (SRI), through the Human Research Protections Program, has implemented centralization of the institutional signatory process for all Sunnybrook investigator-led clinical trial applications and applications for Investigational Testing Authorizations being submitted to Health Canada. All such applications require review by Centre for Clinical Trial Support (CCTS) and approval by the vice-president, research and innovation, before submission to Health Canada and the Research Ethics Board.
Please contact CCTS to set up an intake meeting.
Is your project QI or Research?
Projects designated as research involving humans require the review and approval of a responsible Research Ethics Board (REB) prior to initiation. Quality Improvement (QI) projects have no such oversight body- and the ethical conduct of QI projects relies on the principles that promote ethical conduct in clinical care. Namely: adherence to professional codes of conduct, conformity to role responsibilities, establishment of appropriate supervision, and compliance with the hospitals policies and procedures.
The characteristics that distinguish a QI project from a research project are often not clear. For example, the intention to publish or present on the findings of a prject does not necessarily indicate that a project is a research study. Alternately, a project employing methods typically used in resaerch activities may qualify as QI.
If the intention is to plan and implement a QI project or it is uncertain whether a project qualifies as research or QI, the Ethics Review Self-Assessment Tool (ER-SAT) must be completed. Upon completion of the ER-SAT tool, the requirements for undertaking the project will be outlined. Please see link below for access to the ER-SAT tool.
If the tool indicates your project meets the criteria of a research study, you will be directed to the procedure for submitting a research project to the REB. If the tool indicates your project does not meet the criteria of a research study, please retain a copy of the completed ER-SAT in the project file and follow the instructions for registering your project. It is a Sunnybrook requirement that QI projects be registered with the institution.
For support completing the ER-SAT tool, please contact the Ethics Centre (ext. 7693). For questions about conducting Quality Improvement activities at Sunnybrook, please contact the Department of Quality & Patient Safety at qps@sunnybrook.ca.