Does Your Project Require Review
Research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. The term ‘disciplined inquiry’ refers to an inquiry that is conducted with the expectation that the method, results and conclusions will be able to withstand the scrutiny of the relevant research community (TCPS 2, 2018, Article 2.1).
Projects Requiring REB Review
Studies that meet any of the criteria below need research ethics approval before they begin:
- projects involving living human participants, their biological samples or their health data;
- industry and SHA collaborative projects utilizing SHA Personal Health Information (PHI) if they will lead to commercialized products or technologies;
- research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials or stem cells (this applies to materials derived from living and deceased individuals);
- research utilizing retrospective or prospective PHI;
- projects receiving any form of external funding (e.g., Canadian Institutes of Health Research (CIHR), industry sponsors, non-profit agencies, grants in aid) when such financing is awarded to support research;
- any student or resident project being completed for research training requirements, including but not limited to:
- quality assurance;
- quality improvement; and
- program evaluation activities;
- case studies involving three or more participants undertaken for investigational purposes (e.g., publication in a scientific journal, presentation at a conference);
- please note that for case studies of 1 or 2 cases there is still a privacy requirement for appropriate consent processes being in place prior to the study being initiated; the case study consent template is available on our forms page.
Please note that the REB cannot provide approvals or exemptions once a study has begun. The REB must review the study before research projects are initiated.
Research-related activities that do not require a research ethics review
- The difference between research and non-research activities can be unclear. In general, program evaluation, quality improvement, or quality assurance initiatives when used only for assessment, management, or improvement within the SHA fall outside the scope of this policy and would not require REB review or REB approval.
- Projects that have the dual function of local quality improvement and research such as the creation of new technologies and/or generalized knowledge, such as the intent to apply the results beyond the local institution or in other settings or publication may be a possibility should be submitted for REB review. This is important to keep in mind as the REB cannot review projects retrospectively and cannot provide either an approval or exemption after the fact.
Contact your local REB to find out if your project is considered a research or non-research-related activity.