Does Your Project Require Review

Does Your Project Require Review

In Article 2.1, the Tri-Council Policy Statement 2022 (TCPS2) defines research 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. Any research involving human participants, their data, or human biological materials requires review and approval by a Research Ethics Board (REB).

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;
• 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 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

Not all research activities, or activities that seem like research, require approval by the REB. Such activities are exempt from REB review, and individuals are free to conduct exempt activities without input or clearance from the REB.

Articles 2.1 to 2.6 of the TCPS2 identify and discuss the most common types of exempt projects. The Interpretations – Scope provided by the Panel on Research Ethics may also provide helpful guidance and context regarding exemptions.

However, it can be difficult to make this determination and it is not uncommon for investigators to assume incorrectly that their project is exempt. In order to help, the REB will provide a formal determination of whether a project is exempt from REB approval. The Application for Exemption Determination is designed to elicit the specific information that the REB requires to make an informed determination.  In order to receive this determination, please complete the Application for Exemption Determination and submit it to SHA Research Ethics. You will receive a notice of receipt and a determination, usually within two weeks. It may be helpful to consult the Guidance Notes associated with the application.

Research vs Quality Improvement

The TCPS2 exempts quality assurance and improvement studies from REB review: “Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review.”

It can be particularly difficult to differentiate between research and quality improvement studies, since they often use identical methods. The chart below identifies the typical differences between the two.

If at all uncertain, please submit an Application for Exemption Determination for a formal determination.