GUIDELINES
IS ETHICS REVIEW REQUIRED?
Research that involves human subjects requires review and approval by a REB. However, not all projects meet the definition of research and may therefore be exempt from the requirement of REB review prior to initiation.
Projects that are appropriately classified as quality improvement (QI), educational assessments, or performance evaluations of specific programs typically do not require REB review.
If it is unclear whether a project requires REB review, contact CO-REB to obtain a written determination from the CO-REB Chair.
TYPES OF REVIEW
Delegated (Expedited) Review
Delegated review is assigned to research that involves minimal risk to participants—meaning the probability and magnitude of harm are no greater than those encountered in daily life. One or more delegated CO-REB members review the application rather than the full board.
Delegated review may also apply to:
- Minor modifications to previously approved research
- Continuing review applications that meet minimal risk criteria
Full Board Review
Full board review is required for research involving greater than minimal risk, vulnerable populations, sensitive topics, or complex ethical considerations. In this case, CO-REB discusses the study at a convened meeting.
CO-REB approval must be granted before you can begin the research.
EDUCATION & TRAINING
New submissions will only be approved if all listed investigators have completed the required ethics training and hold valid certification.
This requirement ensures that all research conducted under CO-REB oversight aligns with established ethical standards, safeguarding participant welfare and maintaining research integrity.
CO-REB uses a risk-based approach to determine training requirements. Please refer to the table below to identify which certifications are required based on the level of risk associated with your study.
Scroll horizontally to view more
| Type of Research | Study Role | Required Training | Website |
|---|---|---|---|
| High Risk (e.g., studies involving drug or device intervention) | PI, Co-PI(s), Staff delegated study responsibilities | CITI Canada GCP; CITI Canada – Health Canada Division 5 | https://about.citiprogram.org |
| Moderate Risk (e.g., studies with no drug/device intervention) | PI, Co-PI(s) Staff delegated study responsibilities | CITI Canada GCP TCPS 2: CORE-2022* | https://about.citiprogram.org https://tcps2core.ca/welcome |
| Low Risk (e.g., research eligible for delegated review; observational studies; medical record reviews; application for repositories) | PI, Co-PI(s), Staff delegated study responsibilities | TCPS: 2 CORE-2022* | https://tcps2core.ca/welcome |
Acronyms: CITI, Collaborative Institutional Training Initiative; GCP, Good Clinical Practice; N2, Network of Networks; PI, Principal Investigator; TCPS 2, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2 ed. (TCPS 2)
* Training must be updated to include the most recent version of the TCPS 2: CORE 2022. If your current training was completed prior to 2022, a 6-month grace period from the date of submission to complete the updated training will be given.