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Research Ethics

Risk level

Determining participant vulnerability

Researchers are asked to perform an initial assessment of the level of risk their project entails using the following matrix which expresses BOTH participant vulnerability and research risk. After considering where the study lies on both axes, select the one cell in the table that corresponds to the overall level of risk the study poses.

Participant Vulnerability Low research risk Medium research risk High research risk
Low 1 Minimal Risk 1 Minimal Risk 2 Full Board
Medium 1 Minimal Risk 2 Full Board* 3 Full Board
High 2 Full Board 3 Full Board 3 Full Board

Table has been adapted with permission from UBC's clinical research.

*Potential for Medium Risk Review

In your application, take an opportunity to elaborate on the level of overall risk you have assigned the study. The table above is an important way of justifying your risk assessment, especially if you feel that your study might be perceived by an outsider to be sensitive or risky, but you have evidence to suggest that it is not. Ensure to describe your assessment of both participant vulnerability and research risk. The HREB will use this information along with their own assessment to determine the level of review of your research.

  • If your study includes a low/medium level of research risk and a low vulnerability population, it would receive a "1" ranking and be eligible for minimal risk review.
  • If your study includes a low/medium vulnerability population and a low level of research risk, it would also receive a "1" ranking and be eligible for minimal risk review.
  • Any studies receiving a "2" or "3" ranking when the risk matrix is completed should be submitted for full board review. Please check the deadlines for submission.

How the HREB reviews applications based on risk level

A full board review requires that the submitted protocol be reviewed at the HREB regularly scheduled monthly meeting. If a protocol is NOT minimal risk, it will be reviewed by the full board. A new course designation also automatically goes to the full board. 

A delegated review is a protocol that is minimal risk and can be reviewed and approved by the Chair or Vice-Chair of the HREB and another member of the HREB. The delegated review does not go to the full board review at the monthly meeting nor does it have to wait for the meeting date to be reviewed, but this doesn't necessarily mean it will be reviewed any faster.

If you have questions about minimal risk, contact Research Ethics.

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