Risk and Review Process
Research ethics review is focused on protection of the participants and maximizing benefits while minimizing harms. Harm is anything that has a negative effect on the welfare of the participants, and the nature of the harm may be social, behavioural, psychological, physical or economic. Risk is a function of the magnitude or seriousness of the harm, and the probability that it will occur.
The TCPS2 provides for proportionate review. In other words, the review process is determined by the level of risk the proposed research presents for the participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review).
The level of risk is dependent on the participants, their capacity to provide free and informed consent and the nature of the intervention or activity being studied and the information to be collected. Minimal risk and above minimal risk research is conducted in all domains. The TCPS2 defines minimal risk research as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research. Minimal risk research is generally eligible for delegated review and above minimal risk research is generally reviewed by full board.
Investigators are asked to assess the level of risk the proposed research presents for the participants as part of the application process. However, the final determination of the level of risk and review path for a study is made by the Research Ethics Board.