10/12/22, 6:16 PM TCPS 2: CORE-2022

TCPS 2: CORE-2022

Module A3 - Risks and Benefits

Balancing potential benefits and risks
Because research explores the unknown, outcomes are uncertain. Society as a whole may benefit from the
advancement of knowledge that comes from research (indirect benefits). Individual participants may also benefit
from an improvement to their welfare as a result of their participation in research (direct benefits). However,
much research offers little or no direct benefit to participants.

For a research study to be ethically acceptable, the potential benefits of the research should outweigh the
foreseeable risks associated with the research. For the purposes of the TCPS 2, potential benefits are impacts
that positively affect the welfare of participants, their communities, or society as a whole through the
advancement of knowledge for both present and future generations. Possible benefits to the researchers
themselves, in the form of academic or career advancement, or financial gain, are not relevant considerations in
assessing the appropriate balance between risks and potential benefits of research.

The TCPS 2 defines risk as the possibility of the occurrence of harm to participants or other individuals. Harm
includes any negative effects on individuals’ welfare. The nature of the harm may be social, behavioural,
psychological, physical, or economic. Risk is assessed by considering the magnitude or seriousness of the harm
and the probability that it will occur, whether to research participants, their communities, or society. Some risks
are revealed only after the research has begun. This underscores the importance of the ongoing consent process
and of continuing REB review.

In determining whether a research proposal appropriately balances the risks and potential benefits, researchers
designing a study and REBs assessing it must consider whether the potential benefits outweigh the foreseeable
risks from the perspective of the participants, as well as from their own expertise or role. REBs and researchers
need to understand the influence of the culture, values and beliefs of the population being studied, or the social
and economic circumstances of the individuals being recruited for participation (Chapter 2, Section B).

For more details on these topics – see Module A4 and Module A8.

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