Which statement about consent and participation is most consistent with TCPS 2?

• A. Participation is voluntary and based on information about risks and potential benefits.
• B. Consent is optional for low-risk studies
• C. Consent is only needed for high-risk studies
• D. Consent is not required if the researcher knows the participant

Answer: (A)

Participation in research under TCPS 2 is voluntary and grounded in informed consent, which means people decide to take part only after receiving clear information about what the study involves, including any risks and potential benefits. This information helps them weigh their options and decide whether to participate, and they should be able to withdraw at any time without penalty. Consent is an ongoing process, not a one-time form, and it should be appropriate to the participant’s understanding and context.

Consent is typically required for most research involving human participants, with waivers only in tightly defined situations where obtaining consent is impracticable or would undermine the study and where an ethics board has approved such a waiver. Knowing a participant personally does not remove the need for consent. The idea that consent would be optional in low-risk studies or that high-risk status changes the fundamental need for consent is inaccurate.

So, the statement that participation is voluntary and based on information about risks and potential benefits best captures TCPS 2's stance on consent and participation.