Under TCPS 2, can individuals in vulnerable circumstances participate in research?

Under TCPS 2, can individuals in vulnerable circumstances participate in research?

• A. Yes, so long as participation is necessary to the research and additional protective measures are in place.
• B. No, it is wrong to include vulnerable individuals in research.
• C. Yes, all that matters is that they have the capacity to consent.
• D. No, those in vulnerable circumstances cannot participate in research even if the research focus is on people in their circumstances.

Answer: (A)

Under TCPS 2, individuals in vulnerable circumstances can participate if their involvement is necessary to achieve the research aims and the study includes enhanced protections to safeguard their rights and welfare. Vulnerability raises the risk of coercion and harm, so the inclusion must be justified, with safeguards such as clear and ongoing consent (or consent by a legally authorized representative), assent when appropriate, rigorous risk minimization, independent ethics review, privacy protections, and ongoing monitoring. Capacity to consent is not the sole criterion; some participants may lack full capacity but can be included with proper protections, while inclusion should not be automatic or blanketly excluded.

Under TCPS 2, individuals in vulnerable circumstances can participate if their involvement is necessary to achieve the research aims and the study includes enhanced protections to safeguard their rights and welfare. Vulnerability raises the risk of coercion and harm, so the inclusion must be justified, with safeguards such as clear and ongoing consent (or consent by a legally authorized representative), assent when appropriate, rigorous risk minimization, independent ethics review, privacy protections, and ongoing monitoring. Capacity to consent is not the sole criterion; some participants may lack full capacity but can be included with proper protections, while inclusion should not be automatic or blanketly excluded.