How is risk assessment conducted in TCPS 2?

• A. Only economic risk is considered.
• B. Risks are ignored if study has high potential benefit.
• C. Evaluate physical, psychological, social, economic, and privacy risks and balance with potential benefits; implement mitigations.
• D. Privacy risk is the only concern.

Answer: (C)

Risk assessment in TCPS 2 is a holistic process that requires considering multiple domains of potential harm—physical, psychological, social, economic, and privacy risks—and weighing these against the anticipated benefits to participants and to society. The aim is to identify how likely each risk is and how severe it could be, then implement safeguards to minimize those risks. This includes designing the study to reduce harm, obtaining informed consent, protecting data privacy, and having plans for monitoring and responding to adverse events. Risks should not be ignored simply because a study promises benefits, and privacy concerns are not the only risk to consider; benefits do not override significant harms in other domains. Only when the risk profile is acceptable and mitigations are in place does the study proceed.