What does minimal risk mean in TCPS2 terms?

• A. The probability and magnitude of harm are not greater than those encountered in daily life.
• B. Minimal risk means no risk to participants.
• C. Minimal risk means there is no possibility of harm.
• D. Minimal risk means only physical harm is considered.

Answer: (A)

Minimal risk in TCPS2 means the probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or during routine physical or psychological examinations. This sets a practical benchmark for evaluating risk, recognizing that some risk may exist but should be comparable to ordinary experiences. Importantly, risk is about both the likelihood and the seriousness of potential harms, which can be physical, psychological, social, or economic, depending on the context. Even with minimal risk, safeguards like informed consent, privacy protections, and ethics board review still apply. The other statements misrepresent this concept: minimal risk does not require zero risk, it does not imply no possibility of harm, and it is not limited to physical harm.