What does minimal risk mean in research involving human participants?

What does minimal risk mean in research involving human participants?

• A. Risk is greater than daily life risks.
• B. Minimal risk means there is no risk at all.
• C. Risk is moderate and constant.
• D. Risk is not greater than risks encountered in daily life.

Answer: (D)

Minimal risk means the chance and amount of harm or discomfort in the study are no greater than what people typically experience in everyday life or during routine physical or psychological examinations. It doesn’t mean there’s no risk at all—the possibility of minor discomfort or inconvenience can exist, but it should not exceed ordinary daily risks. If a study elevated risks beyond those common in daily life, it would require stronger protections or a different review level. For example, completing a general health survey or undergoing a standard medical checkup generally falls under minimal risk. The option describing risks not greater than daily-life risks matches this standard best.

Minimal risk means the chance and amount of harm or discomfort in the study are no greater than what people typically experience in everyday life or during routine physical or psychological examinations. It doesn’t mean there’s no risk at all—the possibility of minor discomfort or inconvenience can exist, but it should not exceed ordinary daily risks. If a study elevated risks beyond those common in daily life, it would require stronger protections or a different review level. For example, completing a general health survey or undergoing a standard medical checkup generally falls under minimal risk. The option describing risks not greater than daily-life risks matches this standard best.