Define minimal risk.

• A. probability or magnitude of harm/discomfort is not greater than those ordinarily encountered in daily life
• B. zero risk
• C. risk of major permanent injury
• D. risk is decided by sponsor

Answer: (A)

Minimal risk means the chance and extent of harm or discomfort from participating in a study are not greater than what people normally experience in their daily lives or during routine physical or psychological examinations. This standard helps determine how a study is reviewed—whether it can be expedited or exempt—because it compares research procedures to everyday experiences rather than aiming for zero risk. Remember, it’s not about requiring zero risk; many procedures involve mild inconveniences, but they stay within the level of risk people routinely encounter. Risk is not decided by the sponsor; IRBs assess whether the potential harms align with ordinary life experiences and established regulatory definitions. Scenarios involving major permanent injury would exceed minimal risk.