13. Minimal Risk

Risk is minimal where the probability and magnitude of physical or psychological harm is that which is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. (45 CFR § 46.303(d))

When evaluating risk for DoD-supported research, “the phrase ‘ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests’ in the definition of minimal risk shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).”  (DoD Instruction, 6.b. Selection of Human Subjects and Evaluating Risk, Evaluating Risk)