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Minimal Risk

Category: Definitions

What is minimal risk?

Federal regulations define "minimal risk" as follows: "The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." In broad terms, a project involves minimal risk if:

  1. The participant experiences no pain or physical danger;
  2. The participant experiences no emotional arousal or psychological stress beyond the levels typically expected in everyday life;
  3. The project neither induces nor attempts to induce long-term significant negative change in the participant's behaviors (including attitudes toward self and others);
  4. The data would not embarrass or socially disadvantage the participant, were confidentiality to be violated; and
  5. If the investigator conceals information about the specific purpose of the project, there is no reason to believe the subject would choose not to participate if s/he had known that information initially.