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Submissions :: Protocol review process :: Expedited/Exempt Review :: Minimal Risk

Minimal Risk

The federal regulations define “minimal risk” as the following: “Minimal risk means that 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.” This offers some ambiguities.  For example, whose “daily life” should be considered?  If a study involves interviewing juvenile delinquents who deal drugs, the level of risk encountered in their daily lives could be significantly different from the average teenager.  Does that mean that these participants deserve less protection than the average teenager?  The Board sets the “average person” as the standard for determining “minimal risk.” If a person’s lifestyle makes them more sensitive to risk, making them a subject of a study could make the study more than “minimal risk.” In some cases, the Board may need additional information to understand what is “normal” for the “average person” in your study population.  For example, the Board may not have intimate knowledge about the international population you will study. When you submit your study protocol, providing the Board with information about the study population can help them to understand the population and make an accurate determination as to the level of risk in your study. “Daily life” refers to a level of minimal harm that are normally encountered and easily ameliorated by time, by debriefing, or both.

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