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Minimal Risk

“Minimal risk” is a term used in the federal regulations for human subjects research and it has become the threshold for identifying studies that require more careful scrutiny (full board review), identifying studies that do not need lengthy reviews (expedited review), and identifying studies that do not need review (exempt review).  Studies that are identified as “minimal risk” are often granted exemption from further IRB review and/or receive expedited review privileges.  So how is the “minimal risk” line drawn in IRB review and risk analysis? 

The federal regulations define “minimal risk” as: “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.

For studies that are greater than minimal risk, the Board is required to review them in a full board meeting. If a study is considered “risky,” it does not necessarily mean that the Board will not approve the study, but it is important that you have adequate plan in place to minimize risk and deal with situation should they arise.

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