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Minimal risk describes a level of potential harm in research that does not exceed the risks individuals ordinarily experience in their daily lives or during routine physical or psychological evaluations. Establishing this threshold is essential for institutional review boards (IRBs) to determine the necessary level of oversight, such as qualifying a study for expedited review.

Minimal Risk

Expedited research involves studies that pose a somewhat higher risk than exempt research but still expose participants to no more than minimal risk, which is defined as risks encountered by healthy individuals in daily life or during routine examinations. Because the risk is minimal, expedited review can be conducted by just one member of an institutional review board or by a separate committee under the board's authority, rather than the full committee.

Expedited Research

If a psychological study poses only minimal risk to participants—meaning the potential harm is no greater than what is encountered in daily life or during routine physical and psychological examinations—even a small anticipated benefit to the participants, science, or society is generally considered sufficient to ethically justify the research.

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