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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. Risks to be considered include those that may place subjects at risk of criminal or civil liability or damage the subject’s financial standing, employability, insurability, reputation or be stigmatizing. All reasonable risks of research procedures should be considered. For additional examples of minimal risk in varying contexts and populations, visit this guidance document.
For research to qualify as minimal risk, research procedures must (1) meet the definition of minimal risk AND (2) fit into one of the Expedited Review Categories. These categories apply regardless of age, unless otherwise noted. Protocols involving minimal risk are received by a subcommittee of the IRB, on a weekly, rolling basis.
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