When may the expedited review process be used according to federal regulations?

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The expedited review process may be used when research procedures pose no more than minimal risk to participants. The federal regulations define "minimal risk" as the probability and magnitude of harm or discomfort anticipated in the research being no greater than those ordinarily encountered in daily life or during routine physical or psychological examinations. This allows for a more efficient review of studies that meet this standard, facilitating quicker approval for research that does not significantly jeopardize participant safety.

Using the expedited review process is appropriate when the research involves lesser risks, thereby allowing for the continuation of valuable social and behavioral research while still ensuring ethical standards are met. This principle is designed to streamline the process for studies that do not present significant risks, providing a balance between oversight and the timely advancement of research.