What type of study design is typically reviewed under expedited procedures by the IRB?

The correct answer is a study involving minimal risk as outlined in federal regulations. This is because expedited review processes are designed to facilitate the ethical oversight of research that poses only minimal risk to participants. Federal regulations, particularly those outlined by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA), 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 the performance of routine physical or psychological examinations.

Expedited review allows for certain types of research, such as studies involving the use of existing data, surveys, or interviews that present minimal risk, to bypass the full board review process, making it easier for researchers to begin their studies while still ensuring participant protection. This process is crucial for efficient oversight, especially when dealing with research that is unlikely to cause any physical or mental harm.

The other options do not align with the criteria for expedited review. Studies that involve significant risk to participants require careful scrutiny and full board review to ensure the safety and well-being of those involved. Research that does not include interaction with human subjects might not fall under the jurisdiction of the Institutional Review Board (IRB) at all, and longitudinal studies, particularly those requiring