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

The expedited review process can be used when a study poses no more than minimal risk to participants. This guideline is established to streamline the review process for certain types of research that do not present significant risks to subjects. Minimal risk is defined 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.

By allowing expedited reviews for studies that meet this criterion, ethics review boards can efficiently allocate their resources to more complex studies that may require a full review, while still ensuring that protections are in place for participants involved in lower-risk research. It is crucial for researchers to assess the level of risk associated with their studies carefully to determine eligibility for this expedited pathway.