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

The expedited review process can be utilized when research activities fall within specific regulatory categories defined by federal regulations. This allows Institutional Review Boards (IRBs) to streamline the review process for studies that present minimal risk to participants or involve certain types of research eligible for expedited review. Examples of applicable categories include research on existing data, studies involving minor changes to previously approved research, and certain types of medical procedures.

This process is designed to facilitate timely access to research opportunities while ensuring that protections for human subjects are maintained. It is particularly beneficial for studies that do not involve significant risk, thus allowing for quicker advancements in research without compromising participant safety.

The other options touch on aspects of risk and subject populations, but they do not fully capture the specific criteria that govern the expedited review process as detailed in federal regulations. Studies that pose more than minimal risk or involve only adult subjects don’t automatically qualify for expedited review without meeting the criteria set forth in the regulatory categories.