What triggers an IRB expedited review of a study?

An IRB expedited review is triggered when a study is determined to involve minimal risk to participants. This means that the potential risks involved in the research are not greater than those encountered in daily life or during routine physical or psychological examinations. The expedited review process is designed to streamline the approval of research that is low-risk, allowing researchers to begin their studies more quickly while still upholding ethical standards and participant safety.

In contrast, a study posing a high risk would typically require a full IRB review, ensuring thorough evaluation of the potential risks and necessary protections for participants. A study deemed irrelevant does not warrant any review necessary because it does not present a significant subject of inquiry. Additionally, studies involving multiple institutions may require more complex coordination and compliance with multiple IRBs, typically necessitating a full review rather than an expedited one. Thus, minimal risk is the appropriate condition that allows for an expedited review process.