According to federal regulations, when can the expedited review process be utilized?

The expedited review process is specifically designed for studies that pose no more than minimal risk to participants. This aligns with the federal regulations that define minimal risk as the probability and magnitude of harm or discomfort anticipated in the research being not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.

Choosing this review pathway allows institutional review boards (IRBs) to approve certain types of research more quickly, recognizing that not all studies require the same level of scrutiny. This approach facilitates research responsiveness and efficiency while still ensuring the protection of participants involved in studies that are deemed low-risk.

In contrast, studies that pose considerable risk or involve vulnerable populations typically necessitate a full board review due to the complexities and potential ethical concerns involved, which would exceed the minimal risk threshold. Additionally, the IRB does not have the discretion to approve expedited reviews for all studies; they must adhere to defined criteria that classify research for expedited review reliably.