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

The expedited review process is designed for research studies that present no more than minimal risk to participants. This aligns with federal regulations, which specify that certain categories of research activities can qualify for expedited review if they involve minimal risk. Minimal risk is defined as the likelihood and the harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations.

When a study meets this criterion of minimal risk, it allows the Institutional Review Board (IRB) to review the research more efficiently without necessitating a full board meeting. This serves to expedite the review process for studies that do not require extensive scrutiny due to their low-risk nature, ultimately facilitating the advancement of ethical research while still upholding participant protections.

In contrast, significant risks that might be associated with the study procedures would necessitate a full review to ensure comprehensive oversight, which highlights the difference between minimal and significant risk in the context of research evaluations. While non-physical interventions may be a consideration in the study, the key aspect for expedited review is the risk level, which straightforwardly aligns with the definition of minimal risk. Additionally, the availability of IRB members does not dictate the appropriateness of expedited review but rather the study's risk level and