When may an IRB use expedited review for a new study?

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The use of expedited review by an Institutional Review Board (IRB) is specifically designed for studies that involve minimal risk to participants and fall into certain predefined categories outlined in federal regulations. Expedited review is a mechanism that allows for a streamlined process to approve research that doesn't pose significant risk while still ensuring the protection of participants.

When a study meets the criteria for minimal risk, it can qualify for expedited review if it aligns with specific categories established by regulatory guidelines. These categories include research activities such as certain types of clinical studies, surveys, or the collection of data that involves benign behavioral interventions, among others. This helps facilitate research that is considered less burdensome in terms of risk management while still adhering to ethical standards.

In contrast, studies involving high risk, those conducted by new investigators without prior oversight, or studies simply continuing from past research may require a full board review to address any potential ethical concerns or complexities, which do not align with the expedited review criteria. Thus, the correct answer focuses on the specific conditions under which expedited review is applicable, establishing a clear understanding of the IRB's responsibilities in balancing risk and ethical oversight.

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