When may expedited review for a new proposed study be used according to federal regulations?

Study for the CITI Program Biomedical Research Exam. Utilize our resources with flashcards and multiple-choice questions, complete with hints and explanations. Prepare with confidence!

Expedited review is a process designed to facilitate the review of research protocols that present no more than minimal risk to participants. According to federal regulations, expedited review can be applied to studies that fall into specific categories and involve research procedures that do not pose significant risks.

The correct choice highlights that the study must not only involve minimal risk but also align with allowable categories defined by federal guidelines. These categories may include, for example, certain types of behavioral research, material collections or studies involving benign interventions, and research on the collection of existing data. This ensures that while the study can still be evaluated efficiently, it maintains a necessary standard of ethical oversight for participant safety.

Other options do not meet the criteria for expedited review. For instance, a study being a requirement for a student project does not inherently justify expedited review; it's the risk level that matters. Similarly, the use of only healthy volunteers does not automatically qualify a study for expedited review unless it falls into those allowable categories that also involve minimal risk. Lastly, stating that the study does not require consent or surveys does not address the risk levels or the specific criteria for expedited review, which are essential considerations in the regulatory framework.

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