Which condition qualifies a protocol for expedited review by the IRB?

The identification of minimal risk in research studies is a key factor that qualifies a protocol for expedited review by the Institutional Review Board (IRB). A study is considered to involve minimal risk when the likelihood and severity of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.

This criterion aligns with federal regulations, which allow for an expedited review process for research that meets specific conditions. These conditions include studies that present no more than minimal risk to participants and fit into designated categories defined by federal law. Such a streamlined process helps facilitate research while ensuring the protection of human subjects.

While other options may seem relevant, they do not align with the regulatory framework for expedited review. For example, a lack of written consent is not inherently a criterion for expedited review, as written consent can often be required even for studies undergoing this type of review. Similarly, the inclusion of only healthy participants does not automatically qualify a study for expedited consideration, as the risk level in the study is the determining factor. Lastly, student research projects may or may not qualify for expedited review depending on their risk levels, rather than being automatically eligible based on their status as student research.