To qualify for the expedited review, what is necessary regarding study procedures?

The requirement that study procedures must have no more than minimal risk to qualify for expedited review is rooted in the ethical principles guiding human subject research. Expedited review is designed for studies that pose only minimal risk to participants, which is defined as the possibility of harm or discomfort anticipated to be no greater than that encountered in daily life or during routine physical or psychological examinations.

This criterion is essential for ensuring participant safety and well-being. When research involves procedures that fall under the category of minimal risk, it indicates a lower likelihood of adverse effects, making it more appropriate for expedited review processes. Studies that do not meet this minimal risk threshold typically require more comprehensive scrutiny to ensure that they are ethical and that the risks posed to participants are justified and managed appropriately.

In contrast, options that mention long-term commitments of resources, complex statistical analysis, or benefits that outweigh risks pertain to other considerations within research ethics and review processes but do not specifically address the minimum risk requirement for expedited review. Each of these factors can be relevant to the overall assessment of a study but does not align directly with the specific criterion for expedited review related to minimal risk.