What distinguishes 'exempt', 'expedited', and 'full review' research according to IRBs?

The distinction between 'exempt,' 'expedited,' and 'full review' research as defined by Institutional Review Boards (IRBs) is primarily based on the level of risk involved and the complexity of the research studies.

Exempt research is characterized by minimal risk to participants. It includes studies that typically fall into specific categories outlined by regulations where the risk of harm is negligible, such as certain educational practices or the use of existing data that is publicly available. This category allows researchers to proceed without the full review process, streamlining the approval timeline for low-risk studies.

Full review, on the other hand, is necessary for research that poses significant risks or involves vulnerable populations. This process involves a comprehensive evaluation by an IRB to ensure participant safety, ethical considerations, and compliance with regulatory standards before the research can begin. Complex studies, especially those that may involve higher risks or sensitive data, fall into this category.

Expedited review serves as an intermediate category. It applies to research studies that present no more than minimal risk and involve specific types of research activities, allowing for a faster review process than a full review while still ensuring adequate oversight.

In summary, the correct choice emphasizes that exempt research involves minimal risk, reflecting the streamlined approval process for such studies,