Research is eligible for exemption under federal regulations if it falls into what criteria?

Research can be eligible for exemption under federal regulations if it falls under specific categories of research activity. These categories are defined in the federal regulations governing human subjects research, particularly in 45 CFR 46. The exemptions are designed to allow certain types of research that may pose minimal risk to participants or involve specific activities that the regulations deem appropriate for exemption from more rigorous oversight.

For instance, categories that may be eligible for exemption include educational practices in commonly accepted settings, studies using educational tests or surveys, and research involving the collection of public behavior data. The emphasis on specific categories ensures that the exemption criteria are applied consistently and appropriately, allowing for a streamlined review process for research that meets these established standards.

In contrast, research involving no human subjects might not be subject to these regulations at all, as it does not concern human subjects in the first place. Prior IRB approval, while important for research oversight, does not inherently qualify research for exemption; it is rather a prerequisite for studies requiring approval. Finally, restricting exemptions to research conducted solely by federal agencies is too narrow and does not reflect the broader scope of exemption eligibility that applies to various entities conducting research across different settings.