What is non-exempt human subjects research?

Non-exempt human subjects research refers to research activities involving human participants that do not meet the criteria for exemption under the Common Rule, which governs the ethical conduct of research funded or conducted by federal agencies. To be considered non-exempt, the research typically involves greater than minimal risk to participants or does not fit into the specific categories outlined by the Common Rule that allow for exemption, such as certain educational practices or the use of existing data where no identifiers can be traced back to individuals.

Being classified as non-exempt subjects research means that it is subject to additional ethical oversight and regulatory requirements, including review by an Institutional Review Board (IRB), informed consent from participants, and adherence to specific ethical guidelines to protect the rights and welfare of research participants. These measures are essential to ensure the safety and ethical treatment of individuals involved in research, especially when there are potential risks.

In contrast, other definitions do not accurately capture the primary aspect of non-exempt human subjects research. While activities considered part of a clinical trial may often fall into this category, not all clinical trials are non-exempt. Similarly, saying that activities funded by HHS or government fees defines non-exempt research overlooks the critical qualifying criteria tied to participant risk and ethical oversight.