Is the IRB Chair responsible for determining whether a research study is considered non-exempt human subjects research?

The individual who oversees the Institutional Review Board (IRB) and discusses the nuances of research studies involving human subjects plays a vital role, but the specific responsibility for determining whether a study is classified as non-exempt human subjects research does not solely rest on the IRB Chair. The determination typically involves a review by the entire IRB and is based on multiple criteria outlined by federal regulations and institutional policies. This ensures that the decision on whether research meets the criteria for non-exempt status is not made in isolation but rather through a collective evaluation, considering all relevant aspects and the potential risks to participants.

In many cases, this review includes assessments regarding the type of research being conducted, the nature of participant involvement, and adherence to ethical guidelines safeguarding participant welfare. This shared responsibility within the IRB helps promote comprehensive oversight and informed decisions regarding the protection of human subjects in research. Thus, it is a collaborative effort rather than an individual one.