Which factor is critical when determining if a study requires IRB oversight?

In determining whether a study requires Institutional Review Board (IRB) oversight, the presence of human subjects is the most critical factor. IRBs are designed to protect the rights and welfare of individuals participating in research. If a study involves human subjects—defined as living individuals from whom data is obtained through interaction or intervention or from which identifiable private information is gathered—then it falls under the purview of IRB review to ensure ethical standards are met.

The need for IRB oversight is primarily grounded in federal regulations and ethical guidelines aimed at safeguarding participants from potential harm, ensuring informed consent, and maintaining confidentiality. When evaluating a study, identifying whether human subjects are involved helps determine the degree of risk, the required level of review, and the specific safeguards that need to be implemented.

Factors such as funding sources, the number of participants, and the location of the study may influence other aspects of the research process but do not directly determine the necessity for IRB oversight. Therefore, while these factors can have implications for the logistics or funding of a research project, the critical threshold that dictates the need for IRB review centers on the involvement of human subjects.