Under what circumstances can a research study be exempt from IRB review?

A research study can be exempt from Institutional Review Board (IRB) review primarily when it poses no risk to participants. This standard reflects the ethical principles that guide human subject research, which emphasize the need to protect the welfare of research participants.

The rationale for exemption based on minimal or no risk is rooted in the idea that research involving negligible risk may not require the same level of oversight as studies that could potentially have harmful consequences for individuals. For instance, if a study does not involve sensitive data or procedures, and participants are not subjected to any potential harm or discomfort, an exemption can be justified.

Additionally, research using secondary data alone does not automatically qualify for exemption, as ethical considerations such as identifying information and the sensitivity of the data still need to be evaluated. Hence, while secondary data may sometimes reduce risk, it does not inherently exempt a study from IRB requirements. Furthermore, the idea that exemption applies only to government agencies is incorrect because the criteria for exemption apply across various types of research institutions and settings, not limited to a specific subtype.