Which factors determine if a study can be exempt from IRB review?

The correct answer highlights that a study may be exempt from IRB review if it involves minimal risk and fits within specified exempt categories established by regulatory guidelines. The exemption categories are clearly defined, allowing certain types of research involving minimal risk to human subjects to be conducted without the need for full IRB oversight. This helps streamline research processes while ensuring that the rights and welfare of participants are still safeguarded.

In contrast, while significant funding sources or the volunteer status of participants are relevant considerations in research ethics, they do not alone determine whether a study is exempt from IRB review. Moreover, being a nonclinical research study also does not inherently qualify a research project for exemption. The key determinant remains the level of risk involved in the study and how it aligns with the established categories for exemption.