According to the Common Rule, can all research exemptions be determined by any individual involved in the research?

The correct answer is that not all research exemptions can be determined by any individual involved in the research. According to the Common Rule, exemptions must be reviewed and determined by an appropriate institutional review board (IRB) or a designated official who is knowledgeable and qualified to make such determinations. This process ensures that the protections for human subjects are prioritized, and it prevents any bias or misinterpretation of the exemption criteria by personnel who may lack the necessary expertise.

Furthermore, while individuals involved in research, such as principal investigators, may have input or insights related to their studies, the final determination regarding whether a study qualifies for exemption is a responsibility that rests with an IRB or an appointed authority. This structured approach reinforces the integrity and ethical oversight that is critical in research involving human subjects.