If a proposed study is exempt from federal regulations, is a review required at the foreign site where it takes place?

A study that is deemed exempt from federal regulations does not necessitate a review at the foreign site where the research is conducted, provided that the conditions for exemption are met. If a study qualifies for exemption, it indicates that it is considered low-risk, and thus does not require the same level of oversight as non-exempt studies.

However, it is important to recognize that while federal regulations may not mandate a review, researchers must remain aware of local regulations or ethical standards at the foreign site. These local factors can sometimes impose additional requirements regardless of the federal exemption status. As such, while the exemption alleviates the need for a review under U.S. federal law, it does not automatically exempt the research from consideration of local laws or ethical guidelines in the research setting. This makes the context of local standards relevant in practice, even if not strictly required by federal oversight.