A foreign site study has been deemed exempt by the host institution's policy. According to federal regulations, is review required at the foreign site?

A foreign site study has been deemed exempt by the host institution's policy. According to federal regulations, is review required at the foreign site?

• A. Always required
• B. Not required
• C. Required only if local laws require
• D. Irrelevant to decision

Answer: (B)

Exemption means the study doesn’t require IRB review. Federal regulations allow certain minimal-risk activities to proceed without IRB oversight, and that exemption applies to the project as a whole. If the foreign-site portion has been deemed exempt by the host institution, there’s no federal mandate to conduct additional IRB review at the foreign site solely because it’s abroad. Researchers should still consider local laws and sponsor requirements, but regarding the federal rule, review at the foreign site is not required for exempt research.

Exemption means the study doesn’t require IRB review. Federal regulations allow certain minimal-risk activities to proceed without IRB oversight, and that exemption applies to the project as a whole. If the foreign-site portion has been deemed exempt by the host institution, there’s no federal mandate to conduct additional IRB review at the foreign site solely because it’s abroad. Researchers should still consider local laws and sponsor requirements, but regarding the federal rule, review at the foreign site is not required for exempt research.