International Research: Conducting Studies Outside United States
When conducting research to involve human subjects in countries outside US, the researchers must adhere by the same OHRP regulations that mandate ethical practices when intervening with US population. In instances where the regulations of an external country exceeds the OHRP regulations, then that country's law applies. Review the International Compilation (2013 Edition) for a listing of various non-US government agencies that govern research involving human subjects.
Researchers who seek approval to recruit participants in countries outside the US must complete appropriate CITI training modules prior to submitting their petition. The informed consent document must be presented in English for review and any translations to be used must also be presented. If the study will be conducted online, then the weblink must be submitted along with a hard copy of the study instruments. Any foreign collaborator must also comply with all OHRP regulations in addition to any other restrictions imposed by the non-US nation. All non-English documents presented to the IRB must be appropriately translated by the research team for IRB review. Occasionally, the IRB may use experts to review the non-English documents to confirm accuracy.