International research is research that is:
- conducted outside the U.S. and outside of U.S. territories and possessions; and
- involve one or more subjects who are not U.S. citizens and who are not U.S. government employees.
The Department of the Navy (DON) requires that all human subjects research conducted internationally include host nation approval, host country ethics review, and DON Human Research Protection Program administrative review (unless determined exempt by the IRB).
Please contact the IRB early if you are considering conducting international human subject research so that IRB can assist by providing guidance and samples on how to meet host nation approval and host country ethics review requirements. In most cases approval from the host country’s embassy serves as host national approval and IRB or similar ethics review in country serves as a host country ethics review.
Plan IRB, Command Counsel, and DON HRPP review to take 10 weeks once a complete package is received.