How should IRBs deal with research in foreign countries?
The US institution administering the research has the primary responsibility, normally codified in an Assurance, to ensure that the project complies with US regulations. The Common Rule 101 (h) discusses foreign human subjects regulations and procedures for substituting them for US regulations. When an appropriate foreign IRB exists the regulations foresee involving it in reviewing the research. The US institutions IRB chair determines that the procedures prescribed by the foreign IRB afford protections that are at least equivalent to those provided in the Common Rule. This regulation is most germane to biomedical research, as few foreign countries apply human subjects regulations to social and behavioral science. In many foreign countries IRBs deal only with biomedical research and will refuse to extend their purview to cover social and behavioral science. In other foreign situations there will be no analogue to an IRB and the concept may be irrelevant. When this situation occurs, the
