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To gain entry to the lucrative American market, newly developed drugs must be licensed by the U.S. Food and Drug Administration. Since 1975, the FDA has required applications for licensure from research studies conducted outside the United States to comply with the Declaration of Helsinki, one of the most influential international codes of research ethics. But last October, the FDA announced that it will now use Good Clinical Practice (GCP) regulations, an international quality standard written by the International Conference on Harmonisation, to ensure that foreign-based studies have been conducted ethically. What is the motivation behind the FDA’s change of regulatory requirements, and what is the larger ethical significance of this move as ever more clinical trials are outsourced to resource-poor, developing countries?