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Conflicts Of Interest In International Human Drug Research And The Insufficiency Of International Protections, Robert Gatter

All Faculty Scholarship

The problem of financial conflicts of interest in human subjects research is international in scope as drug manufacturers conduct trials in countries outside of the U.S., Japan, and the European Union, thereby side-stepping domestic regulation of conflicts of interest. Because such out-sourcing of human drug trials results in exporting risks associated with financial conflicts of interest, this essay examines the primary international sources for regulating those conflicts. These sources include the World Health Organization’s Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, the Guidelines for Good Clinical Practice adopted by the International Conference on Harmonisation of Technical Requirements …