Human Research, Conflict of Interest, International Law, Pharmaceutical
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 for Registration of Pharmaceuticals for Human Use, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects adopted by the Council for International Organizations of Medical Sciences. Each source fails to adequately guard against the harm that financial conflicts of interest can do, and there is reason to believe this inadequacy results from the interest that drug manufacturers in the three largest drug-manufacturing and drug-consuming markets have to keep conflict of interest regulation to a minimum. Strategies for improving international standards are discussed.
Gatter, Robert A., Conflicts of Interest in International Human Drug Research and the Insufficiency of International Protections. American Journal of Law and Medicine, Vol. 32, No. 2 & 3, 2006.