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Conflicts Of Interest In International Human Drug Research And The Insufficiency Of International Protections, Robert Gatter
Conflicts Of Interest In International Human Drug Research And The Insufficiency Of International Protections, Robert Gatter
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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 …
Walking The Talk Of Trust In Human Subjects Research: The Challenge Of Regulating Financial Conflicts Of Interest, Robert Gatter
Walking The Talk Of Trust In Human Subjects Research: The Challenge Of Regulating Financial Conflicts Of Interest, Robert Gatter
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There has been a call for more stringent regulation of financial conflicts of interest in human subjects research following the deaths of several individuals who volunteered to participate in human subjects research, which deaths were linked to the financial conflicts of interest of participating researchers and research institutions. Each proposal argues that regulation is necessary to restore trust in medical research. This Article examines whether proposed strategies for regulating financial conflicts of interest are likely to achieve the goal of a trustworthy human research enterprise. It does not question whether enhancing trustworthiness is an appropriate goal; rather, it assumes that …