Human Rights and the Regulation of Transnational Clinical Trials

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Abstract

One of the more worrying trends in globalization today is the growing practice of Western companies relocating clinical trials to impoverished countries. This article begins by providing a comprehensive description of the practice and its current regulatory oversight. It is argued that this regulatory scheme is insufficient for protecting the interests of test subjects in such relocated trials. The article then suggests an alternative scheme, embedded in the general framework of human rights protections, and develops the contours of such a human-rights-based regulatory scheme. It concludes by arguing why this alternative regulatory framework does a better job of protecting the interests of test subjects than those regulatory schemes currently available: the Declaration of Helsinki and the statement of Good Clinical Practice.

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