Human Rights and the Regulation of Transnational Clinical Trials

One of the more worrying trends in globalization today is the growing practice of western companies relocating clinical trials to impoverished countries. This paper starts by providing a comprehensive description of the practice and its current regulatory oversight. It argues that this regulatory scheme is insufficient in protecting the interests of test subjects in such relocated trials. It 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 regulative 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.