Medical Research on Humans: Regulation in Switzerland, the European Union, and the United States

March 2005

60 Food and Drug Law Journal 45-78 (2005).

This article provides an overview of the regulations governing the conditions for clinical trials on an international level including the Nuremberg Code , the Declaration of Helsinki, the Convention on Biomedicine of the Council of Europe and the Guidelines of CIOMS (Council for International Organizations of Medical Science) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), as well as the regulations in Switzerland, the European Union, and the United States.

The general comparison of the different regulations reveals three common features: the high and increasing level of precision, the trend towards international harmonization, and the close interaction between state and private actors. With regard to substantive issues, the basic conflict between the public's interest in effective medical research and the conflicting interest of the human research subjects in the promotion and protection of their health requires careful balancing. Informed consent and the correlation of risks and benefits as well as approval by institutional review boards or ethics committees have become internationally recognized standards. Special groups of research subjects (i.e., children, incapacitated adults, pregnant or breastfeeding women, prisoners and military personnel), research in emergency situations, and placebo studies still pose normative problems that are handled quite differently by the various national and international regulations.


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