ABSTRACT
International law, as well as medical ethics, has long recognized that all participants in research must grant permission before the study begins. This consent must be both “informed” (meaning that risks are identified and understood) and totally “voluntary” (free of coercion). These principles are thought to be timeless and independent of national laws or local customs. Research that violates these principles is both unethical and illegal. For example, German doctors and researchers were convicted by the Allies in 1947 at the war crimes trials in Nuremburg for crimes against humanity, which included conducting harmful experiments on people without obtaining their voluntary, informed consent (for the text of the Nuremburg Code see Hornblum 1998, xi). Some defendants argued that their actions were legal within the framework of German law and ethical according to prevailing norms. They also argued that if the Allies wished to create a new law requiring informed consent that it should not be imposed ex post facto. The Allies asserted that voluntary, informed consent was a fundamental human right that transcended jurisdictional boundaries and that the Nuremburg trials were not establishing new law, but rather reaffirming existing law.
