ABSTRACT

The Nuremberg Code was promulgated by four American judges at the Doctors’ Trial at Nuremberg, in the case of the United States of America v. Karl Brandt et al. in 1946 to 1947. For many years the Nuremberg Code played virtually no role in ethical discussions, public policies, and legal decisions in the United States. Most interpreters of medical research ethics concur that the Declaration of Helsinki was “greatly influenced by the Nuremberg Code,” despite its significant departures from the earlier code. This chapter examines what appears in law, regulations, guidelines, and practices to determine where there are important gaps. Hence, in research involving human subjects, the National Bioethics Advisory Commission has to identify and plug gaps, often by modifying or adding to what already exists. The distinction between principles and other normative formulations, such as rules, often hinges on their level of generality, with principles often being view as more general than rules and other more specific formulations.