Regulating the research enterprise: international norms and the right to bodily integrity in human experiment...

This article analyzes international law claims in human subject litigation, arguing that the failure of federal courts or Congress to oversee this kind of litigation by providing or recognizing a federal cause of action for research torts is an injustice. It is about two distinct and somewhat arcane areas of the law, international law and the law of human subjects research. Because they draw on different historical, social and conceptual frameworks, each has its own descriptive section in the article. In the first section, the author briefly describes international law and its place in the U.S. constitutional order. This section explains why international law claims are routinely rejected by the courts. In the second section, the author discusses the moral underpinnings of the research enterprise and explains how the values of science contradict the values of human rights and medicine. The author concludes that Congress or the judiciary should recognize the social magnitude of the research enterprise, the difference between the values of science and the values of medicine, and the meaninglessness of individual informed consent when considered on a population level. Citizens should be provided with a clearly defined cause of action for research harms to human subjects.