Historical and Regulatory Background

This chapter describes key historical events that have shaped ethical rules and policies concerning research with human subjects, including the Tuskegee Syphilis Study, the Nazi experiments on concentration camp prisoners, the Willowbrook hepatitis experiments, the US government’s secret human radiation experiments, Stanley Milgram’s obedience to authority experiments, the Stanford prison experiment, and Jesse Gelsinger’s tragic death in a gene therapy study. The chapter also discusses the Belmont Report and its impact; provides an overview of the US federal regulations, including the Common Rule, the FDA regulations, and the IRB system; and reviews international guidelines, such as the Nuremberg Code and the Helsinki Declaration. The chapter argues that the social and political response to historical events has been to develop an oversight system to restore and maintain public trust in research. An important question that emerges at the end of this chapter is whether the current system provides too much or too little protection for human research subjects. To answer this question satisfactorily, one needs a philosophical framework that can address ethical and regulatory dilemmas in research with human subjects.