ABSTRACT
This chapter describes the Food and Drug Administration (FDA) role in relationship to the participants. In addition to the FDA, the major participants in clinical investigation are drug company sponsors, clinical investigators, IRBs, and patients and other volunteers. The FDA maintains a clinical bioresearch monitoring program the purpose of which is to monitor both sponsors and clinical investigators to determine whether they are fulfilling their responsibilities. A few years ago the FDA proposed detailed regulations that describe the responsibilities of both clinical investigators and sponsors of investigational drug studies. The FDA's regulations require that, prior to use of a test article, informed consent be obtained from the subjects of research regulated by the FDA. FDA regulations require that, except where a condition is rare in the United States, at least some studies must be performed in this country in order to permit approval of a drug for marketing.
