For many years women were excluded from or underrepresented in clinical research studies. In the early 1990s federal policies governing women and medical research were revised. Two agencies, NIH and the FDA, took the federal guidelines and implemented very different and distinctive policies governing the representation of women in clinical studies. This research focuses on why different policy regulations were adopted by these agencies. In the detailed case studies that are produced, two distinct models of policy making are tested. Each model offers specific predictions concerning when alternative paths are taken by agencies. This research provides a greater understanding of those factors that influence public policy, the procedures by which they are developed and the specification of alternative policy options within the U.S. political system.
