Description: Recent headlines have alerted the public that women suffer from many of the same diseases that strike men (e.g., cardiovascular disease). But research subjects in many clinical studies may be disproportionately composed of men, possibly yielding appropriate treatments for that group only. Is this fair? Is this just? At first, the goal of equal representation in health research seems obviously laudable and relatively easy to reach. But adding more female subjects to research raises questions about science, legal liability, and governmental policies - and recalls the forces that may have led to women's exclusion. Protection of human research subjects began in 1949 in response to the horrible human experiments performed by the Nazis. Efforts to protect research subjects continued in the 1950s and 1960s in response to revelations of abuse - such as the Tuskegee Syphilis Study, in which African American men with the disease were allowed to remain untreated although effective antibiotic therapies were widely available. Indeed, reports of research that was unethical or at least questionable continue to surface today. Injuries caused by thalidomide and DES (diethylstilbestrol) resulted in new restrictions in the mid-1970s on the involvement of pregnant women and women of childbearing age in research. In the 1980s, however, women's desire to take greater control over their own health joined another rising tide in society: AIDS activists calling for greater access to experimental therapies. These two forces were instrumental in shifting the focus away from protection of research subjects toward wider access to the benefits of health research. In fact, measures enacted as protection were now seenas paternalistic. The 1993 National Institutes of Health Revitalization Act is a result of this movement, and it includes a particularly controversial requirement: Each NIH-funded study must include representative samples of subpopulations, particularly women and members of diverse racial and ethnic groups, unless their exclusion can be justified. Observers question whether we can afford studies large enough to ensure that women are adequately represented and that differences in response between men and women will be detected. The cost of implementing this provision may be so great that the Act thwarts its very purpose: promoting justice in clinical research. And justice is the heart of this complex issue. Have women truly been underrepresented in clinical research? How do social biases influence research agendas? What about liability for research-related harm? Do pregnant women and women of childbearing age need special consideration? Although a policy of equal inclusion of women in research rests on strong ethical and scientific arguments, such a policy also raises many urgent questions. This book grapples with the conflict between protection and access that characterizes the debate over the involvement of women as subjects in research. It explores the underlying concepts of justice and ethics that bolster women's demands for equal participation in scientific studies. But it also examines the practical issues such as legal liability - that must be resolved if equal access is to be achieved.

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