In the 19th century, some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The Proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning, yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. This book examines the facts behind the public's perceptions about women participating as subjects in medical research, as leading experts present general principles for the ethical conduct of research on women.

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.

In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues.

Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies.

Leading experts present general principles for the ethical conduct of research on women--principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research.

Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research.

The book addresses present-day challenges to equity in four areas:

• Scientific--Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics.
• Social and Ethical--The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants.
• Legal--Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases.
• Risk--The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed.

This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.