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 womenâ€"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: Scientificâ€"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 Ethicalâ€"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. Legalâ€"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. Riskâ€"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.

In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.

The workplace is where 156 million working adults in the United States spend many waking hours, and it has a profound influence on health and well-being. Although some occupations and work-related activities are more hazardous than others and face higher rates of injuries, illness, disease, and fatalities, workers in all occupations face some form of work-related safety and health concerns. Understanding those risks to prevent injury, illness, or even fatal incidents is an important function of society. Occupational safety and health (OSH) surveillance provides the data and analyses needed to understand the relationships between work and injuries and illnesses in order to improve worker safety and health and prevent work-related injuries and illnesses. Information about the circumstances in which workers are injured or made ill on the job and how these patterns change over time is essential to develop effective prevention programs and target future research. The nation needs a robust OSH surveillance system to provide this critical information for informing policy development, guiding educational and regulatory activities, developing safer technologies, and enabling research and prevention strategies that serves and protects all workers. A Smarter National Surveillance System for Occupational Safety and Health in the 21st Century provides a comprehensive assessment of the state of OSH surveillance. This report is intended to be useful to federal and state agencies that have an interest in occupational safety and health, but may also be of interest broadly to employers, labor unions and other worker advocacy organizations, the workers' compensation insurance industry, as well as state epidemiologists, academic researchers, and the broader public health community. The recommendations address the strengths and weaknesses of the envisioned system relative to the status quo and both short- and long-term actions and strategies needed to bring about a progressive evolution of the current system.