Inclusion in research is a question of both scientific validity of research results and just distribution of the benefits of medical research within a community. Therefore, inappropriate exclusions from research can be regulated as a matter of science or a matter of ethics. In this paper we examine the definitions of appropriate/fair inclusion in the Australian and U.S. regulatory systems and discuss the processes for interpreting and implementing these normative standards. In the second part of the paper, we present original (...) results from the first study of sex-specific research in Australia. One hundred and thirteen published papers were examined: 35 percent were classified as inappropriate sex-specific research, where exclusion was not biologically necessary, and/or there was no justification for the exclusion of one sex. Our results indicate that a scientific approach to inclusion, rather than one grounded in ethical review, is likely to be more effective in achieving appropriate sex-specific research. In the absence of effective regulation, we will continue to see research that discriminates unfairly and perpetuates gender stereotyping. (shrink)

Women’s access to health and medicine in developed countries has been characterized by a range of inconsistent inclusions and exclusions. Health policy has been asymmetrically interested in women’s reproductive capacities and has sought to regulate, control, and manage aspects of women’s reproductive decision making in a manner unwitnessed in relation to men’s reproductive health and reproductive decision making. In other areas, research that addresses health concerns that affect both men and women sometimes is designed so as not to yield data (...) relating to the ways in which women’s physiology and gendered location may affect their experience of the condition and its response to treatment, despite a literature on the significance of sex and gender differences in health research. This paper draws on the situation in Australia to explore the ethical significance of these inconsistencies as failing the ideals of high-quality medical research and evidenced-based health care. (shrink)