Introduction

The ethical governance of biomedical research is an area of intense international debate. Scholars argue about who should regulate and how, the appropriate role for ethics committees, what kind of research should be included, and who should be involved in monitoring compliance. A particular aspect of these debates concerns the inclusion of women as research participants and the efforts to ensure that researchers consistently investigate questions of sex and gender in health research. There is increasing evidence of the role of sex in the manifestation and course of some illnesses and their treatment. Moreover, evidence suggests that gendered expectations also affect health outcomes. This special issue investigates how researchers are addressing these issues and debates the appropriate roles of policy makers, ethicists, and lawyers in ensuring that sex and gender differences are taken into account in the development, conduct, and reporting of health research.

Over the past twenty years, in many jurisdictions, significant work was undertaken to address the historical imbalance between male and female participants in health research. However, a balance in numbers is only one component of sex and gender equity in health research. Analysis of data on the basis of sex is another key element in the development of research instruments and programs that properly manage the impact of sex and gender on disease and treatment options. When deciding to perform sex-specific research, proper justification must be given for the exclusion of one sex, whether male or female. The decision to include or exclude women who are pregnant, breastfeeding, or not using contraceptives raises questions about the relevance of data gathered in such research to significant subpopulations that are likely to need access to the treatments being tested. Careful analysis of a study is required to ensure that gender stereotypes did not unwittingly inform the project design. How are such issues to be dealt with at the policy and regulatory levels? Should we have laws that require researchers to undertake research that is equitable, or should we leave such governance to ethics committees or even to peer reviewers who assess the scientific calibre of the work? The papers in this special issue address these questions.

The first three articles present specific examples of the challenges of equitably including women and men in research. In a carefully argued and thought-provoking analysis, Lyerly, Little, and Faden call for researchers to rethink their approach to including pregnant women in clinical trials. They suggest shifting the burden so that exclusion rather than inclusion of pregnant women must be justified. While arguing for a framework that has an overarching concern for the impact of medications on both the woman and the fetus, nevertheless, they point out that pregnant women need effective treatment during pregnancy. Failure to treat illness during pregnancy can lead to harm for both the pregnant woman and her fetus.

Diniz's contribution from Brazil explores the issue of the ethical governance of social science research involving women. Taking as her example an ethnographic study of women who sought abortions for anencephaly in Brazil during a period of legal uncertainty in 2004, Diniz describes the complexity of the research ethics issues raised by the study. Her analysis aptly demonstrates the limitations of applying a biomedical model of research ethics to the social sciences. One particularly significant difference between social science research and medical research relates to methodology, which can shift dramatically during the course of an ethnographic project. Diniz argues that therefore different strategies are required for dealing with informed consent and vulnerable populations in social science research.

The third piece by Rogers and Ballantyne presents empirical results from a study of sex-specific research in Australia. Having reviewed 113 sex-specific clinical research studies conducted in Australia and published during 2003–2006, they found that approximately 35 percent involved inappropriate exclusion of either men or women. Arguing that in some instances the decision to undertake a single-sex study was based on gendered stereotypes, they note, for instance, that whereas the two male-only injury prevention studies both involved young male sports players, both of the female...