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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 [End Page 1] 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 [End Page 2] involved young male sports players, both of the female-only injury prevention studies focused upon preventing falls in elderly women.

The second group of articles steps back from the particular to examine the role of governance regimes in ensuring appropriate management of gender equity in health research. Dodds explores the relationship between inequity in health research and access to clinical care and treatment. Comparing policy initiatives in two of Australia's state governments that aimed to provide better outcomes for women in relation to reproductive and sexual health, she argues that health policy systems that do not adequately address existing societal inequity will be incapable of developing appropriate governance mechanisms.

Bennett and Karpin explore the regulatory options for gender equity in health research. This is by no means a straightforward issue, given the lack of clarity in relation to legal definitions of sex and gender. The various mechanisms to achieve the goals of gender equity include sex-specific regulatory solutions, gender-neutral forms of regulation, and the use of general rules requiring fairness and justice. Bennett and Karpin argue that sex-specific regulation is better than relying upon general rules about fairness, and legislation is likely to be more effective than non-legal regulation.

Peppin and Mykitiuk explore the regulatory framework for clinical trials in Canada and consider the extent to which Canadian laws and guidelines promote gender equity. They argue that although Canada has developed guidelines and organizations aimed at the inclusion of women in clinical trials, the goal of gender equity has not been fully translated into tangible outcomes. For Peppin and Mykitiuk, achieving gender equity in health research requires a commitment to the use of legislative and administrative tools to support change.

The final two papers address a recent focus of feminist bioethics scholarship—the ethical sourcing of human eggs from female donors for somatic cell nuclear transfer research. Dickenson long has argued that women have been invisible in debates about the ethics of stem cell and cloning research. However, it is only as the demand for human eggs intensifies that the ethical recruitment of donors finally is receiving mainstream attention. In this issue Dickenson and Idiakez eloquently argue that at present, conscientious researchers should not be asking women to donate. They conclude that the risks associated with donation are uncertain, that what is known of the risks indicates that they are too high, and that potential donors or sellers are not fully informed of the extent of the risks. Ballantyne and de Lacey, by contrast, argue that the current reliance on infertile women as sources of eggs breaches the principle of just participant [End Page 3] selection because the vast majority of such research is not related to fertility. Research participants should be selected from the population that stands to benefit from the research, not from a subpopulation that is convenient and accessible. Ballantyne and de Lacey conclude that it is preferable to recruit healthy donors from the general population for stem cell research that investigates general medical conditions.

In her commentary paper, Calkins analyzes the regulatory environment for research through her discussion of the accessibility of historical U.S. government records relating to human radiation experiments. Calkins argues that restrictions on access to government documents impose significant limitations for those working on historical and bioethical research.

The wide diversity of papers in this issue demonstrates the on-going interest that research with women generates for feminist scholarship. Early debates focused predominantly on how many women were being included in medical and health research. From this original point, analysis has extended both in scope and sophistication—probing assumptions about the exclusion of pregnant women, the use of women in stem cell research, the ethical framework in social science research, and the regulatory approaches best suited to managing these issues. We are pleased to offer such a rich and thoughtful collection of papers addressing the cutting-edge issues of women's participation in health research. [End Page 4]

Angela Ballantyne

Angela Ballantyne has a background in genetics and bioethics and is currently a visiting scholar at Yale University's Interdisciplinary Bioethics Center. She has published in leading medical and bioethics journals on research ethics, abortion, vulnerability and trust, and the inclusion of women in research.

Belinda Bennett

Belinda Bennett is Professor of Health and Medical Law and Director of the Centre for Health Governance, Law and Ethics at the Faculty of Law, University of Sydney. She is the lead chief investigator for the Gender Inequities in Health Research project funded by the Australian Research Council.

Isabel Karpin

Isabel Karpin is Senior Lecturer in the Faculty of Law at the University of Sydney. She is currently involved in several major research projects examining legal responses to reproductive technology, disability and emergent genetic technologies, and the challenges these responses pose to the understanding of normality, individuality, and family.

Wendy Rogers

Wendy Rogers is Associate Professor of Medical Ethics and Health Law in the School of Medicine at Flinders University in Australia. Her contributions to feminist ethics literature include the areas of menopause, evidence-based medicine, public health, trust and vulnerability, and gender equity in clinical research.

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