Young people with a variation in sex characteristics in Aotearoa/New Zealand: identity, activism and healthcare decision-making.

Young people born with variations in sex characteristics (VSC) or disorders of sex development (DSD) face numerous challenges in navigating issues relating to identity and to their lived and embodied experience. There is limited published research amplifying the voices of young people with a VSC, especially from Aotearoa/New Zealand. This qualitative study provides an up-to-date picture of the lived experience of 10 young people with a VSC in Aotearoa/New Zealand. The research was conducted in collaboration with the advocacy group, Intersex Youth Aotearoa, and explored the level of support provided by health services, peers and advocacy groups in relation to the ways the participants viewed themselves and their bodies, and their health related decision-making. Findings reveal the pressure on young people with a VSC to conform to cultural and societal norms, specifically, heteronormative and traditional constructs of how male and female bodies should look in Aotearoa/NZ society. Such views, often held and perpetuated by health professionals and parents, contributed to complexities surrounding identity, agency and acceptance of difference experienced by these young people. The implications of these findings are discussed, including the need for better psychological and peer support for young people.

How to do research fairly in an unjust world.

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research.

New Zealand needs guidelines for the safe and responsible inclusion of pregnant women in medical research.

Pregnancy is a crucial window of time that influences long-term population health. As a matter of justice, pregnant woman are entitled to high quality, evidenced-based care. As a matter of population health, we need to better understand foetal development, particularly the impact of lifestyle, stress, chronic conditions and clinical treatment during pregnancy. Pregnancy continues to be dominated by the precautionary principle, advocating for the routine exclusion of pregnant women from medical research, particularly intervention studies, on the grounds of foetal vulnerability. But this stance simply shifts the risk into the community. Due to a lack of evidence-based data, many pregnant women are refused medically important drugs, are subject to dangerous delays in getting drugs, or are prescribed drugs that are thought 'safe', despite evidence of possible teratogenicity. I argue that New Zealand needs to shift to a default position of inclusion of pregnant women in research; and to develop guidelines to facilitate their safe and responsible inclusion. The uniqueness of pregnancy gives rise to specific questions regarding research ethics. These questions warrant focused debate and the answers cannot simply be deduced from the general principles of research ethics we currently have in New Zealand.

Position statement on the provision and procurement of human eggs for stem cell research.

The nature of compensation for women who donate eggs (oocytes) for research remains a contentious issue internationally. This position paper lays out the arguments for, and discusses the arrangements in which, a modest payment might be ethically justifiable.

Sex bias in studies selected for clinical guidelines.

OBJECTIVE: To determine the proportions of female participants in research studies selected to inform the development of national clinical guidelines and to assess these against the proportions of women affected by the conditions. METHODS: We assessed 392 published articles, involving a total of 5.2 million participants, cited as references in five influential clinical guidelines addressing the use of antiarrhythmics, chronic fatigue, depression, diabetes, and colorectal cancer. For each article, we extracted the number of female participants to determine any discrepancies in the sex of participants and if the proportion of female participants as research subjects reflected the sex distribution of patients affected by the condition. RESULTS: The overall and median percentages (per study) of females per guideline were: use of antiarrhythmics (35%, median 38%), chronic fatigue (70%, median 73%), colorectal cancer (67%, median 46%), depression (66%, median 66%), and diabetes (63%, median 50%). The baseline prevalence rates used for comparison purposes were (percentage female): antiarrhythmics (60% of patients 75(+) years); chronic fatigue (66%), colorectal cancer (46%), depression (66%), and diabetes (46%). CONCLUSIONS: The colorectal cancer, depression, and chronic fatigue guidelines were based on research populations that accurately reflected the sex distribution of the condition in the general population. Women were slightly overrepresented in the research studies supporting the diabetes guidelines and were significantly underrepresented in the research studies supporting the guidelines on the use of antiarrhythmics. Guideline developers should be aware of and comment on the potential impact of sex. Where the evidence base is lacking, guideline developers should highlight this and, where necessary, limit their specific conclusions to populations on whom the research was performed.

Exclusion of women from clinical research: myth or reality?

OBJECTIVE: To determine the proportion of male and female research participants and rates of sex-based analysis and sex-specific reporting in published Australian clinical research. PARTICIPANTS AND METHODS: We assessed 400 clinical studies involving Australian-only participants, published in journals between January 1, 2003, and May 31, 2006 (100 per year). Numbers of male and female participants in each study and presence or absence of analysis by sex (covariate adjustment, subgroup analysis, or sex-specific reporting) were recorded. Sex-specific studies were evaluated to determine whether the exclusion of one sex was biologically necessary. RESULTS: The total sample comprised 546,824 participants, of whom 73% were female; 36 studies were male-only, 78 were female-only. Of the participants in 286 studies that were not sex-specific, 56% were female. Of 114 sex-specific studies, the segregation by sex was deemed to be biologically necessary in 62%, ie, the research related directly to male or female biological function. More than one-quarter (28%) of studies with 30 participants or more published covariate adjustment or subgroup analysis by sex; 7% included sex-specific reporting of results. CONCLUSION: We found no routine exclusion of women; however, few publications analyzed results by sex. Some studies excluded women or men for apparently arbitrary reasons. Research performed with male-only participants differed in nature and size from that performed with female-only participants. These data indicate the need to track the sex of research participants. In addition, they provide the basis for assessing appropriate inclusion of men and women in research and for comparing any relationship between different international regulatory models and the rates of female participation in research.

Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs.

OBJECTIVE: To explore the role played by human research ethics committees (HRECs) with regard to the fair inclusion of men and women in Australian clinical research. DESIGN AND PARTICIPANTS: Semi-structured face-to-face and telephone interviews with 25 chairs (or their nominees) of Australian HRECs between 9 June 2006 and 24 January 2007. MAIN OUTCOME MEASURES: Chairs' views about the role of HRECs in identifying sex discrimination, monitoring the inclusion of men and women in clinical research, and interpreting and applying National Health and Medical Research Council (NHMRC) guidelines relating to fair inclusion in research. RESULTS: In general, HRECs do not take an active role in monitoring the sex of research participants. They do not ask for or often receive information about the sex of participants. Most HREC chairs did not believe that sex discrimination in research is currently a significant or widespread problem, and were confident that their committees would be able to identify arbitrary exclusion of either men or women from research. However, many chairs expressed a lack of familiarity with debates about sex equity in research. Most chairs were unaware that anti-sex-discrimination legislation could apply to research. "Fair inclusion" was interpreted in a number of ways by chairs, but most frequently that the sex balance among research participants should reflect the sex distribution in the community of the condition under investigation. Chairs said their committees would be reluctant to reject a research protocol on the grounds that the sex balance among participants was perceived to be unfair. CONCLUSION: Views about, and expertise on, sex equity in research vary among chairs of HRECs. Many HRECs require further guidance about the appropriate standards for fair inclusion of men and women in Australian clinical research.