Statement on Sex, Gender, Variations of Sex Characteristics and Sexual Orientation in Health and Medical Research

Vision

Improved health outcomes for all people in Australia by ensuring the evidence base that informs our health care system considers sex, gender, variations of sex characteristics and sexual orientation.

Purpose

The purpose of the Statement is to improve health outcomes by:

• improving knowledge of research gaps related to historical underrepresentation of sex, gender, variations of sex characteristics and sexual orientation in various research fields and topics
• improving consideration of, and accurate data collection about, sex, gender, variations of sex characteristics and sexual orientation throughout the design, conduct, analysis, reporting, translation and implementation of all research
• promoting increased inclusion of women and men, both cisgender and trans, non-binary people, people with innate variations of sex characteristics and people with diverse sexual orientations in research, particularly where they have been historically underrepresented or excluded
• promoting effective, sensitive and safe involvement of people with lived experience in all stages of research projects
• encouraging more effective partnerships between consumers, researchers, clinicians, and other research stakeholders.

These practices aim to ensure that health and medical research produces an evidence base that is relevant to all people in Australia.

In reading and using this Statement, it is important to note the following:

• The term ‘the Variables’ will be used in some instances in the Statement as an abbreviation of the term ‘sex, gender, variations of sex characteristics and sexual orientation’. This is intended to improve the readability of the Statement only and is not intended to describe (or exclude) any groups of people.
• The intention of this Statement is not to increase the pool of researchers who focus only on the Variables but that all researchers applying for, and in receipt of, NHMRC and/or MRFF grant funding will consider the Variables in research question setting, design, conduct, analysis, reporting, translation and implementation.
• Terminology relating to the Variables is strongly contested, particularly terminology to describe gender identity and intersex variations. Researchers are encouraged to be cognisant of any community sensitivities and integrate them into their research as appropriate to maximise community participation and benefit.
• While consideration of the Variables is encouraged in all research, particular consideration and sensitivity should be given to these variables where there is existing evidence or reason to believe there will be differences or specific influencing factors due to these variables.
• While the Statement is focused on the Variables, it is acknowledged research operates within a larger intersectional framework, including cultural and linguistic diversity, age, socio-economic status, abilities, and geography, that impacts equitable health outcomes.

Background

Health and medical research provides the evidence base to inform Australia’s health care. Including people from all sex, gender, variations of sex characteristics and sexual orientation population and communities in research is primarily an issue of human rights and health equity, and providing higher quality, and safer health care for all people in Australia. Inclusive research is research that is safe, sensitive and effective; will provide critical data to improve understanding of health gaps and solutions; uses funding to support broad application of research across all population and community groups; and will lead to more inclusive, safe and appropriate health care and health outcomes.

Promotion of research that is inclusive of sex, gender, variations in sex characteristics and sexual orientation is now being recognised and put into practice by public funding agencies around the world.¹ This complements the increasing recognition of the need for consumer involvement and co-design in research projects to produce outcomes that are both priorities for and usable by patients, consumers, clinicians and other stakeholders. These approaches are based on the appreciation that the best way to design research for groups of high unmet need is to meaningfully engage with these groups and to work in partnership, harnessing their lived experience, to understand their needs and priorities throughout the research lifecycle. Effective partnerships are at the core of this work. Every part of the research community has a role to play in improving practices.

It is important to acknowledge that inclusion and effective partnerships have not always been the norm. Historically, the limited consideration of sex, gender, variations of sex characteristics and sexual orientation in health and medical research has led to many population groups being excluded or discouraged from research participation, or made invisible in research findings,² or has led to inappropriate and/or harmful health care,³ lack of consideration in health and public policy, and/or continued discrimination. The populations who have been, and still are, impacted by these practices vary based on the research area, and include women and men, both cisgender and trans, non-binary people, people with variations of sex characteristics and people with diverse sexual orientations. However, it is also important to acknowledge that some historical exclusion from research was due to safety concerns. For example, the exclusion of women from clinical trials due to pregnancy or the potential of pregnancy was intended to avoid fetal harm.⁴ It is now acknowledged that it is important to ensure that all populations can be safely and meaningfully included in research to support targeted health care and equitable health outcomes.

Safe involvement in research for any individual or population includes ensuring that effective physical, emotional and psychological safeguards are in place at all stages of the research project. For example, ensuring that:

• research teams have strong capacity and capabilities in safely and sensitively involving people with lived experience
• individuals and population groups with lived experience are meaningfully and effectively involved in prioritisation, design and conduct of research that impacts them or has the potential to impact them
• individuals are provided the information they need to make informed decisions about consenting to participate in research
• the research team recognises the human rights of people with lived experience, including the right to bodily integrity
• support for confidentiality, health and wellbeing of research partners and participants is demonstrated.

The Statement is an opportunity to learn from past practices and apply them in a modern Australian context, to improve research practice and create better evidence and ultimately better health care for all. It has been developed by NHMRC and the Department of Health, Disability and Ageing, responsible for implementation of the MRFF, following both targeted and public consultation processes. The Statement is intended to complement a range of existing NHMRC and MRFF guidance, which researchers must continue to adhere to, including the:

• Australian Code for the Responsible Conduct of Research
• National Statement on Ethical Conduct in Human Research
• Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
• Principles for consumer involvement in research funded by the Medical Research Future Fund
• Statement on consumer and community involvement in health and medical research
• Australian code for the care and use of animals for scientific purposes
• NHMRC’s Research Quality Strategy.

NHMRC and the Department of Health, Disability and Ageing will work with the sector over time to establish improved consideration and increased inclusion of women and men, both cisgender and trans, non-binary people, people with innate variations of sex characteristics and people with diverse sexual orientations in research through each organisation’s respective granting processes. Researchers and their supporting stakeholders are encouraged to reflect and start doing what they can now, to improve consideration of the Variables in their research.

It is acknowledged that effectively introducing and embedding this work is a challenge requiring support and action from all stakeholders, including across all levels of government, research funding organisations, research organisations, ethics committees, researchers, local health networks, non-government organisations, groups of high unmet need, patients, consumers, clinicians and health service providers.

¹ L Hunt, MW Nielsen and L Schiebinger, ‘A framework for sex, gender, and diversity analysis in research’, Science, 2022, 377(6614):1492-1495,DOI: 10.1126/science.abp9775.

² M Carman, C Farrugia, A Bourne, J Power and S Rosenberg, Research Matters: How many people are LGBTIQ? [PDF 104KB], Rainbow Health Victoria, 2020, accessed 24 August 2023; M Carpenter, Researching intersex populations, Intersex Human Rights Australia website, 2023, accessed 24 August 2023.

³ I Zucker and BJ Prendergast, ‘Sex differences in pharmacokinetics predict adverse drug reactions in women’, Biology of Sex Differences, 2020, 11(32), doi:10.1186/s13293-020-00308-5; M Frommer, J Howell, E Santow, S Cochrane and B Alston, Ensuring health and bodily integrity: towards a human rights approach for people born with variations in sex characteristics, Australian Human Rights Commission, Australian Government, 2021, accessed 26 September 2023.

⁴ I Zucker and R van der Graaf, ISE van der Zande ISE, HM den Ruijter, MA Oudijk, JJM van Delden, K Oude Rengerink and RHH Groenwold, ‘Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach’, Trials, 2018, 19(1):78, doi:10.1186/s13063-017-2402-9; A Yakerson, ‘Women in clinical trials: a review of policy development and health equity in the Canadian context’, International Journal for Equity in Health, 2019, 18(56), doi.org/10.1186/s12939-019-0954-x.