Sex and gender in health research policy

We are committed to supporting research that drives equitable health outcomes by advancing inclusive practices in our funded research. Sex and gender can influence whether and how we develop certain health conditions, how well we respond to treatments, and how often we seek health care. Accounting for sex and gender in health research will make the research more rigorous, more reproducible and more applicable to everyone.

We expect researchers we fund to integrate sex and gender throughout the research process where appropriate. This includes considering sex and gender in:

• research design involving human participants and animals, as well as human or animal tissues and cells
• the recruitment of participants in clinical research or trials
• data collection
• analyses conducted
• research publications and other outputs

Research proposals that do not consider sex and gender dimensions must provide a strong, evidence-based rationale for not doing so. 

This policy should be considered alongside our policies and guidance on:

• research involving human participants
• clinical trials
• responsible conduct of research
• use of animals in research
• equity, diversity and inclusion

We acknowledge that the terms ‘sex’ and ‘gender’ are used in different ways in different contexts. It is important that researchers understand which specific sex characteristics, gender characteristics, or both, are relevant for their research question and the affected populations. We use them as terms with distinct meanings as defined here:

Sex: refers to a set of biological attributes in humans and animals.

When considering sex for the purposes of research, the characteristic(s) to account for may include:

• Sex chromosomes
• Gene expression
• Hormone profile
• Secondary sex characteristics
• Internal reproductive organs
• External reproductive organs

This can also include variations of what are considered female-typical and male-typical characteristics (sometimes known as ‘variations in sex characteristics’ or ’intersex’). Researchers who do not know the sex of the cells and tissues they will use should plan to determine this as part of their research.

Gender: refers to an aspect of a person’s identity and to the socially constructed roles, behaviours, expressions and identities of girls, women, boys, men and gender diverse people.

When considering gender for the purposes of research, the characteristics of participants which researchers may need to account for include, but are not limited to:

• Gender identity (the gender with which a person identifies)
• Gender expression (how a person outwardly presents themselves in relation to gendered forces)
• Gender modality (whether a person’s gender identity is the same as their sex assigned at birth or not, that is whether they are cisgender or transgender)
• Perceived or presumed gender (how a person’s gender is typically understood by those around them, which may differ from their gender identity, gender expression, or both)

Additional terminology used in the policy:

• Subject: refers to any entity on which non- or pre-clinical research is conducted, including cells, tissues, organs and animals.
• Participants: refers to people with whom clinical and population health research is conducted.

In their funding applications, researchers must account for the following as part of their research:

Sex as a biological variable in non- or pre-clinical, clinical, health system and population health studies, where appropriate. 

The integration of sex as a biological variable may not be applicable in: 

• research involving pathogens grown in vitro in an acellular environmens
• some pre- and non-clinical research where justifiable
• application of some biomedical technologies

Gender where their research involves human participants or social determinants of health in either clinical, health system or population health studies where appropriate.

The integration of gender as a consideration of health may not be applicable in:

• biomedical research studies that exclusively use cells, tissues and animals
• certain single-sex studies using existing datasets
• secondary data analyses where it is impossible to create a new gender variable

In their funding application and as part of their research, researchers must also:

• Specify the sex characteristic(s), gender characteristic(s), or both, that they will account for in their research.
• Include a sample of sexes, genders or both that represent the affected population in their research design, including in patient and public involvement and engagement activities where appropriate.
• Include details of sampling strategies, relevant recruitment of research participants, and/or use of animals, tissues and cells.
• Conduct disaggregated analysis by sex, gender or both. If researchers are not planning to perform either a sex- or gender-disaggregated analysis, they must explain why.
• Where evidence suggests the potential for differential findings by sex, gender or both, studies should be designed and powered to enable appropriate subgroup analyses.
• Ensure publications and other outputs describe sex and gender dimensions of the study, including sample distribution, analyses and relevant findings. If disaggregated analyses have not been conducted or sex and gender differences identified, this must also be reported.

There may be studies when focusing on single-sex or single-gender samples in the research design is suitable, and we will accept this where appropriate justification is provided.