Sex and Gender Equality: Expectations and Information

From 2026 Heart Research UK expects grant applicants to consider sex and gender equality in their research design and analysis; the involvement of people with lived experience; and in their research reporting and wider dissemination. We will also ask existing grantholders to report data disaggregated for sex and gender where possible.

These changes align with the Research Strategy strategic pillar ‘Reflecting the Patient Population’. Therefore, where possible, we expect research involving human participants to have a target sex and/or gender distribution that reflects the population that is affected by the condition being studied. Similarly, research involving animals or animal cells/data should not be single sex, unless there is a strong justification for doing so. We also expect researchers to outline their planned strategies for meeting the target sex and/or gender distribution.

While we currently only ask specific questions about sex and gender, we encourage researchers to consider multiple relevant demographic factors, as appropriate, into their experimental design, study protocol and dissemination. These could include, but are not limited to, age, sex, gender, ethnicity or socio-economic status.

Expectations for applications and reports

We now ask applicants to account for sex and gender at specific points in the application form.

Detailed Research Proposal:

• We require an overview of the sex and/or gender characteristic(s) that will be considered and accounted for in the study.
• We require an analysis plan, including details of any planned sex- and/or gender-disaggregated analyses. If sex- and/or gender-disaggregated analysis is not planned, you must explain why.

Patient and Public Involvement:

• We require details about recruitment of people with lived experience to be involved and/or participate in the research, including the target distribution of participants/subjects by sex and /or gender.
• We require information on the number to be recruited and planned strategies to meet the target sex and/or gender distribution.

Research involving animals:

• We require details about the target distribution of subjects by sex, how many animals in total, and of each sex, and why this distribution has been selected to answer the research question?
• We require details on the planned actions for procuring, managing and storing/housing the target sex distribution of subjects.

Progress reports

We require grantholders to submit an annual progress report. For those projects which include people with lived experience as participants we expect the annual report to include information on the sex and gender of those recruited to the study to date, as well as other relevant characteristics. If necessary, the report should also include any planned or already undertaken actions to improve diversity.

Final reports

A final report is required within six months of the grant completion. We expect grantholders to include data disaggregated by sex and gender as well as other relevant characteristics.

Resources

Sex and gender:

The MESSAGE (Medical Science Sex and Gender Equity) initiative has developed resources on how to consider sex and gender in research, including a sex and gender e-learning for researchers

Research with human participants:

• Inclusivity Checklist for Clinical Research– Heart Research UK supported the development of a practical checklist of strategies to promote diversity and inclusion in clinical research.
• Trial Forge resources on improving clinical trial diversity– resources to improve diversity and develop inclusive trials.
• Burgess S, Zaman S, Towns C, Coylewright M, Cader FA. The under-representation of women in cardiovascular clinical trials: State-of-the-art review and ethical considerations. Am Heart J. 2025 –assesses the representation of women in clinical trials and actions to increase participation of women in trials.
• Research inclusion toolkit hub on NIHR Learn– you will need to create an NIHR Learn login to access these resources.

Research involving animals:

• NC3Rs have developed the Experimental Design Assistant, which is a free-to-use online tool to help you design in vivo experiments more rigorously.
• NC3Rs and MRC webinar on Using both sexes in animal experiments.
• The Sex Inclusive Research Framework tool provides guidance to researchers in designing preclinical research aligned with a sex-inclusive research philosophy. The framework consists of a decision tree to evaluate a preclinical research proposal, which leads to “traffic light” outcome classifications, indicating whether a proposal is appropriate, carries some risks, or is insufficient with regards to sex inclusion.
• The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) are a checklist of information to include in publications describing animal research

Definitions:

• Sex refers to the biological attributes which differentiate females and males, and which can include variations of what are considered female-typical and male-typical characteristics (sometimes known as “variations in sex characteristics” or “intersex”).
• Gender refers to an aspect of a person’s identity. A person is subjected to a range of social forces (both constraints and privileges) based on their gender, which may influence their behaviours, their perception of themselves and how they are treated by others. All these influences may be relevant for biomedical, health and care research.
• Participation in research is about people giving formal consent and taking part in a trial or study.
• Involvement in research is research done with or by patients and the public, not to, about or for them. It is about working collaboratively with patients and the public and sharing decision-making.