Improving sex and gender data in UK research

This year, our Small Grants Awards Scheme has been the first to include our support of the Medical Science Sex and Gender Equity (MESSAGE) Project. As a result, all medical research carried out through the scheme should now consider the sex and gender of any cell line (a set of cells grown in a laboratory and used in medical research), animal or individual taking part in the study and ensure that this mirrors the sex and gender make-up of the affected group as a whole. Even though the policy was brought in only a few months ago, its impact has been considerable.

What is the meaning of sex and gender?

Medical research is carried out using cells lines, animals and humans. For each of these, sex is defined by their biological features. However, in humans, their roles, behaviours and identity in society determine their gender. A person’s experience of health and disease can be affected by both sex and gender.

Why are we supporting the MESSAGE initiative?

In the UK, most medical research is carried out on male cells lines, animals and people. There is no standard guidance for medical researchers about how to adequately consider sex in cell and animal studies and sex and/or gender in human studies. This has led to gaps in scientific evidence, and not enough is known about how health and disease affects people of different sexes and/or genders. Inevitably, research quality and health outcomes from medical research have not been equal for all people.

However, in December 2023, we joined other UK medical research organisations in announcing that we intended to address these gaps and improve the accuracy of scientific research through The George Institute for Global Health’s Medical Science Sex and Gender Equity (MESSAGE) Project. Through this trailblazing project, we showed our commitment to the idea that all medical research carried out should be done with all sexes and genders in mind. We pledged to provide the research community with the guidance and tools needed to make sure that type 1 diabetes research fully represents all people living with the condition.

What has Breakthrough T1D done to support this initiative?

Over the past 11 months, our research team helped the MESSAGE Project team design and develop the MESSAGE Policy Framework. The framework was released in November 2024, setting out what was expected in any research funding applications, together with guidance on how researchers can meet those expectations.

Critically, all research carried out on cells lines and animals, and all clinical trials carried out with people should include a sample of the sexes that reflect the affected population. The researchers therefore need to justify the sex and/or gender of the cell lines, animal models or people being used in their study in order to improve the research quality and health outcomes for all people living with type 1 diabetes.

This year, we have introduced the MESSAGE Policy framework into the Small Grant Awards Scheme. The framework has had a huge impact on the number of researchers who have thought about the sex and gender of the cell lines, animal models or people taking part from the very beginning of their studies.

In 2021 only 28% of the research applications we received included consideration of sex and/or gender. As a result of the inclusion of new Breakthrough T1D guidance, this rose to 37.5% in 2022 and again to 50% in 2024. However, since the introduction of the MESSAGE Project into the Small Grant Awards Scheme for this year, a remarkable 90% of applications for research funding have taken account of the sex and/or gender of the cell lines, animal models or people taking part in the study.

How will this help Breakthrough T1D’s research?

This improvement in accounting for sex and gender in our Small Grant Awards Scheme should lead to the generation of more complete and inclusive results. Clinical studies will therefore reflect the type 1 diabetes community more accurately, by allowing researchers to reveal difference unnoticed until now. Crucially, this will go some way to ensuring that our understanding of T1D represents all people living with the condition and allow researchers to develop solutions for all.