A significant advancement in UK health research has emerged with the introduction of new sex and gender policies by Wellcome, the National Institute for Health and Care Research (NIHR), and the British Heart Foundation (BHF). These pioneering policies mandate that research funding applications include comprehensive plans for addressing sex and gender considerations from the outset of study design. This initiative aims to enhance the scientific rigor and equity of health research, ensuring it accurately reflects the diverse populations it seeks to serve.
The newly established policies – the Sex and Gender in Health Research Policy by Wellcome, the Sex and Gender in Research Policy by the NIHR, and the Diversity in Research Design Policy by BHF – require researchers to account for sex and gender at every stage of the research lifecycle. This includes critical phases such as research design, participant recruitment, data collection, analysis, and dissemination of results. While specific studies may justify the examination of single sex or gender samples, researchers must provide a robust rationale for their chosen approach.
Historical Context and New Framework
Historically, biomedical and health research has often overlooked non-male participants and seldom disaggregated data by sex or gender during analysis. This gap has impeded scientific accuracy, limited the applicability of findings, and negatively impacted health outcomes, particularly for female patients, trans and non-binary individuals, and those with variations in sex characteristics.
Over the period of 2023-2024, the MESSAGE project team has driven the co-design of the UK’s first comprehensive sex and gender policy framework for funders. This framework delineates clear expectations for researchers regarding the inclusion of sex and gender in their work. It also outlines implications for all stakeholders in medical research, including funders, universities, patients, and the public. The framework provides clear definitions and practical guidance on the application of the terms “sex” and “gender” in health research.
Dr. Charlotte Won, Head of Research and Funding Equity at Wellcome Trust, expressed strong support for the MESSAGE initiative, asserting, “The MESSAGE project aims to integrate sex and gender as a fundamental consideration in health research. This aligns seamlessly with our vision of a future where health research is fully utilized to solve urgent health challenges.” She emphasized the importance of inclusivity and responsiveness to societal needs in research.
Expert Endorsements and Implementation
The MESSAGE project has received notable endorsements, including from The Lancet. The journal’s Editor-in-Chief remarked, “I wholeheartedly welcome the MESSAGE recommendations, which have emerged from a collaboration that I have never seen before in 25-30 years of working in UK medical research. It just doesn’t happen and should happen more often.” This enthusiasm highlights the potential impact of the new policies on the research landscape.
To facilitate the adoption of these policies, the MESSAGE team has developed a comprehensive toolkit for funders, offering detailed guidance on integrating the new expectations regarding sex and gender dimensions into the grant process. This initiative positions the MESSAGE project as a leader in enhancing the consideration of sex and gender in UK biomedical, health, and care research.
The introduction of these policies represents a shift in perception, establishing sex and gender as fundamental components of research quality, reproducibility, and equity. The MESSAGE team encourages the research community to engage with the new requirements to ensure that biomedical, health, and care research is inclusive and representative of all populations. This milestone reflects a commitment to drive improvements in the quality and equity of health research across the UK.
