Major funding organizations in the UK have announced new policies aimed at integrating sex and gender considerations into biomedical, health, and care research. The **Wellcome Trust**, the **National Institute for Health and Care Research (NIHR)**, and the **British Heart Foundation (BHF)** have collectively launched these pioneering guidelines, reinforcing the importance of these dimensions from the initial stages of study design. This initiative marks a significant advancement in the drive towards more equitable and rigorous scientific inquiry.
The newly established policies require researchers to develop comprehensive plans that include considerations of sex and gender throughout the entirety of the research process. This includes research design, participant recruitment, data collection, and the dissemination of findings. While the approach may vary for different studies, all researchers are expected to justify their methodology robustly. This shift is part of a broader movement within the medical research community, coinciding with similar reforms by organizations such as **Breakthrough T1D**, the **Cystic Fibrosis Trust**, and **Fight for Sight**.
Addressing Historical Shortcomings
Biomedicine has long faced criticism for under-representing non-male subjects and failing to analyze data through the lens of sex and gender. Such omissions have hindered scientific accuracy and limited the generalizability of research findings, negatively affecting health outcomes, particularly for female patients and individuals identifying as trans or non-binary. The new policies from Wellcome, NIHR, and BHF aim to rectify these deficiencies by mandating that sex and gender considerations be integrated into every facet of health research.
The **MESSAGE project**, which played a crucial role in developing these policies, emphasizes that sex and gender are not merely supplementary elements but fundamental factors that influence research quality and equity. According to the Head of Research and Funding Equity at Wellcome Trust, “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.”
Guidelines and Toolkit for Implementation
The framework established by the MESSAGE project offers clear expectations for researchers and outlines the implications for all stakeholders involved in medical research, including funders, universities, and the public. It provides detailed definitions and practical guidance on the application of sex and gender concepts within health research.
To facilitate the transition, MESSAGE has also developed a toolkit designed to help funders implement the new requirements effectively. This resource includes actionable steps for embedding the expectations around sex and gender within the grant application process. The Editor-in-Chief of **The Lancet** expressed strong support for this initiative, noting the unprecedented collaboration that led to the recommendations. “We will do everything we can to see its vision is fully realized,” he stated during the MESSAGE launch webinar.
The commitment from these major funders signifies a turning point in the approach to health research, where sex and gender are recognized as core determinants of research excellence. The MESSAGE project team is dedicated to ensuring that these considerations become standard practice within the research community. As they continue to collaborate with various stakeholders, including regulators and publishers, the aim is to create a research culture that prioritizes diversity and equity.
In conclusion, the launch of these new policies underscores a collective recognition that sex and gender are essential to the integrity and effectiveness of health research. The MESSAGE team invites researchers to familiarize themselves with these groundbreaking requirements to ensure that biomedical, health, and care research can adequately address the needs of diverse populations.
