Sex and gender profoundly affect health and disease, including the causes of ill health, the effectiveness of treatment, and individuals’ overall outcomes. Yet sex and gender dimensions have historically been neglected in the majority of biomedical, health, and care research, and this problem persists today. A 2019 review found that only 49% of animal studies reported using both male and female mice,1 and in 2018 just 22% of participants in phase 1 clinical trials were female.2 Reporting and analysis of sex and gender disaggregated data are also inadequate.3 These gaps in the evidence base lead to less targeted, effective, and safe care for everyone, but particularly for cis women and girls, and sex and gender diverse people.4 Whole sector change is needed to tackle these critical gaps and should be leveraged through policy change across the UK’s funding landscape.5
On 11 December 2023, 29 members of the UK research sector published statements signalling their support for improved consideration and reporting of sex and gender in biomedical, health, and care research.67 These include the National Institute for Health and Care Research, the Medical Research Council, the Association of Medical Research Charities, the British Heart Foundation, The BMJ, and publishing group Elsevier. This is a considerable show of unity and collaborative effort across the UK research sector. This commitment marks a major turning point for UK biomedical, health, and care research. The sector is making a landmark statement about the need for more equitable research practices, and moreover this is happening in unison. The collective message is clear: research norms must change if the UK is to maintain its standing as a world leader in rigorous and reproducible science. For scientific research to be high quality, accurate, and robust, researchers must account for sex and gender at all stages of the research cycle—from study design and data collection to analysis and reporting.
Although this sector-wide effort is internationally unprecedented, longstanding sex and gender policies exist elsewhere. The United States’ National Institutes of Health implemented a policy in 1993, with the Canadian Institutes for Health Research (CIHR) following in 2010. These policies are recognised as pioneering in this space, and evaluations have shown their effectiveness in increasing the proportion of funding applications that reported integration of sex and gender. The CIHR, for example, saw four times as many applications integrate sex and three times as many integrate gender over the decade following policy implementation and found that applications that scored highly for sex and gender integration were more likely to be funded.8
But reviews also suggest that policies alone might not have had the widespread and enduring impact that was expected. Although inclusion of non-male participants has improved, for example, analysis and reporting of data disaggregated by sex and gender remain limited in the US.3910 This trend reflects not only the challenges for funders in monitoring whether research outputs mirror the plans set out in application forms,11 but also suggests that wider culture change on embedding sex and gender at the core of researchers’ thinking might not yet have been fully realised. It will take time and perseverance to change the norms that have shaped the way research has been practised over many decades.
The UK sits far behind other countries in development and implementation of sex and gender policies in medical research. The first sex and gender policy was implemented by the Medical Research Council in July 2023, covering cell, animal, and human studies. Although belated in tackling the sex and gender gaps in research, the UK has the advantage of being able to learn from its predecessors. Where previous international policy innovation has been led by single, national funders, the UK is taking a different and more connected approach with the hope of improving buy-in and longer term impact.
Through the MESSAGE (Medical Science Sex and Gender Equity) initiative, led by the George Institute for Global Health, influential organisations from across the UK research sector are collaborating to co-design a sex and gender policy framework.12 The group of stakeholders includes funders, regulators, researchers, patients, publishers, clinicians, and the Department of Health and Social Care. The policy framework will focus on funders initially, but engagement with stakeholders across the sector will ensure that it is grounded in shared principles and best practice expertise.
As improved accounting of sex and gender becomes the new gold standard for published research, actors downstream of funding decisions should begin to adopt policies grounded in MESSAGE’s co-designed principles. Cohesion in the requirements for researchers by all funders and, later, across the sector, will be essential to ease the transition to a new way of working for researchers, which they understand the rationale for and feel committed to.13 With the MESSAGE policy framework being launched in early 2024, future work will support stakeholders to prepare for policy rollout, share learning and resources, and design a roadmap for change in the longer term.
The publication of today’s statements marks a major step in the journey towards a whole sector shift in research practice and shows the research community’s commitment to tackle this together. This collaborative approach will help to ensure that there is accountability and support for researchers at every stage of the research cycle and will increase the likelihood that policies can drive meaningful change. As researchers begin to address current gaps in the evidence base, they will open exciting avenues for new discovery research, enhance scientific rigour, and improve the efficacy and safety of treatment for all patients.