New sex and gender framework addresses ‘one-size fits all’ approach to UK medical research
Recommendations drive funders and researchers to account for the role of sex and gender in health and disease.
In a significant step towards closing the sex and gender health gap, The George Institute for Global Health’s Medical Science Sex and Gender Equity (MESSAGE) project has publicly launched its landmark sex and gender policy framework for UK research funders. The framework sets a new gold standard for scientific consideration of sex and gender in UK biomedical, health and care research and will be used by UK research funders to ensure applicants adequately account for sex and gender variables in study design.
Up to now, most UK medical research has been conducted primarily with male participants, animals or cells, and studies rarely analyse data in a way that enables potential sex or gender differences in outcomes to be identified.
Poor attention to sex and gender has led to critical data gaps in the evidence base, with detrimental effects on health outcomes for all people, but particularly women and girls, as well as trans, non-binary and intersex people.
Research funders in Canada, the United States and Europe have policies dating back to 1993 to address the sex and gender gap in research design. By contrast, when the MESSAGE project began in 2021, no UK research funder had a policy in place to ensure researchers consider the sex and gender of research participants or to sex- and/or gender-disaggregate data when analysing and reporting findings. Failure to recognise these differences can lead to clinical practice perpetuating biases through misdiagnoses and substandard or ineffective treatments.
Over the past two years, the MESSAGE project has co-designed the policy framework with representatives from across the UK research sector. Stakeholders involved in the process include research funders, regulators, researchers, academic journals, patients, clinicians and government officials.
Funders collaborating with MESSAGE – which include government funders as well as medical research charities – contribute an estimated total of £4.1 billion per year to UK medical research. Through MESSAGE’s efforts, since December 2023 more than 30 UK research organisations have made public statements of support for improved consideration of sex and gender in research.
Robyn Norton, Founding Director of The George Institute, Emeritus Professor of Global Health at Imperial College London and co-principal investigator of the MESSAGE project, said,
The UK has one of the largest female health gaps globally, and many of these inequities stem from the earliest stages of medical research. By integrating sex and gender considerations into funding proposals, researchers will now be expected to design and conduct their research in a more equitable and scientifically robust manner.
Professor Robyn Norton
The new framework establishes best practice for UK researchers, provides clear definitions of sex and gender within the context of research, and addresses researchers’ keenest concerns regarding statistical design and possible exceptions to new policies.
Over the coming months, UK funders will adopt sex and gender policy changes based on this framework. Under these changes, researchers will be expected to have equitable sex and gender representation in study samples, describe how they will recruit samples to meet these targets, analyse data separately for each sex and gender group, and report their findings in a way that clarifies any potential differences or similarities. In-depth educational materials to upskill researchers to meet new policy expectations will be provided for researchers on the MESSAGE project website and addressed in a live webinar held today.
Dr Kate Womersley, Research Fellow at The George Institute and Imperial College London, psychiatry doctor in NHS Lothian, and co-principal investigator of MESSAGE said,
These new policies mark a fundamental improvement in how research will be conducted in the UK. It will enhance equity, scientific rigour and reproducibility, solidifying the UK’s leading role in medical research internationally.
Ultimately, we expect new sex and gender-related evidence to address existing data gaps, which will lead to improvements in clinical care and health outcomes for everyone.
Dr Kate Womersley
The George Institute operates in partnership with Imperial College London – the MESSAGE project is funded by the Wellcome Trust.