A new policy framework will require UK health researchers to account for sex and gender variables when designing their studies.

Until now, most UK medical research has been conducted primarily with male participants, animals or cells, while studies rarely analyse data in a way that enables potential sex or gender differences in outcomes to be identified.

That has led to data gaps in the medical evidence base that have negatively affected health outcomes for women and girls, according to the George Institute for Global Health’s Medical Science Sex and Gender Equity (MESSAGE) project, a Wellcome Trust-funded policy initiative that has launched an .

UK research funders will be asked to sign up to the framework to ensure that the biomedical, health and care research they fund uses the “new gold standard for scientific consideration of sex and gender in UK biomedical, health and care research”, according to the MESSAGE project, which operates in partnership with Imperial College London.

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At present, many UK research funders do not have policies to ensure that researchers consider the sex and gender of research participants, or to ensure that data are disaggregated by sex when analysing and reporting findings, says the project, which, it continues, can lead to clinical practice biases that contribute to misdiagnoses and substandard treatments.

In practice, the new framework will mean that research leaders will be asked to include a representative sample of male and female participants in their studies, or to explain why this is not possible.

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Robyn Norton, founding director of the George Institute and co-principal investigator on 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,” said Professor Norton.

The new framework, published on 12 November, will ask researchers to detail how they will classify sex or gender in their studies, with funding applications having to state “which sex and/or gender characteristic(s) will be considered and accounted for”.

These might include sex chromosomes, hormone profile, secondary sex characteristics and internal or external reproductive organs, the framework explains.

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The framework also makes clear that while sex and gender are “multi-faceted concepts which are used and understood differently in different contexts, societies, groups and languages”, sex refers to “biological attributes which differentiate females and males” while gender refers to “an aspect of a person’s identity”.

“Researchers should always report which sex and/or gender characteristic(s) the study accounts for and should clearly state if sex was determined using the ‘sex assigned at birth’ classification,” it explains, noting that “for most people, data on external reproductive organs is recorded at birth and determines a person’s documented sex or ‘sex assigned at birth’”.

The framework, which was drawn up with the involvement of research funders, regulators, researchers, academic journals, patients, clinicians and government officials, follows for improved consideration of sex and gender in research.

Kate Womersley, research fellow at the George Institute and Imperial College London and co-principal investigator on MESSAGE, said the framework’s “new policies mark a fundamental improvement in how research will be conducted in the UK”, which would “enhance equity, scientific rigour and reproducibility”.

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jack.grove@timeshighereducation.com