The new policy aims to ensure the Medical Research Council (MRC) research findings are relevant to and benefit everyone in society.
It means that researchers funded by MRC will need to consider sex as well as other relevant characteristics when designing any research involving humans, animals, cells, and tissues.
In studies involving people, researchers should take into account whether characteristics such as sex, gender, age, ethnicity and socio-economic position are relevant.
Public involvement and engagement activities
Diversity and inclusion should also be part of developing public involvement and engagement activities to support research.
Peer reviewers and MRC committee members will need to be mindful of these requirements when reviewing research proposals.
The policy builds on a requirement introduced in March 2022 when MRC announced that grant applications involving animal or in vitro research experiments must include both sexes as the default.
Embedding diversity in research
Claire Newland, Director of Policy, Ethics and Governance at MRC, said:
The Medical Research Council is committed to accelerating improvements in human health and prosperity by supporting world-class health and biomedical research and innovation.
Central to this commitment is promoting an inclusive approach to research design so that the benefits from research extend across all communities and population groups.
I am pleased to now announce this change in policy to strengthen the embedding of diversity and inclusivity in research design.
The changes are based on the recommendations of a working group of experts in health and biomedical research, statistics and experimental design.
The recommendations were informed by evidence from a review of international funder activities, a survey of the research community in August 2021, and an analysis of research grant proposals submitted to MRC.
Risk of limited applicability
When diversity is not considered, there is a risk that research could have limited applicability, and the ensuing mistakes and biases can be costly to society.
There are multiple examples of bias in clinical and preclinical research when diversity was not taken into account, such as:
- eight drugs were withdrawn from the US market in 2001 because the health risks in women were underestimated in pre-licensing trials
- children and older people are often excluded from clinical trials, making it more difficult for researchers to evaluate doses, efficacy, and safety across all age groups
- a machine-learning algorithm underestimated illness severity in Black patients
- exclusion of pregnant women from drug trials means treatments are not licensed for them
- experiments lack reproducibility because the sex of cell line donors was not recorded
The COVID-19 pandemic demonstrated differences in the way the same virus affects men and women, highlighting the importance of evaluating disease risk and potential interventions by sex and gender.
Continuous improvement
Avoiding such errors is vital to ensure the outputs from health and biomedical research are reproducible, high quality and do not marginalise specific groups in society.
The policy will be effective for all applications submitted to funding opportunities that have deadlines after 1 September 2023.
MRC will provide clear guidance for applicants and peer reviewers and establish a cycle of continuous improvement through monitoring and evaluation of research practice.
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