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Review
. 2025 Apr 22;16(1):3763.
doi: 10.1038/s41467-025-58560-5.

The Sex Inclusive Research Framework to address sex bias in preclinical research proposals

Natasha A Karp  1 , Manuel Berdoy  2 , Kelly Gray  3 , Lilian Hunt  4 , Maggy Jennings  5 , Angela Kerton  6 , Matt Leach  7 , Jordi L Tremoleda  8 , Jon Gledhill  7 , Esther J Pearl  9 , Nathalie Percie du Sert  9 , Benjamin Phillips  10 , Penny S Reynolds  11 , Kathy Ryder  12 , S Clare Stanford  13 , Sara Wells  14   15 , Lucy Whitfield  16
Affiliations
Review

The Sex Inclusive Research Framework to address sex bias in preclinical research proposals

Natasha A Karp et al. Nat Commun. .

Abstract

An interactive Sex Inclusive Research Framework (SIRF) supports the evaluation of in vivo and ex vivo research proposals to address the risk of sex bias in preclinical research. The framework delivers a traffic light classification, indicating whether a proposal is appropriate, risky, or insufficient with regard to sex inclusion. This tool is designed for use by researchers, (animal) ethical review boards, and funders to generate a rigorous and reproducible assessment of sex inclusion at the proposal level, thus helping address and resolve the embedded sex bias in preclinical research.

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Conflict of interest statement

Competing interests: The authors declare the following competing interests: B.P., K.G. and N.A.K. have shareholdings in AstraZeneca. E.J.P. and N.P.d.S. are NC3Rs staff; whose role includes promoting the ARRIVE guidelines and the Experimental Design Assistant (EDA). N.A.K. and S.C.S. are members of the expert group who advise development of the EDA, S.C.S. is also the Chair of the EDA Project Management Board. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1. The Sex Inclusive Research Framework decision tree.
Underpinning the Sex Inclusive Research Framework is a decision tree consisting of twelve questions which, when applied to a research proposal, results in the assignment of one or more traffic light outcome classifications. These indicate whether a proposal is appropriate (green thumbs up symbol), carries some risk (amber caution hand symbol) or is insufficient with regards to sex inclusion (red thumbs down symbol).
See this image and copyright information in PMC

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