Authors will be prompted to provide details on how sex and gender were considered in study design.
In late 2020, the European Commission announced that its research-grant recipients would need to incorporate analyses of sex and gender in their study design. This could include disaggregating data by sex when examining cells, or considering how a technology might perpetuate gender stereotypes. Back then, Nature wrote that this was a significant step and urged other funders to follow suit (see Nature 588, 196; 2020). At the same time, we said that publishers, too, have a role in encouraging sex and gender reporting. The responsibility does not lie only with funders.
It has been known for some time that the efficacy and safety of a pharmacological agent or other treatment can be different depending on the sex of individuals. We also that in many cases, women can be under-represented in the participants. This can result in research that indicates that an intervention has little side-effects and is helpful when for about half of society they are in fact not. So the new sex and gender analyses reporting requirement introduced by the Nature Portfolio journals are especially welcome. Now, we just need other journals to adopt a similar requirement. We have included links to seven related items.
To remedy this, from now on, researchers who submit papers to a subset of Nature Portfolio journals (see list at go.nature.com/3mcu0zj) will be prompted to state whether and how sex and gender were considered in their study design, or to indicate that no sex and gender analyses were carried out, and clarify why. They should note in the title and/or abstract if findings apply to only one sex or gender.
They will also be asked to provide data disaggregated by sex and gender where this information has been collected, and informed consent for reporting and sharing individual-level data has been obtained. The changes apply to studies with human participants, on other vertebrates or on cell lines, in which sex and gender is an appropriate consideration.
At the same time, we’re urging care and caution in communicating findings about sex and gender, to avoid research findings having inadvertent and harmful effects, especially where there is the potential for societal and public-policy impact. More details about these changes can be found at go.nature.com/3mcu0zj. They are part of the SAGER (Sex and Gender Equity in Research) guidelines4.