Guidelines, Governance, and Gender

Article written by Maria Machado, PhD

What are sex and gender? While biologic or physiologic differences are tremendously important, so too are the ways that women and men experience their lives and their work differently. Women often have very different experiences of health care because of bias or prejudice within the system. Equally, men get treated differently and often don’t seek health care because of the ways that gender norms encourage them to be resilient and not seek care. So, is gender an ideology? We were luck to speak with Shirin Heidari, Thomas Babor, and Jocalyn Clark, who helped us navigate the muddy waters of the current climate.

Guidelines

The World Health Organization adopted the SAGER guidelines (Sex and Gender Equity in Research) for their research and health data analysis, acknowledging that failing to account for sex and gender dimensions in research leads to worse health outcomes and perpetuates health inequities. This was partly as a result of advocacy efforts by Shirin Heidari.

Once elected as a council member of EASE (European Association of Science Editors) in 2012, Heidari co­chaired a Gender Policy Committee aimed at shifting the approach taken in research design, implementation, and communication towards a better integration of sex and gender dimensions. As one of the authors of SAGER and the founder and Executive Director of GENDRO, Heidari is still committed to uncovering gender biases in research, bridging evidence gaps, and driving systemic changes in the research ecosystem for tangible real-world impact.

The SAGER guidelines have been accessed more than 1,2 million times since their publication, and provide researchers and authors with a tool to standardize sex and gender reporting in scientific publications (see box). However, their widespread acceptance by the scientific community has been recently attacked.

Governance

In late January 2025, the current Trump Administration instructed scientists and others employed by US federal agencies to comply with an executive order aimed at “defending women from gender ideology extremism” and “restoring biological truth to the federal government.” A Professor Emeritus and former Chairman in the Department of Public Health Sciences, University of Connecticut School of Medicine, USA, Thomas Babor has expressed his concern regarding the pressing gender issues unfolding in the USA nowadays. He stresses that the order’s implementation directly attacks the rights of individuals that interact with the heathcare system.

Babor reminds us that, when it comes to access to health care, effective treatment, and the kind of outcomes that they enjoy, patient experiences differ based on their individual identities. Factors like race, ethnicity, gender, sexual orientation, socioeconomic status, disability, and religion can influence how individuals perceive and interact with the healthcare system, leading to unique needs, access barriers, and quality of care. Identity can also shape a patient’s communication style, health beliefs, and trust in healthcare providers, further impacting their healthcare journey and outcomes. Initiatives such as PPI (public and patient involvement) in medical research were thus included in public health research, and refer to the practice where people with health conditions (patients), carers, and members of the public work together with researchers and influence what is researched and how.

This is also why a sex- and gender-based analysis framework was developed —the Canadian government provides an excellent tool for training and verification in this regard. This type of analysis depends on gathering  of information on how different groups of people may experience the same situation differently. Because, if we don’t disaggregate the data and report findings broken down by sex and gender, then we mask any differences that men, women, and non-binary individuals experience. This may also have an effect on the women’s health agenda, both in terms of research and clinical practice, effectively dismantling a century of progress in women’s rights, and 50 years of progress to address women’s issues in science.

According to the the World Health Organization (WHO):

Sex refers to the different biological and physiological characteristics of females, males and intersex persons, such as chromosomes, hormones, and reproductive organs.

Gender refers to the characteristics of women, men, girls and boys that are socially constructed.  This includes norms, behaviours and roles associated with being a woman, man, girl or boy, as well as relationships with each other. As a social construct, gender varies from society to society and can change over time.

Gender

Jocalyn Clark believes that journals and journal editors play a very important role as one part of a broader ecosystem, which includes funders, ethics committees, the institutions where the researchers are employed, and regulators. Consequently, it is this system as a whole that creates the environment and the incentives for sex and gender to be properly collected and reported.

Clark is a Canadian public health scholar, adjunct professor of Medicine at the University of Toronto, and an Honorary Associate Professor at the Institute for Global Health at University College London. We spoke to her in her role as the International Editor and Head of Scholarly Comment at The BMJ, one of the world’s oldest general medical journals, where she contributes to strategy and works to internationalise the journal’s content. We wanted to undertand the impact of some of the latest developments within the academic publishing world that pertain to the banning of some words and the removal of previously submitted articles that address gender-engaged research.

There is still a lot of biomedical research being published that does not address sex in its design. From using exclusively male laboratory mice to not reporting the way in which sex is determined in patient cohorts, some researchers seem to still be unaware of the potential influence of sex to health outcomes. What is the role of journal editors in this?

While it is true that journals and journal editors are major gatekeepers, there’s two major challenges with our role. The first is that journals intervene near the very end of the lifespan of a piece of work. So, if I receive a submission come to me at the journal, and the researchers haven’t included women, or haven’t analysed the data disaggregated by sex or gender, I can’t ask them to do that post hoc. The levers for change have to come at the very beginning, when researchers are funded, and when they’re enroling their patients or human subjects into the research. If the data and the analysis are there, then we can impose a requirement to include that in the manuscript. And we can hold ourselves to account as journals to publish that, to make sure that’s part of the main manuscript and not relegated to some supplemental file. But we need to kick the responsibility further upstream.

The second, and this is really important, is that SAGER guidelines have now finally been endorsed by many journals, and they’ll be included in a journal’s instructions for authors. It took many, many years of advocacy to get journals to even acknowledge that there was a role for sex and gender related reporting and that these guidelines were important. But endorsing something and enforcing something are very different things. And it’s very easy for journals, for funders, or for universities to say they believe in sex and gender related reporting, and that it is important that we do it. But when people analyse the compliance of researchers towards their funder, their IRB, their regulator, or their journal requirements for sex and gender related reporting, the compliance tends to be very, very low.

So it’s an accountability question. That’s where the focus needs to be. Describing the problem and talking about how great our reporting guidelines are is fine, but not enough. We need to ensure they are enforced.

As knowledge about the social contributors to health and disease advances, could you comment on the future of this research, as the link between healthcare and gender seems to have become wrapped in political battles? For instance, how could we address the funding gap for research on medical problems seen as exclusive to women?

It’s an age-old question, sadly, because there’s never been a time in history when women’s health has been funded or researched to the extent that women are represented. Women are 51% of the world’s population; but only 8.8% of research funded by the US National Institutes of Health, and less than 2% of all venture capital health investments, are focused exclusively on women. What we call the women’s health gap or the gender health gap is about 25%. So that means that women spend 25% more time in poor health than men, because of conditions that affect them either uniquely, or differently, or disproportionately when compared to men.

But, where public funding has failed for women’s health, we’re seeing philanthropy step up. On August 4^th, the Gates Foundation announced a $2.5 billion investment into women’s health innovations. That’s a wonderful bit of news. But there’s two things that have to happen to make that a substantial piece of news. First, it needs to stimulate other funders from within the private philanthropy space, within governments, and within other global agencies to act. Unfortunately, $2.5 billion is not a lot of money for women’s health. The second issue is that that’s very focused on research and development —in other words, on technology. That’s just a tiny little bit of the breadth of women’s health. We need research on sex, which is biological, but we also need research on gender, which is social. Innovations need to be more than just technological – they need to be social, cultural, and political.

The attempt to ban medically relevant terminology from the publications authored by scientists funded by the US government has encountered differing responses from editors at academic journals. The BMJ has made their stance clear, but that has not been the case throughout. How do you see the future of articles that address gender issues and research on gender moving forward? Could they still be published?

Those data and that language must be used, it should be published, and it will be published. For the BMJ, we came out first with a statement after that US executive order in which we denounced the anti-gender ideology, but also the ways in which the US administration was trying to come down on very important, basic health-related language like diversity, disparities, LGBTQ, etc. What I can say is that this executive order and regressiveness don’t apply to us. I mean, as a medical journal we don’t follow political orders. Many other journals have also issued statements. And many of those journals are US-based. The ICMJE, which is the International Committee of Medical Journal Editors, reissued their guidance in support of gender and diversity language.  

Data collection and reporting needs to follow evidence-based guidelines, and it needs to follow reporting guidelines that either we have as a community, like as a scholarly community, or we have at the level of journal policy. It wouldn’t serve the scientific record, nor would it be consistent with our policies to exclude any sex, gender, diversity-related analysis and language. It just simply won’t apply. I hope that we’ve made that clear in our stance; and of course, we’ve changed none of our editorial policies based on the US government stuff.

However, we recognise that this is incredibly destabilising for individual researchers who are seeing their research programmes, their life’s work, their passions, and their talents being profoundly undermined by this wave of destruction. It’s not just defunding. It’s actually weaponising public health. Something which should be associated with people’s well-being, their dignity, and their equality is being turned upside down.