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Transforming Neurological Health with Sex and Gender Data

I began my scientific career as an undergraduate at the University of Winnipeg in the early 90s. I latched on to a researcher who was studying “sex differences” in the brain. I learned very quickly that most of the science we knew, read, and referenced was based on the male brain and that very little was known about the female brain. Studying “Sex Differences” was a novel approach. When I went on to do my doctorate at Dalhousie University, I insisted on using females in all of my studies, which meant doubling the number of animals required for my research. I often had to advocate hard for their inclusion but always managed to do so. My labour didn’t end there though. Every aspect of my science was doubled – more brains to analyze, more surgeries to do, and more data to enter. I even tracked my females’ estrous cycle with daily vaginal swabs, which then meant hours and hours of microscope work to identify the phase of their cycle they were in. This was essentially an analogue version of a hormonal-state identification system that My Normative has made easy machine learning. It was painstakingly time consuming, but I was committed to the mission of including females in science. (For the record, I was working with rats, not humans). In all honesty, it would have been much easier to just ignore females and their hormones and their experiences like most other researchers did at the time. But at what cost? 

The cost of selectively using male and cis-gendered men’s brains at the exclusion of any other sexes or genders is vast and affects every inch of our healthcare knowledge, from bench to bedside. The compounded effect of years, decades, centuries of neglect at all levels of laboratory animal research and human research has created massive sex and gender inequities, at the clinical level, including new and differing symptoms, treatment outcomes, prognoses, and diagnostic criteria. 

We need to catch up. We need to collect sex and gender data. We need to understand the female brain throughout its monthly cycling, throughout puberty, throughout pregnancy, and throughout perimenopause. We also need to understand neurological factors through a non-binary lens. We need to understand and collect data related to the trans experience, the gender non-binary experience, intersex experiences, and all types of queer experiences. The sex and gender equity in health is a problem that has been recognized for many decades now and attempts to rectify this exist.

In 1993 the United States National Institutes of Health (NIH) enacted the Revitalization Plan that pushed for the appropriate participation of women and underrepresented minorities in clinical research. Then in 2015 NIH announced that beginning in 2016, all applicants proposing to carry out studies in vertebrate animals and humans must include sex as a biological variable (SABV) in their research designs, analyses, and reporting and if not, they have to provide strong justification for single-sex investigations.

Meanwhile, in Canada, in 1995 our federal government was also committed to implement what it called “gender-based analysis”, which was renamed in 2011 to “gender-based analysis plus” or GBA+. However, within the Health Portfolio (including health research), the term Sex- and Gender-Based Analysis Plus (SGBA) has been used, after the Health Portfolio Sex- and Gender-Based Analysis Plus Policy came into effect on July 8th, 2009.

The NIH and Government of Canada have pushed and worked hard to rectify the sex- and gender-based plus inequities. The US began providing inclusion data on sex/gender, race, and ethnicity in a format that is disaggregated by research, condition, and disease categorization (RCDC) categories, which can be viewed here: https://report.nih.gov/risr/#/. Canada also provides disaggregated data, available here: https://www.statcan.gc.ca/hub-carrefour/gdis-sgdi/index-eng.htm

Years later, the impact of this has been significant. As stated by Haverfield & Tannenbaum, 2021, “Since 2011, 39,390 [CIHR] applications were submitted [between 2011 and 2018]. The proportion that reported integration of sex rose from 22 to 83%, and gender from 12 to 33%. Across every competition, applications with female principal investigators were more likely to integrate sex (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.50–1.63) and gender (OR 2.40, 95% CI 2.29–2.51) than those who identified as male. Since 2018, applications that scored highly for the integration of sex (OR 1.92, 95% CI 1.50–2.50) and gender (OR 2.53, 95% CI 1.83–3.50) were more likely to be funded.” A similar 5-year review of the NIH policies is also available. This is mostly great news: we are going in the right direction. But we have not yet achieved parity.

So clearly, we can do more. The solution that My Normative offers makes it easy for researchers to include sex and gender variables into their researcher.  This is the minimum requirement for government funding. Yet, a deeper exploration of those variables is possible with the My Normative platform. For example researchers can employ the hormone-state identification, capture symptomatology, integrate other health data, and create a whole host of customizable questions for study participants. Not only will researchers be able to meet the requirements set out by the government funding agencies, they can exceed those expectations and potentially uncover exciting trends relevant to those sex and gender variables. Furthermore, their platform allows for the separation of sex and gender (because they are not the same) and is inclusive of a variety of people’s experiences beyond the binaries and regardless of their assigned sex at birth. Kudos to Danika and Renée (Co-founders of My Normative) for their dedication to this important mission. From one sex and gender advocate to another, thank you!  

And this is why I am so excited about our partnership with My Normative and the grant we created specifically to equip a neurological health researcher with the ability to easily collect a variety of sex and gender data and transform neurological health research. Our goal is to make it easy for researchers to add these important variables into their existing research program. For details about the grant, head here: https://branchoutfoundation.com/grant-opportunities/transform-neurological-health-research-with-sex-and-gender-data  

Citations:

1. https://www.canada.ca/en/women-gender-equality/gender-based-analysis-plus/government-approach.html#commitment.

2. https://www.canada.ca/en/health-canada/corporate/transparency/heath-portfolio-sex-gender-based-analysis-policy.html

3. Haverfield J, Tannenbaum C. A 10-year longitudinal evaluation of science policy interventions to promote sex and gender in health research. Health Res Policy Syst. 2021 Jun 15;19(1):94. doi: 10.1186/s12961-021-00741-x. PMID: 34130706; PMCID: PMC8205200.

4. Arnegard ME, Whitten LA, Hunter C, Clayton JA. Sex as a Biological Variable: A 5-Year Progress Report and Call to Action. J Womens Health (Larchmt). 2020 Jun;29(6):858-864. doi: 10.1089/jwh.2019.8247. Epub 2020 Jan 22. PMID: 31971851; PMCID: PMC7476377.

5. Elizabeth Barr, Ronna Popkin, Erik Roodzant, Beth Jaworski, Sarah M Temkin, Gender as a social and structural variable: research perspectives from the National Institutes of Health (NIH), Translational Behavioral Medicine, Volume 14, Issue 1, January 2024, Pages 13–22, https://doi.org/10.1093/tbm/ibad014