Female Medical Research Hits Unlikely Roadblock: Diversity Mandates

Why you should care

Policies adopted by the U.S. and Canada to include women as research subjects could hurt them in an unexpected way.  

Rebecca Shansky wanted to do a study on the effects of the estrous cycle (think menstrual cycle, for rats) on specific memory processes and had applied for a grant from the U.S. National Institutes of Health. In the past, she could just submit her proposal with the somewhat intuitive assumption that only female rats would need to be included in the study. Now, though, the Northeastern University scientist has to explain herself — or risk not getting funded. 

In the end, Shansky got approved to test just female subjects, but not everyone has had such luck. Liisa Galea, director of the graduate program in neuroscience at the University of British Columbia, researches how sex hormones influence brain health and disease in both males and females. When applying for a grant to study a women’s health topic, she was rejected by the funder “citing a need to include male participants,” Galea wrote in a recently published article. A colleague of hers had a similar problem, she added, and was asked to have a male study when looking at the inflammation of the placenta, which develops during pregnancy and is only found in women.

These instances are the result of North American government arms — most notably, the U.S. National Institutes of Health since 2015 and Canadian Institutes for Health Research since 2016 — linking the funding of studies to the presence of both sexes in the proposed research. In Canada, sex and gender are part of its selection criteria, while in the U.S., gender must be treated as a “biological variable” and accounted for in applications. That shift in policy was aimed at correcting a decades-long approach that by the NIH’s own admission marginalized women from research because of a misplaced idea that their monthly hormonal changes were more volatile — making women less reliable subjects — than the daily testosterone fluctuations of men.

If you are studying what is specific to one sex … then you shouldn’t have to include the ‘other’ sex.

Rebecca Shansky, researcher

But by insisting on the presence of subjects of both genders, this new approach is sparking an unexpected consequence: Some women’s health researchers seeking funding are being denied because they’re seeking support for studies of women-specific medical conditions that have been ignored for years. While there’s no national data in either the U.S. or Canada on rejected grants, statistics suggest research focused on women isn’t benefiting from the diversity mandates of governments. Only 2 percent of research grants in British Columbia go to studying women’s health, for instance, and those grants are often lower in value than for other research, says Galea. She is part of a growing number of researchers who are asking that diversity requirements be dropped when necessary to create true progress for women’s health.

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The U.S. National Institutes of Health since 2015 and Canadian Institutes for Health Research since 2016 have linked the funding of studies to the presence of both sexes in the proposed research.

Source SAUL LOEB/AFP/Getty

“Female-specific experiences such as oral contraceptive use, pregnancy, the postpartum period and menopause have all been implicated in mental health diagnoses. There is an urgent need for more studies focusing on these critical transition periods,” she says. 

Fewer than 10 percent of all fundamental research subjects look exclusively at female subjects, despite the fact that more than half the population is female. That hurts the scientific understanding of biological and medical needs specific to women. In some sectors, such as infertility research, private companies are now filling in the research gaps by sponsoring and supporting their own studies. “While the idea is good (get everyone to study all people), the achievement of that goal isn’t fruitful (people don’t analyze by sex),” says Galea. “The problem of not knowing enough about women’s health will not be solved by studying sex differences alone.” 

 

Yet the “biological variable” that the American and Canadian governments are now striving to capture through research is real too. “Historically, science has been reductionist. Let’s study a single variable at a time, and it’s convenient that it’s an all-white, male cell,” says Cara Tannenbaum, a Université de Montréal professor who led Health Canada’s Health Policy Research Program on the development of gender-sensitive mental health indicators.

The historical preference for male subjects in science has endangered women. For instance, female symptoms of heart attack are different than men’s and, as a result, they have been more likely to die after a cardiac event. Illnesses such as major depressive disorder and post-traumatic stress disorder are twice as common in women, yet are studied through the perspective of the reactions of male rats — creating “an unclear picture of the neural mechanisms that may underlie disease susceptibility in women,” writes Shansky in the journal Science

In order to meet some of the new mandates, some scientists have suggested trialing male subjects and then female ones. Not only does that idea perpetuate the idea that the male mind’s reactions are more normal than that of a woman, but it can also be harmful, argues Shansky. 

None of these researchers is suggesting that the new approach adopted by the U.S. or Canadian research agencies — which did not respond to requests for comment — is aimed at discriminating against women. Tannenbaum says that single-sex studies have still been approved even after the shifts.

Still, research mandates, while well-meaning, are hurting scientists, argues Galea. “Data are showing a wide trend … that inclusion mandates can backfire,” she says, pointing to how researchers have shown that anti-bias training in Starbucks coffee shops may have done more harm than good, just as sexual harassment training in the workplace hasn’t always proven effective. It’s a dark irony if a more equitable process for selecting research subjects leads to less equity for women’s health studies in the research itself. 

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