On Tuesday, Sept. 23, the National Institutes of Health (NIH) began implementing a new policy and announced supplementary awards aimed at combating the lack of sex-based research in NIH-funded studies. The new policy, first announced in May, requires NIH researchers to spell out how they’ll include male and female subjects in their work. In addition, grants totaling $10.1 million will be allocated to 82 grantees to improve their current research by focusing on sex differences in both preclinical and clinical trials.
The research projects, guided by the NIH Office of Research on Women’s Health, span across scientific disciplines, from behavioral health to neural circuitry.
A statement released by the NIH summarizes the goals of the funding program:
This investment encourages researchers to study females and males, and is a catalyst for considering sex as a fundamental variable in research. The current overreliance on male subjects in preclinical research can obscure key findings related to sex that could guide later human studies.
This is a huge step forward for women, since the current medical model has, for so long, centered on the male body. The NIH Revitalization Act of 1993 made initial progress, requiring all NIH-funded studies to include both women and minorities within their subject pools. Thanks to this Clinton-era mandate, researchers (and patients) learned about the risks of hormone replacement therapy and the different symptoms of heart disease that men and women experience.
While the act was a positive step forward, there is still much that needs to be done. Earlier this year, Dr. Susan Wood, the executive director of the Jacob’s Institute on Women’s Health at George Washington University, spoke with Ms. writer Mary Jane Horton about the 1993 act:
There was a real feeling of optimism at the time. Not only did the NIH change their policies about research, so did the Food and Drug Administration (FDA)—they reversed their policy that women of childbearing age could not be in clinical trials for drug approval.
But these changes didn’t have the desired impact: We still lack crucial information about the effects of diseases such as Alzheimer’s, lung cancer and HIV/AIDS on women. Knowledge gaps aside, many of the findings from the mid-to-late ‘90s (e.g., the different symptoms of heart disease between men and women) haven’t passed into future generations—lost in the gaps of institutional knowledge. The heart attack’s visual motif of “man keeling over in chair” has persisted even though women rarely experience this symptom.
The NIH’s new supplemental funding allows researchers to look back on such previous projects as well as moving forward with new studies. The 82 grantees can use the funding in the following ways:
- Adding cells of the opposite sex to allow for sex-based comparisons;
- Generally increasing their sample size to more accurately compare sex-based differences; or
- Further analyzing existing data that includes information from both sexes.
Regarding the new NIH funding, Dr. Wood is both optimistic and skeptical. She tells the Ms. Blog,
This is good news, that the NIH is dedicating resources to expand research in both preclinical and clinical research. At the same time it tells us that we still have more to do, as there shouldn’t be a need for special funding efforts to expand this research, it should be built into the scientific methods and into the original design of the projects. Hopefully this is the beginning of some new approaches to research that will produce some important findings, but it will take time to see the results.
Dr. Nesha Haniff, a lecturer in the departments of women’s studies and Afro-American and African studies at the University of Michigan, studies the lack of diversity in clinical trials, particularly among women and other marginalized populations. She’s hesitant about whether we’ll see tangible changes within the medical community as a result of the new NIH funding. She tells the Ms. Blog,
I don’t think the bulk of scientists are taking this as seriously as they should. I think some women scientists are, but if you look at publications—what gets accepted and not accepted—the journals don’t necessarily pay close attention to whether there are enough women participants, and so forth. It’s a long, contorted process.
These hesitations are natural, especially after witnessing the eventual complacency of the Clinton-era momentum. But, like Wood, Haniff is ultimately optimistic.
I think it’s great. I mean, it’s long overdue. I think there’s still lots of work to be done, but I’m very positive about the possibility now that there’s some publicity being given to it.