Renewing Our Focus on Women’s Health Research

Guest post by Rebbecca Moen, MBA, contract Quality Analyst with the NLM Division of Extramural Programs.

Did you know that women were historically excluded from considerable biomedical research?

In response to the thalidomide disaster, the FDA released new guidelines in 1977 that restricted women of child-bearing age from participating in Phase I and II clinical trials considering the risk of birth defects and miscarriages, with an exception for studies on life-threatening conditions. This reaction is understandable, and in many cases pregnant and lactating women are still excluded today, but NIH has worked to have an overall more inclusive approach to research. In fact, NIH created the Office of Research on Women’s Health just over a decade later, and in 1993, Congress passed a law requiring NIH to include women in the studies it funds.

Despite this mandate, there remain significant gaps in knowledge about women’s health, but these gaps are now receiving renewed attention. Last November, the White House announced a new Initiative on Women’s Health Research, which aims to “fundamentally change how we approach and fund women’s health research.” The announcement was followed by an Executive Order in March 2024 that commits $200 million to NIH specifically for interdisciplinary women’s health research.

A New Initiative

To support this monumental investment, NIH has released a Notice of Special Interest (NOSI) that spans across all NIH Institutes, Centers, and Offices (ICOs) and includes several funding mechanisms such as fellowships, training, and research grants. This unprecedented action is intended to facilitate rapid advances in women’s health research. It also encourages research to include the health of sexual minority women, transgender men and women, and/or nonbinary and other gender diverse people who were assigned female at birth, marking an intersectional approach to women’s health as well.

The NOSI describes NIH’s interest in receiving research applications focused on diseases and health conditions that predominantly affect women or that are female-specific. Applications must explicitly address a particular condition that affects women or focus on one of the high-priority topics listed in the Notice. For research opportunities through NLM, our Division of Extramural Programs has identified several areas of research that investigators might consider when applying for funding.

NLM’s Commitment to Women’s Health

NLM has a history of supporting health research that centers on women’s unique health needs, particularly on developing tools and quantitative methods to address issues in women’s health, and NLM’s support of this NOSI is no exception. Over the past 10 years, NLM has funded research projects on endometriosis, intimate partner violence, disparities among women with disabilities, breast and ovarian cancer, preterm birth, and genetic differences between men and women. Here is just a sampling of those projects:

• The Prediction of Preterm Birth in Nulliparous Women study is a joint program with the National Science Foundation’s Smart Health and Biomedical Research in the Era of Artificial Intelligence and Advanced Data Science (SCH) initiative. In this study, investigators are developing methods for integrating and analyzing multiple data sources to identify the likelihood of whether first-time mothers will experience preterm birth. They have already identified several genetic data elements that help predict preterm birth indications and are continuing to explore the data to find answers to spontaneous preterm birth.

• Another NLM-funded project, Partnering with Women with Disabilities to Develop a Health Information Website, acknowledges that women with disabilities are a significantly understudied and under-resourced group and seeks to reduce the health disparities that affect them. Investigators are focused on curating and providing health information specifically relevant to women with disabilities. Their ultimate goal is to meet their health information needs and empower them in managing their health care.

• Finally, NLM-funded investigators who are part of the Decision-Making Modeling for Treating Intimate Partner Violence project are exploring the best interventions to address intimate partner violence (IPV) against women. While gender-specific group therapy has traditionally been the standard of care for IPV, some participants do not experience a decrease in violent response. The investigators are working to identify customized interventions for IPV and comparatively test the interventions. The goal is to develop a decision-making tool for clinicians that will reduce the inequality faced by these participants.

NLM is committed to funding science that improves the health and lives of women. We are specifically interested in receiving applications that leverage artificial intelligence and data science to detect early signs of sex-specific health conditions, develop personalized risk assessments, and integrate precision medicine to improve outcomes for diseases that disproportionately affect women.

Specific funding opportunities that are available to investigate topics related to women’s health include:

• NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) PA-20-185, which supports specific interests and competencies and must be related to NIH ICOs’ interests.
• NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) PA-20-195, which is intended to encourage new and exploratory research that may lead to a breakthrough in a particular area.

If you are developing a project that aligns with one of our areas and emphasizes women’s health, please contact Meryl Sufian at [email protected]. We are happy to discuss the scope of your potential project and how it advances this vitally important area of research.