Journal of Science Policy & Governance
Volume 26, Issue 01 | June 16, 2025

Policy Memo
​Empowering Women’s Health: Proposed NIH Actions for Enhancing Accountability and Progress in Women’s Health Research

Lauren Hesse1,3, Vivian Su3,4, Phebe Ekregbesi2,3, Abigail Fennell1,3, Corinna Torabi3,5, Ramona Johnson3,6, Esther Whang1,3 
  1. Johns Hopkins School of Medicine, Department of Biomedical Engineering, Baltimore, MD, USA
  2. ​​Johns Hopkins Bloomberg School of Public Health, Department of Molecular Microbiology and Immunology, Baltimore, MD, USA 
  3. Johns Hopkins University, Johns Hopkins Science Policy and Diplomacy Group, Washington, DC, USA
  4. Johns Hopkins University, Department of Materials Science and Engineering, Baltimore, MD, USA
  5. Johns Hopkins University, Department of Mechanical Engineering, Baltimore, MD, USA
  6. Johns Hopkins School of Medicine, Graduate Program in Immunology, Baltimore, MD, USA
​​
​Corresponding author: [email protected] ​​​
Keywords: NIH; women’s health; science policy; sex and gender; biomedical research
https://doi.org/10.38126/JSPG260102 ​

Executive Summary

Women’s health research is defined as the study of health across a woman’s lifespan, which includes sex differences in disease risk and drug responses as well as conditions that are specific to women such as pregnancy and menopause (“The Role of Women’s Health Research” n.d.). Although the anatomical and physiological differences between men and women are critical, women have been historically understudied in health research and female-dominant diseases are underfunded (Smith 2023). Entire subpopulations of women have been excluded or underrepresented in clinical trials, such as those who are pregnant, socioeconomically disadvantaged, and that live in rural areas. The lack of funding opportunities for women’s health research further delays progress that is critical for clinical interventions. In this report, we propose that the National Institute of Health (NIH) implement policies to promote inclusive research studies by amending their 2016 Sex as a Biological Variable (SABV) policy, mandating sex-disaggregated data reporting in NIH repositories, aligning funding allocation with sex-specific disease burden using Disability-Adjusted Life Years (DALYs), and reclassifying pregnant women as a medically complex rather than a vulnerable population. These recommendations will help NIH improve compliance with its existing policies, increase visibility of women’s health issues, and support research imperative to bridging the knowledge and healthcare gap experienced by women.

-Read the full article through download.-

Background header image courtesy of OASH
Lauren Hesse is a recent (December 2024) graduate of Johns Hopkins University, earning an MS in biomedical engineering. She is also a policy fellow at the National Security Commission on Emerging Biotechnology. She has extensively participated in women’s health focused research projects and aims to advocate for biomedical research initiatives throughout her career. The views expressed in this article are her personal, academic views and do not reflect the views of the Department of Defense, U.S. Congress, or National Security Commission on Emerging Biotechnology. 
​
Vivian Su is a PhD student in the Department of Materials Science and Engineering at Johns Hopkins University studying the role of chemomechanics in the cervix in preterm birth (PTB). She is interested in regulatory science to advance the development of safe and effective products. Her broader interests include exploring the connections between environmental factors and public health outcomes. Outside of the lab, she engages with science outreach to bridge research with the community. 

Phebe Ekregbesi is a recent (May 2024) graduate of the Johns Hopkins Bloomberg School of Public Health, earning an MSc for her thesis work developing a novel physiologically relevant model of placental malaria in mice. While at Johns Hopkins, she was an active member of the Johns Hopkins Science Policy and Diplomacy Group, as well as the African Public Health Network, illustrating her desire to not only progress academic research but also actively participate in policy and advocacy efforts. She will be pursuing her PhD in Bioengineering at Rice University following a gap year. 

Abigail Fennell is a Biomedical Engineering PhD student at Johns Hopkins University. In her research, she studies the cellular mechanisms of aging in female reproductive organs. Through her work, she hopes to inform better medical care and policy decisions in women's health. 

Corinna Torabi is a newly minted Ph.D. graduate in Mechanical Engineering Johns Hopkins University. Her research focus is microfluidic devices for clinical translation, including microfluidic tools for fabrication of microscale therapeutic biomaterials and nanoparticles for gene therapy and drug delivery. 

Ramona Johnson is a PhD candidate in the Johns Hopkins School of Medicine Graduate Program in Immunology. She is currently studying mechanisms of rheumatic autoimmune disease, including autoantigen generation and self-activation of innate signaling pathways. Outside of the lab, she engages in science policy and science communication work to advocate for autoimmune disease research and the advancement of women’s health initiatives. 

Esther Whang is a second-year PhD student in Biomedical Engineering advised by Prof. Adam S. Charles and Prof. Ji Yi. She is working on developing computational imaging methods for neural recording modalities. She has a Bachelors and Master’s in Electrical Engineering from the Cooper Union for the Advancement of Science and Art. 

References

  1. Adam MP, Polifka JE, Friedman JM. (2011). Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet. 2011 Aug 15;157C(3):175-82. https://doi.org/10.1002/ajmg.c.30313. Epub 2011 Jul 15. PMID: 21766440. 
  2. American College of Obstetricians and Gynecologists. (2015, November). Ethical considerations for including women as research participants. ACOG. https://www.acog.org/clinical/clinical-guidance/c ommittee-opinion/articles/2015/11/ethical-consi​derations-for-including-women-as-research-partici pants. 
  3. Arnegard, M. E., Whitten, L. A., Hunter, C., & Clayton, J. A. (2020). Sex as a Biological Variable: A 5-Year Progress Report and Call to Action. Journal of women's health (2002), 29(6), 858–864. https://doi.org/10.1089/jwh.2019.8247. 
  4. Ballreich, J. M., Gross, C. P., Powe, N. R., & Anderson, G. F. (2021). Allocation of National Institutes of Health Funding by Disease Category in 2008 and 2019. JAMA network open, 4(1), e2034890. https://doi.org/10.1001/jamanetworkopen.2020.34890. 
  5. Burbank, M., Gautier, F., Hewitt, N., Detroyer, A., Guillet-Revol, L., Carron, L., Wildemann, T., Bringel, T., Riu, A., Noel-Voisin, A., De Croze, N., Léonard, M., Ouédraogo, G. (2023). Advancing the use of new approach methodologies for assessing teratogenicity: Building a tiered approach. Reproductive Toxicology. 2023 September; 120. https://doi.org/10.1016/j.reprotox.2023.108454. 
  6. Colleen Carmody, Charlotte G Duesing, Alice E Kane, Sarah J Mitchell (2022) Is Sex as a Biological Variable Still Being Ignored in Preclinical Aging Research?, The Journals of Gerontology: Series A, Volume 77, Issue 11, November 2022: 2177–2180, https://doi.org/10.1093/gerona/glac042. 
  7. “Coronary Heart Disease - Women and Heart Disease | NHLBI, NIH.” 2024. December 27, 2024. https://www.nhlbi.nih.gov/health/coronary-heart disease/women. 
  8. fact, many of the proposed changes support more conscientious allocation of government resources without necessarily expanding research funding. By addressing historical inequities in the understanding of sex as it relates to women’s health, these guidelines provide a way for the NIH to improve the rigor of the research it supports and promote improved health outcomes for all. 
  9. Cohen, E., D. Z. Kuo, R. Agrawal, J. G. Berry, S. K. Bhagat, T. D. Simon, and R. Srivastava. (2011). "Children with Medical Complexity: An Emerging Population for Clinical and Research Initiatives." Pediatrics 127 (3): 529–538. https://doi.org/10.1542/peds.2010-0910. 
  10. Colavizza, Giovanni, Iain Hrynaszkiewicz, Isla Staden, Kirstie Whitaker, and Barbara McGillivray. (2020). “The Citation Advantage of Linking Publications to Research Data.” PLoS ONE 15 (4): e0230416. https://doi.org/10.1371/journal.pone.0230416. 
  11. Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC). (2023, March 31). Research Portfolio Online Reporting Tools (RePORT). https://report.nih.gov/funding/categorical-spendin g#/. 
  12. Forero, Diego A., Walter H. Curioso, and George P. Patrinos. (2021). The Importance of Adherence to International Standards for Depositing Open Data in Public Repositories. BMC Research Notes 14 (November):405. https://doi.org/10.1186/s13104-021-05817-z.
  13. Gordon, B. G. (2020). "Vulnerability in Research: Basic Ethical Concepts and General Approach to Review." Ochsner Journal 20 (1): 34–38. https://doi.org/10.31486/toj.19.0079. 
  14. Haas, D. M., Marsh, D. J., Dang, D. T., Parker, C. B., Wing, D. A., Simhan, H. N., Grobman, W. A., Mercer, B. M., Silver, R. M., Hoffman, M. K., Parry, S., Iams, J. D., Caritis, S. N., Wapner, R. J., Esplin, M. S., Elovitz, M. A., Peaceman, A. M., Chung, J., Saade, G. R., & Reddy, U. M. (2018). Prescription and other medication use in pregnancy. Obstetrics & Gynecology, 131(5), 789–798. https://doi.org/10.1097/AOG.0000000000002579.
  15. “HIPAA Privacy Rule and Its Impacts on Research.” 2007. National Institutes of Health. February 2, 2007. https://privacyruleandresearch.nih.gov/pr_08.asp #8a. 
  16. Hunt, L., Nielsen, M. W., & Schiebinger, L. (2022). A framework for sex, gender, and diversity analysis in research. Science, 377(6614), 1492–1495. https://doi.org/10.1126/science.abp977. 
  17. Jaklin, M., Zhang, J.D., Schäfer, N., Clemann, N., Barrow, P., Küng, E., Sach-Peltason, L., McGinnis, C., Leist, M., Kustermann, S. (2022). Optimization of the TeraTox Assay for Preclinical Teratogenicity Assessment. Toxicol Sci. 2022 Apr 29; 188(1): 17-33. PCMID: PMC9237991 
  18. Johnson, Carolyn Y., Scott Dance, and Joel Achenbach. (2025). “Here Are the Words Putting Science in the Crosshairs of Trump’s Orders.” The Washington Post, February 4, 2025. https://www.washingtonpost.com/science/2025/02/04/national-science-foundation-trump-executiv e-orders-words/. 
  19. Kim, J. H., & Scialli, A. R. (2011). Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicological sciences : an official journal of the Society of Toxicology, 122(1), 1–6. https://doi.org/10.1093/toxsci/kfr088. 
  20. Kozlov, Max, and Smriti Mallapaty. (2025). “Exclusive: NIH to Terminate Hundreds of Active Research Grants.” Nature 639 (8054): 281–82. https://doi.org/10.1038/d41586-025-00703-1. 
  21. Lee, Bruce Y. (2025). “These 197 Terms May Trigger Reviews Of Your NIH, NSF Grant Proposals.” Forbes. March 15, 2025. https://www.forbes.com/sites/brucelee/2025/03/ 15/these-197-terms-may-trigger-reviews-of-your-n ih-nsf-grant-proposals/. 
  22. Matthews, Stacey, Samantha Cook, Tim Clayton, Sarah Murray, Rochelle Wynne, and Julie Sanders. (2024). “Factors Affecting Women’s Participation in Cardiovascular Research: A Scoping Review.” European Journal of Cardiovascular Nursing 23 (2): 107–14. https://doi.org/10.1093/eurjcn/zvad048. 
  23. Mirin A. A. (2021). Gender Disparity in the Funding of Diseases by the U.S. National Institutes of Health. Journal of women's health (2002), 30(7), 956–963. https://doi.org/10.1089/jwh.2020.8682. 
  24. Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernández-Díaz S; (2008). National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol. 2011 Jul;205(1):51.e1-8. https://doi.org/10.1016/j.ajog.2011.02.029. Epub 2011 Apr 22. PMID: 21514558; PMCID: PMC3793635. 
  25. National Institutes of Health. (2018). Advancing Science for the Health of Women: The Trans-NIH Strategic Plan for Women's Health Research, 2019–2023. Bethesda, MD: National Institutes of Health. https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_02_21_19_V2_508C.pdf.
  26. National Institutes of Health: Better oversight needed to help ensure continued progress including women in health research. (n.d.). U.S. GAO. https://www.gao.gov/products/gao-16-13. 
  27. Nielsen, M.W., Andersen, J.P., Schiebinger, L., Schneider, J.W. (2017). One and a half million medical papers reveal a link between author gender and sex analysis. Nature Human Behaviour, 1, 791-796. https://doi.org/10.1038/s41562-017-0235-x. 
  28. Nimgaonkar, A., Mughal, A. Y., Heimer, H., Nimgaonkar, V., Greenstein, D., & Wright, A. (2022). Exploring static and dynamic relationships between burden of disease and research funding in the United States. Health research policy and systems, 20(1), 60. https://doi.org/10.1186/s12961-022-00837-y. 
  29. Office of Research on Women’s Health. (2021). Report of the Advisory Committee on Research on Women’s Health, Fiscal Years 2019-2020: Office of Research on Women’s Health and NIH Support for Research on Women’s Health. 
  30. “Repositories for Sharing Scientific Data | Data Sharing.” n.d. Accessed May 17, 2024. https://sharing.nih.gov/data-management-and-shar ing-policy/sharing-scientific-data/repositories-forsharing-scientific-data. 
  31. Salloum, M., Paviotti, A., Bastiaens, H., Van Geertruyden, J.P. (2023). The inclusion of pregnant women in vaccine clinical trials: An overview of late-stage clinical trial’s records between 2018 and 2023. Vaccine, 41(48):7076-7083. https://doi.org/10.1016/j.vaccine.2023.10.057. 
  32. Smith K. (2023). Women's health research lacks funding - in a series of charts. Nature, 617(7959), 28–29. https://doi.org/10.1038/d41586-023-01475-2. 
  33. Steinberg, J. R., Turner, B. E., Weeks, B. T., Magnani, C. J., Wong, B. O., Rodriguez, F., Yee, L. M., & Cullen, M. R. (2021). Analysis of Female Enrollment and Participant Sex by Burden of Disease in US Clinical Trials Between 2000 and 2020. JAMA network open, 4(6), e2113749. https://doi.org/10.1001/jamanetworkopen.2021.13749. 
  34. Temkin, S. M., Noursi, S., Regensteiner, J. G., Stratton, P., & Clayton, J. A. (2022). Perspectives From Advancing National Institutes of Health Research to Inform and Improve the Health of Women: A Conference Summary. Obstetrics and gynecology, 140(1), 10–19. 
  35. https://doi.org/10.1097/AOG.0000000000004821. “The Role of Women’s Health Research.” n.d. Society for Women’s Health Research (blog). Accessed March 20, 2025. https://swhr.org/about/the-role-of-womens-health -research/. 
  36. U.S. Food & Drug Administration. (April 2018). Draft Guidance for Industry: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. Retrieved February 13, 2025,https://www.fda.gov/drugs/development-res ources/division-pediatrics-and-maternal-health-cli nical-trials-pregnant-women. 
  37. Waltz, M., Fisher, J. A., Lyerly, A. D., & Walker, R. (2021). Evaluating the National Institutes of Health’s Sex as a Biological Variable Policy: Conflicting Accounts from the Front Lines of Animal Research. Journal of Women's Health, 30(3), 348–354. https://doi.org/10.1089/jwh.2020.8674. 
  38. Waltz, M., Saylor, K. W., Fisher, J. A., & Walker, R. (2021). Biomedical Researchers’ Perceptions of the NIH’s Sex as a Biological Variable Policy for Animal Research: Results from a U.S. National Survey. Journal of Women's Health, 30(10), 1395–1405. https://doi.org/10.1089/jwh.2020.8997. 
  39. Werling, David M., and Daniel H. Geschwind. (2013). "Sex Differences in Autism Spectrum Disorders." Current Opinion in Neurology 26 (2): 146–153. https://doi.org/10.1097/WCO.0b013e32835ee548. 
  40. White, J., Tannenbaum, C., Klinge, I., Schiebinger, L., & Clayton, J. (2021). The Integration of Sex and Gender Considerations Into Biomedical Research: Lessons From International Funding Agencies. The Journal of Clinical Endocrinology and Metabolism, 106(10), 3034–3048. https://doi.org/10.1210/clinem/dgab434. 
  41. Woitowich, Nicole C, Annaliese Beery, and Teresa Woodruff. (2020). “A 10-Year Follow-up Study of Sex Inclusion in the Biological Sciences.” eLife 9 (June):e56344. https://doi.org/10.7554/eLife.56344. 
  42. World Health Organization. (2024, September 25). New global guidance puts forward recommendations for more ef ective and equitable clinical trials. Retrieved November 24, 2024, from https://www.who.int/news/item/25-09-2024-new -global-guidance-puts-forward-recommendations-f 
  43. or-more-effective-and-equitable-clinical-trials. Xing, Enze, Allison C. Billi, and Johann E. Gudjonsson. (2022). "Sex Bias and Autoimmune Diseases." Journal of Investigative Dermatology 142 (3, Part B): 857–866. https://doi.org/10.1016/j.jid.2021.06.008.
DISCLAIMER: The findings and conclusions published herein are solely attributed to the author and not necessarily endorsed or adopted by the Journal of Science Policy and Governance. Articles are distributed in compliance with copyright and trademark agreements.

ISSN 2372-2193
© 2022 Journal of Science Policy & Governance, Inc. All rights reserved. The opinions, findings and conclusions from JSPG publications, additional article commentaries and related events do not necessarily reflect the views of the journal.