ORWH’s Strategic Approach to COVID-19 Response
By Dr. Janine A. Clayton
Successful navigation of a public health emergency such as the COVID-19 pandemic requires short- and long-term strategies. We work not only to safely get out of the woods but also, as researchers, to simultaneously chart a better course for future challenges. The NIH-Wide Strategic Plan for COVID-19 Research guides the work of developing diagnostics, treatments, and preventive interventions—including Phase III trials of vaccines. To complement the strategic plan and guide its COVID-19 response, the NIH Office of Research on Women’s Health (ORWH) developed Guiding Principles: Sex and gender influences in COVID-19 and the health of women. The principles promote rigorous research, advance health equity, and enhance the Nation’s response to this pandemic by laying out a systematic approach to incorporating sex and gender into research to inform and improve the health of women.
Achieving Rigor via the Study and Analysis of Sex and Gender
The application of a sex-and-gender lens by NIH-supported scientists to COVID-19 research ensures that the needed scientific rigor is present in the following areas:
- Strengthening vaccine efficacy
- Identifying novel therapeutics
- Determining sex differences in risk profiles
- Elucidating patterns in treatment adherence, access to health care, and health-seeking behaviors
Fully aligned with the NIH Policy on Sex as a Biological Variable (SABV), the guiding principles also expect researchers to consider how sex could influence their research, encouraging them to design studies that take sex into account and then tabulate, analyze, and report sex-based data. Adherence to the SABV policy will help accelerate the identification and dissemination of sex effects related to immune responses to COVID-19 and potential vaccines and therapeutics, including the contribution of the sex chromosomes, genes, and hormones to immune responses.
The guiding principles focus specific attention on COVID-19 and areas of particular concern:
Sex Differences in Immune Response
Early data suggest that women, who hold more positions in health care, might face more disease exposure but that more men die from the disease. Sex differences in immune response might contribute to this disparity. Previous research has shown that women tend to make more antibodies in response to pathogens, such as viruses. Women might have a lower prevalence or susceptibility to certain viruses because their immune systems might more effectively clear infections.1
Sex and Gender Differences in Mental Health
It is important for the scientific community to understand the different sex- and gender-related responses to lockdown measures and pandemic-related stress and mental health issues. Preliminary information suggests that the effects of lockdowns are worse among women;2 other data indicate that essential workers, unpaid caregivers, and those with preexisting mental health conditions—groups composed disproportionately of women—experience high levels of anxiety, depression, substance use, and suicidal ideation.3
Helping Achieve Safety, Efficacy, and Reproducibility via the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
The multidimensional consideration of the health of women across the life course is an important factor in supported COVID-19 research. NIH requires that NIH-funded clinical research include women, racial and ethnic minorities, and individuals of all ages, absent any justification for excluding them. The guiding principles address three specific aspects of the pandemic:
The Health of Pregnant Women
The COVID-19 pandemic has introduced particular challenges to both maternal–fetal therapeutic research and the clinical care of pregnant women. NIH has launched a multipronged study to understand the effects of the COVID-19 pandemic on pregnancy and pregnancy outcomes. Researchers will review women’s medical records to assess whether pandemic-related alterations in health care delivery result in more pregnancy-related complications and rates of cesarean delivery. The study will also examine the risk of SARS-CoV-2 infection transmission from pregnant women to their fetuses.
The Health of Understudied, Underrepresented, and Underreported (U3) Populations of Women
U3 women are potentially more vulnerable to COVID-19, for a variety of reasons, including limited health care access and disproportionate exposure from working in public-facing essential roles or residence in crowded living spaces.4 NIH expanded the scope of a recent notice of special interest (NOSI) so researchers can conduct COVID-19-related investigations in the ORWH-supported U3 Administrative Supplement Program.
Gendered Experiences and Dissimilarities
The research community must gain a better understanding of how gendered experiences and dissimilarities affect the risk of infection, disease progression, and outcomes in the setting of COVID-19, as well as the gender-related factors that hinder health-promoting behaviors and act as barriers to treatment.
Understanding the Consequences of COVID-19 on the Biomedical Workforce
The need for social distancing during the COVID-19 era has had substantial ramifications on biomedical workforce projects, including the stoppage of research programs and laboratory activities and reassignment away from planned studies. Early-career investigators (ESIs) are particularly vulnerable because of interruptions in establishing their independent scientific work and the need to make long-term adjustments.5,6 Additional caregiving and family responsibilities disproportionately affect women scientists and can interfere with publishing and other professional activities that advance scientific careers.7
To date, several initiatives have been launched to help manage the impact of COVID-19 on biomedical careers. NIH provides numerous flexibility options and offers an opportunity for scientists to apply for an extension of their ESI status because of COVID-19-related delays. NIH recently published two NOSIs announcing administrative supplements to support and enhance retention of early-career biomedical investigators during critical life events, the Administrative Supplements to Promote Research Continuity and Retention of NIH Mentored Career Development (K) Award Recipients and Scholars and the Administrative Supplement for Continuity of Biomedical and Behavioral Research Among First-Time Recipients of NIH Research Project Grant Awards. Additionally, ORWH launched the NIH Prize for Enhancing Faculty Gender Diversity in Biomedical and Behavioral Science, which will recognize institutions that have achieved sustained improvement in gender diversity.
Incorporating Sex and Gender Is Good Strategy
The coronavirus poses substantial risks to the health of women, as well as their advancement in biomedical research. The NIH-Wide Strategic Plan for COVID-19 Research and ORWH guiding principles are aligned with a common purpose. Together, they provide an NIH road map for developing, testing, and implementing responses to the pandemic’s multifaceted consequences that meet everyone’s needs, especially those of women.
1 Office of Research on Women’s Health. (2020). Bench to Bedside: Integrating Sex and Gender to Improve Human Health (Module 1: Immunology) [MOOC]. https://orwh.od.nih.gov/career-development-education/e-learning/bench-bedside
2 Adams-Prassl, A., et al. (2020). Cambridge-INET Working Paper WP2021. https://www.inet.econ.cam.ac.uk/research-papers/wp-abstracts?wp=2021
3 Czeisler, M. É., et al. (2020). Morbidity and Mortality Weekly Report. PMID: 32790653.
4 Webb Hooper, M., et al. (2020). JAMA. PMID: 32391864.
5 Levine, R. L., & Rathmell, W. K. (2020). Nature Reviews Cancer. PMID: 32503987.
6 Termini, C. M., & Traver, D. (2020). BMC Biology. PMID: 32731867.
7 Kramer, J. (2020, August 12). Women in science may suffer lasting career damage from COVID-19. Scientific American. https://www.scientificamerican.com/article/women-in-science-may-suffer-lasting-career-damage-from-covid-19