Notice of Special Interest (NOSI): Administrative Supplements for Research on Sex and/or Gender Influences (Admin Supp Clinical Trial Optional)

Funding Agency:
National Institutes of Health

The Office of Research on Women's Health (ORWH) announces the availability of administrative supplements to support research highlighting the impact of sex and/or gender influences in human health and illness. Sex and/or gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. With continuous interaction between sex and gender, human health is determined by both biology and the expression of gender. The most robust experimental designs include consideration of both sex and gender; therefore, applications proposing to investigate the influence of both sex and gender factors are highly encouraged. The proposed research must address at least one objective from the five strategic goals of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women".

The National Academies' report, “Exploring the Biological Contributions to Human Health: Does Sex Matter?" (IOM Report, 2001) defined the term sex and gender. The terms sex and gender were used to refer to distinct but inextricably linked influences in health and diseases. However, sex and gender are conceptually complex, and our understanding is likely to evolve with the availability of a more complete body of research.

Consideration of sex and/or gender variables and comparisons of males and females may be critical to the accurate interpretation, validation, and generalization of research findings. Sex and/or gender influences may also determine how health and disease processes differ among women, or between women and men, and inform the development and testing of sex- and gender-aware preventive and therapeutic interventions. Sex- and gender-based results reporting and comparisons in research may also ensure that findings are applicable to both women and men.

A broad range of research topics studied at the basic, pre-clinical, translational, and clinical levels that address the role of sex and/or gender in health and disease are encouraged. Studies that explore sex or gender influences or the intersection of sex and gender are also encouraged. Please contact your program officer to discuss potential research topics responsive to this NOSI.

Potential topics include, but are not limited to:

  • The influence of sex and gender on disease incidence, prevention, treatment, and re-occurrence
  • Gender roles influencing caretaking responsibilities, and effects on health, resilience, and disease
  • Research considering the roles of sex and/or gender together on the outcome of human health
  • Population-based studies examining the role of gender in different cultural, social, and ethnic populations
  • SARS-CoV-2/COVID-19: ORWH encourages applications seeking to study SARS-CoV-2 virus or COVID-19 disease in alignment with efforts across NIH to develop and implement effective therapeutics and vaccines and to accelerate research on technologies to validate and improve programs that will overcome barriers and increase uptake of effective therapeutics and vaccines at the point of care. Within the focus of this NOSI, research topics of interest could include, but are not limited to:
    • Sex and/or gender influences in the development and administration of effective therapeutics and vaccines
    • Investigations of sex and/or gender differences in access to care (e.g., admission, diagnosis, and treatment) of COVID-19 affected individuals
    • Investigation of sex and/or gender influences on the outcome of patient interactions with health care providers
    • The impact of sex and/or gender on morbidity or mortality due to co-morbid condition(s), preference will be given to proposals studying more than one co-morbid conditions
    • Sex and/or Gender influences in Post-Acute Sequelae of SARS-CoV-2 Infection or Long-term effects of COVID-19 or Long COVID

Application Due Date(s) – January 26, 2022, and January 26, 2023


Agency Website

Eligibility Requirements

Only PDs/PIs of an active DP1, DP2, DP4, DP5, K01, K08, K23, K76, K99/R00, P01, P20, P30, P40, P41, P50, P51, P60, PM1, R01, R03, R21, R21/R33, R24, R37, R41, R41/R42, R42, R43, R43/R44, R44, RM1, U01, U10, U19, U44, U54, U56, UG1, UG3/UH3, UH2, UH2/UH3, UH3, UL1, UM1, or UM2 award from NIH are eligible to apply. Only electronically submitted applications will be accepted.

Funding Type





Medical - Basic Science
Medical - Clinical Science
Medical - Translational
Social Sciences

External Deadline

January 26, 2022