Notice of Change: Expansion of Research Scope of NOT-OD-20-049 "Notice of Special Interest: Administrative Supplements for Research on Sex/Gender Influences (Admin Supp Clinical Trial Optional)"
Notice Number:
NOT-OD-21-010

Key Dates

Release Date:

October 30, 2020

Related Announcements

NOT-OD-20-049 - Notice of Special Interest: Administrative Supplements for Research on Sex/Gender Influences (Admin Supp Clinical Trial Optional)

Issued by

Office of Research on Women's Health (ORWH)

Purpose

The purpose of this notice is to inform potential applicants that the Office of Research on Women's Health (ORWH) has expanded the scope, effective immediately, in NOT-OD-20-049, Notice of Special Interest: Administrative Supplements for Research on Sex/Gender Influences (Admin Supp Clinical Trial Optional) .

Current Language:

Specific Areas of Research Interest

A broad range of research may be appropriate for this initiative. Areas of interest include the study of both male and female subjects, and the comparison of their outcomes in the following general areas:

  • Preclinical research projects aimed at increasing mechanistic understanding of sex differences
  • Comparative studies of male and female cells (including stem cells), tissues, organs or physiological systems
  • Systems biology (e.g., "omics") approaches and outcomes
  • Bioengineering and imaging studies of structural and/or functional differences; medical device development and implementation, including body armor, assistive exoskeletons, and organs or tissues on chips
  • In vivo methods and techniques to identify fetal sex prior to visualization of gonads
  • Computational models of disease progression, transmission, prevention, treatment, and relapse
  • Prenatal, perinatal, and postnatal development, both normal and abnormal
  • Assessment of differences in phenotypic characterization and risk factors for mental disorders; neurobehavioral mechanisms of psychopathology; trajectories of risk and resilience.
  • Neurobiological mechanisms relating to alcohol and other addictive drugs
  • Sensitivity and specificity of biomarkers (e.g. screening, predisposition/risk assessment, diagnostic, prognostic, predictive, therapeutic)
  • Therapeutic interventions for treatment or prevention; development of drugs/identification of targets; Pharmacokinetic/Pharmacodynamic (PK/PD) profiles. Examples Pain; Depression; Prescription drug abuse, addictive drugs; Atherothrombosis including coronary, cerebrovascular, and peripheral artery diseases; Heart failure; Asthma; Myelodysplasia/myeloproliferative disorders; Insomnia- and sleep-related fatigue, depression, stress, and suicide; Sleep-disordered breathing.

ORWH is specifically interested in supporting studies related to the influence of gender on human health. Topics of interest include, but are not limited to:

  • The influence of gender on disease incidence, prevention, treatment, and relapse
  • Gender roles influencing caretaking responsibilities, and effects on health, resilience, and disease
  • Research considering the roles of sex and gender together on the outcome of human health
  • Population study examining the role of gender in different cultural, social, and ethnic populations

The following text has been added/edited to reflect changes in the NOSI (NOT-OD-20-049) (changes are shown in italics below):

Specific Areas of Research Interest

A broad range of research may be appropriate for this initiative. Areas of interest include the study of both male and female subjects, and the comparison of their outcomes in the following general areas:

  • Preclinical research projects aimed at increasing mechanistic understanding of sex differences
  • Comparative studies of male and female cells (including stem cells), tissues, organs or physiological systems
  • Systems biology (e.g., "omics") approaches and outcomes
  • Bioengineering and imaging studies of structural and/or functional differences; medical device development and implementation, including body armor, assistive exoskeletons, and organs or tissues on chips
  • In vivo methods and techniques to identify fetal sex prior to visualization of gonads
  • Computational models of disease progression, transmission, prevention, treatment, and relapse
  • Prenatal, perinatal, and postnatal development, both normal and abnormal
  • Assessment of differences in phenotypic characterization and risk factors for mental disorders; neurobehavioral mechanisms of psychopathology; trajectories of risk and resilience.
  • Neurobiological mechanisms relating to alcohol and other addictive drugs
  • Sensitivity and specificity of biomarkers (e.g. screening, predisposition/risk assessment, diagnostic, prognostic, predictive, therapeutic)
  • Therapeutic interventions for treatment or prevention; development of drugs/identification of targets; Pharmacokinetic/Pharmacodynamic (PK/PD) profiles. Examples Pain; Depression; Prescription drug abuse, addictive drugs; Atherothrombosis including coronary, cerebrovascular, and peripheral artery diseases; Heart failure; Asthma; Myelodysplasia/myeloproliferative disorders; Insomnia- and sleep-related fatigue, depression, stress, and suicide; Sleep-disordered breathing.

ORWH is specifically interested in supporting studies related to the influence of gender on human health. Topics of interest include, but are not limited to:

  • The influence of gender on disease incidence, prevention, treatment, and relapse
  • Gender roles influencing caretaking responsibilities, and effects on health, resilience, and disease
  • Research considering the roles of sex and gender together on the outcome of human health
  • Population study examining the role of gender in different cultural, social, and ethnic populations

ORWH is encouraging application submissions and is seeking to support studies on the 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 funding opportunity announcement, research topics of interest could include, but are not limited to:

  • Sex and gender influences in the development and administration of effective therapeutics and vaccines
  • Investigations of sex and gender differences in access to care (e.g., admission, diagnosis, and treatment) of COVID-19 affected individuals
  • Investigation of sex and gender influences on the outcome of patient interactions with health care providers
  • The impact of sex and gender on mortality due to co-morbid conditions

All other aspects of the FOA/NOSI (NOT-OD-20-049) remain the same.

Inquiries

Please direct all inquiries to:

Rajeev K. Agarwal, Ph.D.
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-7058
Email:rajeev.agarwal@nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices