Notice of Special Interest (NOSI): Administrative Supplements for Research on Sex and/or Gender Influences (Admin Supp Clinical Trial Optional)
Notice Number:
NOT-OD-22-030

Key Dates

Release Date:

December 2, 2021

First Available Due Date:
January 26, 2022
Expiration Date:
January 27, 2023

Related Announcements

NOT-GM-22-022 - Notice of NIGMS Participation in NOT-OD-22-030, "Notice of Special Interest (NOSI): Administrative Supplements for Research on Sex and/or Gender Influences (Admin Supp Clinical Trial Optional)".

PA-20-272: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

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

NOT-CA-22-040: Notice of NCI Participation in NOT-OD-22-030

Issued by

Office of Research on Women's Health (ORWH)

National Cancer Institute (NCI)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Office of Strategic Coordination (Common Fund) - New participating organization as of 01/14/2022 for due dates on/after 01/26/2022

Purpose

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".

Background

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.

For the purpose of this FOA, the following definitions are utilized to describe and differentiate sex and gender-based factors:


Specific Areas of Research Interest

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


 

Eligibility

  • 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.

    For the purposes of this NOSI - Specific aims added to the parent grant per the SARS-CoV-2/COVID-19 Competitive Revisions process are considered as part of the parent application and are eligible to apply for a supplement under this NOSI.


PDs/PIs of the above-mentioned activity codes must also fulfill all the following requirements, otherwise, their applications will be deemed non-responsive to this NOSI.

  • The parent peer-reviewed NIH-funded grant must have at least 16 months of active grant support remaining from the due date. A no-cost extension is not an eligibility criterion. An exception may be given for the proposals studying SARS-CoV-2 or COVID-19, please contact the ORWH scientific contact for approval.
  • Only one Sex and/or Gender Admin. Supp. award is permitted to a peer-reviewed NIH-funded grant in one grant cycle. An exception may be given for the proposals studying SARS-CoV-2 or COVID-19, please contact the ORWH scientific contact for approval.
  • One or more objectives 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" must be proposed and identified in the application.
  • One or more of the three Sex- and/or Gender-based Study Types must be proposed:
    • Pre-Clinical Research includes Cell line, Primary culture from animals, Animal models, Xenograft, Non-human primates
    • Clinical Research includes Human subjects, Human Biospecimens, Primary culture from human subjects
    • Both Pre-Clinical and Clinical Research includes above-mentioned examples of both study types, and Patients derived xenografts
       
  • One or more of the three Sex- and/or Gender-based Research Approaches must be included:
    • Add Another Sex and/or Gender: The addition of animal or human subjects, tissues, or cells of another sex and/or gender to that used in the parent grant to allow sex and/or gender-based comparisons. Applicants should discuss measures to ensure comparability of new data to data already collected under the parent grant.
    • Increase Sample Size: The addition of more animal or human subjects, tissues, or cells to a sample that already includes both males and females to increase the power of a study to analyze for sex and/or gender difference. Applicants should discuss methods used to ensure control of potential cohort differences related to the new data compared to data already collected.
    • Analyze Existing Data: Comparative analyses of existing samples/datasets/databases and/or data-mining to investigate the role of sex and/or gender. Applicants should explain how the proposed experiments or analyses will complement, without expanding the scope of the funded grant.


Foreign Institutions:

  • Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
  • Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
  • Foreign components, as defined in the NIH Grants Policy Statement, are allowed.


Budget

  • ORWH intends to commit up to $1 million per year to award up to 10 applications.
  • Application budget is limited to one year only.
  • Application budget cannot exceed a maximum direct cost of $100,000. In addition to the direct cost, applicable F&A (indirect) cost can also be requested.
  • Supplements may provide support above the dollar limits of the funding opportunity announcement of the parent grant award.
  • Earliest start date – July/August 2022 and July/August 2023


Scientific Review Process

The NIH program staff will conduct administrative reviews of submitted applications and will support the most meritorious applications, pending the availability of funds.

Application and Submission Information

  • The process for streamlined submissions using the eRA Commons cannot be used for this initiative.
  • Continuous Submission is not permitted. In other words, no late applications will be accepted.
  • Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
    • PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
  • All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
    • Application Due Date(s) – January 26, 2022, and January 26, 2023, by 5:00 PM local time of applicant organization.
    • For funding consideration, applicants must include “NOT-OD-22-030” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
    • Request is for one year of support only.
    • The Research Strategy section of the application is limited to 6 pages.
    • It is strongly recommended that the applicant contact the ORWH scientific contact and their respective program officers at the IC supporting the parent award to confirm ahead of time that the supplement falls within the scope of the parent award.
    • Applicants are strongly encouraged to notify the program contact at the IC supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

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