January 25, 2023
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOT-OD-23-043 - Notice of Early Termination of NOT-OD-23-029 Notice of Special Interest (NOSI): Research on Gender Measurement (Admin Supp Clinical Trial Optional)
Office of Research on Women's Health (ORWH)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Sexual and Gender Minority Research Office (SGMRO)
National Cancer Institute (NCI)
Background
Gender is a social and cultural variable that encompasses several domains, each of which influences health: gender identity and expression, gender roles and norms, gender relations, structural sexism, power, and equality and equity. Gender socialization and norms of masculinity influence boys’ and men’s health-seeking behaviors. Structural gender inequalities limit girls’ and women’s access to health services and contribute to health inequities. Other social variables—including race, ethnicity, socioeconomic status, and State and Federal policies—may additionally interact with gender to influence health, highlighting the importance of an intersectional approach to health research.
Disaggregation of research data on sex and gender allows identification of and responses to how sex differences and gender inequalities affect health. The two-step method of data collection – collecting sex assigned at birth and current gender identity as distinct, independent variables – is widely utilized in clinical and health care settings. In recent years, definitions and understandings of sex and gender have shifted, and few tools to measure sex and gender have been widely available and validated.
A 2022 report from the National Academies of Sciences, Engineering, and Medicine (NASEM) reviewed evidence related to measuring sex, gender, and sexual orientation. That report called for continued utilization of the two-step method of data collection. The NASEM report noted that, in the absence of other evidence, the panel recommended using the terminology female/male for current gender identity, in keeping with response options that are used by the majority of current two-step measures. However, the panel also recommended that additional research aimed at improving the quality and inclusivity of the recommended two-step gender measure be conducted by testing gender terminology for current gender identity questions (e.g., woman, man, nonbinary). Additional testing to confirm the optimal ordering of the two-step components was also recommended. As a result of publication of these recommendations on the collection of gender, the rigor of any survey that includes ‘gender’ ascertainment could be enhanced by incorporating a two-step approach for gender measurement and evaluating the use of gender terminology to measure gender identity.
This administrative supplement will support research testing gender terminology (e.g., woman, man, nonbinary) for measuring current gender identity as part of the two-step method of data collection (sex assigned at birth and current gender identity), within the scope of the parent grant. Supplements will support additional costs associated with incorporating, testing, validating, and/or refining a two-step method of gender ascertainment.
Supplements can only be used to meet increased costs that are within the scope of the approved award but were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted. None of the funds can be used to support additional items that were not included in the parent grant.
Specific Areas of Research Interest
Administrative supplements supported by this Notice of Special Interest will support research testing gender terminology (e.g., woman, man, nonbinary) for measuring current gender identity as part of the two-step method of data collection (sex assigned at birth and current gender identity).
Specific Areas of Research Interest of SGMRO
SGMRO works with the 27 NIH Institutes and Centers to advance rigorous research related to sexual and gender minority (SGM; defined for NIH research in NOT-OD-19-139) populations, including intersex individuals and those with variations in sex characteristics. For this funding opportunity, SGMRO is particularly interested in advancing research recommendations for a measurement made in the 2022 NASEM report Measuring Sex, Gender Identity, and Sexual Orientation:
- Additional research related to measuring variations in sex characteristics, including but not limited to identifying people with intersex conditions.
- Additional research related to including a “nonbinary” response option in the current gender portion of the two-step gender identity measure.
The SGMRO does not have grant-making authority and can only support grants deemed meritorious after review by one of the ICs participating in this announcement and after a co-funding request is initiated through the IC. Please reach out to the relevant Scientific/Research Contact(s) identified in this announcement with any questions about IC-specific research priorities and funding. More SGM- and SGMRO-specific information is available in the NIH Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities FYs 2021-2025 and on the office’s Research Resources webpage.
Specific Areas of Research Interest of NCI
Eliminating cancer-related disparities by promoting and conducting health equity research is a top priority of the National Cancer Institute. SGM populations face disparities related to cancer risk and outcomes, and they also encounter barriers in cancer prevention, treatment, and survivorship care.
NCI is interested in increasing adoption and supporting sexual orientation and gender identity (SOGI) measurement in clinical, administrative, research, and surveillance contexts, as recommended in the 2022 National Academies of Sciences, Engineering, and Medicine report, “Measuring Sex, Gender Identity, and Sexual Orientation,” particularly in terms of a two-step gender identity question, with a collection of both sex assigned at birth and current gender identity. NCI has an interest in research that includes an expansive collection of current gender identity options, including but not limited to, man/male, woman/female, transgender, intersex, Two-Sprit (for Indigenous populations), nonbinary, and gender-fluid.
Specific Areas of Research Interest of NIAID
NIAID’s mission is to support basic and translational research that improves the understanding, diagnosis, prevention, and treatment of infectious and immune-mediated diseases, as well as advance immunologic and transplantation strategies. Because these conditions impact the health of sexual minority and majority populations, NIAID endorses adoption of meaningful sexual orientation and gender identity (SOGI) measurement in research, clinical care, and administrative settings as recommended in the 2022 National Academies of Sciences, Engineering, and Medicine (NASEM) report, “Measuring Sex, Gender Identity, and Sexual Orientation.” This includes a two-step SOGI question with collection of not only sex assignment at birth but also in tandem with current gender identity. NIAID has an interest in research within its mission that will evaluate expanded gender identity options for data collection such as (but not limited to): cisgender man, cisgender woman, transgender, intersex, two-spirit (for indigenous populations), nonbinary, and gender-fluid.
Eligibility
- Individual(s) must hold an active grant or cooperative agreement from NIH. This NOSI will support supplements for all activity codes. Individuals are encouraged to work with their organizations to develop applications for support. Only electronically submitted applications will be accepted.
Note: Specific aims added to the parent grant per 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 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. No-cost-extension is not an eligibility criterion. An exception may be given for proposals studying SARS-CoV-2 or COVID-19, please contact the ORWH scientific contact for approval.
- The proposed research must address Objective 2.2 of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women” (Develop and adapt reliable and valid measures relevant to the health of women).
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 $450,000 for this program.
- The application budget should not exceed $100,000 in direct costs.
- The application budget is limited to one year only.
- The proposed project period cannot exceed that of the parent award.
- Supplements may provide support above the dollar limits of the funding opportunity announcement of the parent grant award.
- Earliest start date – July/August 2023
Scientific Review Process
NIH program staff will conduct administrative reviews of the application submissions; the most meritorious applications will receive funding consideration pending availability of funds.
Application and Submission Information
- 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: 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) – February 28, 2023 by 5:00 PM local time of applicant organization
- For funding consideration, applicants must include “NOT-OD-23-046” (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.
- The Research Strategy section of the NOSI is limited to 6 pages.
- It is strongly recommended that the applicant contact both the program officer at the Institute supporting the parent award and the ORWH scientific contact to confirm, ahead of time, that the supplement falls within the scope of the parent award.
- To facilitate efficient processing, applicants are strongly encouraged to notify the program contact at the IC supporting the parent award that supplement application has been submitted in response to this funding opportunity.
Elizabeth Barr, Ph.D.
Office of Research on Women's Health
Telephone:301-402-7895
Email: [email protected]
and Human Services (HHS)
