Opportunity Information: Apply for PAR 22 186
The National Institutes of Health (NIH) is offering a discretionary grant opportunity under Funding Opportunity Announcement PAR-22-186, titled "Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21 Clinical Trial Not Allowed)." This call uses the NIH R21 mechanism, which is generally intended for early-stage, exploratory, and hypothesis-generating work rather than large, definitive studies. The central goal is to support research focused on transgender people that clarifies how gender-affirming interventions, including hormones, medications, and surgical procedures, may influence biology and immune function in ways that affect vulnerability to HIV and other sexually transmitted infections (STIs). The emphasis is on understanding mechanisms and generating foundational evidence that can guide future, larger research efforts and, ultimately, improve prevention and treatment strategies that are biologically and clinically relevant for transgender communities.
The scientific focus is specifically on characterizing biological and immunological impacts associated with interventions used for gender affirmation or gender reassignment. In practical terms, this means projects might examine how hormone regimens or other gender-affirming therapies alter immune responses, mucosal immunity, inflammation, tissue characteristics, or other biological factors that could change susceptibility to HIV or STIs, or potentially modify how prevention and treatment approaches work in the body. The scope is deliberately tied to immunity, prevention, and treatment, but within an exploratory frame: building plausible mechanistic explanations, identifying biomarkers or pathways, and clarifying how these interventions may intersect with HIV/STI acquisition risk or disease processes. Importantly, the announcement states "Clinical Trial Not Allowed," which means applicants need to design studies that do not meet NIH’s definition of a clinical trial (for example, not prospectively assigning participants to interventions to measure health outcomes). Observational, mechanistic, or laboratory-based human studies that do not involve assigned interventions are typically more aligned with this restriction.
From an administrative standpoint, the opportunity is categorized as a grant in the health funding activity area and is associated with CFDA number 93.855. The award ceiling is listed as $275,000, indicating an upper bound on funding per award under this announcement. While the source data lists "ExpectedAwards" without a specific number, the key implication is that funding is competitive and dependent on NIH priorities, budget availability, and peer review outcomes rather than a guaranteed count of awards.
Eligibility is broad and includes many types of U.S.-based organizations, such as state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; and public housing authorities/Indian housing authorities. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, as long as they are not institutions of higher education in that category. For-profit organizations (other than small businesses) and small businesses are also eligible, along with an "Others" category that typically covers additional entity types NIH allows. The announcement further highlights additional eligible applicants and settings, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, U.S. territories or possessions, and certain non-U.S. entities such as foreign organizations and regional organizations. This wide eligibility is consistent with NIH’s intent to encourage participation from diverse institutions, including those closely connected to communities most affected by HIV/STI inequities.
Key dates in the provided record include a creation date of May 19, 2022, and an original closing date of December 7, 2024. Applicants considering this opportunity would generally be expected to align proposed work with the R21 exploratory intent, keep the project within the funding cap, ensure the research approach fits the "clinical trial not allowed" requirement, and clearly connect gender-affirming interventions to measurable biological or immunologic factors relevant to HIV and STI susceptibility, prevention, or treatment in transgender populations.Apply for PAR 22 186
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2022-05-19.
- Applicants must submit their applications by 2024-12-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $275,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIH PAR-22-186 - Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21 Clinical Trial Not Allowed)
What is this funding opportunity?
This is a discretionary grant opportunity from the National Institutes of Health (NIH) under Funding Opportunity Announcement (FOA) PAR-22-186, titled "Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21 Clinical Trial Not Allowed)."
What grant mechanism is being used?
The FOA uses the NIH R21 mechanism, which is intended for early-stage, exploratory, and hypothesis-generating research rather than large, definitive studies.
What is the main purpose or goal of this FOA?
The central goal is to support research focused on transgender people that clarifies how gender-affirming interventions (including hormones, medications, and surgical procedures) may influence biology and immune function in ways that affect vulnerability to HIV and other sexually transmitted infections (STIs). The intent is to generate foundational, mechanistic evidence that can guide future, larger research and improve prevention and treatment strategies relevant to transgender communities.
What scientific topics does NIH want applicants to focus on?
The scientific focus is on characterizing biological and immunological impacts associated with interventions used for gender affirmation or gender reassignment, and how those impacts may relate to HIV/STI susceptibility, prevention, or treatment.
What kinds of biological or immunological factors are relevant under this FOA?
Examples of relevant areas (as described in the opportunity summary) include immune responses, mucosal immunity, inflammation, tissue characteristics, and other biological factors that could influence susceptibility to HIV or STIs or modify how prevention and treatment approaches work in the body.
Does this FOA support research on gender-affirming hormones?
Yes. The description explicitly includes hormones as one of the gender-affirming interventions of interest, especially in terms of how hormone regimens may alter immune function or other biological pathways related to HIV/STI vulnerability, prevention, or treatment.
Does the scope include gender-affirming medications and surgical procedures?
Yes. The opportunity summary identifies hormones, medications, and surgical procedures as examples of gender-affirming interventions that may be studied for their biological and immunological effects relevant to HIV and STIs.
How should applications connect gender-affirming interventions to HIV and STI outcomes?
Applications should clearly link gender-affirming interventions to measurable biological or immunologic factors that are relevant to HIV/STI susceptibility, prevention, or treatment in transgender populations, and frame the work as mechanism-focused and foundational.
Is this intended to fund large confirmatory studies?
No. The R21 mechanism is described as supporting exploratory, early-stage, and hypothesis-generating work. The FOA emphasizes building plausible mechanistic explanations and generating foundational evidence to inform future larger research efforts.
What does "Clinical Trial Not Allowed" mean for this FOA?
The FOA states "Clinical Trial Not Allowed," meaning applicants must design studies that do not meet NIH's definition of a clinical trial. The summary specifically cautions against studies that prospectively assign participants to interventions to measure health outcomes.
What types of study designs are generally more aligned with the "Clinical Trial Not Allowed" restriction?
Based on the information provided, observational, mechanistic, or laboratory-based human studies that do not involve assigned interventions are typically more aligned with this restriction.
What is the maximum award amount?
The award ceiling is listed as $275,000, which indicates an upper funding bound per award under this announcement.
How many awards will NIH make under this FOA?
The provided record lists "ExpectedAwards" without a specific number. This implies awards are competitive and dependent on NIH priorities, available budget, and peer review outcomes rather than a guaranteed number of funded projects.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.855.
What funding activity area does this opportunity fall under?
It is categorized as a grant in the health funding activity area.
Who is eligible to apply?
Eligibility is broad and includes many types of organizations and entities, including state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; and public housing authorities/Indian housing authorities.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, as long as they are not institutions of higher education in that category.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.
Are community-based or faith-based organizations eligible?
Yes. The opportunity highlights faith-based or community-based organizations among additional eligible applicants and settings.
Are minority-serving institutions specifically encouraged or included as eligible?
Yes. The announcement highlights Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs) among eligible applicants and settings.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly listed among eligible applicants and settings.
Are non-U.S. entities eligible?
Yes. The eligibility description includes certain non-U.S. entities, such as foreign organizations and regional organizations.
Are federal agencies eligible to apply?
Yes. Eligible federal government agencies are listed among additional eligible applicants and settings.
What is the closing date for this opportunity?
The original closing date listed in the provided record is December 7, 2024.
When was this opportunity created?
The creation date listed in the provided record is May 19, 2022.
What should applicants keep in mind when shaping a project for this R21?
Applicants should align with the R21 exploratory intent, keep the proposed budget within the $275,000 funding cap, ensure the research approach fits the "Clinical Trial Not Allowed" requirement, and clearly connect gender-affirming interventions to measurable biological or immunologic factors relevant to HIV and STI susceptibility, prevention, or treatment in transgender populations.
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