Opportunity Information: Apply for RFA MH 20 115
The National Institutes of Health (NIH) announced this discretionary grant opportunity, RFA-MH-20-115, titled "Understanding the Mechanisms of Neuropsychiatric Side Effects and Neurological Toxicities of HIV Medicines (R21 Clinical Trial Not Allowed)." It uses the R21 mechanism, which is designed for exploratory, early-stage, or high-risk/high-reward work. The central goal is to support innovative research that clarifies why some people living with HIV experience neuropsychiatric symptoms (for example, mood, sleep, anxiety, or cognitive changes) and other neurological toxicities that appear to be associated with HIV medications. The emphasis is on uncovering mechanisms and risk factors that could ultimately point to better prevention, safer prescribing, targeted interventions, or more personalized HIV treatment strategies.
Projects supported under this FOA are expected to be primarily basic or preclinical in nature, rather than clinical trials. The "Clinical Trial Not Allowed" designation means applicants should not propose studies that meet the NIH definition of a clinical trial (for instance, prospectively assigning human participants to an intervention to evaluate effects on health-related outcomes). Instead, the opportunity is geared toward mechanistic, translationally oriented research that could include laboratory-based investigations, preclinical model systems, and other approaches that build credible biological or behavioral explanations for observed side effects and toxicities. Research may be conducted in domestic or international settings, reflecting NIH interest in findings that can generalize across different populations and treatment contexts.
A key theme of the FOA is identifying underlying mechanisms and risk factors. Mechanisms can include, for example, drug effects on central nervous system pathways, neuroinflammation, neurotransmitter systems, mitochondrial function, blood-brain barrier transport, or other biological processes that might plausibly link specific antiretroviral agents or regimens to neuropsychiatric outcomes. Risk factors may involve host characteristics (such as genetics, age, sex, comorbid mental health conditions, substance use, or co-infections), treatment-related variables (dose, combinations, drug-drug interactions), and contextual factors that influence vulnerability. The FOA signals particular interest in work that can move beyond documenting associations to explaining why they occur, and in doing so, reveal actionable targets for therapeutic intervention or precision medicine approaches (for example, predictors that could guide regimen selection for individuals more likely to experience adverse neuropsychiatric effects).
The program encourages innovative, multidisciplinary thinking. While not mandatory, collaborative alliances and teams that span relevant expertise areas are welcomed, such as neuropharmacology, psychiatry, neurology, virology, immunology, genetics, computational biology, toxicology, and behavioral science. The intent is to foster creative projects that might be too early or too unconventional for larger confirmatory grants, but that have a clear rationale and a plausible path toward generating decisive preliminary findings.
From an administrative standpoint, this is a grant in the health activity category (CFDA 93.242) administered by NIH. The original closing date listed is May 2, 2019, and the award ceiling noted is $200,000. While the number of expected awards is not specified in the provided excerpt, the R21 format typically supports smaller, focused studies intended to generate proof-of-concept data, develop new methods, or test novel hypotheses that can later be scaled into larger projects.
Eligibility is broad. In addition to standard eligible applicants such as state, county, and local governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses, the FOA explicitly notes additional eligible categories. These include 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), tribal governments and tribal organizations (including those other than federally recognized), faith-based or community-based organizations, U.S. territories or possessions, eligible federal agencies, and non-U.S. entities (foreign organizations) as well as regional organizations. This breadth is consistent with NIH interest in drawing from diverse institutional perspectives and ensuring that research on HIV treatment-related neuropsychiatric and neurological harms can be informed by varied populations, settings, and scientific approaches.
Overall, the opportunity is best understood as a targeted call for creative, mechanism-driven research that explains neuropsychiatric side effects and neurological toxicities linked to HIV medications, with the practical long-term aim of improving tolerability, safety, and individualized treatment decisions, while staying firmly outside the boundaries of proposing a clinical trial.Apply for RFA MH 20 115
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding the Mechanisms of Neuropsychiatric Side Effects and Neurological Toxicities of HIV Medicines (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): 93.242.
- This funding opportunity was created on 2019-02-27.
- Applicants must submit their applications by 2019-05-02. (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 $200,000.00 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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Frequently Asked Questions (FAQs)
What is the official title and identifier of this NIH funding opportunity?
The opportunity is NIH RFA-MH-20-115, titled "Understanding the Mechanisms of Neuropsychiatric Side Effects and Neurological Toxicities of HIV Medicines (R21 Clinical Trial Not Allowed)."
Which grant mechanism does this funding opportunity use?
This FOA uses the NIH R21 mechanism, which is intended for exploratory, early-stage, or high-risk/high-reward research projects.
What is the main goal of this FOA?
The central goal is to support innovative research that clarifies why some people living with HIV experience neuropsychiatric symptoms (such as mood, sleep, anxiety, or cognitive changes) and other neurological toxicities that appear to be associated with HIV medications.
What types of symptoms or outcomes are in scope for this FOA?
The FOA highlights neuropsychiatric symptoms and neurological toxicities linked to HIV medicines. Examples mentioned include mood changes, sleep problems, anxiety-related symptoms, and cognitive changes, along with other neurological toxicities connected to HIV medication exposure.
Is this opportunity focused on understanding associations or on explaining causes?
The emphasis is on moving beyond documenting associations and toward uncovering mechanisms and risk factors that explain why these side effects and toxicities occur.
Are clinical trials allowed under this FOA?
No. This FOA is designated "Clinical Trial Not Allowed," meaning applicants should not propose studies that meet the NIH definition of a clinical trial.
What does "Clinical Trial Not Allowed" mean in practical terms?
Applicants should not propose research that prospectively assigns human participants to an intervention in order to evaluate effects on health-related outcomes. The FOA is aimed at mechanistic, translationally oriented research rather than clinical trial designs.
If clinical trials are not allowed, what kinds of studies are expected?
Projects are expected to be primarily basic or preclinical in nature. The FOA points to mechanistic and translationally oriented approaches that could include laboratory-based investigations, preclinical model systems, and other methods designed to build credible biological or behavioral explanations for observed side effects and toxicities.
What kinds of mechanisms does NIH appear interested in for this topic?
The FOA lists examples of mechanisms such as drug effects on central nervous system pathways, neuroinflammation, neurotransmitter systems, mitochondrial function, and blood-brain barrier transport, as well as other biological processes that could plausibly connect antiretroviral agents or regimens to neuropsychiatric outcomes.
What kinds of risk factors are relevant to this FOA?
Risk factors may include host characteristics (for example genetics, age, sex, comorbid mental health conditions, substance use, or co-infections), treatment-related variables (dose, combinations, drug-drug interactions), and contextual factors that influence vulnerability.
Does this FOA encourage research that supports precision medicine or personalized prescribing?
Yes. The FOA expresses interest in work that can reveal actionable targets for intervention or precision medicine approaches, such as predictors that could guide regimen selection for individuals more likely to experience adverse neuropsychiatric effects.
Is multidisciplinary collaboration required?
Collaboration is encouraged but not mandatory. The FOA welcomes collaborative alliances and teams spanning relevant areas of expertise.
What scientific disciplines are specifically mentioned as relevant?
The FOA mentions areas such as neuropharmacology, psychiatry, neurology, virology, immunology, genetics, computational biology, toxicology, and behavioral science.
Can the research be conducted outside the United States?
Yes. The FOA notes that research may be conducted in domestic or international settings, reflecting interest in findings that generalize across populations and treatment contexts.
What is the broader long-term purpose of the research supported by this FOA?
While the projects themselves are mechanistic and not clinical trials, the longer-term aim is to enable better prevention, safer prescribing, targeted interventions, and more personalized HIV treatment strategies by clarifying mechanisms and risk factors.
What is the listed award ceiling for this opportunity?
The excerpt notes an award ceiling of $200,000.
What is the health activity and CFDA number associated with this grant?
This is a grant in the health activity category associated with CFDA 93.242.
What was the original closing date listed for this FOA?
The excerpt states the original closing date was May 2, 2019.
Does the excerpt specify how many awards NIH expects to make?
No. The number of expected awards is not specified in the provided excerpt.
How does the R21 mechanism typically frame the scope of supported projects?
As described in the excerpt, R21 awards typically support smaller, focused studies aimed at generating proof-of-concept data, developing new methods, or testing novel hypotheses that could later be scaled into larger projects.
Who is eligible to apply for this FOA?
Eligibility is broad and includes (among others) state, county, and local governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
What additional types of institutions or organizations are explicitly listed as eligible?
The FOA explicitly includes 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); tribal governments and tribal organizations (including those other than federally recognized); faith-based or community-based organizations; U.S. territories or possessions; eligible federal agencies; non-U.S. entities (foreign organizations); and regional organizations.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) as eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes tribal governments and tribal organizations, including those other than federally recognized.
Are faith-based or community-based organizations eligible?
Yes. The FOA explicitly lists faith-based or community-based organizations among eligible applicants.
What general kind of project "fit" is NIH looking for under this FOA?
The opportunity is positioned as a targeted call for creative, mechanism-driven research that explains neuropsychiatric side effects and neurological toxicities linked to HIV medications, with an emphasis on innovative approaches that may be too early or unconventional for larger, confirmatory grants.
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