Opportunity Information: Apply for RFA MH 15 310
Apply for RFA MH 15 310
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants.
- This funding opportunity was created on Jan 27, 2015 and posted on Feb 24, 2014.
- Applicants must submit their applications by Feb 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Private institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33) opportunity (Funding Opportunity Number RFA-MH-15-310) is a National Institutes of Health grant designed to support early, efficient clinical testing of brand-new intervention ideas for mental disorders in both adults and children. It focuses on pilot or exploratory clinical trials that follow an "experimental therapeutics" approach, meaning the trial is not just meant to see whether symptoms improve, but is built to test whether the intervention engages a specific, scientifically grounded mechanism of action. The core expectation is that the study will generate clear, decision-ready evidence that supports a straightforward go/no-go choice about whether the intervention is worth further development, refinement, or larger-scale testing.
A central feature of this FOA is the emphasis on high-utility results regardless of outcome. Applicants are expected to design trials so that even negative or null findings still teach the field something important, such as whether the proposed target was actually engaged, whether the hypothesized mechanism holds up in humans, or whether the link between the mechanism and functional or clinical change is present. In other words, the trial should be informative by design, not just hopeful, and should reduce uncertainty about the intervention's promise and the underlying scientific rationale.
The FOA is broad about what counts as a "novel intervention." It explicitly includes behavioral approaches, pharmacological agents, biologics-based interventions, cognitive interventions, device-based strategies, interpersonal approaches, physiological interventions, and combinations of these. That breadth signals that the program is mechanism-driven rather than modality-driven: the key is that the intervention is innovative, grounded in emerging science about processes underlying mental disorders, and testable in a way that can validate whether it meaningfully affects the intended mechanism and whether that effect relates to clinical or functional outcomes.
Mechanism validation is not treated as an optional add-on. The announcement states that support will be provided to test and validate the intervention's mechanism of action and to conduct studies that relate the mechanism to functional or clinical effects. Practically, this implies that applicants should include measures capable of demonstrating target engagement or mechanism change (for example, behavioral assays, cognitive tasks, physiological markers, neurobiological measures, or other validated indicators) alongside clinically relevant endpoints. The overall goal is to speed translation from basic science discoveries about mechanisms and processes into interventions that can be tested efficiently and rigorously for their potential to reduce symptoms and restore function for people living with mental disorders.
From an administrative standpoint, this is a discretionary grant opportunity within the health funding activity category (CFDA 93.242, Mental Health Research Grants). It does not require cost sharing or matching. The posting date was February 24, 2014, with key dates indicating an original closing date of February 17, 2015, a current closing date of February 19, 2015, and an archive date of March 19, 2015. The estimated total funding listed is $3,000,000, indicating a finite pool intended to support a set of selected projects rather than an open-ended funding stream.
Eligibility is intentionally expansive and includes many types of domestic and non-domestic entities. Eligible applicants include for-profit organizations (other than small businesses) and small businesses; nonprofit organizations with or without 501(c)(3) status; public and private institutions of higher education; independent school districts; local and state governmental entities (city/township, county, special district, and state governments); public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations (both federally recognized and other than federally recognized). The eligibility list also explicitly includes various mission-focused institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. Foreign organizations and foreign institutions are eligible, non-U.S. components of U.S. organizations may apply, and foreign components are allowed as defined by NIH policy, which opens the door for international collaborations or trials conducted in non-U.S. settings when scientifically justified.
In summary, RFA-MH-15-310 funds exploratory clinical trials that are tightly engineered to answer mechanistic questions while producing practical development decisions for novel mental health interventions. It is aimed at shortening the path from promising basic science to real-world treatment candidates by requiring trials that can credibly show whether an intervention hits its intended mechanism and whether that mechanistic effect translates into meaningful clinical or functional change. For full details, the announcement points to the NIH Grants Guide link (http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-15-310.html), and for access or technical issues, the NIH Office of Extramural Research webmaster contact is provided at FBOWebmaster@OD.NIH.GOV.
FAQs: Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33) (RFA-MH-15-310)
What is the Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33) opportunity?
This NIH funding opportunity (Funding Opportunity Number RFA-MH-15-310) supports early, efficient clinical testing of brand-new intervention ideas for mental disorders in adults and children. It is aimed at pilot or exploratory clinical trials designed to produce clear, decision-ready evidence about whether an intervention should move forward to further development, refinement, or larger-scale testing.
What does the R33 mechanism support in this FOA?
The FOA supports exploratory clinical trials that are tightly engineered to answer mechanistic questions and enable a straightforward go/no-go decision about the intervention's promise and next steps.
What is meant by an "experimental therapeutics" approach?
In this FOA, "experimental therapeutics" means the trial is not only looking for symptom improvement. It is designed to test whether the intervention engages a specific, scientifically grounded mechanism of action (a defined target or process), and whether changes in that mechanism relate to functional or clinical effects.
What is the core expectation for study outcomes?
The central expectation is that the study will generate clear evidence that supports a practical go/no-go decision about whether the intervention is worth further development, refinement, or larger-scale testing.
Are negative or null results acceptable under this FOA?
Yes. A central feature of the FOA is the emphasis on high-utility results regardless of outcome. Applicants are expected to design trials so that negative or null findings are still informative, such as clarifying whether the target was engaged, whether the hypothesized mechanism holds up in humans, or whether mechanistic change is linked to clinical or functional change.
What types of interventions are considered "novel" for this opportunity?
The FOA is broad and explicitly includes behavioral approaches, pharmacological agents, biologics-based interventions, cognitive interventions, device-based strategies, interpersonal approaches, physiological interventions, and combinations of these. The focus is mechanism-driven rather than based on intervention modality.
Is mechanism validation optional, or required?
Mechanism validation is not treated as optional. The FOA states that support will be provided to test and validate the intervention's mechanism of action and to conduct studies that relate the mechanism to functional or clinical effects.
What kinds of measurements are expected to demonstrate target engagement or mechanism change?
Applicants are expected to include measures capable of demonstrating target engagement or mechanism change alongside clinically relevant endpoints. The FOA provides examples such as behavioral assays, cognitive tasks, physiological markers, neurobiological measures, or other validated indicators.
Does the FOA focus only on adults, or can studies include children?
Studies may involve both adults and children. The FOA supports early clinical testing of novel intervention ideas for mental disorders across these populations.
What is the overall goal of this funding opportunity?
The overall goal is to speed translation from basic science discoveries about mechanisms and processes into interventions that can be tested efficiently and rigorously, including whether the intervention affects the intended mechanism and whether that effect translates into meaningful clinical or functional change.
What is the funding activity category and CFDA number?
This is a discretionary grant opportunity within the health funding activity category, listed under CFDA 93.242 (Mental Health Research Grants).
Is cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching.
What is the estimated total funding amount listed for this FOA?
The estimated total funding listed is $3,000,000, indicating a finite pool intended to support a set of selected projects rather than an open-ended funding stream.
What were the key dates for this opportunity?
The posting date was February 24, 2014. The key dates listed include an original closing date of February 17, 2015, a current closing date of February 19, 2015, and an archive date of March 19, 2015.
Who is eligible to apply?
Eligibility is expansive and includes many domestic and non-domestic entities. Eligible applicants include for-profit organizations (other than small businesses) and small businesses; nonprofit organizations with or without 501(c)(3) status; public and private institutions of higher education; independent school districts; local and state governmental entities (city/township, county, special district, and state governments); public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations (federally recognized and other than federally recognized).
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The eligibility list explicitly includes institutions such as HBCUs, Hispanic-serving institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs. It also includes faith-based or community-based organizations.
Can foreign organizations or international components participate?
Yes. Foreign organizations and foreign institutions are eligible. Non-U.S. components of U.S. organizations may apply, and foreign components are allowed as defined by NIH policy, supporting international collaborations or trials conducted in non-U.S. settings when scientifically justified.
Where can applicants find the full official announcement?
The FOA points to the NIH Grants Guide link: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-15-310.html
Who should be contacted for access or technical issues related to the posting?
For access or technical issues, the FOA lists the NIH Office of Extramural Research webmaster contact: FBOWebmaster@OD.NIH.GOV
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