Opportunity Information: Apply for RFA MH 21 111
The National Institute of Mental Health (NIMH), within the National Institutes of Health (NIH), offered this R34 funding opportunity (RFA-MH-21-111) to support pilot effectiveness research on practical, service-ready tools and technologies that can strengthen suicide prevention services in real-world settings. The core idea is to move beyond early development and instead focus on resources that are already close to being deployable in routine care, where they can directly improve how individuals at risk for suicide are identified, supported, and treated. The opportunity sits on the effectiveness-implementation continuum, meaning applicants are expected to pay attention not only to whether a tool works, but also to whether it can realistically be adopted, delivered with fidelity, and sustained over time in everyday clinical workflows.
Projects supported under this announcement are intended to evaluate preliminary effectiveness while also answering the kinds of pragmatic questions that determine whether a tool will actually get used. NIMH is looking for studies that generate evidence about feasibility (can it be done in the intended setting), tolerability and acceptability (will patients and providers actually use it and stick with it), safety (particularly important in suicide prevention contexts), and early signals that the approach improves relevant outcomes. These pilot data are meant to set up the next step: a well-designed, fully powered effectiveness trial. In other words, the R34 is positioned as a bridge between a promising, nearly practice-ready tool and a definitive trial that can establish real-world impact at scale.
NIMH emphasizes two main research directions. First, applicants can propose to develop and test the preliminary effectiveness of optimized, service-ready tools for suicide risk identification, prevention, and treatment. The emphasis on "optimized" and "service-ready" implies that the tool should already be refined enough for real-world use, not a basic prototype. Second, applicants can focus on strategies that improve adoption, fidelity, and sustainment of these tools, explicitly using an implementation science framework. That expectation matters because it pushes projects to specify how implementation barriers will be assessed and addressed, how training or workflow changes will be supported, and how quality will be monitored so that outcomes do not degrade over time due to implementation drift.
A notable feature of this opportunity is its strong preference for scalable design and deployment-focused thinking. NIMH encourages the use of technology and design elements that help tools remain consistent and usable across sites and over time, such as automated decision supports, digital training resources, measurement and feedback systems, or other approaches that reduce burden on a stretched workforce. The announcement also highlights the importance of incorporating stakeholder perspectives, including service users, providers, and administrators, and of accounting for system-level constraints like workforce capacity and the realities of clinical operations. The practical takeaway is that an application is expected to show, in a concrete way, how the tool fits into clinical workflows and how the project team will increase the odds that it will be used correctly and routinely.
This R34 is "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial component, but a trial is not mandatory. The key requirement is that the research be aimed at pilot effectiveness and implementation-relevant outcomes for a service-ready resource. For applicants whose long-term plan is a large, definitive effectiveness study, NIMH directs that later-stage work to a companion R01 opportunity (RFA-MH-21-110). For small business-focused development and evaluation pathways, NIMH points to the SBIR mechanisms (RFA-MH-21-112; R43/R44). This positioning clarifies that the R34 here is meant for early, but practice-oriented, effectiveness testing and implementation planning rather than a final, large-scale evaluation.
In terms of eligibility, the opportunity is broadly open to many U.S.-based organizations and government entities, reflecting an intent to bring in applicants from healthcare delivery systems, academic settings, community organizations, and other applied research environments. Eligible applicants include state, county, and local governments; 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 tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other organizations that meet NIH eligibility requirements. The announcement also explicitly calls out additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, certain tribal governments (other than federally recognized), and U.S. territories or possessions.
Foreign eligibility is restricted in a way that is typical for many NIH opportunities but is stated clearly here. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components (as NIH defines them in its Grants Policy Statement) are allowed, which generally means a U.S. applicant may include certain collaborations or activities abroad when well-justified and compliant with NIH policy, even though the primary applicant organization must be domestic.
From the posted source details, this was a discretionary grant program in the health category (CFDA 93.242) administered by NIH, created on November 13, 2020, with an original closing date of June 15, 2022. The public listing does not provide an award ceiling or expected number of awards in the excerpt provided, suggesting those details may have been specified elsewhere in the full funding announcement or were not captured in the summary fields.
Overall, the opportunity is best understood as a targeted push to make suicide prevention more reliably evidence-based in everyday practice by funding pilot studies of tools that are ready to be used now, paired with thoughtful, implementation-grounded strategies that help those tools actually take root in real systems of care. The strongest-fitting projects would typically be those that can show a credible path to near-term integration into clinical workflows, measurable improvements in care processes and patient outcomes, and a clear plan for scaling up to a definitive effectiveness trial if the pilot results support it.Apply for RFA MH 21 111
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R34 Clinical Trial Optional)" 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 2020-11-13.
- Applicants must submit their applications by 2022-06-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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 this funding opportunity?
This is an NIMH (NIH) R34 funding opportunity (RFA-MH-21-111) focused on pilot effectiveness research for practical, service-ready tools and technologies that strengthen suicide prevention services in real-world settings.
What is the main goal of the R34 projects under this announcement?
The goal is to generate pilot evidence that a near-deployable suicide prevention tool or technology can work in routine care and can realistically be adopted, delivered with fidelity, and sustained over time. The expectation is that the project will produce the kind of preliminary effectiveness and implementation-relevant data needed to justify and plan a later, fully powered effectiveness trial.
What kinds of tools or technologies is NIMH trying to support?
NIMH is focused on practical, service-ready tools and technologies that can improve how people at risk for suicide are identified, supported, and treated in everyday clinical workflows. The emphasis is on resources that are already close to being deployable in routine care, rather than early-stage prototypes or basic development work.
What does "service-ready" or "nearly deployable" mean in this context?
Based on the description, "service-ready" implies the tool is already optimized and refined enough for real-world use. The intent is to move beyond early development and instead test resources that are close to implementation in routine clinical settings.
Is this funding for early-stage development or prototype building?
The opportunity is positioned to move beyond early development. It prioritizes pilot effectiveness and implementation-relevant evaluation of tools that are already optimized and close to being used in real-world practice.
What is meant by the "effectiveness-implementation continuum"?
This means applicants are expected to consider both whether the tool works (effectiveness in real-world conditions) and whether it can be implemented successfully (adoption, fidelity, sustainment) within typical clinical operations and workflows.
What research directions does NIMH emphasize for this R34?
The announcement highlights two main directions: (1) develop and test preliminary effectiveness of optimized, service-ready tools for suicide risk identification, prevention, and treatment; and (2) study strategies to improve adoption, fidelity, and sustainment of these tools using an implementation science framework.
What kinds of outcomes or questions should a pilot study address?
NIMH is looking for evidence related to feasibility (whether the tool can be used in the intended setting), tolerability and acceptability (whether patients and providers will use it and stick with it), safety (especially important in suicide prevention), and early signals of improvement in relevant outcomes.
Why does safety receive special emphasis here?
Because the focus is suicide prevention services, safety is particularly important when evaluating tools and technologies intended to identify risk or influence prevention and treatment in real-world care settings.
How is this R34 intended to fit into a longer research pathway?
This R34 is described as a bridge between a promising, nearly practice-ready tool and a definitive, fully powered effectiveness trial. The pilot data are intended to support planning and justification for the next stage of evaluation.
If a project succeeds, what is the next step funding mechanism mentioned?
For later-stage, fully powered effectiveness work, NIMH points to a companion R01 opportunity (RFA-MH-21-110).
Is a clinical trial required under this opportunity?
No. The opportunity is described as "Clinical Trial Optional." Applicants may propose studies that include a clinical trial component, but a trial is not mandatory. The key requirement is that the research targets pilot effectiveness and implementation-relevant outcomes for a service-ready resource.
What does "Clinical Trial Optional" mean for applicants?
It means the project may include a clinical trial component if it fits the aims, but the FOA does not require every application to be structured as a clinical trial. The application still needs to focus on pilot effectiveness and implementation-related questions for a near-deployable tool.
What role does implementation science play in this R34?
Implementation science is explicitly encouraged, especially for projects focused on improving adoption, fidelity, and sustainment. The expectation is that projects specify how implementation barriers will be assessed and addressed, how workflow changes or training will be supported, and how quality will be monitored over time to reduce implementation drift.
What kinds of implementation challenges are applicants expected to consider?
Applicants are expected to consider practical barriers and constraints such as workforce capacity and the realities of clinical operations, and to show how the tool fits into routine workflows. They are also expected to address how correct and routine use will be supported over time.
Does NIMH encourage scalable designs? What does that look like?
Yes. The announcement shows a strong preference for scalable, deployment-focused thinking. It encourages technology and design elements that help tools remain consistent and usable across sites and over time, such as automated decision support, digital training resources, and measurement/feedback systems that reduce burden on a stretched workforce.
Who should be involved in designing or evaluating the tool?
The opportunity highlights the importance of incorporating stakeholder perspectives, including service users, providers, and administrators, to ensure the tool is usable and fits real-world settings.
What kinds of organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and government entities. Examples listed include state, county, and local governments; 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 tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other organizations meeting NIH eligibility requirements.
Are specific institution types explicitly called out as eligible?
Yes. The announcement explicitly calls out additional eligible types including HBCUs, Hispanic-serving Institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, regional organizations, certain tribal governments (other than federally recognized), and U.S. territories or possessions.
Can foreign organizations apply as the applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply.
Are any foreign activities allowed at all?
Yes. Foreign components (as NIH defines them in its Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain collaborations or activities abroad when justified and compliant with NIH policy, even though the applicant organization must be domestic.
Is this opportunity connected to small business pathways?
Yes. For small business-focused development and evaluation pathways, NIMH points to SBIR mechanisms (RFA-MH-21-112; R43/R44), indicating that the R34 described here is not the primary route for SBIR-specific projects.
Which NIH institute is offering this program?
The program is offered by the National Institute of Mental Health (NIMH), within the National Institutes of Health (NIH).
What is the assistance listing/category information provided?
The posted source details describe it as a discretionary grant program in the health category, with CFDA 93.242.
When was this opportunity created and when did it close (based on the provided details)?
The source details provided indicate it was created on November 13, 2020, and had an original closing date of June 15, 2022.
Does the provided excerpt include the award ceiling or number of expected awards?
No. The excerpt states that the public listing does not provide an award ceiling or expected number of awards in the information provided, suggesting those details may be in the full funding announcement or not captured in the summary fields.
What types of projects are likely to be a strong fit for this R34?
Projects that can credibly demonstrate near-term integration into clinical workflows, measure improvements in care processes and patient outcomes, and include a clear implementation-grounded plan to support adoption, fidelity, and sustainment. The strongest matches are those designed to produce pilot evidence that can directly inform and justify a later, definitive effectiveness trial.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA MH 21 111) also looked into and applied for these:
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|---|
| Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R01 Clinical Trial Optional) Apply for RFA MH 21 110 Funding Number: RFA MH 21 110 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Social Drivers of Mental Illnesses in Low- and Middle-Income Countries: Mechanisms and Pathways of Interventions for Youth (R01 Clinical Trial Optional) Apply for RFA MH 21 160 Funding Number: RFA MH 21 160 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
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| NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) Apply for PAR 21 079 Funding Number: PAR 21 079 Agency: National Institutes of Health Category: Health Funding Amount: $225,000 |
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| Mood and Psychosis Symptoms during the Menopause Transition (R21 Clinical Trial Optional) Apply for RFA MH 21 106 Funding Number: RFA MH 21 106 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) Apply for PAR 21 059 Funding Number: PAR 21 059 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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| Graduate Research Training Initiative for Student Enhancement (G-RISE) (T32 - Clinical Trial Not Allowed) Apply for PAR 21 026 Funding Number: PAR 21 026 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCR Small Grant Program for New Investigators (R03 Clinical Trial Not Allowed) Apply for PAR 21 084 Funding Number: PAR 21 084 Agency: National Institutes of Health Category: Health Funding Amount: $100,000 |
| Limited Competition: Small Grant Program for ORIP Special Emphasis Research Career Award (SERCA) K01 Recipients (R03 Clinical Trials Not Allowed) Apply for PAR 21 090 Funding Number: PAR 21 090 Agency: National Institutes of Health Category: Health Funding Amount: $75,000 |
| NEI Institutional Mentored Physician Scientist Award (K12 Clinical Trial Optional) Apply for PAR 21 073 Funding Number: PAR 21 073 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NHLBI Program Project Applications (P01 Clinical Trials Optional) Apply for PAR 21 088 Funding Number: PAR 21 088 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIH Faculty Institutional Recruitment for Sustainable Transformation (FIRST) Program: FIRST Coordination and Evaluation Center (U24 Clinical Trial Not Allowed) Apply for RFA RM 20 023 Funding Number: RFA RM 20 023 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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