Opportunity Information: Apply for PA 18 350

The NIMH Exploratory/Developmental Research Grant (R21 - Clinical Trial Not Allowed) is a discretionary grant opportunity from the National Institutes of Health, specifically aligned with the National Institute of Mental Health (NIMH) mission. It is designed to fund early-stage, exploratory, and developmental research that is still in the conceptual or pilot phase. The program is meant for ideas that are promising but not yet fully proven, where preliminary data may be limited or where the approach is considered high-risk. The central aim is to help investigators test new directions quickly and generate the kind of feasibility or pilot evidence that could later justify a larger, more definitive research project.

A key feature of this R21 opportunity is its emphasis on innovation and potential impact. NIMH is looking for projects that could open new scientific or clinical pathways, even if the work carries a meaningful chance of failure. Supported projects might focus on developing novel techniques, tools, agents, methods, measures, models, or intervention strategies, or on establishing proof-of-concept results. The expectation is that, if successful, the work could meaningfully influence biomedical, behavioral, or clinical mental health research, or improve how mental health care is delivered. While the research may involve human participants in some contexts, the funding notice clearly specifies "Clinical Trial Not Allowed," meaning applicants must not propose studies that meet NIH's definition of a clinical trial (for example, prospective assignment to an intervention to evaluate effects on health-related outcomes).

From a funding structure standpoint, this opportunity is a grant mechanism (Funding Instrument Type: Grant) within the health category (Funding Activity Category: Health) and is associated with CFDA number 93.242. The listed award ceiling is $200,000, reflecting the R21 mechanism's typical role as a smaller, time-limited investment intended to help researchers establish early feasibility and strong rationale rather than to support a full-scale program of research. The opportunity number is PA 18 350, and the source information indicates an original closing date of 2021-05-07, with an initial creation date of 2017-11-07.

Eligibility is broad and includes a wide range of organizational types, which signals NIMH's interest in encouraging diverse institutions and sectors to contribute innovative mental health research ideas. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; and public housing authorities/Indian housing authorities. Academic institutions are eligible as well, including public and state-controlled institutions of higher education and private institutions of higher education. Tribal entities are included both as federally recognized Native American tribal governments and as Native American tribal organizations that are not federally recognized tribal governments. The opportunity also permits applications from nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories), for-profit organizations other than small businesses, and small businesses. In addition, the notice highlights other eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Indian/Native American Tribal Governments other than federally recognized; eligible federal agencies; faith-based or community-based organizations; regional organizations; non-U.S. entities (foreign organizations); and U.S. territories or possessions.

Overall, this grant is best understood as a stepping-stone funding mechanism for bold mental health research ideas that need initial support to become viable, competitive candidates for larger-scale funding later. It prioritizes creativity, early validation, and the development of new research capabilities, with the explicit boundary that the proposed work cannot be a clinical trial.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIMH Exploratory/Developmental Research Grant (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 2017-11-07.
  • Applicants must submit their applications by 2021-05-07. (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 $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.
Apply for PA 18 350

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FAQs: NIMH Exploratory/Developmental Research Grant (R21 - Clinical Trial Not Allowed)

What is this grant opportunity?

This is the NIMH Exploratory/Developmental Research Grant (R21 - Clinical Trial Not Allowed), a discretionary grant opportunity from the National Institutes of Health (NIH) aligned with the National Institute of Mental Health (NIMH) mission. It supports early-stage, exploratory, and developmental research that is still conceptual or in a pilot phase.

What is the main purpose of the NIMH R21 mechanism described here?

The purpose is to help investigators test new research directions quickly and generate feasibility or pilot evidence that could later justify a larger, more definitive research project. It is positioned as a stepping-stone mechanism rather than support for a full-scale research program.

What types of projects is NIMH looking to fund under this opportunity?

NIMH is looking for projects that are innovative and potentially high-impact, including promising ideas that are not yet fully proven. The opportunity emphasizes work that could open new scientific or clinical pathways, even if there is a meaningful chance the approach will fail.

Is preliminary data required?

The opportunity is intended for projects where preliminary data may be limited. It is designed to support conceptual or pilot-stage efforts where early feasibility evidence still needs to be generated.

Why does the opportunity emphasize "high-risk" research?

The program is specifically meant for promising but not-yet-validated ideas, including approaches that may be considered high-risk. The goal is to enable early testing and proof-of-concept work that could meaningfully influence mental health research or care if successful.

What are examples of activities that may be supported?

Supported projects may include developing novel techniques, tools, agents, methods, measures, models, or intervention strategies, as well as establishing proof-of-concept results.

What kinds of impact does NIMH expect from funded projects?

If successful, the work is expected to meaningfully influence biomedical, behavioral, or clinical mental health research, or improve how mental health care is delivered.

Are clinical trials allowed under this opportunity?

No. The notice states "Clinical Trial Not Allowed." Applicants must not propose studies that meet NIH's definition of a clinical trial, such as prospective assignment to an intervention to evaluate effects on health-related outcomes.

Can the research involve human participants?

The description notes that the research may involve human participants in some contexts, but applicants must not propose a study that meets NIH's definition of a clinical trial.

What is the funding instrument type?

The funding instrument type is a grant (Funding Instrument Type: Grant).

What is the funding activity category?

The funding activity category is Health (Funding Activity Category: Health).

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 93.242.

What is the maximum award amount listed?

The listed award ceiling is $200,000.

What does the $200,000 ceiling imply about the scope of projects?

The ceiling reflects the R21 mechanism's typical role as a smaller, time-limited investment meant to establish early feasibility and a strong rationale, rather than to fund a full-scale program of research.

What is the opportunity number?

The opportunity number is PA 18 350.

What dates are provided for this opportunity?

The source information indicates an initial creation date of 2017-11-07 and an original closing date of 2021-05-07.

Who is the sponsoring institute for this opportunity?

The opportunity is from NIH and is specifically aligned with the National Institute of Mental Health (NIMH).

What types of organizations are eligible to apply?

Eligibility is broad and includes government entities, academic institutions, tribal entities, nonprofits, for-profits, small businesses, eligible federal agencies, regional organizations, faith-based or community-based organizations, non-U.S. entities (foreign organizations), and U.S. territories or possessions.

Are state, local, or municipal government entities eligible?

Yes. Eligible applicants include state governments, county governments, and city or township governments.

Are special district governments eligible?

Yes. Special district governments are listed as eligible applicants.

Are independent school districts eligible?

Yes. Independent school districts are listed as eligible applicants.

Are public housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.

Are colleges and universities eligible?

Yes. Eligible academic institutions include public and state-controlled institutions of higher education and private institutions of higher education.

Are Minority Serving Institutions included?

Yes. The notice highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and Indian/Native American Tribal Governments other than federally recognized.

Are tribal governments and tribal organizations eligible?

Yes. Eligible applicants include federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized tribal governments.

Are nonprofits eligible?

Yes. Eligible applicants include nonprofits with 501(c)(3) status (other than institutions of higher education) and nonprofits without 501(c)(3) status (other than institutions of higher education).

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are eligible, and small businesses are also eligible.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among other eligible applicants.

Are foreign organizations allowed to apply?

Yes. Non-U.S. entities (foreign organizations) are explicitly listed as eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed among the eligible applicants.

How should this grant be viewed in a larger research plan?

It is described as a stepping-stone funding mechanism intended to support bold ideas through early validation and capability development, with the expectation that successful projects can become competitive candidates for larger-scale funding later.

What is the key boundary applicants must keep in mind when designing a project?

The explicit boundary is that the proposed work cannot be a clinical trial under NIH's definition, including prospective assignment to an intervention to evaluate effects on health-related outcomes.

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