Opportunity Information: Apply for PA 19 054
The NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required), funding opportunity number PA-19-054, is a National Institutes of Health discretionary grant mechanism designed to support early-stage, high-potential research that is still in the exploratory or conceptual phase. The core purpose of the R21 is to help investigators generate initial findings, proof-of-concept data, or prototype approaches that could open up a new line of inquiry or substantially change how a problem is studied or addressed. NIH emphasizes that these projects can be higher risk than typical research grants, but the payoff can be significant, such as a breakthrough discovery or the creation of new techniques, agents, methodologies, models, or practical applications with broad impact across biomedical, behavioral, or clinical research.
A defining feature of this specific parent announcement is that it is a "clinical trial required" opportunity. That means the application must include at least one clinical trial as part of the proposed work, consistent with NIH's definition of a clinical trial. In practice, this requires applicants to propose research in which human participants are prospectively assigned to an intervention (which can include behavioral strategies, diagnostics, devices, or other approaches) in order to evaluate effects on biomedical or behavioral outcomes. NIH also flags an important nuance: some participating NIH Institutes and Centers will only accept applications under this announcement if the proposed clinical trial is mechanistic in nature (meaning it is intended to understand how or why an intervention produces an effect, rather than primarily testing effectiveness). Because NIH participation and acceptance policies can vary by Institute or Center and may be updated through related notices, applicants are expected to confirm that their topic and trial type align with the specific programmatic interests and rules of the Institute or Center they plan to apply to.
The scope is intentionally broad, as a "parent" funding opportunity, but proposals must clearly connect to the scientific missions and interests of one or more participating NIH Institutes and Centers. This typically means the project should address a health condition, biological process, behavioral phenomenon, prevention strategy, diagnostic approach, treatment concept, or health services issue that falls within an NIH Institute or Center portfolio. The parent structure is meant to provide a flexible entry point for many scientific areas while still requiring applicants to fit within the boundaries of NIH priorities.
In terms of who can apply, eligibility is expansive and includes many organization types across the public, private, nonprofit, and academic sectors. Eligible applicants listed include state, county, and city or township 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; and Native American tribal organizations that are not federally recognized tribal governments. It also includes public housing authorities and Indian housing authorities, nonprofits with or without 501(c)(3) status (when not functioning as institutions of higher education), for-profit organizations other than small businesses, and small businesses. The announcement also explicitly calls out additional eligible applicant categories such as 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 agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This broad eligibility signals NIH's intent to allow strong clinical trial concepts to come from many settings, including community-based and underserved-serving institutions, as long as they can meet NIH requirements for human subjects research and trial oversight.
The opportunity is categorized under the Health funding activity area, with CFDA numbers spanning multiple NIH programs (including, among others, 93.113, 93.172, 93.173, 93.273, 93.279, 93.307, 93.361, 93.846, 93.855, and 93.866), reflecting that multiple NIH components may support awards through this announcement. The listed award ceiling in the source data is $200,000, which typically reflects a cap on direct costs per year or per project in the R21 context depending on NIH policy and the specific Institute or Center; applicants generally need to confirm budget rules in the full announcement and any Institute-specific guidance. The source data also shows an original closing date of 2020-05-24 and a creation date of 2018-11-05, which helps place the announcement historically, though applicants should always verify current submission dates, active cycles, and any updates or replacements for this FOA through NIH and Grants.gov postings.
Overall, this R21 clinical trial required parent announcement is best understood as a mechanism for launching innovative, early-stage clinical trial work that may be too preliminary for larger, longer-term NIH awards. It is aimed at accelerating new ideas into human testing, while still insisting on alignment with NIH Institute and Center priorities and, in some cases, a mechanistic focus depending on where the application is assigned.Apply for PA 19 054
- The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.172, 93.173, 93.273, 93.279, 93.307, 93.361, 93.846, 93.855, 93.866.
- This funding opportunity was created on 2018-11-05.
- Applicants must submit their applications by 2020-05-24. (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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FAQs: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) - PA-19-054
What is the NIH R21 (Parent R21 Clinical Trial Required) funding opportunity?
The NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required), funding opportunity number PA-19-054, is a discretionary NIH grant mechanism meant to support early-stage research ideas that are still exploratory, developmental, or conceptual, but that include at least one clinical trial.
What is the main goal of an R21 award under this announcement?
The R21 is designed to help investigators generate early findings such as proof-of-concept results, initial data, or prototype approaches. The intent is to open a new line of inquiry or meaningfully shift how a problem is studied or addressed.
Is this opportunity intended for early-stage or exploratory projects?
Yes. The R21 mechanism is specifically positioned for projects that are not yet mature enough for larger-scale funding and need support to establish feasibility, develop a prototype, or generate initial evidence.
Does this FOA require a clinical trial?
Yes. This parent announcement is explicitly labeled "clinical trial required," meaning the proposed work must include at least one clinical trial consistent with NIH's definition.
What does NIH mean by a "clinical trial" for this R21?
In practice, NIH describes a clinical trial as research in which human participants are prospectively assigned to an intervention in order to evaluate effects on biomedical or behavioral outcomes. The intervention can include approaches such as behavioral strategies, diagnostics, devices, or other types of interventions.
What kinds of interventions can be studied in the required clinical trial?
Based on the description provided, interventions can include behavioral strategies, diagnostics, devices, or other approaches, as long as human participants are prospectively assigned and outcomes are evaluated.
Are higher-risk projects appropriate for this mechanism?
Yes. NIH emphasizes that R21 projects may be higher risk than typical research grants, with the idea that successful projects can yield high-impact payoffs.
What types of outcomes or payoffs does NIH expect from a successful R21 project?
NIH highlights potential payoffs such as breakthrough discoveries or the creation of new techniques, agents, methodologies, models, or practical applications that can have broad impact across biomedical, behavioral, or clinical research.
Is this a "parent" funding opportunity, and what does that mean for scope?
Yes. As a parent announcement, the scope is intentionally broad and can accommodate many research areas. However, the project still must align with the scientific mission and interests of at least one participating NIH Institute or Center.
Do proposals need to align with a specific NIH Institute or Center?
Yes. Even though this is a parent announcement, applications must clearly connect to the missions and programmatic interests of one or more participating NIH Institutes and Centers.
What kinds of topics are generally within scope?
The description indicates that appropriate topics may include work related to a health condition, biological process, behavioral phenomenon, prevention strategy, diagnostic approach, treatment concept, or health services issue, as long as it falls within an NIH Institute or Center portfolio.
Are mechanistic clinical trials required for all applicants?
Not necessarily for all applicants. NIH notes an important nuance: some participating Institutes and Centers will only accept applications under this announcement if the proposed clinical trial is mechanistic in nature.
What is a mechanistic clinical trial in the context of this FOA?
A mechanistic clinical trial is described as one intended to understand how or why an intervention produces an effect, rather than primarily testing whether it works in an effectiveness-oriented sense.
How can applicants confirm whether their chosen NIH Institute or Center will accept their trial type?
Because acceptance policies can vary by Institute or Center and can be updated through notices, applicants are expected to confirm that their topic and trial type align with the Institute or Center they plan to apply to, using NIH and Grants.gov postings and any related NIH notices.
Who is eligible to apply for PA-19-054?
Eligibility is broad and includes a wide range of organization types across the public, private, nonprofit, academic, tribal, community-based, and international sectors, as long as NIH requirements for human subjects research and clinical trial oversight can be met.
Are government entities eligible to apply?
Yes. Eligible applicants listed include state, county, and city or township governments, as well as special district governments.
Are school systems and higher education institutions eligible?
Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.
Are tribal governments and tribal organizations eligible?
Yes. Eligibility includes federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized tribal governments.
Are housing authorities eligible to apply?
Yes. Public housing authorities and Indian housing authorities are listed as eligible applicant types.
Are nonprofits eligible, and does 501(c)(3) status matter?
Yes. Nonprofits with or without 501(c)(3) status are included as eligible applicants, when they are not functioning as institutions of higher education.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also explicitly included.
Are underserved-serving and mission-specific institutions eligible?
Yes. The announcement explicitly calls out Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, and TCCUs.
Are faith-based and community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically listed among eligible applicant categories.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are included in the eligibility list provided.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicant categories.
Are non-U.S. (foreign) organizations eligible?
Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).
What funding activity area does this opportunity fall under?
The opportunity is categorized under the Health funding activity area.
What CFDA numbers are associated with this announcement?
The description lists CFDA numbers spanning multiple NIH programs, including (among others) 93.113, 93.172, 93.173, 93.273, 93.279, 93.307, 93.361, 93.846, 93.855, and 93.866, reflecting that multiple NIH components may support awards under this parent announcement.
What is the award ceiling listed for PA-19-054?
The source data lists an award ceiling of $200,000. The description notes this typically reflects a cap on direct costs per year or per project in the R21 context, depending on NIH policy and the specific Institute or Center, so applicants should confirm budget rules in the full announcement and any Institute-specific guidance.
What dates are provided for this funding opportunity?
The source data shows a creation date of 2018-11-05 and an original closing date of 2020-05-24. Applicants are expected to verify current submission dates, active cycles, and any updates or replacements through NIH and Grants.gov postings.
Why does NIH stress verifying Institute or Center policies before applying?
NIH emphasizes that participation and acceptance policies can vary across Institutes and Centers and may be updated through related notices, including whether a mechanistic clinical trial is required for acceptance under this announcement.
What is the overall intent of this R21 clinical trial required parent announcement?
Overall, it is meant to launch innovative, early-stage clinical trial work that may be too preliminary for larger, longer-term NIH awards, while requiring alignment with NIH Institute and Center priorities and clinical trial requirements.
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Applicants also applied for:
Applicants who have applied for this opportunity (PA 19 054) also looked into and applied for these:
| Funding Opportunity |
|---|
| NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed) Apply for PA 19 052 Funding Number: PA 19 052 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $50,000 |
| NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) Apply for PA 19 091 Funding Number: PA 19 091 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required) Apply for PA 19 092 Funding Number: PA 19 092 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 - Independent Basic Experimental Studies with Humans Required) Apply for PA 19 088 Funding Number: PA 19 088 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed) Apply for PAR 19 098 Funding Number: PAR 19 098 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required) Apply for PA 19 121 Funding Number: PA 19 121 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Not Allowed) Apply for PA 19 122 Funding Number: PA 19 122 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Independent Scientist Award (Parent K02 - Independent Clinical Trial Required) Apply for PA 19 131 Funding Number: PA 19 131 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Independent Scientist Award (Parent K02 - Independent Clinical Trial Not Allowed) Apply for PA 19 132 Funding Number: PA 19 132 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| U.S.-China Program for Biomedical Collaborative Research (R01 Clinical Trial Optional) Apply for RFA CA 19 009 Funding Number: RFA CA 19 009 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $150,000 |
| Bioengineering Research Grants (BRG) (R01 Clinical Trial Not Allowed) Apply for PAR 19 158 Funding Number: PAR 19 158 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Summer Research Education Experience Program (Clinical Trials Not Allowed R25) Apply for PAR 19 164 Funding Number: PAR 19 164 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $100,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Senior Fellowship (Parent F33) Apply for PA 19 187 Funding Number: PA 19 187 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Summer Research Education Experience Program (R25 Clinical Trial Not Allowed) Apply for PAR 19 197 Funding Number: PAR 19 197 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $100,000 |
| Building Interdisciplinary Research Careers in Women's Health (BIRCWH); K12 Clinical Trial Optional Apply for RFA OD 19 020 Funding Number: RFA OD 19 020 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $600,000 |
| Basic and Translational Research on Adducts in Cancer Risk Identification and Prevention (R21 Clinical Trial Optional) Apply for PAR 19 252 Funding Number: PAR 19 252 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| Environmental Influences on Aging: Effects of Extreme Weather and Disaster Events on Aging Populations (R01 Clinical Trial Optional) Apply for PAR 19 250 Funding Number: PAR 19 250 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Basic and Translational Research on Adducts in Cancer Risk Identification and Prevention (R01 Clinical Trial Optional) Apply for PAR 19 251 Funding Number: PAR 19 251 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Dissemination and Implementation Research in Health (R21 Clinical Trial Optional) Apply for PAR 19 275 Funding Number: PAR 19 275 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| Mechanism for Time-Sensitive Research Opportunities in Environmental Health Sciences (R21 Clinical Trial Not Allowed) Apply for RFA ES 19 011 Funding Number: RFA ES 19 011 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
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