NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) | PA 19 054

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.

• 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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