NIH Research Project Grant (Parent R01 Clinical Trial Required) | PA 25 305

Opportunity Information: Apply for PA 25 305

The NIH Research Project Grant (Parent R01 Clinical Trial Required), funding opportunity number PA 25 305, is a discretionary NIH grant that supports a clearly defined, stand-alone research project led by one or more investigators. The intent is to fund a discrete, specified, and circumscribed body of work that fits the scientific expertise of the research team and advances knowledge in areas aligned with NIH priorities. What makes this particular Parent R01 distinct is that it requires the application to include at least one clinical trial, meaning the proposed research must involve a prospective assignment of human participants (or groups) to an intervention or condition with the goal of evaluating effects on biomedical or behavioral outcomes. In practical terms, applicants need to be prepared to justify the clinical trial rationale, describe the intervention and outcomes, and address the full set of clinical trial expectations typically required by NIH (such as participant protections, safety monitoring, and trial-related oversight).

This opportunity is designed to be broad and flexible, but the proposed project must match the programmatic interests of one or more participating NIH Institutes and Centers (ICs). Because it is a parent funding announcement, it is not limited to a narrow disease area or a single scientific topic; instead, it functions as an umbrella mechanism for investigator-initiated ideas, as long as those ideas fall within the mission space of an NIH IC that is participating in the announcement. Applicants typically benefit from aligning the project aims and clinical trial focus with an ICs priorities and, when appropriate, communicating with relevant NIH program staff to confirm fit before submitting.

Eligibility is expansive and includes a wide range of domestic and non-domestic organizations. Eligible applicants include state, county, city or township, and 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; public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); small businesses; and other organizations as allowed by NIH policy. The announcement explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and 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; non-domestic (non-U.S.) entities (foreign organizations); and Indian/Native American tribal governments other than federally recognized entities. This breadth is meant to encourage participation across many institutional settings, including community-centered and minority-serving organizations and international research groups, when appropriate for the science and trial design.

Administratively, the sponsoring agency is the National Institutes of Health, and the funding instrument is a grant under the Research Project Grant (R01) framework. The opportunity lists multiple CFDA numbers (now commonly referenced as Assistance Listing numbers), reflecting that many NIH Institutes and Centers may use this parent announcement to support projects that fall under their respective portfolios. The opportunity was created on 2024-12-18, and the listed original closing date is 2028-01-07, indicating it is intended to remain open across multiple receipt cycles over several years rather than as a one-time solicitation. The notice does not specify an award ceiling or expected number of awards in the provided source data, which is common for NIH parent announcements because award sizes and volumes vary by Institute/Center priorities, available appropriations, and the merit of applications received.

Overall, this funding opportunity is best understood as a standard, investigator-initiated NIH R01 pathway with one major requirement: the application must propose at least one clinical trial. Applicants should plan a strong hypothesis-driven or outcome-driven research project with a well-justified clinical trial component, ensure alignment with an NIH Institute or Center mission, and demonstrate the operational readiness to conduct a trial (including recruitment, human subjects protections, data management, and monitoring appropriate to the level of risk).

• The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "NIH Research Project Grant (Parent R01 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, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867, 93.879.
• This funding opportunity was created on 2024-12-18.
• Applicants must submit their applications by 2028-01-07.
• 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 25 305

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