NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) | PA 25 301

Opportunity Information: Apply for PA 25 301

The NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity designed to support a single, well-defined research project that an investigator (or team of investigators) can clearly describe, scope, and carry out within a coherent plan of work. The emphasis is on a discrete and circumscribed project that aligns with the scientific expertise of the applicant and fits squarely within the programmatic priorities of at least one participating NIH Institute or Center (IC). In practical terms, applicants are expected to propose research questions, aims, and methods that map to an NIH IC mission area, since applications are ultimately assessed not only for scientific merit but also for mission relevance and program fit.

A key constraint of this specific Parent R01 announcement is that it does not accept applications that propose clinical trials. That means projects cannot include prospective assignment of human participants to an intervention to evaluate effects on health-related biomedical or behavioral outcomes. Researchers whose work involves human participants must be careful to design studies that remain non-clinical-trial in nature under NIH definitions, such as many types of observational, mechanistic, secondary data analysis, or basic human research approaches, provided they do not cross into clinical trial territory. If a project includes any element that NIH would classify as a clinical trial, it would need to be directed to a different NIH funding opportunity that allows clinical trials rather than this one.

This opportunity is categorized as a discretionary grant, with the funding instrument listed as a grant, and it spans a wide range of activity areas including health as well as related domains such as education, environment, food and nutrition, and income security and social services, reflecting the breadth of NIH-supported research that can intersect with these topics. The listing includes numerous CFDA (now commonly referenced as Assistance Listing) numbers under the NIH umbrella, signaling that multiple NIH components and research areas may be relevant depending on the science proposed.

Eligibility is broad and includes many types of domestic organizations and governmental entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public housing authorities and Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and other Native American tribal organizations that are not federally recognized tribal governments. The announcement also allows applications from nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations (other than small businesses), and small businesses, as well as other categories described by NIH. In addition, NIH explicitly highlights a set of “other eligible applicants” that includes 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 government agencies; regional organizations; U.S. territories or possessions; non-domestic entities (foreign organizations); and Indian/Native American tribal governments other than federally recognized entities. Taken together, this is intended to ensure that a wide variety of institutions with strong research capability or community relevance can compete, including organizations serving populations that are historically underrepresented in biomedical research.

From an administrative standpoint, the opportunity number is PA 25 301, the sponsoring agency is NIH, and the record creation date is December 18, 2024. The opportunity shows an original closing date of January 7, 2028, indicating a multi-year open period typical of NIH parent announcements that accept applications across multiple standard receipt dates. The award ceiling and expected number of awards are not specified in the provided source data, which is also common for NIH mechanisms where budgets and award counts depend on scientific merit, institute priorities, and available appropriations rather than a single fixed pool published in the announcement.

Overall, this Parent R01 is best understood as NIH’s primary, broad-purpose research project grant pathway for investigator-driven science that fits NIH missions but does not involve clinical trials. Applicants succeed when they present a compelling, well-justified research problem; rigorous and feasible methods; clear aims that are achievable within the proposed scope; and a strong alignment with the priorities of the NIH Institute or Center most likely to support the work.

• 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 Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.143, 93.172, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 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 25 301

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