NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) | PA 20 185

Opportunity Information: Apply for PA 20 185

The NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed), Funding Opportunity Number PA 20 185, is a long-standing National Institutes of Health (NIH) funding mechanism designed to support a single, clearly defined research project led by one or more investigators. The core idea of the R01 is to fund a discrete, specified, and circumscribed body of work, meaning the application should present a focused set of aims that can realistically be completed within the proposed project period and budget. Projects are expected to align with the scientific missions and programmatic interests of at least one participating NIH Institute or Center (IC), so applicants generally need to ensure their topic fits an NIH IC portfolio area and reflects a strong rationale for why the chosen IC(s) is the appropriate home for the work.

A key restriction in this particular parent announcement is that it does not accept applications that propose clinical trials. In practical terms, the proposed research must be non-clinical-trial in nature, even if it involves human data or human samples, and applicants need to be careful to avoid designing a study that meets NIH's definition of a clinical trial (for example, prospectively assigning human participants to an intervention to evaluate effects on health-related outcomes). This makes the opportunity especially relevant for basic, mechanistic, observational, methodological, preclinical, or other forms of biomedical, behavioral, and related research that do not involve a clinical trial framework.

The opportunity is categorized as a discretionary grant program and is associated with a broad range of CFDA (Assistance Listing) numbers, reflecting participation across many NIH components and scientific areas. The activity category spans multiple public benefit areas including health, education, environment, food and nutrition, and social services, though the dominant focus is biomedical and health-related research consistent with NIH's mission.

Eligibility is intentionally broad and includes many types of domestic U.S. organizations, such as state, county, and local governments; special district governments; independent school districts; public housing authorities/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. It also includes nonprofit organizations both with and without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses, as well as an "other" category that can apply depending on NIH policy and the specifics of an applicant entity. Beyond these general categories, NIH explicitly notes additional eligible applicants including 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, tribal governments that are not federally recognized, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth reflects NIH's intent to support meritorious science wherever the appropriate expertise and infrastructure exist, while still requiring strong alignment with NIH priorities and rigorous scientific review standards.

The announcement was created on May 5, 2020, and lists an original closing date of January 7, 2025. The posted summary does not specify an award ceiling, expected number of awards, or other budgetary limits, which is common in parent NIH announcements because actual award sizes and counts can vary widely by institute, scientific area, and annual appropriations. In practice, R01 budgets are typically justified based on the needs of the project, and applicants are expected to request a realistic level of support that matches the scope of the proposed aims, staffing, supplies, and other direct costs, while adhering to NIH policies and any institute-specific guidance.

Overall, this opportunity is best understood as NIH's general-purpose R01 route for investigator-initiated research that fits an NIH Institute or Center mission area but explicitly excludes clinical trials. It is aimed at supporting strong, hypothesis-driven or discovery-oriented projects with clear significance, innovation, and a well-developed approach, carried out by investigators and organizations that can demonstrate the expertise, facilities, and management capability to complete the proposed 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, 93.172, 93.173, 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 2020-05-05.
• Applicants must submit their applications by 2025-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 20 185

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