Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) | PAR 25 322

Opportunity Information: Apply for PAR 25 322

The Stephen I. Katz Early Stage Investigator Research Project Grant is an NIH-funded R01 opportunity (PAR-25-322) designed specifically for early stage investigators who want to make a real pivot in their research career. The key idea is to support a bold, innovative project that clearly departs from the applicant's prior work and represents a new research direction, especially in cases where the investigator does not yet have the usual foundation of pilot results. Unlike many R01 programs that implicitly expect a body of preliminary findings, this program is built around the premise that early career scientists sometimes need room to test a fresh idea before they can generate that evidence base.

A defining feature of this NOFO is that applications must not include preliminary data. That is not just a soft preference or a strategic suggestion; it is a requirement of the opportunity. The program is meant to fund high-potential concepts at an earlier, more exploratory stage than a typical R01 would tolerate, so applicants are expected to make their case through strong rationale, a well-constructed research plan, compelling innovation, and a clear explanation of why the new direction is important and feasible without relying on existing pilot results. In addition, every application must include a separate attachment that describes the proposed change in research direction. That attachment is central to the purpose of the award: reviewers need to see, in a straightforward way, how the project represents a meaningful shift for the early stage investigator and why this departure is scientifically justified and timely.

This is an R01 mechanism and it explicitly does not allow clinical trials (the title states "Clinical Trial Not Allowed"). In practical terms, the work proposed must fit NIH's definition of non-clinical-trial research under this funding announcement. Applicants need to be careful with study design language and aims so the project does not inadvertently cross into clinical trial territory, such as prospective assignment of human participants to an intervention to evaluate effects on health-related outcomes. The best fit will generally be mechanistic, preclinical, foundational, or otherwise non-trial research that still has strong significance and potential impact.

Eligibility is broad across U.S.-based organizations and includes many common applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits both with and without 501(c)(3) status (as long as they are not institutions of higher education in those categories); public housing authorities and Indian housing authorities; federally recognized tribal governments; tribal organizations that are not federally recognized governments; for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The NOFO also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, and U.S. territories or possessions. At the same time, the opportunity draws a firm boundary around foreign involvement: non-U.S. (foreign) organizations cannot apply; non-domestic components of U.S. organizations are not eligible; and foreign components, as NIH defines them in the NIH Grants Policy Statement, are not allowed. In other words, the applicant organization and the work supported under this award must remain entirely domestic.

From an administrative standpoint, the sponsoring agency is the National Institutes of Health. The opportunity is categorized as a discretionary grant, and it spans multiple CFDA/Assistance Listing numbers across NIH, reflecting that it can align with a range of NIH institutes and program areas (including health and related domains such as environment, nutrition, and social services). The opportunity shows an original closing date of August 25, 2028, indicating a multi-year window during which applications may be accepted on the published schedule for this NOFO. The listing does not specify an award ceiling or an expected number of awards in the provided text, so applicants should rely on the full NOFO and any institute-specific guidance for budgeting expectations, submission dates, and review considerations.

Overall, this grant is best understood as a way for an early stage investigator to compete for an R01 while taking a calculated scientific risk: proposing something genuinely new for their program of research, without leaning on preliminary datasets, and explaining convincingly why the shift is important and how the project will be executed successfully within a domestic, non-clinical-trial framework.

• 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 "Stephen I. Katz Early Stage Investigator Research Project Grant (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, 93.286, 93.307, 93.313, 93.351, 93.361, 93.393, 93.398, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.865, 93.866, 93.867, 93.879.
• This funding opportunity was created on 2025-08-25.
• Applicants must submit their applications by 2028-08-25.
• 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 PAR 25 322

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