Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required) | PAR 25 323

Opportunity Information: Apply for PAR 25 323

The Stephen I. Katz Early Stage Investigator Research Project Grant is an NIH R01 funding opportunity (PAR-25-323) designed specifically for early stage investigators who want to pivot into a genuinely new line of work. The core idea is to encourage a clear change in research direction rather than a straightforward extension of an existing program. A defining feature of this opportunity is that it is meant for projects where preliminary results do not yet exist, and NIH explicitly requires that applications under this NOFO must not include preliminary data. To make that point concrete in the application, applicants also have to include a separate attachment that explains the change in research direction and why the proposed work represents a new path for the investigator.

Scientifically, the project has to align with the mission and program interests of one or more participating NIH Institutes and Centers. What makes this NOFO unusual relative to many basic science mechanisms is that it is reserved for basic experimental studies that involve humans and that fall under NIH rules as a clinical trial, while still being considered basic research. In other words, this is not a patient-oriented efficacy or implementation study aimed at testing a treatment, product, or service for a specific practical use. Instead, it supports prospective studies where human participants are assigned to different conditions and researchers manipulate one or more independent variables, then measure biomedical or behavioral outcomes to understand fundamental mechanisms or phenomena. The emphasis is on advancing foundational knowledge in humans, not on developing or evaluating a specific intervention intended for real-world deployment.

This also means applicants need to be careful about fit: studies that do not involve a prospective assignment to conditions, or that do not meet the NIH clinical trial definition, generally should not be submitted here. Likewise, studies that are not aimed at specific applications and also do not meet the clinical trial definition are directed to a different NIH pathway, typically a "Clinical Trial Not Allowed" NOFO. The takeaway is that this opportunity sits in a narrow but important niche: basic mechanistic experimentation in human participants that still triggers the clinical trial definition because of prospective assignment and outcome assessment.

In terms of who can apply, NIH lists a wide range of eligible applicant organizations across the public, private, nonprofit, and educational sectors. Eligible applicants 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; nonprofits with and without 501(c)(3) status (as long as they are not higher education institutions in those specific categories); for-profit organizations (other than small businesses); and small businesses. It also includes federally recognized Native American tribal governments, tribal organizations that are not federally recognized, public housing authorities/Indian housing authorities, and additional categories such as faith-based or community-based organizations and various minority-serving institutions (including HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities). U.S. territories or possessions are also included as eligible applicant types.

At the same time, NIH draws firm boundaries around foreign involvement for this NOFO. Non-domestic (non-U.S.) entities are not eligible to 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. Practically, that means the applicant organization must be U.S.-based, and the work cannot be structured to include foreign components as part of the funded project.

Administratively, the opportunity is issued by the National Institutes of Health as a discretionary grant mechanism under the R01 activity code, and it is tied to multiple CFDA numbers spanning different NIH Institutes and Centers. The opportunity record lists an original closing date of August 25, 2028, indicating a multi-year window during which applications can be submitted according to the NOFO schedule. The award ceiling and expected number of awards are not specified in the provided source details, so applicants would need to consult the full NOFO text and the relevant NIH Institute or Center guidance for budget expectations, project period norms, and any IC-specific considerations.

• The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.173, 93.242, 93.273, 93.313, 93.361, 93.393, 93.398, 93.846, 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 25 323

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