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

Frequently Asked Questions (FAQs)

What is the Stephen I. Katz Early Stage Investigator Research Project Grant?

The Stephen I. Katz Early Stage Investigator Research Project Grant is an NIH-funded R01 funding opportunity (PAR-25-322) aimed at early stage investigators who want to make a clear pivot to a new research direction. It is designed to support bold, innovative ideas that depart meaningfully from an investigator's prior work, including situations where the investigator does not yet have the typical pilot evidence base.

What is the main purpose of this opportunity?

The main purpose is to give early stage investigators room to test a high-potential new idea that is genuinely different from their prior research trajectory. The program is built around the premise that early career scientists may need support to establish a new direction before preliminary data exists.

What makes this R01 different from a typical R01?

A defining difference is that this program is explicitly meant to fund projects at an earlier and more exploratory stage than a typical R01. Many R01 applications implicitly rely on preliminary findings; this opportunity is specifically structured so applicants make the case without pilot results, emphasizing rationale, innovation, and a well-constructed research plan instead.

Are preliminary data allowed in the application?

No. Applications must not include preliminary data. This is a requirement, not a suggestion. The intent is to evaluate and fund strong concepts that are not yet supported by a traditional preliminary dataset.

If preliminary data are not allowed, how should an applicant support the feasibility of the project?

Based on the description provided, applicants are expected to support feasibility through a strong scientific rationale, a clearly articulated and well-constructed research plan, compelling innovation, and a clear explanation for why the new direction is important and feasible even without pilot results.

Is a research-direction-change statement required?

Yes. Every application must include a separate attachment describing the proposed change in research direction. This attachment is central to the goal of the award and is intended to show reviewers how the project represents a meaningful shift for the early stage investigator and why the departure is scientifically justified and timely.

What should the change-in-research-direction attachment explain?

It should explain how the proposed project clearly departs from the applicant's prior work, why the shift is scientifically justified, and why it is timely. The attachment is meant to present the change in direction in a straightforward way for reviewers.

Does this funding opportunity allow clinical trials?

No. The opportunity is labeled "Clinical Trial Not Allowed." Proposed work must fit NIH's definition of non-clinical-trial research under this funding announcement.

What types of study designs might accidentally be considered a clinical trial?

The description cautions applicants to avoid language and aims that cross into clinical trial territory, such as the prospective assignment of human participants to an intervention to evaluate effects on health-related outcomes.

What kinds of projects are likely to be the best fit?

The description suggests the best fit will generally be mechanistic, preclinical, foundational, or other non-trial research that still has strong significance and potential impact.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

What is the funding mechanism for this opportunity?

This is an R01 mechanism under an NIH Notice of Funding Opportunity (NOFO) identified as PAR-25-322.

Is this a discretionary grant?

Yes. The opportunity is categorized as a discretionary grant.

Which organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations and includes: 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 (with or 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.

Are specific institution types highlighted as eligible?

Yes. The NOFO 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.

Can foreign (non-U.S.) organizations apply?

No. Non-U.S. (foreign) organizations cannot apply under this opportunity.

Are non-domestic components of U.S. organizations eligible?

No. Non-domestic components of U.S. organizations are not eligible.

Are foreign components allowed on the project?

No. Foreign components, as NIH defines them in the NIH Grants Policy Statement, are not allowed. The applicant organization and the work supported under this award must remain entirely domestic.

Does the opportunity specify an award ceiling?

No award ceiling is specified in the information provided. Applicants are advised (based on the text) to rely on the full NOFO and any institute-specific guidance for budgeting expectations.

Does the opportunity specify the expected number of awards?

No. The expected number of awards is not specified in the information provided.

What is the application window or closing date mentioned?

The listing 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.

Are there multiple NIH program areas or Assistance Listing numbers associated with this opportunity?

Yes. The opportunity 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.

What is the core strategy for a competitive application under this program (based on the description)?

The core strategy is to propose a bold, innovative project that clearly departs from prior work, avoid including preliminary data, stay within a non-clinical-trial framework, and present a convincing case built on strong rationale, a well-structured research plan, and a clear explanation of why the new direction is important, feasible, and timely.