Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required)
Can you apply?
This grant is for early stage investigators (ESIs) proposing a significant change in research direction with no preliminary data. Applicants must be affiliated with eligible institutions, including universities, HBCUs, minority-serving institutions, tribal colleges, faith-based organizations, and federal agencies. The proposed research must be a basic science experimental study involving human participants. Geographic scope is U.S.-based institutions only; non-domestic organizations and foreign components are ineligible.
A research direction change must be documented in a separate attachment. The project must align with the scientific mission of at least one participating NIH institute or center. Studies must prospectively assign participants to conditions and assess biomedical or behavioral outcomes for fundamental understanding without specific application to processes or products.
Program description
The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Notice of Funding Opportunity Announcement (NOFO) must not include preliminary data. Applications must include a separate attachment describing the change in research direction. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.This Funding Opportunity is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies that are NOT conducted with specific applications toward processes or products in mind and which also do not meet the clinical trial definition should submit under the appropriate Clinical Trial Not Allowed NOFO .
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- HBCU
- HSI (Hispanic Serving Institution)
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
How to apply
Application links
Required documents
- Research strategy (narrative proposal)
- Change in research direction attachment
- Biographical sketches of key personnel
- Budget and budget justification
- Institutional support/commitment letters
- Human subjects protection documentation (IRB approval or plan)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.173 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$67,501,043
-
$41,811,330
-
$29,666,573
-
$25,009,162
-
$22,883,624
-
$22,740,456
-
$16,596,227
-
$13,255,879
-
$12,363,350
-
$12,276,804
Top States by Funding
- MA 11 awards $142.6M
- CA 10 awards $101.6M
- IA 5 awards $77.5M
- CT 2 awards $76.3M
- MD 7 awards $56.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.173). How funding has trended year over year.
| 2024 | $422,034,489 | |
| 2025 | $422,700,014 | |
| 2026 est. | $427,030,000 |
FAQ
Who qualifies as an early stage investigator (ESI)?
ESIs are researchers within a defined period of their first independent research award, typically within 10 years of PhD or MD. Consult the NIH ESI definition on the grant guidelines.
Can I include preliminary data in my application?
No. Applications must not include preliminary data and must describe your change in research direction in a separate attachment.
What types of human studies are eligible?
Basic science experimental studies that prospectively assign humans to conditions and assess outcomes for fundamental understanding—not studies targeting specific product applications.
What documents do I need to submit?
Typical NIH R01 documents include research strategy, change in direction attachment, biographical sketches, institutional support letters, and budget justification.
When is the deadline?
This NOFO has a fixed deadline of May 24, 2026. Check NIH's funding opportunity page for any updates or future submission windows.
💡 Tips for applicants
- Frame your change in research direction clearly in the required separate attachment. Reviewers need to understand why this pivot is justified and scientifically sound.
- Emphasize the fundamental science aspects of your study without mentioning specific product or clinical application goals, even if long-term applications exist.
- Connect your project explicitly to the scientific mission of at least one NIH IC. Review their strategic plans and cite relevant research priorities.
- Ensure your study design prospectively assigns human participants to experimental conditions. Observational or retrospective studies typically do not fit this NOFA.
- Review the NIH Grants Policy Statement for current ESI definitions and verify your institutional eligibility before investing application effort.
⚠️ Common mistakes
Applications including preliminary data are ineligible and will be rejected. Studies designed primarily for product development rather than fundamental understanding are not appropriate for this mechanism. Failure to connect proposed research to an NIH IC's scientific mission weakens competitiveness.
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