Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you're an early-career researcher pivoting into fundamental human-subjects research with zero preliminary data, NIH will fund your high-risk, high-novelty idea.
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What this is
This NIH program funds innovative basic research projects where early-stage investigators are shifting into a completely new research area with zero preliminary results. The focus is on prospective experimental studies with human participants—meaning you assign people to conditions and measure biomedical or behavioral outcomes to understand how things work at a fundamental level, not to develop a specific product or treatment. Applications must be from NCCIH, NICHD, NIDCD, NIDDK, NINDS, NIDCR, NIMH, NIAID, NCI, NEI, NHLBI, NIAAA, NIA, or NIEHS participating institutes.
Who can apply
Eligible applicants include universities, small businesses, nonprofits, tribal organizations, and government entities. The principal investigator must be classified as an early-stage investigator (ESI) by NIH criteria, meaning no preliminary data can exist for this project and it must represent a significant change in research direction from prior work.
Eligible applicant types
- Native American tribal organizations (other than Federally recognized tribal governments)
- Public and State controlled institutions of higher education
- Private institutions of higher education
- City or township governments
- State governments
- Native American tribal governments (Federally recognized)
- For profit organizations other than small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Public housing authorities/Indian housing authorities
- Independent school districts
- Small businesses
- County governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Special district governments
Full description — from the agency
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 .
Topics: early stage investigator · basic science research · human subjects · NIH grant · experimental studies · research direction change · biomedical research
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.