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

HHS-NIH11 PAR-25-323

Posted: Aug 25, 2025 12:00:00 AM EDT

Closes: 05/24/2026

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 .

Synopsis

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 .

Eligibility

Eligible Applicants:

Special district governments Small businesses Public housing authorities/Indian housing authorities For profit organizations other than small businesses Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education County governments Others (see text field entitled "Additional Information on Eligibility" for clarification) Native American tribal governments (Federally recognized) City or township governments Private institutions of higher education 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 State governments

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Funding Activity Categories

Education Environment Health Income Security and Social Services

CFDA Numbers

93.113 - Environmental Health
93.121 - Oral Diseases and Disorders Research
93.173 - Research Related to Deafness and Communication Disorders
93.242 - Mental Health Research Grants
93.273 - Alcohol Research Programs
93.313 - NIH Office of Research on Women's Health
93.361 - Nursing Research
93.393 - Cancer Cause and Prevention Research
93.398 - Cancer Research Manpower
93.846 - Arthritis, Musculoskeletal and Skin Diseases Research
93.865 - Child Health and Human Development Extramural Research
93.866 - Aging Research
93.867 - Vision Research
93.879 - Medical Library Assistance

Contact Information

Agency: National Institutes of Health

Contact: National Institutes of Health

Email: grantsinfo@nih.gov

Phone: 301-402-2541

NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis

Opportunity Category: Discretionary

Version: 3

Last Updated: Apr 21, 2026 12:03:14 PM EDT

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