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

The Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed), funded by the National Institutes of Health (NIH) through its Office of the Director and numerous participating Institutes and Centers (ICs), is designed to support early stage investigators (ESIs) initiating new, innovative research directions without preliminary data. Named in honor of Dr. Stephen I. Katz, this funding opportunity (PAR-24-075) was created in 2020 to encourage ESIs to pursue high-risk, high-reward projects that depart significantly from their prior research and training. Projects must align with the programmatic interests of one or more participating NIH ICs, which include, but are not limited to, the National Institute on Aging, National Cancer Institute, and National Institute on Drug Abuse. Applications must be scientifically distinct and represent a true departure from prior research. Inclusion of unpublished or preliminary data is strictly prohibited. Applicants are required to submit a separate "New Research Direction" attachment detailing the deviation from previous work. Multiple PD/PI applications are allowed, provided all investigators are designated as ESIs and the project constitutes a new direction for each. Proposals cannot involve clinical trials and must demonstrate innovation, conceptual soundness, and potential to advance scientific understanding substantially. The absence of preliminary data is a hallmark of the Katz Grant, reinforcing its focus on bold and untested research ideas. The grant provides flexibility in funding as application budgets are not capped, though they must be justified based on project needs. The maximum project period is five years. This opportunity is open to a wide range of applicants including higher education institutions, nonprofits, for-profits, local governments, tribal organizations, and more. Foreign organizations may not apply, although foreign components of U.S. organizations are permitted. The application process mandates compliance with standard NIH submission procedures including registrations with SAM, Grants.gov, and eRA Commons. Applications must be submitted electronically, and failure to follow submission instructions, including exceeding page limits or omitting required components, will result in disqualification. Key application dates span from January 2024 through September 2026, with multiple due dates per year and an overall expiration date of May 24, 2025. Applications will be reviewed based on significance, innovation, investigator qualifications, approach, and environment. Reviewers will particularly evaluate whether the proposal represents a substantive change in research direction, the strength of conceptual framing without preliminary data, and the potential scientific impact. Funding decisions will be made based on merit, availability of funds, and program priorities. Awardees must comply with NIH policies including data management and sharing, and annual and final reporting requirements. For assistance, applicants may contact specific NIH IC program staff listed in the opportunity. Key contacts include Hye-Sook Kim (NCCIH), Nathan Stinson Jr. (NIMHD), and Scott Rogers (NCI), among others. General submission and technical support are available via Grants.gov, eRA Commons, and NIH’s grants support teams.