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

The Department of Health and Human Services, through the National Institutes of Health, has reissued the Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required) under Funding Opportunity Number PAR-25-323. This program honors the late Stephen I. Katz, former Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and provides a unique pathway for early stage investigators (ESIs) to initiate new directions in research. It is open to applications from multiple NIH Institutes and Centers, including the National Eye Institute, National Institute on Aging, National Institute of Mental Health, and others, with support from offices such as the Office of Research on Women's Health. The initiative specifically targets projects that represent a change in direction from the investigator’s prior research and do not include preliminary data. The purpose of this grant is to stimulate innovation by allowing ESIs to pursue fundamentally new areas of research without reliance on preliminary results. Applications must clearly demonstrate how the proposed project departs from prior work and must include a separate attachment entitled “New Research Direction” to explain this change. Projects that include preliminary unpublished data are considered noncompliant and will not be reviewed. The focus is on basic science experimental studies involving human participants that qualify both as clinical trials and as basic research. These are defined as prospective studies where participants are assigned to experimental conditions and biomedical or behavioral outcomes are measured to advance understanding of fundamental phenomena. The funding does not support studies with direct application toward products or interventions. Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system platform. Registrations in SAM.gov, eRA Commons, and Grants.gov are required in advance. Eligible organizations include higher education institutions, nonprofits, for-profits, governments at all levels, tribal entities, special districts, school districts, and public housing authorities. Individuals eligible to apply as principal investigators must hold NIH-designated ESI status. Multiple principal investigators are allowed, but all must qualify as ESIs and propose research in a new direction. Foreign organizations and foreign components are not eligible. Award budgets are not capped but must be reasonable for the scope of work, with a maximum project period of five years. The number of awards depends on available appropriations and the quality of applications received. Applications undergo peer review by the NIH Center for Scientific Review and a second-level review by Advisory Councils. Evaluation criteria emphasize the importance and innovation of the research, the rigor and feasibility of the proposed approach, and the expertise and resources available to the investigators. Applications are judged on their potential for advancing fundamental knowledge and the clarity with which applicants articulate the novelty of their research direction. The funding opportunity was posted on August 25, 2025, with applications opening the same day. Due dates occur multiple times annually, with the earliest application deadline on September 26, 2025, and cycles recurring through May 2028. All submissions are due by 5:00 PM local time of the applicant organization. The program will expire on August 26, 2028. This NOFO does not require cost sharing or matching funds. Pre-award costs are allowed in accordance with NIH policy. All applications must include a Data Management and Sharing Plan, and compliance with NIH data policies is mandatory. Applicants are strongly encouraged to contact NIH program officers to confirm alignment of their project with institute priorities. Questions regarding submission should be directed to the eRA Service Desk, GrantsInfo at NIH, or Grants.gov support. The Katz Award program provides a significant opportunity for new investigators to redefine their research trajectories and contribute to advancing biomedical knowledge through high-risk, high-reward basic science studies involving human participants.