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

The Stephen I. Katz Early Stage Investigator Research Project Grant, issued by the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, is designed to support innovative projects from Early Stage Investigators (ESIs) who are pursuing new research directions without preliminary data. Named in honor of Stephen I. Katz, M.D., Ph.D., former Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the program emphasizes innovation by requiring applicants to propose projects that represent a distinct shift from their previous research efforts. A defining requirement of this program is the exclusion of preliminary data, which distinguishes it from other NIH R01 opportunities. The purpose of this funding opportunity is to provide ESIs with the ability to propose bold, innovative projects that may involve a new methodology, paradigm, therapeutic target, or discipline different from their prior research. By removing the requirement for preliminary data, the program reduces barriers for ESIs to establish themselves in new areas of investigation. All applications must include a separate one-page attachment entitled “New Research Direction” that clearly explains how the proposed project diverges from the investigator’s prior research. Applications that fail to include this attachment, or that include preliminary data, will be deemed noncompliant and withdrawn. Applications are reviewed under NIH’s peer review system, with reviewers assessing significance, innovation, rigor, feasibility, expertise, and resources. Evaluation emphasizes the importance of the change in research direction, the scientific merit of the conceptual framework, and the potential to advance knowledge despite potential risks. Applications will undergo scientific merit review by NIH Scientific Review Groups, followed by advisory council review before awards are issued. Reviewers will not score every section individually, but they will evaluate significance and innovation, approach, investigator qualifications, and feasibility, along with protections for human subjects, use of vertebrate animals, and data management where applicable. Funding under this opportunity is not capped by a budget ceiling; however, budgets must reflect the true needs of the project. The maximum project period is five years. Applicants requesting $500,000 or more in direct costs must contact a program officer at least six weeks prior to submission. The total number of awards will depend on appropriations and the quality of submissions. No cost sharing or matching is required. NIH grant policies as outlined in the NIH Grants Policy Statement apply to all awards. Applications proposing clinical trials are not eligible. Eligibility for this program is broad, encompassing higher education institutions (both public and private), nonprofit organizations, for-profit organizations including small businesses, local governments, tribal governments, state governments, independent school districts, public housing authorities, and certain other organizations such as faith-based or regional entities. However, foreign organizations and non-domestic components of U.S. organizations are not eligible to apply. All principal investigators must meet NIH’s definition of Early Stage Investigator. If multiple principal investigators are proposed, each must qualify as an ESI, and the proposed research must represent a change in direction for each. The application process requires organizations to register with multiple federal systems including SAM.gov, eRA Commons, and Grants.gov. Submissions must be made electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. All applications are due by 5:00 PM local time of the applicant organization. The funding announcement was posted on August 25, 2025, and applications open the same day. Deadlines occur on a recurring basis, with the first due date on September 26, 2025, followed by subsequent cycles on January 27, 2026, May 27, 2026, and continuing through May 26, 2028. The final expiration date for this funding opportunity is August 26, 2028. Applicants may seek assistance from NIH contacts for submission support, programmatic questions, and grants management. For technical support with submissions, the eRA Service Desk and Grants.gov Contact Center are available. General NIH grants information is available by phone or email through the NIH Office of Extramural Research. Specific program and financial management contacts are listed by participating NIH Institutes and Centers, which include nearly all major NIH components, such as the National Cancer Institute, National Heart, Lung, and Blood Institute, and National Institute on Aging, among others.