The Stephen I. Katz Early Stage Investigator Research Project Grant (R01) supports innovative projects that represent a change in research direction for early stage investigators (ESIs) and for which no preliminary data exist. 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. • The grant is intended for ESIs who wish to initiate a research project in an area different from their previous research focus and/or training experience. • 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. • Proposed research projects can rely on the PD/PI’s prior work and expertise as its foundation, but must not be an incremental advancement, expansion, or extension of a previous research effort. • The change in research direction could involve, for example, a new approach, methodology, technique, discipline, therapeutic target, and/or new paradigm, different from the ESI’s previous research efforts.