The National Institutes of Health (NIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for the Stephen I. Katz Early Stage Investigator Research Project Grant (R01). The Katz award is appropriate for ESIs who wish to initiate a research project in an area different from their previous research focus and/or training experience, and therefore have not produced preliminary data. 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. Importantly, the proposed direction must represent a change in research direction for the PD/PI. Because a change in research direction is heavily dependent upon the area of investigation, potential applicants are strongly encouraged to contact a program director to discuss their proposed project. If the application proposes multiple Principal Investigators (MPIs), all PD/PIs must be ESIs and the research direction must be a change in research direction for all MPIs.

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 .

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