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

- Applicant name and contact information

- Early stage investigator (ESI) status verification or explanation of eligibility

- Research project title

- Research project summary or abstract

- Description of the change in research direction for the early stage investigator

- Statement confirming no preliminary data exist for the proposed project

- Alignment of the proposed project with the programmatic interests of one or more NIH Institutes and Centers (ICs)

- Explanation of how the proposed project falls within the definition of a clinical trial and basic research

- Description of the types of studies that should submit under this Funding Opportunity Announcement (FOA)

- Statement regarding the purpose of the proposed study (understanding fundamental aspects of phenomena without specific application towards processes or products)

- Statement confirming that the proposed study does not have specific applications toward processes or products in mind

- Identification of the appropriate FOA for studies conducted with specific applications toward processes or products in mind (Clinical Trial Required or Clinical Trial Not Allowed)

- Budget request and justification

- Timeline and milestones for the proposed project

- Plans for data management and sharing

- Statement of potential ethical considerations and plans for human participant protection

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