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

Launch a bold, basic-science clinical trial without preliminary data. The NIH Stephen I. Katz R01 (BESH) funds Early Stage Investigators to pursue a clear change in research direction using prospective human experiments aimed at fundamental discovery.

Eligibility Criteria

• PD/PI must be an NIH-designated Early Stage Investigator (all MPIs must be ESIs).

• Project must be a new research direction; attach a one-page “New Research Direction.”

• No unpublished preliminary data allowed.

• Eligible U.S. applicant types: higher education, nonprofits, small businesses/for-profits, and eligible public entities; foreign organizations/components not allowed.

• Required registrations: SAM (UEI), eRA Commons, Grants.gov.

Funding Details

• Mechanism: R01 (BESH — clinical trial required; basic research).

• Budget: Not limited; must match project needs (≥500,000 USD direct costs/year requires prior contact).

• Project period: Up to 5 years.

• Application types: New; Resubmission.

Deadline

• Standard cycles through 2028; first due date: September 26, 2025 (5:00 PM local).

• FOA expires August 26, 2028.

Where to Go for Further Information

• Program details.

• Help: [email protected].