Funder: National Institutes of Health
Due Dates: November 5, 2026 (Renewal/resubmission/revision) | February 5, 2027 (New) | March 5, 2027 (Renewal/resubmission/revision) | June 5, 2027 (New) | July 5, 2027 (Renewal/resubmission/revision) | October 5, 2027 (New) | November 5, 2027 (Renewal/resubmission/revision) | January 7, 2028 (Closing date)
Funding Amounts: No budget limit; requests must reflect actual project needs; maximum project period of 5 years
Summary: Supports investigator-directed research projects proposing at least one clinical trial aligned with a participating NIH Institute or Center.
Key Information: Some participating Institutes and Centers accept only mechanistic clinical trials; foreign subawards/subcontracts are prohibited.
Description
This NIH Parent R01 opportunity (PA-25-305) supports discrete, specified research projects in scientific areas reflecting investigators’ interests and competencies. Every application must propose at least one NIH-defined clinical trial and address the scientific mission of one or more participating NIH Institutes and Centers (ICs). Not all ICs participate, and nonparticipating ICs will not consider applications for funding.
Supported work includes safety and efficacy trials, mechanistic exploratory studies, and biomarker studies meeting NIH’s clinical trial definition. Mechanistic studies examine biological or behavioral processes, disease pathophysiology, or how interventions work. The program seeks to advance fundamental discoveries and innovative research strategies that ultimately protect and improve health. Applicants are encouraged to discuss scientific fit with relevant IC staff before submitting.
