Funder: National Institutes of Health
Due Dates: June 5, 2025 (New) | July 5, 2025 (Renewal/Resubmission/Revision) | September 7, 2025 (AIDS) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | January 7, 2026 (AIDS) | Additional standard NIH due dates through January 7, 2028
Funding Amounts: No budget cap; budgets must reflect actual project needs. Maximum project period: 5 years.
Summary: Supports investigator-initiated research projects that require at least one clinical trial, aligned with the scientific interests of participating NIH Institutes and Centers.
Key Information: All applications must propose at least one clinical trial; some NIH Institutes accept only mechanistic trials under this announcement.
This opportunity supports discrete, investigator-initiated research projects that require at least one clinical trial, in areas that align with the scientific missions of participating NIH Institutes and Centers (ICs). The R01 mechanism is NIH’s original and most widely used grant type for health-related research and development. Projects must be related to the programmatic interests of at least one participating IC, and applicants are strongly encouraged to review IC-specific interests and contact relevant program staff before applying.
The clinical trial(s) proposed may include safety/efficacy studies, mechanistic studies, or biomarker studies, as long as they meet NIH’s definition of a clinical trial. Some ICs only accept mechanistic clinical trials under this announcement; applicants should verify IC participation and requirements.
Upcoming deadlines:
All applications are due by 5:00 PM local time of the applicant organization.
Expiration date: January 8, 2028
Full list of NIH standard due dates
Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.
Eligible applicants include:
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to apply. Multiple applications from the same organization are allowed if scientifically distinct.
Submission platforms:
Required registrations:
Application instructions:
Clinical trial requirements:
Review process:
Topic | Contact | Details |
---|---|---|
General Grants Info | GrantsInfo@nih.gov | |
General Grants Info | Phone | 301-480-7075 |
Application Submission (eRA) | Online | eRA Service Desk |
Application Submission (eRA) | Phone | 301-402-7469 or 866-504-9552 |
Grants.gov Support | support@grants.gov | |
Grants.gov Support | Phone | 800-518-4726 |
Scientific/Research Contacts | Web | IC-Specific Contacts |
For additional details, see Section VII. Agency Contacts in the full announcement.