NIH Research Project Grant (Parent R01 Clinical Trial Required)

---

Description

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.

---

Due Dates

• Upcoming deadlines:

  • June 5, 2025 (New applications)
  • July 5, 2025 (Renewal/Resubmission/Revision)
  • September 7, 2025 (AIDS-related applications)
  • October 5, 2025 (New)
  • November 5, 2025 (Renewal/Resubmission/Revision)
  • January 7, 2026 (AIDS)
  • Additional standard NIH due dates through January 7, 2028

• 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

---

Funding Amount

• Budget: No specific budget limit; budgets must reflect the actual needs of the proposed project.
• Project period: Up to 5 years.
• Number of awards: Contingent on NIH appropriations and the number of meritorious applications.

Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

---

Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Native American tribal governments and organizations
• Independent school districts
• Public housing authorities/Indian housing authorities
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities and foreign components of U.S. organizations

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.

---

Application Process

• Submission platforms:

  • NIH ASSIST
  • Grants.gov Workspace
  • Institutional system-to-system solutions

• Required registrations:

  • System for Award Management (SAM)
  • eRA Commons
  • Grants.gov
  • Unique Entity Identifier (UEI)

• Application instructions:

  • Follow the NIH How to Apply - Application Guide
  • Strict adherence to page limits and format is required
  • All applications must include a Data Management and Sharing Plan
  • Only limited appendix materials are allowed

• Clinical trial requirements:

  • All applications must propose at least one clinical trial as defined by NIH
  • Some ICs only accept mechanistic trials; check IC-specific requirements

• Review process:

  • Peer review based on significance, innovation, approach, investigator(s), and environment
  • Additional review for human subjects, vertebrate animals, and biohazards as applicable

---

Additional Information

• No cost sharing or matching required.
• Foreign organizations and components are eligible.
• Applicants requesting $500,000 or more in direct costs in any year must contact NIH program staff at least 6 weeks before submission.
• All awards are subject to NIH policies and the NIH Grants Policy Statement.
• Clinical trial registration and results reporting on ClinicalTrials.gov is required for applicable studies.

---

External Links

• Full Funding Opportunity Announcement (PA-25-305)
• NIH R01 Clinical Trial Required IC-Specific Interests and Contacts
• NIH How to Apply - Application Guide
• NIH Grants Policy Statement
• NIH Clinical Trial Definition & Resources
• Research Methods Resources for Clinical Trials
• Grants.gov Opportunity Listing

---

Contact Information

For additional details, see Section VII. Agency Contacts in the full announcement.