NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

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Description

This opportunity supports investigator-initiated basic science experimental studies involving humans, specifically those that prospectively assign participants to conditions (i.e., manipulate independent variables) and assess biomedical or behavioral outcomes to advance fundamental understanding of phenomena. Projects must meet both the NIH definition of a clinical trial and of basic research, and should not be designed with specific applications toward processes or products in mind. The research must align with the scientific missions of one or more participating NIH Institutes or Centers.

Studies with specific applications (e.g., mechanistic clinical trials, safety/efficacy studies, FDA Phase 0/1 studies) should apply under other appropriate NIH clinical trial funding opportunities. Observational studies should use the Clinical Trial Not Allowed mechanism.

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Due Dates

• Standard NIH R01 due dates apply:
  • New applications: June 5, 2025 | October 5, 2025 | February 5, 2026 | June 5, 2026 | October 5, 2026 | February 5, 2027 | June 5, 2027 | October 5, 2027
  • Renewal/Resubmission/Revision: July 5, 2025 | November 5, 2025 | March 5, 2026 | July 5, 2026 | November 5, 2026 | March 5, 2027 | July 5, 2027 | November 5, 2027
  • AIDS-related applications: September 7, 2025 | January 7, 2026 | May 7, 2026 | September 7, 2026 | January 7, 2027 | May 7, 2027 | September 7, 2027 | January 7, 2028

All applications are due by 5:00 PM local time of the applicant organization.

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Funding Amount

• Budget: No upper limit; budgets must be well-justified and reflect the actual needs of the project.
• Project period: Up to 5 years.
• Note: Applicants requesting $500,000 or more in direct costs in any year must contact NIH program staff at least 6 weeks before submission.

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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
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments and organizations (federally recognized and other)
• 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

Eligible individuals with the skills, knowledge, and resources to carry out the proposed research are encouraged to apply.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required registrations: Applicant organizations must register with SAM, Grants.gov, and eRA Commons. PDs/PIs must have an eRA Commons account.
• Application instructions: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
• Clinical trial requirements: Applications must propose a study that meets both the NIH definition of a clinical trial and of basic research. Applicants must answer "yes" to all four questions on the Clinical Trial Questionnaire in the application.
• Data Management and Sharing Plan: Required for all applications.
• Appendix: Only limited materials allowed (e.g., blank surveys/questionnaires).

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Additional Information

• Participating NIH Institutes and Centers: Not all NIH ICs participate in this announcement. Applicants should confirm IC participation and research priorities via the IC-specific information page.
• Review criteria: Scientific merit, innovation, rigor, feasibility, investigator expertise, and environment.
• Multiple applications: Allowed if each is scientifically distinct.
• No cost sharing required.
• Foreign organizations: Eligible to apply.

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External Links

• Full Funding Opportunity Announcement (NIH)
• NIH How to Apply - Application Guide
• IC-Specific Scientific Interests and Contacts
• NIH R01 Activity Code Information
• NIH Clinical Trial Definition
• Funding Opportunity Types by Clinical Trial Allowability (PDF)
• Research Methods Resources
• Grants.gov Opportunity Page

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Contact Information

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