Funder: National Institutes of Health
Due Dates: June 16, 2025 (New) | July 16, 2025 (Renewal/Resubmission/Revision) | October 16, 2025 (New) | November 16, 2025 (Renewal/Resubmission/Revision) | AIDS: January 7, 2028 | Standard NIH cycles through January 2028
Funding Amounts: Up to $275,000 direct costs over 2 years; no more than $200,000 in any single year; project period max 2 years.
Summary: Supports high-risk, early-stage basic science studies with human participants to advance understanding of fundamental phenomena, excluding application-driven research.
Key Information: Only basic experimental studies with humans that meet both the NIH clinical trial and basic research definitions are eligible; not all NIH Institutes participate—check IC-specific interests before applying.
Description
This opportunity supports exploratory and developmental research projects in the early and conceptual stages, specifically for basic experimental studies involving humans. The focus is on high-risk, innovative research that may lead to breakthroughs or the development of novel techniques, methodologies, or models with significant impact on biomedical, behavioral, or clinical research. Projects must prospectively assign human participants to conditions (i.e., manipulate independent variables) and assess biomedical or behavioral outcomes to understand fundamental aspects of phenomena, without a specific application toward processes or products.
Studies with specific application goals (e.g., mechanistic clinical trials, safety/efficacy studies) should apply under other NIH clinical trial funding opportunities. This program is distinct from the traditional R01 mechanism and is not intended for long-term or well-established research areas.
Due Dates
- New Applications: June 16, 2025 | October 16, 2025 | February 16, 2026 | June 16, 2026 | October 16, 2026 | February 16, 2027 | June 16, 2027 | October 16, 2027
- Renewal/Resubmission/Revision: July 16, 2025 | November 16, 2025 | March 16, 2026 | July 16, 2026 | November 16, 2026 | March 16, 2027 | July 16, 2027 | November 16, 2027
- AIDS-related Applications: January 7, 2028 (final AIDS deadline for this cycle)
- All applications are due by 5:00 PM local time of the applicant organization.
- See NIH Standard Due Dates for full schedule.
Funding Amount
- Maximum Direct Costs: $275,000 over a 2-year project period.
- Annual Limit: No more than $200,000 in direct costs in any single year.
- Project Duration: Up to 2 years.
- Number of Awards: Contingent on NIH appropriations and the number of meritorious applications.
Eligibility
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Eligible Organizations:
- 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 (foreign organizations) and foreign components of U.S. organizations
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Eligible Individuals: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD/PI.
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Key Restrictions:
- Applications must propose basic experimental studies with humans that meet both the NIH clinical trial and basic research definitions.
- Not all NIH Institutes and Centers (ICs) participate; applicants must confirm IC participation and programmatic fit via the IC-Specific Interests and Contacts page.
Application Process
- Submission Platforms: Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
- Required Registrations: Applicant organizations must register with SAM.gov, eRA Commons, and Grants.gov. Registration can take 6+ weeks.
- Application Guide: Follow the NIH How to Apply - Application Guide and all program-specific instructions in the funding announcement.
- Clinical Trial Questionnaire: Applicants must answer "yes" to all four questions in the Clinical Trial Questionnaire and complete the PHS Human Subjects and Clinical Trials Information form.
- Data Management and Sharing Plan: Required for all applications.
- Appendix: Only limited materials allowed (e.g., blank surveys/questionnaires).
Additional Information
- Review Criteria: Emphasis on innovation, conceptual framework, and potential for significant impact. Preliminary data are not required.
- Multiple Applications: Organizations may submit more than one application if each is scientifically distinct.
- Cost Sharing: Not required.
- Foreign Applicants: Non-U.S. organizations and components are eligible.
- Large Budgets: Applications requesting $500,000+ in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.
- Recent Update: As of March 31, 2025, the opportunity was updated to align with agency priorities. Applicants should review the full announcement for changes.
External Links
Contact Information
For additional details, see Section VII of the full announcement.