Funder: National Institutes of Health
Due Dates: May 13, 2025 | September 15, 2025 | January 13, 2026 | May 13, 2026 | September 14, 2026 | January 13, 2027
Funding Amounts: No budget cap; project period up to 5 years; budgets must reflect actual needs of the proposed high-risk clinical trial.
Summary: Supports investigator-initiated, high-risk clinical trials and mechanistic studies in NIAID priority areas; one clinical trial per application.
Key Information: All planning must be complete at submission; prior consultation with NIAID is required for budgets ≥$500,000 direct costs/year.
Description
This opportunity supports the implementation of investigator-initiated, milestone-driven, high-risk clinical trials and associated mechanistic studies in areas aligned with the mission and high-priority research areas of the National Institute of Allergy and Infectious Diseases (NIAID). Mechanistic studies are encouraged, as they can advance understanding of human diseases and inform future therapeutic strategies. Only one clinical trial may be proposed per application.
The program is intended for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial networks or infrastructure. The focus is on high-risk trials, defined as those involving non-routine interventions, unlicensed products, or licensed products used for unapproved indications, or those requiring regulatory oversight (e.g., IND/IDE).
Applicants must be ready to implement the proposed trial at the time of award; all planning activities must be completed prior to submission.
Due Dates
- Upcoming deadlines: May 13, 2025 | September 15, 2025 | January 13, 2026 | May 13, 2026 | September 14, 2026 | January 13, 2027
- Letter of Intent: 30 days prior to the application due date (optional but encouraged)
- All applications are due by 5:00 PM local time of the applicant organization.
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.
- Note: Applications requesting $500,000 or more in direct costs in any year require prior consultation with NIAID at least 10 weeks before submission.
Eligibility
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Eligible Organizations:
- Public/State 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 (foreign organizations) and foreign components of U.S. organizations
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Individuals: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s) may apply.
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Other Requirements:
- Applicant organizations must complete all required registrations (SAM, eRA Commons, Grants.gov, etc.) prior to submission.
- Only one clinical trial may be proposed per application.
- Applications proposing more than one clinical trial, or those focused solely on planning activities, are not eligible.
Application Process
- Submission: Applications must be submitted electronically via Grants.gov using ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
- Required Application Components:
- Complete clinical protocol (must be included in the Appendix)
- Data Management and Sharing Plan
- Letters of support for critical resources and collaborators
- Budget reflecting all costs for trial conduct, monitoring, regulatory compliance, and data analysis
- PHS Human Subjects and Clinical Trials Information form
- Milestone-driven timeline and contingency plans
- Consultation: Applicants requesting ≥$500,000 in direct costs in any year must consult with NIAID at least 10 weeks before submission. Consultation is strongly encouraged for all applicants.
- Review: Applications are peer reviewed for scientific and technical merit, with additional review for milestones, feasibility, and alignment with NIAID priorities.
Additional Information
- Scope: Supports the conduct, completion, and analysis of high-risk clinical trials, including training, recruitment, data management, regulatory activities, and mechanistic studies.
- Mechanistic Studies: Required for DAIT-supported trials; encouraged for all.
- Non-Responsive Applications: Applications focused on planning activities, lacking mechanistic studies (for DAIT), or proposing more than one clinical trial will not be reviewed.
- Milestones: Applications must include clear, feasible milestones and contingency plans.
- Data Sharing: All applications must address NIH Data Management and Sharing Policy.
- Foreign Applicants: Non-U.S. organizations and components are eligible and must follow NIH foreign organization policies.
External Links
Contact Information