Funder: National Institutes of Health
Due Dates: June 20, 2025 (New) | July 18, 2025 (Renewal/Resubmission/Revision) | October 20, 2025 (New) | November 19, 2025 (Renewal/Resubmission/Revision) | February 19, 2026 (New) | March 16, 2026 (Renewal/Resubmission/Revision) | June 18, 2026 (New) | July 20, 2026 (Renewal/Resubmission/Revision) | October 19, 2026 (New) | November 19, 2026 (Renewal/Resubmission/Revision)
Funding Amounts: No set budget limit; UG3 phase up to 1 year, UH3 phase up to 4 years (up to 6 years with strong justification); budgets must reflect actual project needs.
Summary: Supports multi-site clinical trials, biomarker validation, and ancillary studies for stroke treatment, recovery, and prevention, conducted within the NIH StrokeNet infrastructure.
Key Information: All applications must use NIH StrokeNet infrastructure; prior NINDS approval required before submission; foreign organizations may not apply, but foreign components are allowed.
Description
This opportunity from the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS), supports multi-site exploratory and confirmatory clinical trials, biomarker or outcome measure validation studies, and ancillary studies related to stroke treatment, recovery, and prevention. All funded projects are conducted within the NIH StrokeNet, a national network designed to accelerate and standardize stroke research.
The program uses a bi-phasic, milestone-driven cooperative agreement (UG3/UH3). The initial UG3 phase (up to 1 year) supports planning and start-up activities, with possible transition to a UH3 implementation phase (up to 4 years, or up to 6 years with strong justification) upon meeting defined milestones.
Projects may include:
- Multi-center clinical trials of promising interventions (including pragmatic and adaptive designs)
- Biomarker or outcome validation studies preparatory to clinical trials
- Ancillary studies adding scientific aims to active StrokeNet studies
Applicants do not need to be part of the existing StrokeNet infrastructure but must plan to use it for their proposed research.
Due Dates
- 2025: June 20 (New), July 18 (Renewal/Resubmission/Revision), October 20 (New), November 19 (Renewal/Resubmission/Revision)
- 2026: February 19 (New), March 16 (Renewal/Resubmission/Revision), June 18 (New), July 20 (Renewal/Resubmission/Revision), October 19 (New), November 19 (Renewal/Resubmission/Revision)
All applications are due by 5:00 PM local time of the applicant organization.
Funding Amount
- Budget: No set limit; budgets must reflect the actual needs of the project.
- Project Period: UG3 phase up to 1 year; UH3 phase up to 4 years (up to 6 years with strong justification).
- Guidance: NINDS expects total costs (direct + F&A) to be less than $25,000 per subject enrolled, unless well justified.
- Award Instrument: Cooperative Agreement (substantial NIH involvement).
Eligibility
Eligible applicants include:
- Public and private institutions of higher education (U.S. only)
- Nonprofits (with or without 501(c)(3) status), other than institutions of higher education
- 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 (federally recognized and other)
- Native American tribal organizations (other than federally recognized)
- Faith-based and community-based organizations
- Regional organizations
- U.S. territories and possessions
- Eligible agencies of the federal government
Not eligible: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations. However, foreign components (as defined by NIH) are allowed as part of a U.S.-based application.
Note: Applicants must complete all required registrations (SAM, eRA Commons, Grants.gov) before submission. Prior NINDS approval is required for all applications, regardless of budget.
Application Process
- Pre-Submission: Contact NINDS program staff at least 6–8 months before the planned submission to discuss project suitability and obtain required approval.
- Submission: Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
- Application Guide: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
- Required Attachments:
- Clinical protocol synopsis (for non-clinical trial studies)
- Ancillary study approval (if applicable)
- NIH Biosketches for all key personnel
- Data Management and Sharing Plan
- Letters of support (for subcontracts, industry partners, CTSA resources, etc.)
- Budget: Include all study-related costs not covered by StrokeNet infrastructure. Budgets should be detailed and justified, with separate itemized budgets for each subcontract or collaborating center.
- Milestones: Clearly define annual milestones for both UG3 and UH3 phases; continuation to UH3 is contingent on meeting UG3 milestones.
Additional Information
- Scope: All NINDS-supported multi-center stroke trials are expected to use StrokeNet unless an exception is granted.
- Study Types: Includes confirmatory (Phase 3) trials, exploratory trials, biomarker validation, and ancillary studies.
- Trial Design: Innovative and efficient designs (e.g., adaptive, pragmatic) are encouraged.
- Infrastructure: NIH StrokeNet provides centralized coordination, data management, and site support.
- Regulatory: Trials using investigational agents/devices must have an active IND/IDE or exemption at application.
- Data Sharing: All applications must include a Data Management and Sharing Plan.
- Review Criteria: Scientific merit, feasibility, investigator expertise, and use of StrokeNet resources are key review factors.
External Links
Contact Information