Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional)

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Description

This opportunity from the National Institutes of Health (NIH), led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), funds innovative, investigator-initiated, multisite clinical trials and observational studies. The focus is on research relevant to infants, children, women (including pregnant and lactating individuals), and persons with disabilities. Projects must leverage the infrastructure of at least one NICHD-supported clinical research network.

The funding mechanism is a bi-phasic, milestone-driven cooperative agreement (UG3/UH3), with an initial start-up phase (UG3, up to 2 years) and a full implementation phase (UH3, up to 5 years), for a total project period of up to 7 years. Transition from UG3 to UH3 is contingent on meeting pre-specified milestones and NICHD approval.

Applications must be developed in conjunction with the relevant NICHD-supported Network Data Coordinating Center (DCC) and require a rigorous pre-application process to assess feasibility and alignment with network priorities.

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Due Dates

• Next due date: July 15, 2025 (for new, renewal, resubmission, and AIDS-related applications)
• Additional cycles: November 14, 2025; March 15, 2026; July 15, 2026; November 13, 2026; March 15, 2027; July 15, 2027; November 15, 2027
• All applications are due by 5:00 PM local time of the applicant organization.
• No letter of intent is required.

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Funding Amount

• Direct costs limit: $6,250,000 total for the entire project period (UG3 + UH3 phases).
• Project period: Up to 7 years (UG3 phase up to 2 years; UH3 phase up to 5 years).
• Larger budgets: Projects exceeding $6,250,000 direct costs require additional NICHD approval during the pre-application process.
• Funding mechanism: Cooperative Agreement (UG3/UH3).
• Number of awards: Contingent on NIH appropriations and the number of meritorious applications.

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Eligibility

Eligible Applicants

• Public and private institutions of higher education (including both public/state-controlled and private)
• Nonprofits with or without 501(c)(3) status (excluding institutions of higher education)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Native American tribal governments (federally recognized and other)
• Public housing authorities/Indian housing authorities
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Eligible agencies of the federal government

Note: Non-domestic (non-U.S.) entities are not eligible to apply as the primary applicant, but non-U.S. components of U.S. organizations may participate.

Eligible Individuals

• Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s).
• Multiple PD/PI applications are required; the Network DCC PI typically serves as the contact PI.

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Application Process

Pre-Application Process

• Mandatory: All applicants must complete a pre-application process with NICHD to assess scientific scope and feasibility.
• Start early: The pre-application process can be lengthy, especially for non-network investigators.
• Details: See the NICHD Pre-Application Process for Network Multisite Clinical Research.

Application Submission

• Applications must be submitted as multi-PD/PI grants in conjunction with the relevant NICHD-supported Network DCC.
• Use the NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution.
• Follow the NIH How to Apply - Application Guide and all program-specific instructions in the NOFO.
• All required registrations (SAM, eRA Commons, Grants.gov) must be completed prior to submission.

Required Application Components

• Specific Aims and Milestones: Clearly defined for both UG3 and UH3 phases.
• Research Strategy: Must address significance, innovation, approach, and integration with network infrastructure.
• Budget: Detailed annual budgets, including justification for all costs not covered by network infrastructure awards.
• Multiple PD/PI Leadership Plan: Required.
• Letters of Support: From the Network Steering Committee Chair and all non-network sites.
• Data Management and Sharing Plan: Required for all applications.
• Resource Sharing Plan: Address biospecimen and software sharing as applicable.

Review Criteria

• Importance, innovation, and potential impact on clinical care and public health.
• Rigor and feasibility of the approach, including study design, milestones, and integration with clinical practice.
• Expertise and resources of the investigative team and network.
• Inclusion of junior investigators is strongly encouraged.

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Additional Information

• Scope: Projects must utilize the infrastructure of at least one NICHD-supported network. Single-center, animal, or basic science studies are not eligible.
• Networks: Examples include the Collaborative Pediatric Critical Care Research Network, Global Network for Women’s and Children’s Health Research, Maternal-Fetal Medicine Units Network, Neonatal Research Network, and Pelvic Floor Disorders Network.
• Preference: Given to large-scale clinical trials, innovative study designs, and projects that can be integrated into real-world clinical care.
• Data Sharing: Use of the NICHD Data and Specimen Hub (DASH) is expected for human clinical trial data.
• Transition to UH3: Not guaranteed; depends on successful completion of UG3 milestones and NICHD approval.

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External Links

• Full Funding Opportunity Announcement (PAR-25-311)
• NICHD Pre-Application Process for Network Multisite Clinical Research
• NIH How to Apply - Application Guide
• NICHD Clinical Research Networks
• NIH Grants Policy Statement
• Grants.gov Opportunity Listing

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Contact Information

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