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

The funding opportunity titled "Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional)" is administered by the National Institutes of Health (NIH), particularly through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with co-funding potential from the Office of Research on Women’s Health (ORWH). This notice of funding opportunity (NOFO), PAR-25-311, aims to promote multisite, investigator-initiated clinical trials and observational studies that utilize existing NICHD-supported clinical research networks. It reissues PAR-23-037, incorporating updates in response to prior program feedback and agency priorities. The purpose of this NOFO is to leverage NICHD clinical research infrastructure for innovative projects that impact populations such as infants, children, women (including pregnant and lactating individuals), and persons with disabilities. The grant follows a two-phase structure (UG3 and UH3), where the UG3 phase (start-up, up to two years) must meet specific milestones before advancing to the UH3 phase (implementation, up to five years), culminating in a total project length of up to seven years. Projects must propose novel, impactful research that has the potential to influence clinical practices, treatment guidelines, or result in FDA indications for biomedical interventions. Funding under this opportunity supports studies across multiple NICHD-affiliated networks, including 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 the Pelvic Floor Disorders Network. The research must align with one or more of these networks and their scientific missions. Eligible applicants are required to submit a pre-application concept proposal for NICHD approval, and all applications must involve collaboration with the respective Network Data Coordinating Center (DCC). Eligible applicants include a wide range of U.S.-based organizations, including higher education institutions, nonprofits, small and large businesses, tribal governments, and state and local governments. Foreign organizations may not apply, though foreign components of U.S.-based organizations may participate. Applications must follow NIH submission protocols, including using systems like ASSIST, eRA Commons, and Grants.gov. Required documentation includes detailed budget justifications, Data Management and Sharing Plans, and resource sharing plans, among others. Applications will be evaluated based on three scored review factors: importance of the research (significance and innovation), rigor and feasibility of the approach, and expertise and resources (investigators and environment). Reviewers will also assess protections for human subjects, budget justification, and other key criteria. Projects must meet defined milestones to maintain funding across phases. The program anticipates regular submission cycles with deadlines in March, July, and November, extending through November 2027.