Clinical Trials and Ancillary Studies Conducted within NIH-Funded Clinical Trial Research Networks (UG3/UH3 - Clinical Trial Required)

The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS) and in collaboration with other NIH Institutes and Centers (ICs), is forecasting a funding opportunity titled “Clinical Trials and Ancillary Studies Conducted within NIH-Funded Clinical Trial Research Networks.” This program is structured under the UG3/UH3 cooperative agreement mechanism, indicating that it will fund both planning and implementation phases for eligible research projects. NINDS and participating ICs aim to leverage existing NIH-funded Clinical Trial Research Networks to conduct high-quality, multi-center clinical trials and related ancillary studies. The initiative supports NIH’s mission to enhance health, extend healthy lives, and reduce the burdens of illness and disability. This opportunity specifically encourages proposals that are aligned with the infrastructure and scientific objectives of currently funded Clinical Trial Research Networks under NIH. Successful applicants will design trials that integrate seamlessly within these established networks, allowing for efficient execution and scientific rigor. The UG3 phase will cover up to two years of planning and start-up activities, including protocol finalization, site selection, and regulatory approvals. Transition to the UH3 implementation phase—lasting up to five years—will depend on meeting pre-defined milestones during the planning phase. This phased approach allows NIH to ensure that resources are being used effectively and that proposed studies are ready for execution at scale. Funding under this program supports multi-center clinical trials, which may include behavioral, surgical, or pharmacologic interventions, as well as ancillary studies that add significant scientific value to existing trials. All studies must be conducted within the bounds of established NIH research networks, with governance and oversight provided in coordination with the administering IC. Although full program funding amounts and individual award ceilings have not yet been released, applicants should plan for multi-year, cooperative research involving multiple institutions. Cost sharing or matching is not required for this opportunity, and indirect cost limitations have not been specified in the current forecast. The eligibility for this funding opportunity is broad and includes public and private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit entities including small businesses, Native American tribal entities, state and local governments, public housing authorities, independent school districts, U.S. territories, and foreign institutions. Faith-based and community-based organizations are also eligible, as are certain federal agencies. This inclusivity ensures a wide applicant pool, promoting diverse scientific contributions and equity in research access. As this is a forecasted opportunity, applications are not currently being solicited. The estimated application open date is October 10, 2026, with a submission due date of November 10, 2026. The estimated award date and project start date are both set for April 13, 2027. Interested applicants are strongly encouraged to begin building collaborative relationships and to design research projects in alignment with NIH-funded clinical networks. No pre-application requirements such as letters of intent or concept papers have been indicated in the forecast. Applicants are advised to contact the NINDS Division of Clinical Research at [email protected] for additional guidance or clarification. Since the opportunity involves established clinical networks and milestone-based cooperative agreements, early communication with program staff is encouraged to ensure alignment with NIH priorities and readiness for future submission. Detailed information about the funding opportunity will be released when the full notice is published, expected on or after October 10, 2026.