Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional)

The Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) is a funding initiative offered by the Department of Health and Human Services through the National Institutes of Health (NIH), with coordination by the National Center for Advancing Translational Sciences (NCATS) and support from multiple other NIH institutes. This opportunity is focused on addressing unmet clinical and translational research needs in rare diseases, defined as conditions affecting fewer than 200,000 people in the United States. The RDCRN aims to improve diagnosis, management, and treatment of rare diseases through collaborative, multi-site, patient-centered research. The program emphasizes translational approaches and clinical trial readiness and mandates the involvement of patient advocacy groups. Eligible applicants include a wide array of U.S. and foreign institutions such as public and private higher education institutions, nonprofits, small and large businesses, and various governmental entities including tribal and territorial governments. Foreign components of U.S. organizations are not eligible. Principal Investigators must have significant experience in rare disease research and multi-component clinical research programs. Each application must include at least three rare diseases, two to four clinical research projects (one of which must be longitudinal), and must collaborate with a designated Data Management and Coordinating Center (DMCC). The total maximum funding per award is $1 million in direct costs per year, with a project duration of up to five years. The number of awards will depend on the availability of NIH funds and the number of meritorious applications. No cost sharing is required. Applications may propose clinical trials, though these are optional. The RDCRN infrastructure includes an Administrative Core, Pilot/Feasibility Governance Core, Career Enhancement Core, and coordinated projects leveraging state-of-the-art tools and collaboration with the DMCC. Applications must be submitted through the ASSIST platform or an institutional system-to-system solution. The earliest submission date and opening date for applications is June 5, 2025. Two application cycles are available with due dates of July 7, 2025, and October 16, 2025. All applications are due by 5:00 PM local time of the applicant’s organization. The earliest possible award start dates are September 2025 and July 2026 respectively. This opportunity will expire on October 17, 2025. Evaluation criteria include scientific merit, clinical trial readiness, data sharing and management plans, involvement of patient advocacy groups, sustainability, and compliance with NIH policies on rigor, transparency, and data sharing. Applications must include a justification for rare disease status, and adhere to multi-project NIH application guidelines. Coordination with the DMCC is required to ensure standardized data collection and sharing. Milestones and governance structures will be reviewed and negotiated upon award. Contact with NIH scientific staff early in the application process is strongly encouraged.

Follow the Multi-Project (M) instructions closely. Align proposals with the scientific priorities of participating NIH institutes. Include meaningful patient advocacy participation.