Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)

The Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required) is a federal funding opportunity issued by the National Institute of Diabetes and Digestive and Kidney Diseases within the National Institutes of Health under the U.S. Department of Health and Human Services. The funding opportunity number is RFA-DK-26-308 and it reissues RFA-DK-20-003 to continue support for the Liver Cirrhosis Network. The initiative is intended to sustain and complete ongoing multicenter clinical research activities focused on liver cirrhosis, particularly through continued enrollment and follow-up activities in the Liver Cirrhosis Network Cohort Study and the Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States clinical trial. The program uses the U01 cooperative agreement mechanism, meaning NIH staff will have substantial scientific and programmatic involvement throughout the project period. The funding opportunity addresses a major public health concern related to chronic liver disease and cirrhosis in the United States. The announcement explains that cirrhosis develops from numerous chronic liver diseases including viral hepatitis, alcohol-related liver disease, autoimmune disorders, metabolic dysfunction associated steatohepatitis, and genetic conditions. The NOFO emphasizes that liver transplantation remains the only viable treatment for many patients with advanced disease, yet only a small percentage of eligible patients receive transplants. Through the Liver Cirrhosis Network, NIDDK seeks to improve understanding of fibrosis progression and regression, identify biomarkers and mechanisms associated with disease outcomes, and support translational research that could improve prevention, treatment, and long-term management of cirrhosis complications. Eligible applicants are limited to organizations and Program Directors/Principal Investigators that previously received awards under RFA-DK-20-003. Although the NOFO lists many eligible organization categories such as higher education institutions, nonprofits, tribal governments, local governments, and for-profit organizations, the competition is specifically restricted to current Liver Cirrhosis Network Clinical Center recipients. Foreign organizations and non-domestic components are not eligible to apply. Applicants are required to maintain registrations in SAM.gov, Grants.gov, eRA Commons, and obtain a Unique Entity Identifier prior to submission. Applications may be submitted as renewal or revision applications only. The funding opportunity permits only one application per institution under the limited competition eligibility rules described in the announcement. Applications must propose strategies to improve patient recruitment, retention, and biospecimen collection for the ongoing cohort and RESCU studies. Applicants are also required to include a separate Scientific Exploratory Specific Aim leveraging the existing Liver Cirrhosis Network data or biospecimen resources. The exploratory aim must remain distinct from the primary objectives of the existing network studies and cannot include a budget request because implementation would require future funding availability. The NOFO encourages research topics related to biomarkers, omics analyses, environmental and nutritional contributors to cirrhosis progression, bioinformatics integration, imaging analysis, and other translational science priorities relevant to cirrhosis outcomes. Applicants are expected to demonstrate their ability to operationalize multicenter clinical studies, use electronic medical records efficiently for recruitment, and collaborate within the broader cooperative network structure governed by a Steering Committee and monitored by an independent Data and Safety Monitoring Board. The application process requires electronic submission through NIH-approved systems including ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. Applications must comply with the NIH Research Instructions and the SF424 application requirements. Required components include a detailed Research Strategy, Human Subjects and Clinical Trials Information, Data Management and Sharing Plan, and all other standard NIH submission materials. Applications are due by 5:00 PM local time of the applicant organization. The earliest submission date is February 6, 2026. Renewal applications are due March 6, 2026 for the first review cycle and March 8, 2027 for the second cycle. Scientific merit review is scheduled for July 2026 and July 2027 respectively, with Advisory Council review planned for October 2026 and October 2027. Earliest project start dates are December 2026 and December 2027 depending on the cycle. The NIDDK intends to commit approximately $3.3 million in fiscal year 2026 to support up to ten awards under this NOFO. Budgets are not capped but must reflect the actual needs of the proposed project, and the maximum project period is five years. No cost sharing or matching requirement is mandated. The cooperative agreement structure includes substantial NIH involvement in protocol oversight, recruitment monitoring, data management coordination, publication activities, and network governance. Award recipients must comply with NIH data sharing, clinical trial registration, and reporting policies, including depositing data and biospecimens into the NIDDK Central Repository according to approved data management plans. Applicants are encouraged to contact NIDDK scientific and grants management staff for questions regarding programmatic or administrative requirements. The funding opportunity is recurring in nature because the NOFO includes multiple submission cycles extending through March 2027 and reflects an ongoing federal clinical research network initiative.

Emphasize realistic recruitment and retention strategies tied to cirrhosis populations including patients living with HIV. Demonstrate strong operational collaboration within the Liver Cirrhosis Network and provide clear plans for biospecimen collection and translational data use. Ensure exploratory aims leverage existing LCN resources while remaining distinct from current cohort and RESCU objectives.