Viral INfections in the Young Lung- The VINYL Clinical Consortium- Data Analytics and Coordinating Center (DACC) (U24 Clinical Trial Optional)

The U.S. Department of Health and Human Services, through the National Institutes of Health and the National Heart, Lung, and Blood Institute, has released a Notice of Funding Opportunity to establish a Data and Analytics Coordinating Center for the Viral Infections in the Young Lung Consortium. This cooperative agreement supports the creation of a research network that will advance understanding of viral lower respiratory tract infections in children aged 0 to 2 years. The Consortium will coordinate with companion awards establishing a Clinical Coordinating Center, five clinical centers, and a biorepository. Together, these entities will build the largest multidimensional and publicly accessible database on viral lung infections in young children. The purpose of the Data and Analytics Coordinating Center is to provide the organizational, analytic, and technological backbone of the Consortium. It will harmonize data ingestion across sites, manage clinical and imaging data, support protocol development, and oversee quality control. The DACC will link clinical data to biospecimens stored in the Consortium’s biorepository and make resources available through public repositories such as BioData Catalyst and BioLINCC. It will also coordinate with the Clinical Coordinating Center on enrollment of 1,500 pediatric participants hospitalized with bronchiolitis, pneumonia, or pediatric acute respiratory distress syndrome, with follow-up at six months post-discharge and again at ages four to five. Applications must demonstrate the capacity to support a longitudinal, multi-site observational study. The DACC is expected to provide statistical expertise, data management compliant with federal regulations, logistical and meeting support, website development, and robust data-sharing practices. Applicants must also lead a Skills Development Core to mentor early-stage physician scientists and data scientists in pediatric research and informatics. The Center must establish procedures for secure storage, transfer, and quality oversight of data and ensure compliance with NIH data management and sharing policies. Eligibility for this program is broad and includes public and private higher education institutions, nonprofits, for-profit entities, state and local governments, tribal organizations, and certain federal entities. Foreign organizations are not eligible to apply, and applications that propose foreign subawards will not be considered. All applicants must maintain current registrations with SAM, eRA Commons, and Grants.gov, and principal investigators must hold eRA Commons accounts. The program will provide up to seven years of support. Direct costs are limited to $500,000 in the first year, $600,000 in the second, and $700,000 annually in years three through seven. NHLBI intends to commit $800,000 in FY26 to support one award under this NOFO. The award will be made as a cooperative agreement, ensuring significant federal involvement in study oversight, data safety, and advisory board activities. Applications open October 10, 2024, and the deadline is November 10, 2025, with review and award decisions anticipated in March through May 2026. The earliest start date is July 2026, and the program period may run for seven years. Interested applicants must submit through NIH ASSIST, Grants.gov Workspace, or an institutional S2S system. Questions may be directed to the NHLBI scientific contact, Dr. Marrah Lachowicz-Scroggins. The Consortium will operate under strong collaborative governance by a Steering Committee, an independent Data and Safety Monitoring Board, and an Advisory Board of experts.