The Bench-to-Bassinet (B2B) Congenital Heart Disease Advancing New Understanding in Genomics Cohort (CHANGE) funding opportunity (RFA-HL-26-007) is a single-source cooperative agreement issued by the National Heart, Lung, and Blood Institute (NHLBI) under the National Institutes of Health (NIH). This award is intended exclusively for the Cincinnati Children’s Hospital Medical Center to transition the current B2B Administrative Coordinating Center into a Data Coordinating Center (CC) for the B2B CHANGE Cohort. It leverages the existing infrastructure of the Pediatric Cardiac Genomics Consortium (PCGC) to perform deep longitudinal phenotyping and genomic studies on individuals with congenital heart disease (CHD).
The initiative aims to sustain and expand one of the largest CHD cohorts, combining clinical and genomic data from approximately 6,000 participants. The program focuses on enhancing diversity within the cohort through limited new enrollments and community engagement. Its objectives include understanding the genetic architecture of CHD, improving clinical outcomes, and advancing genomic research to inform medical treatments. Additionally, the CC will enable data and resource sharing with the broader scientific community, fostering collaborations and ancillary studies.
Funding is available for up to $6,416,600 annually in total costs over a maximum project period of six years, with direct costs capped at $4,010,000 per year. The program emphasizes diverse and inclusive research perspectives, requiring a Plan for Enhancing Diverse Perspectives (PEDP) to outline actionable strategies for inclusivity. Only the current PCGC Coordinating Center, located at Cincinnati Children’s Hospital, is eligible to apply.
Applications must detail plans for operations, cohort engagement, protocol development, data management, and governance. Key responsibilities of the CC include supporting clinical research sites, issuing subawards, maintaining data repositories and biorepositories, and facilitating ancillary studies. Comprehensive oversight mechanisms, including a Steering Committee, External Oversight Committee, and Observational Study Monitoring Board, will guide and monitor the program’s activities.
Applications are due by March 18, 2025, with Letters of Intent requested 30 days prior. The project period is set to begin in December 2025, following scientific merit reviews in July and Advisory Council reviews in October. Submissions must conform to NIH policies and guidelines, including those for data sharing, inclusivity, and research rigor.
For additional information, prospective applicants can contact NHLBI program staff, peer review, and financial management offices as listed in the Notice of Funding Opportunity. This program operates under the authority of the Public Health Service Act and related federal regulations.
