Development of Animal Models and Related Biological Materials for Down Syndrome Research (R24 Clinical Trials Not-Allowed)

The NIH is offering funding through the *Development of Animal Models and Related Biological Materials for Down Syndrome Research* program, aiming to support studies that advance understanding and treatment of Down syndrome (DS) by developing and improving animal models. Part of the NIH’s INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE), this funding opportunity is intended for research that focuses on creating, refining, or expanding access to animal models and other biological resources relevant to DS, such as genetic resources and specialized research technologies. The projects funded will enhance the rigor, reproducibility, and translational value of DS research, aiming to benefit both basic science and targeted studies, with broader impacts for DS-related health conditions. This initiative supports new projects that may involve various animal models, including non-rodent vertebrates, high-throughput genetic screens, and AI-based phenotyping tools. It seeks innovative approaches to integrate multi-omics data, create atlases at cellular levels, develop organoid models, and investigate unique DS co-occurring conditions like Alzheimer’s and certain immune disorders. The INCLUDE Project’s primary objectives emphasize creating valuable biological resources, addressing genetic and phenotypic diversity, and improving collaboration and data-sharing mechanisms in DS research. Eligible applicants include U.S. higher education institutions, non-profit and for-profit organizations, government agencies, and certain foreign entities collaborating with U.S. institutions. Applications should provide a detailed research strategy, including plans for tracking the use and impact of developed resources. Projects can span up to four years and require budgets reflecting actual project needs, though applicants requesting over $500,000 annually must consult with NIH representatives at least six weeks before submission. NIH expects to allocate about $1.5 million annually from 2023 to 2026, funding at least two awards per year, contingent on project feasibility and NIH budget availability. Applications should adhere strictly to NIH submission guidelines. Applicants must register with SAM.gov, Grants.gov, and NIH’s eRA Commons to access the necessary application tools (NIH ASSIST or Grants.gov Workspace). Due dates align with NIH’s standard application schedule, with multiple submission windows from December 2022 through May 2025. Specific NIH contacts are available for application questions, scientific queries, peer review processes, and financial matters. Evaluation criteria focus on the significance of the project to DS research, the experience of the research team, the innovative nature of the approach, and alignment with INCLUDE’s goals. Additionally, proposals must address plans for sharing resources and ensuring compliance with ethical standards for animal research. Emphasis will be placed on projects that foster collaboration, ensure rigorous scientific methods, and demonstrate broad relevance to the DS research community. Awardees will be notified via a formal Notice of Award, and award conditions will require adherence to NIH policies, including civil rights obligations and data-sharing practices. Reporting requirements include annual Research Performance Progress Reports and compliance with NIH’s Data Management and Sharing policies.