The "Development of Animal Models and Related Biological Materials for Down Syndrome Research (R21 Clinical Trial Not Allowed)" funding opportunity supports innovative research to develop or improve animal models and related biological tools for studying Down syndrome (DS). This initiative is part of the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project, which aims to enhance understanding of DS and its co-occurring conditions, fostering medical advancements for individuals with DS and related conditions. Projects should emphasize the development, characterization, or application of animal models and resources to fill critical gaps in DS research.

Eligible projects include the creation of genetic resources, advanced phenotyping tools, and informatics technologies such as artificial intelligence (AI) and machine learning (ML) to improve rigor and reproducibility in DS studies. Research areas may involve comparative studies across animal models, new methods for studying DS-related comorbidities, and innovative approaches like organoid systems or genome editing technologies. High-priority objectives include addressing unique DS-related health outcomes such as early-onset Alzheimer's, immune dysregulation, and developmental disorders while exploring associated resilience factors against certain conditions like cancer or atherosclerosis.

Applicants may request up to $200,000 in direct costs per year, with a maximum of $275,000 over the two-year project period. The program supports exploratory and developmental projects without requiring preliminary data. However, projects must demonstrate alignment with INCLUDE Project priorities and clearly address gaps in DS research. Sharing plans for developed models or tools after the grant period are mandatory.

Eligible applicants include higher education institutions, nonprofits, for-profits, local and state governments, and federally recognized tribal entities. Non-U.S. organizations and components are ineligible. Registration with SAM, Grants.gov, and eRA Commons is required. Applications must follow NIH guidelines for human and animal research and include a robust Data Management and Sharing Plan.

Applications are reviewed based on significance, innovation, rigor, and alignment with INCLUDE goals. Specific considerations include the project’s ability to address DS research gaps and plans for disseminating resources to the scientific community. Award decisions also consider the project’s potential to contribute to long-term advances in DS research.

Key dates include an initial submission opening on January 15, 2025, with deadlines in February, June, and October. Applicants are encouraged to consult NIH program officers to ensure their proposals align with program priorities. Awards are subject to NIH policies and oversight, with detailed reporting and compliance requirements.