INCLUDE Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed)

The NIH Investigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project, under solicitation RFA-OD-27-004, seeks Transformative Research Award applications to support groundbreaking and unconventional research aimed at improving the health and quality of life for individuals with Down syndrome. This initiative targets high-risk, high-reward basic science studies that have the potential to create new scientific paradigms, develop transformative technologies, or establish innovative clinical approaches. The program is open to individual scientists or groups, including small businesses and other for-profit organizations, and does not require preliminary data for application. Clinical trials are explicitly not allowed under this specific announcement. The National Institutes of Health intends to commit approximately 3,000,000 dollars per year for fiscal years 2027, 2028, and 2029, funding up to four awards annually. Individual application budgets are limited to a maximum of 500,000 dollars in direct costs per year. Awards are evaluated based on scientific and technical merit, significance, innovation, and transformative potential through a peer review system. Applicants must maintain active registration in the System for Award Management and provide specific, quantifiable milestones for their proposed research. Recipients are also required to adhere to strict cybersecurity incident reporting guidelines, notifying the agency within 48 hours of discovery, and must ensure all human subject protocols are approved by an Institutional Review Board.