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

The NIH 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 focuses on high-risk, high-reward basic science studies that have the potential to create new scientific paradigms, develop transformative technologies, or establish improved 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. However, clinical trials are explicitly not allowed under this specific announcement. The NIH intends to commit approximately 3,000,000 dollars per year for fiscal years 2027, 2028, and 2029, funding up to four awards annually with a budget limit of 500,000 dollars in direct costs per year. Applications are evaluated based on scientific and technical merit, with a heavy emphasis on significance, innovation, and transformative potential. Reviewers assess the likelihood that a project will exert a sustained and powerful influence on the research field. Applicants must maintain active registration in the System for Award Management and provide specific, quantifiable milestones for the project period. Cybersecurity compliance is required, including the development of an incident response plan and notification of any breaches within 48 hours of discovery.