INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)
Grant Opportunity Analysis
The National Institutes of Health, through the INCLUDE Project, is funding phased R61/R33 clinical trial awards to improve health and quality of life for individuals with Down syndrome. The program supports development of clinical trials targeting critical co-occurring health conditions, including innovative adaptations of existing therapies, new technologies, and improved healthcare delivery systems. Applications must propose clinical trials with measurable R61 milestones and milestone-driven plans, with up to two years for preliminary development under R61 and up to three years for trial support under R33, for a total project period not to exceed five years. Review will emphasize scientific merit, rigor, feasibility, investigator expertise, impact, ethical considerations, and adherence to human subjects and data sharing requirements. NIH anticipates $3,000,000 annually to fund up to four awards, and applications are due June 15, 2028.
Eligible Applicants
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.