INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)
National Institutes of Health · Research Related to Deafness and Communication Disorders (93.173)
Posted 13 May 2026 · About 21 months left
Summary
The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. The purpose of this Notice of Funding Opportunity (NOFO) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this NOFO may not exceed five years. This NOFO provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition to clinical trial support (R33) of up to three years, although the total duration of the award may not exceed five years. This NOFO requires measurable R61 milestones.
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Eligibility and conditions
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Applicant types: Native American tribal organizations (other than Federally recognized tribal governments); Special district governments; Small businesses; City or township governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); Independent school districts; Native American tribal governments (Federally recognized); Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Private institutions of higher education; For profit organizations other than small businesses; County governments; Public housing authorities/Indian housing authorities; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; State governments; Public and State controlled institutions of higher education
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.