INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)
OpenUpdated: Oct 30, 2025
Summary
The NIH INCLUDE Project aims to enhance health and quality of life for individuals with Down syndrome by funding exploratory and developmental clinical trials targeting critical co-occurring health conditions. Eligible applicants include for-profit organizations, nonprofits, government entities, educational institutions, and various other organizations, including tribal and foreign entities. Application details are not specified, but interested parties can contact the grantor via email at ryanl@nih.gov for more information.
Full Description
Description
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.
Eligibility
Eligible applicants
Business
- For-profit organizations other than small businesses
- Small businesses
Nonprofit
- Nonprofits non-higher education with 501(c)(3)
- Other Native American tribal organizations
- Nonprofits non-higher education without 501(c)(3)
Government
- City or township governments
- Public and Indian housing authorities
- County governments
- Special district governments
- Federally recognized Native American tribal governments
- State governments
Education
- Independent school districts
- Private institutions of higher education
- Public and state institutions of higher education
Miscellaneous
- Other
Additional information
Grantor contact information
Description
ryanl@nih.gov
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