INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)
About
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.
The INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research is a NIH-funded opportunity designed for researchers and research institutions committed to improving health outcomes and quality of life for individuals with Down syndrome. This grant specifically supports the development and execution of clinical trials targeting critical and co-occurring health conditions that affect people with Down syndrome. The funding is structured as a phased R61/R33 award, providing up to two years of support during the exploratory and developmental phase (R61) for preliminary studies and planning, with potential transition to up to three additional years of clinical trial support (R33). This approach allows researchers to establish proof-of-concept and meet measurable milestones before advancing to full-scale clinical trials. Researchers should apply if they have innovative treatment approaches for Down syndrome-related health conditions and are prepared to develop rigorous clinical trial protocols. The nationwide program welcomes domestic and international collaborations, making it an excellent opportunity for research institutions and organizations positioned to conduct evidence-based clinical research that will directly benefit the Down syndrome community.
Funding Facts
● Applications openDeadline
June 15, 2028
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle; structured as phased R61/R33 award up to 5 years total
Deadline
2028-06-15
Grant Type
federal
Application Cycle
Annual with deadline of June 15, 2028
Best For
Research institutions, universities, and organizations developing clinical trials for Down syndrome health conditions
Eligibility
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.
Frequently Asked Questions
Who is eligible for INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)?
Eligible applicants include research institutions, universities, and organizations capable of conducting clinical research. Both domestic and non-U.S. entities are eligible to apply, as well as non-domestic components of U.S. organizations. Foreign components are allowed within U.S. organizations. For complete eligibility requirements, refer to Section III of the Notice of Funding Opportunity (NOFO) on the NIH website.
How much funding does INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required) provide?
Specific funding amounts vary by cycle and are not published in advance. The award structure includes up to two years of R61 phase support for preliminary studies, followed by potential R33 phase support of up to three years for clinical trials, with a maximum total project period of five years. Contact the NIH or review the official NOFO for current funding levels.
How do I apply for INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)?
Applications are submitted through the NIH online application system (Grants.gov and NIH eRA Commons). Applicants must prepare a research proposal outlining their clinical trial development plan with measurable R61 phase milestones. The next deadline is June 15, 2028. Visit the official NIH INCLUDE Project website and the specific NOFO for detailed submission instructions, required forms, and technical assistance.
What can INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required) funding be used for?
Funding supports the development and execution of clinical trials addressing critical and co-occurring health conditions in individuals with Down syndrome. The R61 phase supports preliminary studies, developmental research, and clinical trial planning with measurable milestones. The R33 phase supports the actual clinical trial implementation. Research must be milestone-driven and designed to improve health outcomes and quality of life for individuals with Down syndrome.
Last updated: July 5, 2026