health · HHS-NIH11

INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)

National Institutes of Health · RFA-OD-27-005

665 days left

Total Program Funding

$3.0M

Expected Awards

Deadline

June 15, 2028

GRANTQUICK SUMMARYPlain-English Overview

NIH INCLUDE Project Clinical Trials Phased Award funds 4 grants for clinical trials specifically including people with Down syndrome — studying treatments and interventions where DS populations have historically been excluded.

Who Should Apply

Clinical researchers conducting trials that include participants with Down syndrome.

Who Should NOT Apply

Researchers excluding DS populations, basic scientists.

Key Requirements (Plain English)

•Must include people with Down syndrome in clinical trials
•4 awards
•Must address DS health disparities
•Rolling through 2028

💡 GrantQuick Tip

INCLUDE initiative specifically funds research INCLUDING people with DS. Propose trials of Alzheimer's interventions (DS has high AD rates), cardiac treatments, sleep therapies, or other conditions where DS populations are typically excluded.

Competitiveness: Moderate — 4 awards in a growing inclusion-focused initiative.

What This Grant Funds

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.

Attachments

PDF

RFA-OD-27-005-Full-Announcement.html

Who Can Apply

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.

Eligible Applicant Types

City/Township GovernmentsIndependent School DistrictsCounty GovernmentsPrivate Colleges & UniversitiesSpecial District GovernmentsPublic Colleges & UniversitiesPublic And Indian Housing AuthoritiesNonprofits without 501(c)(3)State GovernmentsFederally Recognized Tribal Governments501(c)(3) NonprofitsSmall BusinessesFor-Profit OrganizationsOther Tribal OrganizationsOther (see NOFO for details)

Funding Details

Total Program Funding: $3.0M
Expected Number of Awards: 4
Cost Sharing Required?: No
Funding Instrument: grant

Key Dates

Posted: May 13, 2026

Application Deadline: June 15, 2028 (665 days remaining)

Agency Contact

The INCLUDE Project DownSyndromeINCLUDE@mail.nih.gov

DownSyndromeINCLUDE@mail.nih.gov

Ready to apply?

View the full NOFO and submit your application on Grants.gov

View on Grants.gov