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

Open Posted

Opportunity number
RFA-OD-27-005
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Grant
Category
  • Health
Eligible applicants
  • City/Township Governments
  • Independent School Districts
  • County Governments
  • Higher Education Inst. (Private)
  • Special District Governments
  • Higher Education Inst. (Public)
  • Public or Indian Housing Auth.
  • Non-501(c)(3) Nonprofits
  • State Governments
  • Tribal Governments (Federally Recognized)
  • 501(c)(3) Nonprofits
  • Small Businesses
  • For Profit Organizations
  • Tribal Organizations (Not Federally Recognized)
  • Other

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health is soliciting applications for R61/R33 Exploratory/Developmental Phased Innovation grants to support development of clinical trials treating co-occurring health conditions in individuals with Down syndrome, with applications due June 15, 2028. The INCLUDE Project offers up to two years of R61 support for preliminary, developmental, and planning studies, followed by optional transition to up to three years of R33 support for clinical trial implementation, with a maximum total project period of five years. The R61 phase requires measurable milestones; transition to R33 is contingent upon achieving these milestones.

Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, small businesses, state and local governments, tribal organizations, and foreign entities, provided applications do not involve foreign subawards or subcontracts. NIH intends to commit approximately $3 million to fund up to four awards per year for fiscal years 2027, 2028, and 2029, contingent on appropriations and meritorious applications. Award budgets are not limited but must reflect actual project needs.

Research must address Down syndrome co-occurring conditions across the lifespan, including outcomes research, health services research, and development of novel therapeutic adaptations. Responsive applications may focus on co-occurring neurological conditions, Alzheimer's disease interventions, epilepsy treatment, obstructive sleep apnea management, and immunosuppressive therapies. The R61 phase supports trial preparatory activities including biomarker validation, feasibility studies, and technology development. Applications must include a Data Management and Sharing Plan addressing submission to NIH-designated repositories and the INCLUDE Data Coordinating Center. Review criteria emphasize significance and innovation, rigor and feasibility, investigator expertise and resources, human subjects protections, and budget justification. All PD/PIs must register with eRA Commons and ORCID; applicants must complete SAM.gov and Grants.gov registrations prior to submission. The earliest application submission date is September 15, 2026, with peer review and advisory council review scheduled for October 2026, with earliest start dates of March 2027.

Synopsis

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

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.

Files

File Type Posted
PKG00292770.pdf PDF
RFA-OD-27-005-Full-Announcement.html HTML file

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