INCLUDE Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed)

Open Posted

Opportunity number
RFA-OD-27-004
Agency
Applications due
Award size
Up to $500,000

Opportunity facts

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

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks Transformative Research Award applications by June 15, 2028, to support groundbreaking, exceptionally innovative research proposing new scientific paradigms, clinical approaches, or transformative technologies related to Down syndrome and co-occurring conditions. No preliminary data are required; projects must demonstrate compelling potential for major impact based on logical strength.

Eligible applicant categories include county governments, tribal governments, city/township governments, higher education institutions (public and private), nonprofits (both 501(c)(3) and non-501(c)(3)), small businesses, for-profit organizations, state governments, and special district governments. Foreign organizations and non-domestic components of U.S. organizations are eligible; however, foreign subawards and subcontracts are prohibited.

The program will fund up to 4 awards per year across fiscal years 2027, 2028, and 2029, with a total annual commitment of approximately $3 million and a maximum direct cost ceiling of $500,000 per award per year. Project period is a maximum of five years.

Applications address all topics relevant to Down syndrome research or co-occurring conditions, including chromosome 21 silencing, gene editing approaches, immune dysregulation, neurobiological mechanisms, and associated health conditions such as Alzheimer's disease, hearing loss, cardiac defects, and leukemia. The Research Strategy must include project importance, state-of-the-art challenges, fundamental insights driving the work, overall approach, discussion of risks with alternate strategies, elements of exceptional innovation, appropriateness for transformative awards, and a detailed timeline with measurable milestones.

Peer review emphasizes Importance of Research (Significance and Innovation), Rigor and Feasibility (Approach), and Expertise and Resources (Investigator and Environment), with scoring weight on significance, innovation, and magnitude of potential impact rather than preliminary data. A Data Management and Sharing Plan (maximum 2 pages) is required, with expectation that de-identified human data will be submitted to NIH-designated repositories in coordination with the INCLUDE Data Coordinating Center.

Applications are due June 15, 2027, June 15, 2028, and June 15, 2029. Peer review occurs in October/March; scientific merit review in October/November; Advisory Council review in January/February; earliest start dates are July 2027, April 2028, and April 2029. Participating NIH components include the Office of the Director, National Eye Institute, National Heart Lung and Blood Institute, National Institute on Aging, National Institute of Allergy and Infectious Diseases, and eleven additional institutes and centers.

Required pre-application registrations include System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov, all completed before submission.

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) is to solicit Transformative Research Award applications to support individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research that has the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies related to Down syndrome. Applications are welcome in all topics relevant to Down syndrome-related research or its co-occurring conditions. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in research related to Down syndrome.

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
PKG00292762.pdf PDF
RFA-OD-27-004-Full-Announcement.html HTML file

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