The National Institutes of Health INCLUDE Project has opened RFA-OD-27-004, INCLUDE Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed). The program supports groundbreaking, exceptionally innovative, original, and unconventional research with the potential to create new paradigms, clinical approaches, or technologies relevant to Down syndrome and co-occurring conditions. Preliminary data are not required.
Deadline: October 15, 2026 at 5:00 PM local time of the applicant organization. The opportunity opened September 15, 2026. Additional listed cycles include June 15, 2027 and June 15, 2028.
Funding: NIH intends to commit an estimated $3,000,000 to fund up to four awards per year in FY2027, FY2028, and FY2029. Application budgets are limited to a maximum of $500,000 in direct costs per year, and the maximum project period is five years. Cost sharing is not required.
Eligibility: Eligible applicants include public and private institutions of higher education, qualifying nonprofits, small businesses and other for-profit organizations, state and local governments, federally recognized and other eligible Tribal governments and organizations, independent school districts, public and Indian housing authorities, faith-based and community-based organizations, regional organizations, eligible federal agencies, U.S. territories and possessions, and eligible foreign organizations. NIH policy for this NOFO prohibits foreign subawards and subcontracts under otherwise eligible applications.
Submission: Applications are submitted electronically using NIH ASSIST, an institutional system-to-system solution through Grants.gov, or Grants.gov Workspace, and are tracked in eRA Commons. Required SAM/UEI, Grants.gov, and eRA Commons registrations must be active. Applications follow the NIH Research (R) Application Guide and the NOFO-specific instructions.
Required application controls: The Research Strategy must follow the NOFO-specific required structure and explain the project overview, approach, innovation, appropriateness for a Transformative Research Award, and timeline and milestones. End-of-project milestones must be specific, quantifiable, and scientifically justified, and the timeline must identify measurable intermediate objectives, critical decision points, and alternative paths. A Data Management and Sharing Plan is required when the project will generate scientific data. Applicable human-subjects materials are required when relevant. Clinical trials are not allowed under this funding opportunity.
Atlas fit: This is a strong healthcare, disability-research, and academic-research opportunity with broad organization eligibility, including for-profit entities, and no mandatory match. Dr. Miltie is structurally eligible as an organization type, but that does not make a direct application submission-ready. A legitimate direct pursuit requires a genuinely transformative Down syndrome research concept, a qualified PD/PI and research team, institutional resources and scientific capability, active NIH registrations, compliant milestone planning, and all required research and data-sharing materials. Preferred posture: Dr. Miltie Direct / Structural Eligibility Only / Needs Marc Review, while also routing to applicable state academic-health, disability-research, university, nonprofit, and research pathways.