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

US · MD National Institutes of Health (NIH) grant open #RFA-OD-27-005
Response due Jun 15, 2028 · 00:00 UTC

Summary

The NIH INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project is soliciting phased clinical trial research awards (R61/R33 mechanism) focused on Down syndrome. The R61 phase supports early-stage trial development and feasibility, while the R33 phase supports the full clinical trial upon successful milestone completion. This opportunity targets research into conditions co-occurring with Down syndrome across the lifespan.

What they want

Applicants must propose phased clinical trials (R61/R33) related to Down syndrome research under the NIH INCLUDE Project. The R61 phase is a milestone-driven feasibility/planning phase, and the R33 phase is the full clinical trial execution phase, contingent on meeting R61 milestones. Clinical trial inclusion is required. Research must align with the INCLUDE Project's goals of investigating co-occurring conditions across the lifespan in individuals with Down syndrome.
Technical requirements
  • Clinical trial must be required (not optional) as part of the proposed research
  • Phased R61/R33 award mechanism — R61 milestone achievement required to advance to R33 phase
  • Research must address Down syndrome and co-occurring conditions across the lifespan
  • Compliance with NIH clinical trial policies and reporting requirements

How they evaluate

  • Scientific and technical merit reviewed by NIH peer review panel (study section)
  • Relevance to INCLUDE Project priorities and Down syndrome research goals
  • Feasibility of R61 milestones and pathway to R33 full trial
  • Qualifications of the research team
Submission: Electronic submission via Grants.gov federal grants portal

Eligibility & certifications

SAM.gov registration (required for all federal grant applicants)NIH eRA Commons accountInstitutional assurances for human subjects research (IRB approval)Compliance with NIH clinical trial registration and reporting (ClinicalTrials.gov)

Risks & flags

  • Extremely long open period (over 2 years: May 2026–June 2028) which may indicate rolling receipt dates or multiple submission cycles rather than a single deadline — applicants should consult the full RFA for specific receipt dates
  • Clinical trial requirement is mandatory, which substantially narrows the eligible applicant pool to those with clinical trial infrastructure

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

INCLUDE Project: Clinical Trials Phased Aw…
Due Jun 15
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