Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)
Can you apply?
This grant is for biomedical researchers and research institutions seeking to fund clinical trials focused on Down syndrome research. The R61/R33 mechanism is a two-phase phased award designed to support the transition from early-stage research to late-stage clinical trials. Eligible applicants typically include academic institutions, NIH-funded research centers, and research-driven nonprofits with institutional research infrastructure. The grant supports activities advancing treatment, prevention, or symptom management for individuals with Down syndrome through well-designed clinical trial protocols. Geographic scope is United States-based institutions. Applicants must demonstrate institutional commitment, research capacity, and a clear pathway from the R61 feasibility phase to the R33 clinical trial phase.
Program description
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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- HBCU
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) form and associated NIH forms (PHS 398, Cover Letter Supplement, Project Summary/Abstract)
- Detailed research plan narrative (typically 25 pages) describing R61 and R33 phases separately
- Statistical and analytical plans with power calculations for the proposed clinical trial
- Budget and budget justification forms for both phases
- IRB approval letter or evidence of IRB review plan
- Clinical trial protocol and regulatory documentation (IND application status or plan if required)
- Biosketches for all key personnel (NIH format, 5 pages each)
- Letters of support and institutional commitment from department leadership and clinical trial infrastructure resources
- If applicable, letters of collaboration from biostatisticians, patient advocacy organizations, or other research partners
Program contact
- 👤 National Institutes of Health
- 📧 DownSyndromeINCLUDE@mail.nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.395 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$333,720,995
-
$226,323,195
-
$180,463,644
-
$148,820,579
-
$130,290,027
-
$125,672,442
-
$124,513,663
-
$112,462,142
-
$109,067,856
-
$96,205,648
Top States by Funding
- CA 9 awards $709.2M
- PA 5 awards $513.3M
- NY 7 awards $462.6M
- MA 7 awards $282.8M
- IL 3 awards $274.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.395). How funding has trended year over year.
| 2024 | $1,298,551,504 | |
| 2025 | $1,414,965,434 | |
| 2026 est. | $926,626,977 |
FAQ
Who is eligible to apply for the INCLUDE Project R61/R33 award?
Eligible applicants include research institutions (academic medical centers, universities, hospitals), NIH-funded research centers, and 501(c)(3) research organizations with documented research infrastructure and administrative capacity to conduct clinical trials. Principal investigators must have appropriate doctoral degrees and research experience.
What is the R61/R33 phased award structure?
The R61 phase (typically 1-2 years) focuses on research feasibility and preparation. If successful, applicants transition to the R33 phase (typically 2-3 years) to conduct the full clinical trial. This structure reduces risk by allowing scientific evaluation before committing to the larger trial phase.
What types of Down syndrome research does this grant support?
The grant funds clinical trials investigating treatments, interventions, or management strategies for Down syndrome. Research areas may include cognitive development, cardiac health, medical complications, aging, and quality of life improvements.
How competitive is this grant program?
As an NIH clinical trials program, this is highly competitive. Success rates typically range from 10-20% depending on the specific funding cycle. Applications must demonstrate rigorous trial design, feasibility, and significant potential impact.
What is the typical funding range?
R61/R33 awards typically provide $200,000-$500,000 per year depending on research scope and institutional needs. The total project period funding varies, but applicants should review the current funding opportunity announcement for specific guidelines.
💡 Tips for applicants
- Develop a rigorous clinical trial protocol that aligns with NIH standards for safety, statistical power, and regulatory compliance before submission
- Build a multidisciplinary team including clinicians, biostatisticians, and patient advocates to strengthen the application and trial design
- Clearly articulate the R61 feasibility milestones and explain how success in this phase will transition to the R33 clinical trial phase
- Engage with the Down syndrome research community and existing INCLUDE Project resources to ensure your research addresses priority gaps and builds on existing knowledge
- Budget conservatively and justify all costs in the context of trial phase activities; NIH reviewers scrutinize clinical trial budgets closely
⚠️ Common mistakes
Applications often fail to sufficiently justify why the R61 feasibility phase is necessary—reviewers want to see clear obstacles to launching the trial immediately and specific milestones that will be achieved. Another common pitfall is underestimating the complexity and timeline required for clinical trial execution, including regulatory approvals, participant recruitment, and retention strategies. Finally, weak engagement with the Down syndrome community and patient perspectives can reduce competitiveness; applicants should integrate input from patients, families, and patient advocacy organizations throughout the research design.
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