Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers conducting transformative research on Down syndrome. Eligible applicants include research institutions, universities, medical schools, and other nonprofit and for-profit organizations with appropriate research infrastructure. Principal Investigators must hold an academic degree and have appropriate training in biomedical research. The grant supports novel, high-impact research that could substantially advance the understanding of Down syndrome and its treatment. Clinical trials are not permitted under this award mechanism. Geographic scope is limited to U.S.-based institutions and their international collaborators, though primary awardees must be domestic organizations. Eligible activities include basic research, translational research, and clinical studies (excluding trials), laboratory investigations, and data analysis related to Down syndrome etiology, prevention, and intervention.
This grant is for researchers conducting transformative research on Down syndrome. Eligible applicants include research institutions, universities, medical schools, and other nonprofit and for-profit organizations with appropriate research infrastructure. Principal Investigators must hold an academic degree and have appropriate training in biomedical research. The grant supports novel, high-impact research that could substantially advance the understanding of Down syndrome and its treatment. Clinical trials are not permitted under this award mechanism. Geographic scope is limited to U.S.-based institutions and their international collaborators, though primary awardees must be domestic organizations. Eligible activities include basic research, translational research, and clinical studies (excluding trials), laboratory investigations, and data analysis related to Down syndrome etiology, prevention, and intervention.
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) 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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for researchers conducting transformative research on Down syndrome. Eligible applicants include research institutions, universities, medical schools, and other nonprofit and for-profit organizations with appropriate research infrastructure. Principal Investigators must hold an academic degree and have appropriate training in biomedical research. The grant supports novel, high-impact research that could substantially advance the understanding of Down syndrome and its treatment. Clinical trials are not permitted under this award mechanism. Geographic scope is limited to U.S.-based institutions and their international collaborators, though primary awardees must be domestic organizations. Eligible activities include basic research, translational research, and clinical studies (excluding trials), laboratory investigations, and data analysis related to Down syndrome etiology, prevention, and intervention.
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) application form
- Project narrative (up to 15 pages for Specific Aims and Research Strategy combined, as per NIH guidelines)
- Detailed budget and budget justification
- Biosketches for all key personnel (NIH format CV, limited to 5 pages each)
- Current and pending support documentation
- Letters of support from collaborating institutions (if applicable)
- Data management plan
- Facilities and administrative resources description
- Vertebrate animals or human subjects protocol documentation (if applicable)
- Conflict of interest disclosures
Program contact
- 👤 National Institutes of Health
- 📧 DownSyndromeINCLUDE@mail.nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.867 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$73,768,606
-
$60,555,044
-
$35,143,434
-
$27,603,179
-
$22,003,615
-
$19,986,536
-
$18,103,377
-
$17,077,254
-
$16,012,672
-
$15,913,078
Top States by Funding
- MA 13 awards $156.3M
- FL 4 awards $152.1M
- CA 11 awards $119.8M
- PA 8 awards $110.1M
- NY 10 awards $108.8M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.867). How funding has trended year over year.
| 2024 | $696,472,579 | |
| 2025 | $702,696,370 | |
| 2026 est. | $863,753 |
FAQ
What types of research are supported?
This award supports transformative research on Down syndrome, including basic science, translational research, and clinical investigations. Clinical trials are explicitly not eligible under this mechanism. Research may focus on etiology, genetics, therapeutic development, and outcomes.
Who can serve as Principal Investigator?
Early-career and established researchers are eligible, though some NIH awards prioritize early-stage investigators. Applicants must hold a relevant doctoral degree (Ph.D., M.D., D.D.S., D.V.M., or equivalent) and have appropriate research experience.
What is the typical funding range?
R01 awards typically range from $250,000–$500,000 total costs per year, though this varies. Check the NIH guide for specific budget constraints.
When are applications due?
The deadline for this round is June 15, 2028. Applications must be submitted through NIH's eRA Commons system by 5 p.m. ET on the deadline date.
How competitive is this award?
R01 awards are highly competitive, with success rates typically 15–25%. Reviewers focus on research innovation, feasibility, significance, and potential for transformative impact on Down syndrome research.
💡 Tips for applicants
- Emphasize the transformative potential of your research; show how your work diverges from incremental studies and could reshape Down syndrome science. Preliminary data alone is insufficient—articulate why your approach is novel.
- Clearly state why clinical trials are not appropriate for your research aims, and explain how your non-trial methodology will yield actionable findings.
- Build a strong biosketches and narrative for your research team; demonstrate that collaborators bring complementary expertise in Down syndrome biology or intervention.
- Align your budget with your research scope and justify all personnel costs. R01s are scrutinized for efficiency; avoid inflated indirect costs or vague budget justifications.
- Submit your application well before the deadline through eRA Commons and verify all sections (abstract, specific aims, research plan, biosketches) meet NIH guidelines and are free of inconsistencies.
⚠️ Common mistakes
Many applicants submit incremental or descriptive research plans that lack clear innovation or transformative vision—reviewers want disruptive science, not extensions of existing work. Applications often underestimate the review timeline for strong biosketches and preliminary data, resulting in weak narratives. Additionally, some teams fail to clearly articulate why their research cannot be conducted as a clinical trial, leading to misalignment with the award mechanism's scope.
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