Project: Exploratory/Developmental Research Awards for Down syndrome (R21 Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers and research institutions seeking to conduct exploratory and developmental research on Down syndrome. Applicants typically include academic institutions, research hospitals, nonprofit research organizations, and other entities with NIH-eligible status. The grant explicitly excludes clinical trials, making it suitable for basic science, translational research, mechanistic studies, and early-stage investigations that generate preliminary data. Both individual investigators and teams may apply, though there is typically a primary PI requirement. The grant supports high-risk, high-reward research ideas that may not yet have sufficient preliminary data for larger NIH awards. Applicants must have institutional affiliation and compliance with federal research regulations including IRB/IACUC oversight where applicable.
This grant is for researchers and research institutions seeking to conduct exploratory and developmental research on Down syndrome. Applicants typically include academic institutions, research hospitals, nonprofit research organizations, and other entities with NIH-eligible status. The grant explicitly excludes clinical trials, making it suitable for basic science, translational research, mechanistic studies, and early-stage investigations that generate preliminary data. Both individual investigators and teams may apply, though there is typically a primary PI requirement. The grant supports high-risk, high-reward research ideas that may not yet have sufficient preliminary data for larger NIH awards. Applicants must have institutional affiliation and compliance with federal research regulations including IRB/IACUC oversight where applicable.
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. This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of new exploratory and developmental research projects that address critical needs for Down syndrome projects, as articulated in the INCLUDE Project objectives. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- 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
Details
This grant is for researchers and research institutions seeking to conduct exploratory and developmental research on Down syndrome. Applicants typically include academic institutions, research hospitals, nonprofit research organizations, and other entities with NIH-eligible status. The grant explicitly excludes clinical trials, making it suitable for basic science, translational research, mechanistic studies, and early-stage investigations that generate preliminary data. Both individual investigators and teams may apply, though there is typically a primary PI requirement. The grant supports high-risk, high-reward research ideas that may not yet have sufficient preliminary data for larger NIH awards. Applicants must have institutional affiliation and compliance with federal research regulations including IRB/IACUC oversight where applicable.
How to apply
Application links
Required documents
- SF-424 (R&R) Application for Federal Assistance
- Project Narrative (research strategy) including specific aims, background, significance, innovation, and preliminary data
- Detailed budget and justification (typically lower dollar caps than R01s)
- Biographical sketches (NIH CV format) for all key personnel
- Institutional commitment letter(s) and facilities description
- Letters of support or collaboration agreements if applicable
- Budget justification narrative addressing personnel, equipment, travel, and other direct costs
- Institutional certifications (IRB, IACUC, compliance, conflicts of interest)
- Previous progress report (if renewal or competing continuation)
Program contact
- 👤 National Institutes of Health
- 📧 DownSyndromeINCLUDE@mail.nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.351 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$189,307,929
-
$188,853,963
-
$179,413,083
-
$156,271,917
-
$140,230,629
-
$132,964,607
-
$122,234,337
-
$37,946,246
-
$37,475,785
-
$33,218,050
Top States by Funding
- OR 7 awards $270.5M
- CA 8 awards $254.8M
- TX 10 awards $224.3M
- WA 2 awards $219.0M
- LA 5 awards $184.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.351). How funding has trended year over year.
| 2024 | $279,889,905 | |
| 2025 | $284,089,258 | |
| 2026 est. | $283,084,958 |
FAQ
Can I submit a clinical trial protocol under this R21?
No. This grant explicitly excludes clinical trials. The funding is restricted to exploratory and developmental research such as basic science studies, mechanistic research, and preliminary investigations.
Who is eligible to serve as a Principal Investigator?
Typically, individuals with a research doctoral degree (PhD, MD, DO, DVM, or equivalent) and institutional affiliation. NIH eligibility criteria apply. Consult your institution's grants office to confirm PI eligibility.
What is the typical funding range and project duration?
R21 awards generally provide lower dollar amounts than R01s with shorter durations (typically 2 years). Consult the current RFP or INCLUDE project materials for exact budget caps, which may vary by year.
How competitive is this award?
R21 awards are moderately competitive. They are designed to support innovative, high-risk ideas with preliminary findings. Strong applications articulate clear significance and feasibility despite limited preliminary data.
Are there restrictions on what Down syndrome research topics are supported?
The INCLUDE Project has broad scope for Down syndrome research. Review the current program announcement to confirm which research areas are prioritized in the funding cycle you're targeting.
💡 Tips for applicants
- Clearly articulate why this exploratory phase is necessary and how the R21 funding will generate preliminary data for a future, larger grant (R01). Reviewers want to understand the progression and feasibility.
- Emphasize the innovation and novelty of your approach. R21s reward high-risk ideas with clear scientific merit; avoid overly incremental extensions of existing work.
- Provide realistic timelines and milestones for your 2-year project. Show that you can generate publishable results and sufficient preliminary data within the award period.
- Engage your institution's grants office early to ensure compliance with NIH eligibility requirements, cost-sharing policies, and any institutional caps on federal indirect costs.
- Address feasibility head-on. Even though the R21 allows for higher-risk proposals than R01s, you must still convince reviewers that your team can execute the proposed work and overcome anticipated challenges.
⚠️ Common mistakes
Applicants frequently underestimate the need for preliminary data or feasibility demonstration—even exploratory awards require convincing evidence that the proposed research is doable. Another common pitfall is including clinical trial components or promising clinical translation without adequate mechanistic foundation; this grant explicitly excludes clinical trials, and proposals blurring that line risk desk rejection. Finally, weak impact statements or failure to articulate how this exploratory work will lead to larger future grants often weaken competitiveness; reviewers want to see a clear scientific trajectory and long-term research vision.
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