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NIH Phase 1 Exploratory/Developmental Grant (R61)

INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research

Funds planning then running a milestone-driven clinical trial for a health condition that co-occurs with Down syndrome.

The INCLUDE Project is NIH's cross-institute effort to improve health and quality of life for people with Down syndrome, covering the condition itself and everything that co-occurs with it. This is the clinical-trials award in the INCLUDE family, and the only one of the three that requires one.

The mechanism is phased. An R61 phase of up to two years funds preliminary, developmental and planning

Phased R61/R33 clinical trial awards developing and running milestone-driven clinical trials to treat critical and co-occurring health conditions in people with Down syndrome — up to two years of R61 planning work, followed by up to three years of R33 clinical trial support, with a five-year total project limit. A clinical trial is required.

CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.Multiple per year
Next deadlineiThe next date applications are due. Rolling means you can apply any time.15 Jun 2028
Decision timeiTypical time from the deadline to the funder's decision.26 weeks
Project durationiHow long the funded work is expected to run.
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Grant
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.
Funding pooliThe total budget available across all awards in this round.$3M

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Last verified: 25 Aug 2026Funder reference: RFA-OD-27-005Source: www.grants.gov