INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed) | RFA OD 19 015

Opportunity Information: Apply for RFA OD 19 015

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness funding opportunity (RFA-OD-19-015) is an NIH grant program designed to help the Down syndrome research community get better prepared to run successful future clinical trials. It supports clinical research projects that remove practical and scientific roadblocks that often slow down or derail trials, especially in populations with Down syndrome where co-occurring conditions, wide variability in functioning, and age-related changes can make study design and measurement more complicated. This is an R21 mechanism, meaning it is aimed at early, exploratory, or high-impact preparatory work rather than large-scale definitive studies, and it explicitly does not allow clinical trials under this announcement.

The core purpose is “clinical trial readiness,” which, in this context, means building the tools and evidence base needed so that when a promising therapeutic or diagnostic is ready, researchers can move into trials efficiently and with a higher chance of generating clear, interpretable results. Projects are expected to focus on one or more enabling steps: developing and testing biomarkers that could be used to detect disease, stratify participants, monitor progression, or show biological response to an intervention; developing and testing clinical outcome assessment measures (for example, endpoints that are valid, reliable, and feasible for people with Down syndrome across different ages and ability levels); piloting and improving trial methods (such as study designs, assessment schedules, remote or hybrid approaches, and procedures that reduce burden); and creating or testing recruitment and retention strategies that realistically work for individuals with Down syndrome and their families. Another major emphasis is clarifying how common co-occurring conditions present and progress across the lifespan in Down syndrome, since understanding the natural history and variability of these conditions is often essential for choosing endpoints, defining eligibility criteria, estimating sample sizes, and selecting trial duration.

A key theme running through the announcement is that Down syndrome rarely exists in isolation clinically. Many individuals experience co-occurring conditions that can affect cognition, behavior, sleep, cardiovascular health, immune function, and other systems, and these conditions may change over time. By supporting projects that better define the presentation and course of these co-occurring conditions, the FOA aims to help investigators design future trials that are realistic about baseline differences, comorbidities, and age-related risk, and that can distinguish true treatment effects from background variation. In practice, that could mean building stronger characterization of endpoints, validating measurement tools in specific age groups, or establishing which markers and assessments are most sensitive to meaningful change.

Administratively, this is a discretionary NIH grant in the health-related assistance domain and is tied to multiple CFDA program numbers. The award ceiling listed is $200,000, and the original closing date for the opportunity was March 14, 2019, with a creation date of February 5, 2019. Because it uses an R21 format, the expectation is typically a focused project with a clear deliverable that advances readiness for later-stage clinical testing, rather than a broad, long-term research program.

Eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses, along with other eligible entities. The announcement also calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

At the same time, there are specific limits related to foreign involvement. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant can include certain types of foreign collaboration or performance sites when justified and compliant with NIH policy.

Overall, this opportunity is best understood as a targeted push to build the practical foundation for stronger Down syndrome clinical research: better biomarkers, better endpoints, better methods, better recruitment, and clearer understanding of co-occurring conditions across the lifespan. The intended payoff is that future clinical trials in Down syndrome can be launched faster, designed more intelligently, and interpreted with more confidence, ultimately improving the odds that promising therapeutics and diagnostics can be tested rigorously and translated into real-world benefit.

• The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.351, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2019-02-05.
• Applicants must submit their applications by 2019-03-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA OD 19 015

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