Opportunity Information: Apply for RFA OD 22 009

The Transformative Research Award for the NIH INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project is a federal grant opportunity designed to accelerate bold, high-impact research that can noticeably improve health and quality of life for people with Down syndrome. It uses the NIH R01 mechanism and is explicitly marked as Clinical Trial Not Allowed, meaning the funded work cannot be proposed as a clinical trial. The intent is to back ideas that are not incremental or routine, but instead have a credible chance of reshaping the field through new scientific paradigms, radically improved clinical approaches (without being a clinical trial), or transformative technologies that change what is possible in Down syndrome research and related care.

This funding announcement is focused on supporting exceptionally innovative, original, and even unconventional projects. Applicants do not need to provide preliminary data, which signals that NIH is willing to invest in earlier-stage, higher-risk concepts as long as the proposal is logically compelling and makes a strong case for major impact. In practice, that means reviewers will be looking for clear reasoning, a persuasive scientific rationale, and a project design that matches the ambition of a transformative award, rather than a traditional, step-by-step extension of existing work.

The research scope is intentionally broad. Applications can address any topic relevant to Down syndrome across the lifespan, including co-occurring conditions that frequently intersect with Down syndrome. The INCLUDE framing encourages investigators to look at health and disease in a holistic way, recognizing that Down syndrome is often associated with multiple overlapping medical and developmental conditions that may change across childhood, adolescence, adulthood, and aging. Proposals can be grounded in basic, translational, or other non-clinical-trial research approaches, as long as they are clearly tied to Down syndrome or its co-occurring conditions and are positioned to deliver outsized scientific or practical advances.

A major feature of the opportunity is its emphasis on broad participation and workforce diversity. NIH states that it is seeking applications that reflect the full diversity of the nation’s research community. Investigators from underrepresented groups, and applicants from a wide range of institutions and geographic locations, are strongly encouraged to apply. The eligible applicant pool is wide and includes many types of organizations that may not always be front-and-center in biomedical research competitions, reinforcing the program’s interest in bringing in new perspectives and novel research strategies.

Eligibility includes typical public-sector and higher-education applicants such as state, county, city, and special district governments; independent school districts; and public or state-controlled institutions of higher education. It also includes private institutions of higher education, nonprofits with and without 501(c)(3) status, public housing authorities/Indian housing authorities, and both federally recognized tribal governments and other tribal organizations. In addition, for-profit organizations (other than small businesses) and small businesses are eligible, and the announcement also highlights a range of other eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations. This broad eligibility is consistent with the program’s goal of attracting unconventional ideas and diverse teams.

Administratively, this opportunity is run by the National Institutes of Health under Funding Opportunity Number RFA-OD-22-009. It is categorized as a discretionary grant within health, education, and social services-related activity categories, and it references multiple CFDA numbers (including 93.121 and others) that correspond to various NIH programs and institutes involved in the broader INCLUDE effort. The original closing date listed for this announcement is 2024-07-01. The award ceiling is listed as 6,000,000, indicating that very large projects are possible under this mechanism when justified by scope and transformative potential. The listing does not specify the exact number of expected awards in the provided source data, but the ceiling and the “transformative” framing suggest a competitive, selective program aimed at funding a smaller number of particularly bold projects.

In short, this FOA is best read as an invitation to propose a big swing: a research plan that is grounded in strong logic, directly relevant to Down syndrome and/or its co-occurring conditions, and capable of changing the direction of the science or enabling new approaches and technologies, without requiring preliminary data and without proposing a clinical trial.

  • The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Transformative Research Award for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project (R01 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): 93.121, 93.172, 93.173, 93.233, 93.242, 93.351, 93.393, 93.396, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.855, 93.865, 93.866, 93.867.
  • This funding opportunity was created on 2022-04-05.
  • Applicants must submit their applications by 2024-07-01. (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 $6,000,000.00 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.
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