Opportunity Information: Apply for RFA OD 19 016
The Transformative Research Award for the NIH INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project is a Request for Applications (RFA) that uses the NIH R01 grant mechanism to fund bold, high-impact research focused on Down syndrome across the lifespan. The central aim is to back projects that are genuinely transformative: work that is groundbreaking, exceptionally innovative, original, or even unconventional, and that has a real chance of shifting scientific thinking, opening new research directions, creating fundamentally improved clinical approaches, or producing transformative technologies relevant to Down syndrome and its co-occurring conditions. A key feature of this opportunity is that little or no preliminary data are expected, which signals that NIH is intentionally making room for higher-risk ideas that may be too early-stage for traditional R01 competitions but still have strong rationale and potentially major payoff.
This funding opportunity sits within the broader NIH INCLUDE Project, which emphasizes understanding Down syndrome in the context of co-occurring conditions (for example, medical, developmental, neurological, and other health-related issues that can occur alongside Down syndrome) and how these conditions unfold and interact from early life through older adulthood. The scope is intentionally broad: applicants can propose research in any topic area relevant to Down syndrome, as long as they make a convincing case that the work could have major impact. The RFA is designed to attract investigators who want to take big swings, including multidisciplinary teams or individual scientists with an unusually creative approach, and it explicitly welcomes applicants from diverse backgrounds.
The activity is an R01 but is labeled "Clinical Trial Not Allowed," meaning the proposed work cannot include an NIH-defined clinical trial. In practical terms, that typically limits projects to preclinical studies, mechanistic work, observational or natural history research that does not meet the NIH clinical trial definition, method and technology development, data science approaches, and other human-subjects research that does not involve prospective assignment to an intervention to measure health-related outcomes. Applicants would need to be careful to structure any human research so it stays outside the clinical trial boundary as NIH defines it.
Eligibility is broad and includes many U.S.-based organization types commonly allowed for NIH grants: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; public housing authorities/Indian housing authorities; federally recognized tribal governments and other tribal organizations; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The announcement also highlights 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it draws clear boundaries around non-U.S. participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed, which means a U.S. applicant may be able to include certain international elements or collaborations if they meet NIH requirements and are justified for the project.
Administratively, the opportunity is issued by the National Institutes of Health as a discretionary grant program. The funding opportunity number is RFA-OD-19-016, and it is associated with multiple CFDA numbers (now often referred to under broader assistance listing structures), reflecting NIH’s multi-institute participation. The original closing date listed is March 14, 2019, and the posting (creation) date is February 5, 2019. The excerpt provided does not specify an award ceiling or the expected number of awards, so applicants would normally rely on the full RFA text for budget format, project period limits, and any institute-specific funding details.
In short, this RFA is best understood as a targeted invitation for ambitious, paradigm-shifting Down syndrome research under the INCLUDE umbrella, with an emphasis on outsized impact, openness to unconventional ideas, and reduced expectation for preliminary data, while explicitly excluding clinical trials and maintaining U.S.-based applicant eligibility with limited, defined pathways for foreign components.Apply for RFA OD 19 016
- The National Institutes of Health in the education, environment, 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): 93.113, 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, 93.855, 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.)
- 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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| Funding Opportunity |
|---|
| Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required) Apply for RFA OD 19 018 Funding Number: RFA OD 19 018 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed) Apply for RFA OD 19 015 Funding Number: RFA OD 19 015 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $200,000 |
| PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required Apply for PA 19 273 Funding Number: PA 19 273 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed) Apply for PAR 19 276 Funding Number: PAR 19 276 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $50,000 |
| Dissemination and Implementation Research in Health (R01 Clinical Trial Optional) Apply for PAR 19 274 Funding Number: PAR 19 274 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Marmoset Coordination Center (U24 Clinical Trials Not Allowed) Apply for RFA MH 20 150 Funding Number: RFA MH 20 150 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Marmoset Colonies for Neuroscience Research (U24 Clinical Trials Not Allowed) Apply for RFA MH 20 145 Funding Number: RFA MH 20 145 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Blueprint for Neuroscience Research Education Program on Translational Devices (R25 Clinical Trial Not Allowed) Apply for RFA NS 20 003 Funding Number: RFA NS 20 003 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $250,000 |
| NIH Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (BP-ENDURE) (R25 Clinical Trial Not Allowed) Apply for RFA NS 20 015 Funding Number: RFA NS 20 015 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed) Apply for RFA OD 20 004 Funding Number: RFA OD 20 004 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $200,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32) Apply for PA 20 142 Funding Number: PA 20 142 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) Apply for PA 20 184 Funding Number: PA 20 184 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Pathway to Independence Award (Parent K99/R00 Independent Basic Experimental Studies with Humans Required) Apply for PA 20 189 Funding Number: PA 20 189 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Quantitative Research Development Award (Parent K25 Independent Basic Experimental Studies with Humans Required) Apply for PA 20 198 Funding Number: PA 20 198 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Basic Experimental Studies with Humans Required) Apply for PA 20 204 Funding Number: PA 20 204 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Basic Experimental Studies with Humans Required) Apply for PA 20 201 Funding Number: PA 20 201 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required) Apply for PA 20 202 Funding Number: PA 20 202 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional) Apply for RFA OD 20 013 Funding Number: RFA OD 20 013 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Tools for Germline Gene Editing in Marmosets (U01 - Clinical Trial Not Allowed) Apply for RFA DA 21 006 Funding Number: RFA DA 21 006 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Fertility Status as a Marker for Overall Health (R01 Clinical Trial Optional) Apply for PAR 20 281 Funding Number: PAR 20 281 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
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