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.Apply for RFA OD 22 009
- 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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Frequently Asked Questions (FAQs)
What is the Transformative Research Award for the NIH INCLUDE Project?
It is a federal grant opportunity from the National Institutes of Health (NIH) designed to accelerate bold, high-impact research that can noticeably improve health and quality of life for people with Down syndrome. The award aims to support projects that could reshape the field through new scientific paradigms, transformative technologies, or radically improved approaches to care (as long as the work is not a clinical trial).
What funding mechanism does this opportunity use?
This opportunity uses the NIH R01 mechanism.
Are clinical trials allowed under this funding opportunity?
No. The funding opportunity is explicitly marked as "Clinical Trial Not Allowed," meaning the proposed funded work cannot be a clinical trial.
What kind of projects is NIH trying to fund through this award?
NIH is looking for exceptionally innovative, original, and potentially unconventional projects that are not incremental or routine. The emphasis is on ideas with a credible chance of producing outsized impact, such as shifting the scientific direction of the field, enabling entirely new research capabilities, or making major practical advances in Down syndrome research and related care (without conducting a clinical trial).
Do applicants need preliminary data to apply?
No. Applicants do not need to provide preliminary data. This signals that NIH is willing to consider earlier-stage, higher-risk concepts if the proposal is logically compelling and makes a strong case for major impact.
If preliminary data is not required, what will reviewers focus on instead?
Based on the description provided, 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 incremental extension of existing work.
What research topics are considered within scope?
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.
What does "across the lifespan" mean in this context?
It means proposals may focus on Down syndrome and associated health or developmental issues as they appear or change across childhood, adolescence, adulthood, and aging.
What are "co-occurring conditions" and why are they emphasized?
In this opportunity, co-occurring conditions refer to additional medical or developmental conditions that frequently overlap with Down syndrome. The INCLUDE framing encourages a holistic view of health and disease, recognizing that multiple conditions can interact and change over time.
What types of research approaches are acceptable?
Proposals can be grounded in basic research, translational research, or other non-clinical-trial research approaches, as long as they are clearly tied to Down syndrome or its co-occurring conditions and positioned to deliver transformative advances.
Is this award meant for routine or incremental research projects?
No. The intent is to back ideas that are not incremental or routine. The program is positioned as an invitation to propose a "big swing" with potential to change what is possible in the field.
How does NIH describe the desired level of innovation?
The description emphasizes exceptionally innovative, original, and even unconventional projects, aiming for new scientific paradigms, transformative technologies, or radically improved approaches that could reshape Down syndrome research and related care (without proposing a clinical trial).
Who is encouraged to apply?
NIH states 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.
What kinds of organizations are eligible to apply?
The eligible applicant pool is broad and includes public-sector and higher-education entities (such as state, county, city, special district governments, independent school districts, and public or state-controlled institutions of higher education), as well as private institutions of higher education and a wide range of other organizations.
Are nonprofit organizations eligible?
Yes. Nonprofits with and without 501(c)(3) status are included as eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. Both federally recognized tribal governments and other tribal organizations are listed as eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) and small businesses are listed as eligible.
Are institutions that serve specific communities explicitly included in the eligible categories?
Yes. The announcement highlights eligibility for categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, and Tribally Controlled Colleges and Universities, among others.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are included in the eligible applicant categories.
Can federal agencies apply?
Yes. Eligible federal agencies are listed among the eligible applicant categories.
Are applicants from U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the eligible applicant categories.
Are non-U.S. (foreign) organizations eligible?
Yes. Non-U.S. (foreign) organizations are explicitly included as eligible.
Which agency runs this funding opportunity?
The opportunity is run by the National Institutes of Health (NIH).
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is RFA-OD-22-009.
What general activity areas does this opportunity fall under?
It is categorized as a discretionary grant within health, education, and social services-related activity categories.
Does the opportunity reference CFDA numbers?
Yes. It references multiple CFDA numbers, including 93.121 and others associated with NIH programs and institutes involved in the broader INCLUDE effort.
What is the original closing date listed for this opportunity?
The original closing date listed is 2024-07-01.
What is the maximum (ceiling) award amount?
The award ceiling is listed as 6,000,000, indicating that very large projects may be possible when justified by the scope and transformative potential.
How many awards will NIH make under this announcement?
The provided information does not specify the exact number of expected awards.
What is the overall "best fit" for an application to this FOA?
Based on the description, the best fit is a logically strong, high-impact research plan that is directly relevant to Down syndrome and/or its co-occurring conditions, is designed to be transformative rather than incremental, does not rely on preliminary data, and does not propose a clinical trial.
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| Funding Opportunity |
|---|
| 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 22 007 Funding Number: RFA OD 22 007 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $275,000 |
| Small Research Grants for Analysis, Curation, and/or Sharing of Down syndrome-related Research Data for the INCLUDE Project (R03 Clinical Trial Not Allowed) Apply for RFA OD 22 008 Funding Number: RFA OD 22 008 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed) Apply for RFA NS 22 052 Funding Number: RFA NS 22 052 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Clinical Trial Not Allowed) Apply for RFA NS 22 040 Funding Number: RFA NS 22 040 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Basic Experimental Studies with Humans Required) Apply for RFA NS 22 041 Funding Number: RFA NS 22 041 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Basic Experimental Studies with Humans Required) Apply for RFA NS 22 039 Funding Number: RFA NS 22 039 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Transformative Brain Non-invasive Imaging Technology Development (UG3/UH3 Clinical Trial Not Allowed) Apply for RFA EB 22 001 Funding Number: RFA EB 22 001 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional) Apply for RFA DA 23 042 Funding Number: RFA DA 23 042 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) (R01 Clinical Trial Required) Apply for RFA DA 23 041 Funding Number: RFA DA 23 041 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATCH-IN) Clinical Research Centers (UG1 Clinical Trial Optional) Apply for RFA HD 23 013 Funding Number: RFA HD 23 013 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PATC3H Implementation Science Network (PATC3H-IN) Coordination, Translation and Advanced Methods and Analytics Center (UM2 Clinical Trial Optional) Apply for RFA HD 23 014 Funding Number: RFA HD 23 014 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $25,000,000 |
| NIH HEAL Initiative: Coordinated Approaches to Pain Care in Health Care Systems (UG3/UH3 - Clinical Trial Optional) Apply for RFA NS 22 053 Funding Number: RFA NS 22 053 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Brain Behavior Quantification and Synchronization (R61/R33 Clinical Trial Optional) Apply for RFA MH 22 240 Funding Number: RFA MH 22 240 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional) Apply for RFA DA 23 054 Funding Number: RFA DA 23 054 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) Apply for RFA DA 23 053 Funding Number: RFA DA 23 053 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed) Apply for RFA EB 22 002 Funding Number: RFA EB 22 002 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed) Apply for RFA HD 23 030 Funding Number: RFA HD 23 030 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R21 Basic Experimental Studies with Humans Required) Apply for RFA HD 23 033 Funding Number: RFA HD 23 033 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R21 Clinical Trial Not Allowed) Apply for RFA HD 23 031 Funding Number: RFA HD 23 031 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Time-Sensitive Opportunities for Health Research (R61/R33 Clinical Trial Not Allowed) Apply for PAR 22 233 Funding Number: PAR 22 233 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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