Notice Number: NOT-OD-20-012
Key DatesRelease Date: November 05, 2019
Office of The Director, National Institutes of Health (OD)
Individuals with Down syndrome (DS) face significant and changing health challenges but have often been excluded from participation in research that could improve their health outcomes and quality of life. This population is understudied even though DS is the most common genetic cause of intellectual and developmental disabilities (IDD) and, in the past 25 years, the average lifespan has doubled, from 30 to 60 years.
The fiscal year (FY) 2019 Budget appropriation directed the NIH to continue support of “research grants and early-stage investigators that will expand the current pipeline of Down syndrome research, as well as implementation of the new trans-NIH initiative”. In addition, the NIH was encouraged “to prioritize funding for research for emerging scientific opportunities to improve the health and neurodevelopment of individuals with Down syndrome and typical individuals at risk for immune system dysregulation, Alzheimer’s disease, cancer, cardiovascular disease, and autism.” The INCLUDE initiative aims to address these issues by advancing research on DS in 3 domains: (1) targeted, high-risk, high-reward basic science studies of trisomy 21; (2) assembly of a large clinical cohort of individuals with DS across the lifespan; and (3) inclusive clinical trials research on current and future therapies for co-occurring conditions in DS.
The Office of the Director of theNational Institutes of Health (NIH) announces that the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project (https://www.nih.gov/include-project) will continue in FY 2020 to address priorities in Down syndrome research.
NIH Institutes and Centers likely to participate include some or all of the following:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
The NIH intends to re-issue the three Funding Opportunity Announcements (FOAs) initiated in 2019:
Research Initiative Details
The purpose of this FOA is to support research in the targeted, high risk, high reward basic science domain and seeks unusually innovative research projects, which, if successful, would have a major impact in understanding the biology of DS or potential to lead to the development of new treatments for health conditions experienced by individuals with DS.
This initiative will support clinical projects that address critical needs for clinical trial readiness in DS by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for DS and its co-occurring conditions, or increasing their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of co-occurring conditions in individuals with DS to enable the design of future clinical trials.
This initiative will support development of clinical trials to treat critical and co-occurring health conditions in individuals with DS and to develop or test new and innovative adaptations of current drugs, interventions, and therapies for the treatment and management of these co-occurring conditions. Because there will likely be a need to obtain preliminary data or conduct early-stage clinical trial preparatory activities before moving to a full-scale project in this domain, this RFA will utilize the R61/R33 (Clinical Trial Required) Phased Exploratory/Developmental Grant Award activity code.
The NIH also expects to issue Notices of Special Interest (NOSI) or Funding Opportunity Announcements (FOA) to encourage submission of DS-related research directed toward:
This initiative will support the career development of trainees aiming to establish a career in DS-related research. By providing scientists early in their careers with training, resources and mentorship, the INCLUDE Project aims to ensure a robust pipeline of investigators entering the field of DS-related research. This will enable the NIH to achieve the INCLUDE Project’s long-term goals to improve both our understanding of the biology of DS and to support development of new treatments for health conditions experienced by those with DS. Applications will be solicited for individual mentored awards through standard fellowship and career development activity codes, and expansion of existing institutional programs will be solicited using administrative supplements.
The INCLUDE Project intends to leverage the NIH/Office of Research Infrastructure Programs (ORIP) FOAs for Resource-Related Research Projects for Development of Animal Models and Related Materials (R24- Clinical Trial Not Allowed; RFA-OD-19-027) and Development of Animal Models and Related Biological Materials for Research (R21- Clinical Trial Not Allowed; PAR-19-369).
This initiative will support the development of a center to coordinate the collection, storage, quality control, and harmonization of data and biospecimens related to the creation of a large clinical cohort of individuals with DS across the lifespan; it will also provide an integrated data portal for investigators. The goal is to advance the diagnosis, management, and treatment of DS and its co-occurring conditions through the collection of ‘omics datasets from existing and prospective DS clinical cohorts. A uniform minimal dataset will be essential, along with linkages via Global Unique Identifiers, to ensure appropriate tracking of data derived from the same individual. This initiative will focus on projects in the second domain of INCLUDE. Data coordinating centers with experience in integrated data solutions to NIH-funded projects will be most competitive for this FOA.
This initiative, focusing on research in the second domain of INCLUDE, will encourage applicants that propose to conduct primary data analysis or interpretation of DS data from existing cohorts or secondary analysis of publicly available NIH-funded data sets to enhance an understanding of DS across the lifespan. Expanded use of existing data sets and biorepositories will allow researchers to address research questions within the scientific scope of the INCLUDE project at relatively low cost and effort and enhance the value of INCLUDE investments in research.
The FOAs are expected to be published in late 2019/early 2020 with expected application due dates in early 2020. Earliest award dates for fiscal year 2020 awards will be July 1 or September 1, 2020.
This Notice is being provided to allow potential applicants sufficient time to develop responsive applications.
For a list of NIH Institutes and Centers participating in the INCLUDE project and their research priorities, visit the INCLUDE Frequently Asked Questions webpage (https://www.nih.gov/include-project). A list of projects funded by the INCLUDE Project in FY19 is also available on the INCLUDE website (https://www.nih.gov/include-project/funding).
Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.310
Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
For-Profit Organization (Other than Small Business)
Indian/Native American Tribal Government (Federally Recognized)
Independent school districts
Public housing authorities/Indian housing authorities
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Please direct all inquiries to:
Anna E. Mazzucco, PhD
Office of the Director, National Institutes of Health (NIH)
Melissa Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Please direct inquiries related to specific interests of the participating NIH Institutes and Centers to the IC contacts listed on the Table of IC-Specific Information, Requirements and Staff Contacts to be listed on the INCLUDE website ( https://www.nih.gov/include-project ).