Notice of Special Interest (NOSI): NIH Research Project Grants on Down Syndrome (R01) for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project

Notice Number: NOT-OD-20-025

Key Dates
Release Date: December 18, 2019
First Available Due Date: February 05, 2020
Expiration Date: January 08, 2022

Related Announcements

NOT-OD-20-022

NOT-OD-20-012 Notice of Intent to Publish Funding Opportunity Announcements in Fiscal Year 2020 for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project

PA-19-055 Research Project Grant (Parent R01 Clinical Trial Required)

PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-19-091 NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required

NOT-OD-20-017 Notice of Special Interest (NOSI) to Encourage Development of Animal Models and Related Biological Materials for Research Related to Down Syndrome

NOT-OD-20-020 Notice of Special Interest (NOSI): Ruth L. Kirschstein National Research Service Award (NRSA) Fellowship Awards to Support Training in Research Related to Down Syndrome as Part of the INCLUDE Project

NOT-OD-20-021 Notice of Special Interest (NOSI): Mentored Career Development Awards To Support Training in Research Related to Down Syndrome as Part of the INCLUDE Project

NOT-OD-20-022 Notice of Special Interest: Administrative Supplements for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project to NIH-funded K12 and KL2 Institutional Career Development Awards

NOT-OD-20-023 Notice of Special Interest: Availability of Competitive Supplements/Revisions for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project (Competitive Supplement/Revision Clinical Trial Optional)

NOT-OD-20-024 Notice of Special Interest: Availability of Administrative Supplements for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project

NOT-OD-20-025 Notice of Special Interest: NIH Research Project Grants on Down Syndrome (R01)

RFA-OD-20-003 Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)

RFA-OD-20-004 INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)

RFA-OD-20-005 Transformative Research Award for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project (R01 Clinical Trial Not Allowed)

RFA-OD-20-006 Small Research Grants for Analyses of Down Syndrome-related Research Data for the INCLUDE Project (R03 Clinical Trial Not Allowed)

RFA-OD-20-007 Development of the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project Data Coordinating Center (U2C)

Issued by
Office of The Director, National Institutes of Health (OD)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

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 Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

Background

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project was developed in response to Fiscal Year 2018 and 2019 Omnibus Appropriations Reports, which encouraged the NIH to expand its current efforts on Down syndrome (DS) and common co-occurring conditions also seen in the general population while increasing the pipeline of DS investigators. Information about projects that were funded in 2018 and 2019, as well as the INCLUDE Project Research Plan, is available on the INCLUDE Project website.

Individuals with 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. In addition to intellectual disability, DS is associated with an increased prevalence of autism and epilepsy. About 75% of individuals with DS experience cognitive decline in a syndrome that resembles Alzheimer’s disease, but with onset a decade or two earlier than typical Alzheimer’s disease. Individuals with DS also have high rates of hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, and other autoimmune or immune dysregulation disorders including celiac disease. However, people with DS infrequently develop solid tumors such as breast or prostate cancer. Despite multiple risk factors for coronary artery disease and high rates of obesity, sleep apnea, and type 1 diabetes, people with DS rarely develop atherosclerosis or have myocardial infarctions. Understanding this unique combination of risk and resiliencies will inform medical advances for individuals with DS and for individuals who do not have DS but who share these co-occurring conditions.

Research Objectives

The purpose of this Notice of Special Interest (NOSI) is to support research project grant (R01) applications that are focused on Down syndrome and that meet programmatic objectives for the INCLUDE Project. Sharing of resources and effective communication of outputs of appropriate interest to broader communities are a high priority of the INCLUDE Project. Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches (see Goal 3, NIH Strategic Plan For Data Science).

A list of Funding Priorities by Institute and Center is available on the INCLUDE website. Applications in response to this NOSI should be aligned with the overall INCLUDE Project Research Plan, which consists of three components:

  • Component 1: Targeted, high risk-high reward, basic science studies in areas highly relevant to Down syndrome
  • Component 2: Cohort Study to connect existing resources and expand to inclusion of individuals with Down syndrome
  • Component 3: Inclusive clinical trials research for co-occurring conditions in individuals with Down syndrome

Projects that propose to recruit subjects with Down syndrome are encouraged to promote enrollment of research subjects in the Down syndrome patient registry supported by NIH, DS-Connect®. For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use biorepositories designated by INCLUDE staff that meet requirements for broad sharing. An NIH resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing.

The INCLUDE website has a list of Funding Priorities by Institute and Center for the project, as well as list of contacts for each participating NIH Institute and Center.

Program Directors/Principal Investigators (PD/PIs) planning to submit applications in response to this NOSI are strongly encouraged to contact the scientific contacts of this NOSI prior to submission to be advised on appropriateness of the intended resource and research plans for this program, competitiveness of a potential application, and alignment with program priorities of the INCLUDE initiative.

Application and Submission Information

This Notice applies to due dates on or after February 5, 2020 and subsequent receipt dates through September 7, 2022.

The following Funding Opportunity Announcements (FOAs) or their reissued equivalents must be used for submissions for this initiative. Although not all NIH components indicated above are listed as Participating Organizations in all the FOAs listed below, applications for this initiative will be accepted by the participating Institutes and Centers at NIH.

  • PA-19-055 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
  • PA-19-056 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
  • PA-19-091 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

  • For funding consideration, applicants must include NOT-OD-20-025 in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

 

Inquiries

Please direct all inquiries to:

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

A list of contacts for each participating NIH Institute and Center is available on the INCLUDE website.