INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE)
Deadline: July 01, 2024
5 pm
Amount: The combined budget for direct costs for the two-year project period may not exceed $275,000.
No more than $200,000 may be requested in any single year.
Purpose
R21 Clinical Trial not allowed
This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of new exploratory and developmental research projects that address critical needs for Down syndrome projects, as articulated in the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) project objectives. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Background
The 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 between 2018 and 2020, 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.
The purpose of this Request for Applications is to support exploratory and developmental research project grant (R21) applications focused on the 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).
Research Objectives
The evolution and vitality of the biomedical, behavioral, and clinical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. Through the NIH Exploratory/Developmental Research Grant Program, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical, behavioral, and clinical research.
This program is intended to encourage new exploratory and developmental research projects that address critical needs for Down syndrome (DS) projects, as articulated in the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) project objectives. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research in the area of DS. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Scope
Applications will be eligible for funding if they address one or more of the following components related to the INCLUDE Project research objectives:
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
More Info: https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-007.html