Funding Opportunities

The INCLUDE Transformative Research Award Program supports collaborative investigative teams or individual scientists who propose unusually innovative research projects, which, if successful, would have a major impact in understanding the biology of Down syndrome or related co-occurring conditions, or development of new treatments for health conditions experienced by individuals with Down syndrome. To be considered transformative, projects must have the potential to create or overturn fundamental scientific paradigms through novel concepts or perspectives, transform the way research is conducted through the development of novel tools or technologies, or lead to major improvements in health through the development of highly innovative diagnostic, therapeutic, or preventive strategies. Several key features of this Notice of Funding Opportunity (NOFO) are designed to emphasize to applicants and peer reviewers that Transformative Research applications are very different from conventional, investigator-initiated research applications. The Transformative Research application focuses on the importance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on preliminary data or experimental details. Reviewers will be instructed to emphasize the significance and innovation of the application in their evaluations. Applicants and reviewers should keep the goal of the Transformative Research Award initiative in mind throughout the process– to solicit and fund unusually innovative and potentially transformative research. Since outstanding research is conducted at a broad spectrum of institutions, it benefits the national scientific enterprise to support exceptionally innovative and impactful science that represents this breadth. Therefore, this NOFO encourages applications from the full range of eligible institutions. Applications are welcome in all topics relevant to Down syndrome-related research or its co-occurring conditions. The primary requirements are that the research be highly innovative and have the potential to impact Down syndrome-related research. Down syndrome is the most common genetic cause of intellectual disability, the most common autosomal trisomy, and one of the most visible and universally recognized genetic syndromes. Each year there are approximately 5300 babies born in the United States with Down syndrome. Within the past 25 years, the average lifespan for a person with Down syndrome has doubled, from 30 to 60 years. Despite this increase in lifespan, individuals with Down syndrome and their families face significant and changing health challenges with age. However, they have often been excluded from participation in research that could improve their health outcomes and quality of life. While all people with Down syndrome are connected by the common feature of a complete or partial copy of chromosome 21 (trisomy 21), there are significant physical and cognitive differences among them, indicating that inter-individual variability exists. Down syndrome is associated with an increased prevalence of autism and epilepsy. The lifetime risk of Alzheimer's dementia is over 90% in individuals with Down syndrome with symptom onset a decade or two earlier than typical Alzheimer’s disease. Individuals with Down syndrome 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 Down syndrome infrequently develop solid tumors such as breast or prostate cancer, and despite multiple risk factors for coronary artery disease and high rates of obesity, sleep apnea, and type 1 diabetes, they rarely develop atherosclerosis or have myocardial infarctions. Understanding this unique combination of risk and resiliencies will inform medical advances for individuals with Down syndrome, and for individuals who do not have Down syndrome but share these co-occurring conditions. This NOFO is one of several trans-NIH research initiatives created in response to Omnibus Appropriations Reports starting in Fiscal Year 2018, which encourage NIH to expand its current efforts on Down syndrome and common co-occurring conditions also seen in the general population, while increasing the pipeline of Down syndrome investigators. Together, the initiatives are called the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE). Information about projects that were funded in prior years, as well as the NIH INCLUDE Down Syndrome Research Plan, are available on the INCLUDE Project website at https://www.nih.gov/include-project. The INCLUDE Project has three components: - Component 1: Conduct targeted, high-risk, high-reward basic science studies on chromosome 21 - Component 2: Assemble a large study population of individuals with Down syndrome - Component 3: Conduct clinical trials research inclusive of individuals with Down syndrome