Key Dates

Related Announcements

PA-20-187 NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required)

PA-20-188 NIH Pathway to Independence Award (Parent K99/R00 - Independent Clinical Trial Not Allowed)

PA-20-189 NIH Pathway to Independence Award (Parent K99/R00 Independent Basic Experimental Studies with Humans Required)

PA-20-190 Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed)

PA-20-191 Mentored Research Scientist Development Award (Parent K01 Independent Basic Experimental Studies with Humans Required)

PA-20-176 Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required)

PA-20-201 Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Basic Experimental Studies with Humans Required)

PA-20-202 Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required)

PA-20-203 Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed)

PA-20-204 Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Basic Experimental Studies with Humans Required)

PA-20-205 Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed)

PA-20-206 Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required)

PAR-21-271 Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Independent Clinical Trial Not Allowed)

PAR-21-272 Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Clinical Trial Required)

PAR-21-273 Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Basic Experimental Studies with Humans Required (BESH))

PAR-21-277 Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Institutionally-Focused Research Education Award to Promote Diversity (UE5 - Clinical Trial Not Allowed)

PAR-21-251 Emerging Global Leader Award (K43 Independent Clinical Trial Required)

PAR-21-252 Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed)

PAR-21-104 International Research Scientist Development Award (IRSDA) (K01 Independent Clinical Trial Not Allowed)

PAR-21-105 International Research Scientist Development Award (IRSDA) (K01 Independent Clinical Trial Required)

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 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 Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

Fogarty International Center (FIC)

National Cancer Institute (NCI)

Purpose

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome (DS). This Notice of Special Interest (NOSI) announces NIH support for the professional development of early career scientists aiming to establish a career in DS-related research. By providing these scientists with training, resources, and mentorship, the NIH intends to support the career development of junior investigators in DS who will lead future research to improve the understanding of the biology of DS and support development of new treatments for health conditions experienced by those with DS. 

Background 

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, and 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. About 75% of individuals experience cognitive decline in a syndrome that resembles Alzheimer’s disease but has its 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 FOA is one of several trans-NIH research initiatives created in response to Fiscal Year 2018, 2019, 2020, 2021, and 2022 Omnibus Appropriations Reports, 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/.   

Research Objectives 

The purpose of this Notice of Special Interest (NOSI) is to support Career Development Award 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 for the project is available on the INCLUDE website. Applications in response to this NOSI should be aligned with the overall NIH 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: Assembly of a large cohort of individuals with Down syndrome across the lifespan to perform deep phenotyping and study co-existing conditions  

• Component 3: Inclusive clinical trials of existing and future treatments and interventions for co-occurring conditions in individuals with Down syndrome 

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. The Frequently Asked Questions page of the INCLUDE website has a list of contacts for each participating NIH Institute and Center under "General".

Projects that propose to recruit subjects with DS are encouraged to promote enrollment of research subjects in the DS patient registry supported by NIH, DS-Connect®. For other data and biospecimens collected 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. For those applications that generate clinical data, it is expected that the data sharing plan will include the INCLUDE Data Coordinating Center (DCC).

Application and Submission Information

Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent Announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

This notice applies to due dates on or after July 12, 2022 and subsequent receipt dates through November 13, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

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-22-124” (without quotation marks) 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.

Applicants planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with an NIH Program Officer listed on this NOSI well in advance of the grant receipt date.

Although an NIH Institute is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

The Frequently Asked Questions page of the INCLUDE website has a list of contacts for each participating NIH Institute and Center under "General".

Scientific/Research Contact(s)

Charlene Schramm, PhD

National Heart, Lung, and Blood Institute

Telephone: 301-402-3793
Email: [email protected]

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Kelly Fritz

NICHD, GMB

Telephone:301-827-5429

Email: [email protected]