Notice Number: NOT-OD-20-022
Release Date: December 19, 2019
First Available Due Date: March 02, 2020
Expiration Date: March 03, 2020
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-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOT-OD-20-017 Notice of Special Interest 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)
Office of The Director, National Institutes of Health (OD)
National Center for Advancing Translational Sciences (NCATS)
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.
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 career development research experiences , resources, and mentorship, the NIH intends to foster a pipeline of investigators in DS and other intellectual disabilities 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. Sharing of resources and effective communication of outputs of appropriate interest to the 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).
The NIH is issuing this NOSI to expand the community of investigators conducting research related to DS by encouraging CTSAs to recruit scientists and physicians early in their research careers to develop research projects related to co-occurring conditions associated with DS. This NOSI will support additional scholar slots to those KL2 grants currently approved under the CTSA Program. Sharing of resources and effective communication of outputs to the 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:
Projects that propose to recruit subjects with DS 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.
For further information on INCLUDE priorities, resource sharing expectations, and participating NIH Institutes and Centers, see Frequently Asked Questions.
Application and Submission Information: Applications in response to this NOSI must be submitted to PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) or its subsequent reissued equivalent. All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:
Instructions for Electronic Application Submission through Grants.gov: Use the “Apply” button(s) in Part I of the PA-18-591 program announcement to access the application forms package posted at Grants.gov.
When presented with more than one form package, use the form package with Competition ID "FORMS-E-ADMINSUPP-K12-KL2-KM1-D43".
Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:
Program Plan: (may not exceed 12 pages)
Letters of Support: Attach appropriate letters from all individuals confirming their roles in the proposed supplement program. Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned proposed research project. The letter should provide assurance that the candidate scholar will be able to devote a minimum of 9 person-months (75 percent of full-time professional effort) to the supplement project. The letter should confirm that the scholar will be supported by the KL2 if the supplement is funded. The letter should also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the scholar for the research project.
Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
Senior/Key Person form:
Budget forms: Using the R&R budget form, only include funds requested for the additional supplement activities.
R&R Other Project Information form, Facilities and Other Resources attachment:Describe how the scientific environment in which the career development activities will be done contributes to the probability of the scholar's success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Program hub Training Resources, describe the training resources that are available to the scholar.
PHS Human Subjects and Clinical Trials Information form:Complete this section if the scholar will design and conduct their own independent human subjects research. Approval by the human subjects Institutional Review Board (IRB) at the grantee institution is required prior to award. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.
Please direct all inquiries to:
Erica Rosemond, Ph.D.
National Center for Advancing Translational Sciences (NCATS)