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NOT-OD-20-025 - 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

Issued by

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

Purpose

The purpose of this Notice is to inform applicants in response to NOT-OD-20-025, "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" of a change to the research objectives, changes to the Application and Submission Information, and a change in the award structure.

The following new language is being added to this FOA (in bold italics)

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. For those applications that generate clinical data, it is expected that the data sharing plan will include the INCLUDE Data Coordinating Center (DCC). Applications generating clinical data should describe the anticipated timelines, formats, and approach to submitting data to the INCLUDE DCC. 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.

Application and Submission Information

This Notice applies to due dates on or after March 17, 2021and subsequent receipt dates through January 7, 2022.

The following Funding Opportunity Announcements (FOAs) or their reissued equivalents must be used for submissions for this initiative. Applications will be accepted by all participating Institutes and Centers listed in NOT-OD-20-025.

• PA-20-183 – Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-184 – Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185 -- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

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.

All other aspects of this FOA remain the same.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Please direct all inquiries to:

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