Down Syndrome Cohort Research Sites (DS-CRS) for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project (U01 Clinical Trial Not Allowed)

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. This Notice of Funding Opportunity (NOFO) invites applicants to participate in a new INCLUDE Project Down Syndrome Cohort Development Program (DS-CDP) as Cohort Research Sites (DS-CRS). The purpose of this program is to recruit participants with Down syndrome across the lifespan; collect biospecimens; assemble phenotypic data, images, and omics for deep phenotyping; and make the data readily available to the scientific community. Research sites will participate in all aspects of planning and conducting a common protocol, as well as interpretation and translation of results. This NOFO runs in parallel with a companion NOFO (RFA-OD-24-005) that will solicit applications for the Clinical Cohort Coordinating Center (DS-4C) to provide overall coordination of the DS-CDP. A related NOFO (RFA-OD-24-004) will support a Federated Biobanking Resource to store and distribute biospecimens collected by the Cohort Research Sites. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.