FAQs for Down Syndrome Cohort Research Sites (DS-CRS)

Under the U01 to be published in response to NOT-OD-23-134, individual sites can apply to be a DS-CRS, or groups of up to 6 total partners can apply to be a collaborative team of DS-CRS with a single proposed protocol for phenotyping and biosample acquisition. Applicants are strongly encouraged to include at least 3 partner institutions, with a maximum of 6 total institutions as part of an application, with an emphasis on including at least one partner from low-resourced institutions or institutions serving groups underrepresented in biomedical research, such as Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCU), other Minority Serving Institutes (MSIs), and states eligible under the Institutional Development Award (IDeA) program. In addition, sites are encouraged to work with their local DS and other community partners when they propose a recruitment plan. NIH will select several DS-CRS applications to fund, some of which may represent a single site and others that may represent collaborative teams made up of several partner sites.

Since the purpose of the DS-CDP is to build a cohort of individuals with DS across the lifespan, the milestones should reflect phenotyping and activities related to cohort creation and biosample collection, rather than specific scientific research projects. Milestones should include scheduled events such as the anticipated time frame for IRB submission, and timelines for the achievement of sequential recruitment and retention goals. Each DS-CRS should, however, develop a phenotyping protocol that reflects the co-occurring conditions that impact the age range of a given DS population proposed for study.

All DS-CRS will be following the same or similar protocol (adjusted for age), so the costs of phenotyping will be borne by the DS-4C using a capitation model, with established per-participant reimbursement costs that will be developed along with the shared protocol. The first year of the award will be devoted to development of the common protocol across the sites, working in conjunction with the DS-4C (NOT-OD-23-135) and the federated biospecimen repository (DS-Biorepository, described in NOT-OD-23-136). As the oversight will be managed by the DS-4C, the budget request should reflect the costs of supporting the site personnel and/or equipment necessary to recruit and enroll participants into the cohort, including the minimal staffing required to administer the protocol and collect biological specimens, neuropsychology evaluations, radiological studies, etc. Costs for each site are capped at $300,000 in direct costs per year for a total of 5 years. The non-personnel costs of enrollment and phenotyping will be supported by per-person fees provided by the DS-4C (see Question 13) and should not be part of the DS-CRS budget.

This language was not intended to suggest that specific research projects should be proposed. However, some of these collaborative roles may form a part of the research team for either the DS-CRS or the DS-4C. Note that a common protocol, adjusted for co-occurring conditions that impact individuals with DS across various time points during the lifespan, will be developed by the awarded sites, the DS-4C, and the DS-Biorepository in the first year of the project, so the emphasis for the NOFO to be published in response to this notice (NOT-OD-23-134) is on a proposal for a comprehensive phenotyping protocol.

Yes. Applicants are strongly encouraged to include at least 3 partner institutions, with a maximum of 6 total partner institutions, with an emphasis on including at least one partner from a low-resourced institution or an institution serving groups underrepresented in biomedical research (for example, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCU), other Minority Serving Institutes (MSIs), and states eligible under the Institutional Development Award (IDeA) program). If partner institutions are included, the budget can be scaled to accommodate such partnerships, with a maximum allowed budget of $200,000 direct costs per year for each site. There will be a requirement for a diversity plan as part of the application, emphasizing the importance of including diverse recruitment sites.

No, we recognize that sites or clinics may specialize in certain age ranges of individuals with DS. Thus, an individual DS-CRS should propose an age range and protocol that is consistent with the expertise of the investigators. However, each DS-CRS should propose a study protocol that reflects the breadth of co-occurring conditions that manifest in the age range(s) proposed for recruitment, rather than one or a few focused phenotypes. A common protocol across the lifespan will be developed among the DS-CRS, DS-4C, and DS-Biorepository during the first year of the awards to cover the co-occurring conditions across the lifespan. If adults are proposed for ascertainment, the protocol should include adult phenotyping components compatible with those developed by the Alzheimer Biomarkers Consortium — Down Syndrome (ABC-DS) project.