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General FAQs for Down Syndrome Cohort Development Program (DS-CDP) and Down Syndrome Federated Biobanking Resource (DS-Biorepository)
The following FAQs are for NOT-OD-23-134, NOT-OD-23-135 and NOT-OD-23-136.
Description of “deep phenotyping" in the NOFO.
Is the total estimated $5M budgeted for 1) all years or 2) for each year?
$5 Million is the estimated costs for each year for the DS-CRS. This is an estimate and may be higher or lower depending on the final number of sites and awards made.
Can 3-6 partner institutions be made up of different departments from the same university, or should they be from the different universities?
How should U01 sites complete the Human Subjects section? Should it be specified for the hypothesis/common protocol that is proposed in the U01? Or as general compliance with the common protocol that will be agreed upon?
For DS-CRS, is each U01 required to propose a specific scientific hypothesis, or simply commit to performing “deep phenotyping” as determined by the consortium after funding?
The RFA mentions that phenotyping costs do not need to be included in the site budget, is this inclusive of all phenotyping costs, such as personnel?
Can more than one group of 6 sites point to the same 4C?
Could behavioral data be part of the interest for U01?
Do partner sites need to recruit, or can they provide aspects of the phenotyping without directly recruiting?
Where should the "Table of Study Population" document be attached in ASSIST?
While phenotyping costs are not in the site budget, because estimates are requested, does this go in the justification, but not R&R forms?
Does NIH have a target number for cohort size from each site?
How can we reach out other recruitment sites to co-apply for this grant? Should we contact each other by ourselves?
Would you consider behavioral coding of observational videos to be behavioral data (for deep phenotyping)? If yes, I'm curious if that coding activity falls to the U01 sites, or to the U54 sites.
The NOFO asks for a statistical plan and power analysis. Given that the purpose is to establish a longitudinal cohort with deep phenotyping, what outcome are we to power the analysis on?
Can you please provide some more detail on how you recommend discussing potential overlap between PIs and co-investigators who will be responding on the different NOFOs, particularly the clinical and biorepository coordinating centers? In similar efforts in other disease areas, there is considerable overlap in co-PIs and co-Is between biobanking and clinical research coordination.
Are recruitment milestones to be set for the entire U01 or by partner site within a U01? For example, an RLI may have small numbers, but important diverse enrollment.
Will the U54 cover the cost of a central IRB, or will that need to be budgeted by each U01 coordinating center?
Can you please elaborate on what the structure of a “Component” for the DS-CRS site could look like if it’s not a traditional sub-contract?
Could you clarify which components of the budget will be covered by the Cohort sites, and which will be covered by the coordinating center? Could you also elaborate - the request requires estimates of all costs, including costs that would be covered by the coordinating center during the award as part of the capitated budget?
Can one "site" do all the recruitment and additional "sites" provide necessary collaborative support and expertise needed but not be separately recruiting (e.g., one site for recruitment, one site for clinical review, one site for phenotyping)?
Is the common protocol focused on the repository or will a proposed CRs' aims/procedures be potentially adopted for a common protocol?
In terms of cohort size, could an application propose a large cohort for one aspect of phenotyping, with a smaller subset undergoing a more resource-intensive aspect of phenotyping?
For rich phenotyping from areas of under-resourced areas, is the plan to submit support for travel/lodging to institutions with CTSAs or is the thought to set up an infrastructure for rich phenotyping in areas that do not typically conduct patient-oriented research?
Regarding the biobanking resource NOFO (RFA-OD-24-004), how many awards does this grant support in FY2024? Should we apply for the DS-4C and biobanking resource award?
How many hypotheses should be included in the proposal? Should this be written to the rigor of aims in a standard R01 or as justified proposed ideas to be considered by the network?
As the U01s are recommended to have a Community Advisory Board, how will the CAB connect with the Outreach Core of the U54?
Can you speak to the longitudinal goals of the NOFOs? Should the DS-CRS sites propose collecting data longitudinally (for the 5 years of the grant) or is the idea that the data will be combined across all DS-CRS sites and used to infer longitudinal results?
About estimating level of effort for investigators, is it only the main application PI who attends the steering committee meetings to come up with the common protocol, or is it the site PI’s as well?
Should a CRS “focus” on one phenotype in the application? Could we focus on ~3 and note that we’ll collect others based on the common protocol? And if we focus on ~3 phenotypes - can we propose different sample sizes based on the intensity of phenotyping?
Are you hoping to line up the U54 and U01 start dates? It sounds like the U01s will not be able to do a lot of planning if their start date is 6 months prior to the U54's start date.
Is the partner site’s $300K cost direct or total cost?
If a partner site is doing aspects of phenotyping but not recruiting participants directly, what would the budget be for that partner site?
I assume we won’t include funds for incentives?
Does the biobank award applicant need to have Down syndrome expertise? If we have expertise in biobanking but not in DS, does that qualify?
Is longitudinal assessment encouraged or is the idea to do a single assessment for phenotyping?
Would recruited cohort participants be recruitable to other studies?
Will all the sites in a CRS U01 application sink or swim together or do you envision pulling certain sites out of individual U01s?
At one place in the U54 DS-4C NOFO, it states that the Call Center would be under the Outreach core; at two other places, it states that this would be part of the Administrative Core, would you clarify that?
What is the purpose of the Down Syndrome Cohort Development Program (DS-CDP) and the Down Syndrome Federated Biobanking Resource (DS-Biorepository)?
The purpose of the DS-CDP is to establish a cooperative program committed to the assembly of a longitudinal, diverse cohort of people with Down syndrome (DS) across the lifespan to better understand the co-occurring conditions that impact them and their quality of life though deep phenotyping and multi-omics analysis of biospecimens. There are 2 components to the DS-CDP:
- The Down Syndrome Cohort Research Sites (DS-CRS) will identify and enroll people with DS to participate as part of a diverse cohort under a common protocol to be developed after award.
- The Down Syndrome Clinical Cohort Coordinating Center (DS-4C) will provide overall project coordination and outreach, support development of new cohorts of people with DS, and curate metadata from the new cohorts.
In addition, the DS-Biorepository is a related resource that will establish an infrastructure to facilitate coordination, collection, management, and dissemination of biospecimen materials from individuals with DS who are part of the DS-CDP and other INCLUDE-funded clinical research projects to advance clinical research of co-occurring conditions in individuals with DS.
How will diversity be promoted within each Funding Opportunity?
Each proposal in response to any of the NOFOs will be expected to include a Plan for Enhancing Diverse Perspectives, as described in NOT-MH-21-310, submitted as an attachment in Other Project Information to ensure the diversity and representation of the cohort collected as well as the investigator team. In addition, the DS-CRS applications will be encouraged to include partners that represent low-resourced institutions or those serving groups underrepresented in biomedical research, as well as local DS and community groups.
Where can I turn for additional information about these funding opportunities? Will there be a pre-application webinar to answer questions in real time?
Yes, return to this page or the Funding Opportunity notice for details about the timing of the pre-application webinar and other resources. In addition, NIH program staff, as designated in the NOITPs, are available to answer questions.
Can the same site propose both a DS-4C and a DS-CRS? What about a DS-Biorepository?
Yes, the same site can propose to be 2 or 3 of the components represented by the 3 funding opportunities. However, each proposal needs to ensure that there is adequate level of effort and expertise to support the functions required by each component.
Are foreign sites allowed?
One or more foreign sites can be included as a subaward or a component of a DS-CRS, DS-4C, or DS-Biorepository application but cannot serve as the primary application site.
How will the ‘omics evaluations proposed as part of the DS-CDP common protocol be funded? Should I describe the ‘omics I think should be collected under the DS-CDP with a justification for each? Should I propose a budget for ‘omics evaluations as part of my proposal for a DS-CRS or DS-4C?
Each DS-CRS proposal application should describe, justify and budget accordingly for proposed biospecimen collections and ‘omics evaluations for cohort participants. The costs for ‘omics evaluations will be supported through separate awards to NIH-funded sequencing resources such as those that support the NIH Common Fund Kids First Research Program (https://commonfund.nih.gov/kidsfirst) or the NHLBI Trans-Omics for Precision Medicine (https://topmed.nhlbi.nih.gov/) initiatives.
This page last reviewed on January 8, 2024