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FAQs for Down Syndrome Federated Biobanking Resource (DS-Biorepository)
The following FAQs are specific to NOT-OD-23-136:
What is the role and function of the DS-Biorepository?
The DS-Biorepository will be a resource to support the collection, storage, distribution of, and linkage of biosamples from DS clinical research. The aim is to facilitate the coordinated receipt and distribution of biospecimens, from future and previously funded clinical research studies. As a federated system, the DS-Biorepository will also provide linkages to existing and legacy biospecimen repositories housing specimens from DS-focused clinical research. The DS-Biorepository should include a cost-recovery estimate for sample collection, storage, and distribution.
What do you mean by a “federated” biorepository?
In addition to collecting and storing biospecimens, the DS-Biorepository will develop a centralized system that links and/or connects, through a web-based user interface, distributed networks of existing biorepositories to facilitate the search of all publicly accessible biospecimens relevant to the study of DS. This model does not require existing biorepositories to relinquish their collections of biospecimens.
How will the Cohort Development Program (DS-CDP) integrate with the Federated Biospecimen Repository (DS-Biorepository) described in NOT-OD-23-136?
The DS-CDP will coordinate the collection of biospecimens from registered participants in the longitudinal cohort study to be deposited in the DS-Biorepository. The DS-CRS applicants will propose a phenotyping protocol, but the final common protocol will be developed collaboratively by the DS-4C, DS-CRS sites, and DS-Biorepository during the first year of the awards. As part of the proposed protocol, the DS-CRS sites will describe the biospecimens to be collected and recommended ‘omics evaluations.’ The DS-Biorepository will have the capacity to collect and distribute a variety of biospecimens, including, but not limited to blood, plasma, skin, biopsy or surgical tissues, brain (whole or sections), spinal cord, cerebrospinal fluid, and amniotic fluid. In addition, the DS-Biorepository will be responsible for the assembly, distribution, and tracking of biospecimen collection kits to the DS-CRS sites along with any shipping costs for submission of samples back to the DS-Biorepository.
We have an existing biospecimen repository funded by an entity other than NIH. Are we eligible to apply?
Yes, existing biospecimen repositories that are not currently receiving NIH funding are eligible to apply.
We have an existing biospecimen repository focusing on a specific type of tissue collection (e.g., brain collection or blood collection). Are we eligible to apply?
An existing biobank can apply, but it needs to demonstrate proficiency with collection of more than one tissue type (e.g., plasma, skin, and biopsy tissues, etc.).
Will the biorepository be enrolling patients along with the clinical centers or will the biorepository just be responsible for accepting the samples to be processed from the clinical centers?
The DS-Biorepository NOFO is a resource grant, and it will support the infrastructure for this biorepository, and will not focus on enrolling participants. If an applicant who is applying for the biorepository NOFO as well as one of the other two NOFOS (DS-4C, DS-CRS), then they would be considered eligible to enroll participants. This biorepository NOFO is a resource grant.
Does this funding cover the sample processing – (i.e., PBMC processing costs and transport)?
Yes, it will cover costs for required processing of the samples. Those applying to the DS-Biorepository NOFO would be expected to recover the costs for transporting samples from clinical sites and processing those samples.
It would be helpful to know the number of sites (and projected total number of participants) as this relates to budget for arranging/training staff for processing at sites, as well as shipping costs back to the central biorepository.
For budgeting and planning purposes, what is a ballpark number of stored samples per year to plan for storage? Also, the number of samples to be processed and what type of processing they will undergo?
How many other INCLUDE programs will utilize the biorepository for storage and processing and if so, how do we know the volume to expect for budgeting purposes?
How many pages do we need to write for this grant?
Existing biospecimen repositories that are not currently receiving NIH funding are eligible to apply?
Is this award a standalone submission?
Does NIH maintain a complete list of existing biospecimen repositories?
Is there a minimal set of specimen types anticipated?
Is the expectation that the samples are processed at the selected biorepository, or can you contract with another laboratory?
Any restrictions on where the samples are processed (i.e., outside of US) prior to contribution to the biobank?
Beyond storing and processing the biospecimens, can we propose to sequence some samples and get genetic data of these samples in this grant? Will this grant cover this cost of sequencing?
Are the samples anonymized at the site? If so, is the biorepository responsible for developing a common system for that across sites?
Is a premortem clinical evaluation a prerequisite for accepting a specimen?
Could we get some more detail about how the biospecimen request approval process might work and how will tissue dissemination be managed? Would generation of certain data types be prioritized?
Will this biobank be considered human subject research if the biobank site does not intend to enroll DS patients and collect samples? Or must the biobank site also enroll DS patients and collect samples?
Will the biobank work only with deidentified samples for purposes of the human subject’s research exception, or will they also have the full PHI and require a full study record?
If we are already enrolling in our own DS biobank, would we not be expected to continue to do that for this biorepository?
For this biobank, do you expect to merge with other DS biobanks?
For material transfer, is the biorepository responsible for creating the material transfer and data use agreement or just to follow the regulations?
Do you expect this new web interface to also disseminate biospecimen requests to repositories or only query ability?
Creating a web system and linking datasets may take a long time, how long do you expect it to take to establish this system? What is the role of the INCLUDE DCC in this web-based interface?
This page last reviewed on January 8, 2024