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.

The number of participants will depend on the study that has been proposed. The function for this Biorepository includes taking samples from studies that are from INCLUDE as well as other Down syndrome studies that are not necessarily part of INCLUDE. In terms of sites, this biorepository will be the primary one for the Cohort Development Project (CDP) program, which is why it is highly encouraged that the DS-4C and DS-CRS NOFOS are also read. For the CDP program, 3 to 6 sites per application, and 3 to 8 awards total are allowed. It is assumed that the best estimate will be presented.

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?

For budgeting purposes, there is no ballpark number of samples stored per year, but the sample numbers will have a limit in terms of the budget. Samples can be processed based on the overall budget. It will be different for different sites because costs are going to be unique to the institution.

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?

It is anticipated that in the future other INCLUDE projects will also utilize this biorepository. INCLUDE Projects are not required to use this biorepository as there are alternatives also available currently. The focus should be on the CDP for this repository and if it needs to be scaled, we will consider additional funding in the future to meet that need. The intent is to direct project leads to the availability of the biorepository once it is in place prior to requesting additional funding to utilize another repository.

How many pages do we need to write for this grant?

The page limit is twelve (12) pages. All page limitations are described in the SF424 Application Guide, and the Table of Page Limits must be followed.

Existing biospecimen repositories that are not currently receiving NIH funding are eligible to apply?

It is not necessary to be an NIH supported biorepository to apply for this grant, however NIH supported biospecimen repositories can also apply.

Is this award a standalone submission?


Does NIH maintain a complete list of existing biospecimen repositories?

Through the NIH-wide Biomedical Informatics Coordinating Committee (BMIC), NIH has a listing of NIH-supported repositories available through: https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html

Is there a minimal set of specimen types anticipated?

There is not a minimal list of the types of specimens that will be banked, but applicants should have the capability to handle the brain biopsy, skin, plasma sample types, and the other types of samples listed in the NOFO (RFA-OD-24-004)

Is the expectation that the samples are processed at the selected biorepository, or can you contract with another laboratory?

The cohort studies will be utilizing the selected biorepository for the cohort. The biorepository itself will need to be performing those functions as a resource for the INCLUDE project.

Any restrictions on where the samples are processed (i.e., outside of US) prior to contribution to the biobank?

As part of this NOFO, foreign components are allowed, so there are no restrictions from NIH. Please take into consideration any restrictions specific to the countries where the samples will be sent.

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?

No, the sample sequencing and plans for collecting genetic data would be covered by other INCLUDE Project grants and not from this grant.

Are the samples anonymized at the site? If so, is the biorepository responsible for developing a common system for that across sites?

Yes, all samples will be de-identified at the clinical site before being sent to the biorepository. The biorepository is part of the federated user interface, web-based, system that will develop a common system for matching across various sites. Cross site linking is being developed with the DCC and will be rolled out when ready via NIH approved applications. Linkages will be limited to the approved protocol and will be between the research sites and the DS-4C. This limitation will ensure that a participant is enrolled to just one site.

Is a premortem clinical evaluation a prerequisite for accepting a specimen?

The actual protocol practices and SOP for that will be developed together with the CDP program and the NIH. Having clinical data linked to biospecimen will be key.

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?

Because this is a resource grant, the approval process and related SOPs will be provided by the CDP program. This will be happening once awards are made. A steering committee with representation from the CDP, staff from the clinical research sites, the cohort center, and the biorepository will be developed and approve the common protocol.

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?

The biobank is only for human subject research or human participant research. If the institution that houses the biorepository is located at one of the institutions that is awarded as a clinical core site, then it can enroll DS patients.

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?

The Biorepository should only work with de-identified samples.

If we are already enrolling in our own DS biobank, would we not be expected to continue to do that for this biorepository?

If another existing biorepository is being used, it can be linked to the INCLUDE Project, but it is not required.

For this biobank, do you expect to merge with other DS biobanks?

A goal of this NOFO is to create a federated system that will link with existing Down syndrome biorepositories and existing repositories with Down syndrome samples. So, in addition to linking to other existing resources, this Biorepository will collect and process samples from the DS-CRS cohort NOFO that is part of DS-CDP, and other INCLUDE research projects. If an existing Down syndrome biorepository does not apply to this NOFO, it is requested that the Biorepository be able to link to that external, existing biorepository as the information is better publicly shared. This allows the ability to know where requests and access these bio samples can be made.

For material transfer, is the biorepository responsible for creating the material transfer and data use agreement or just to follow the regulations?

The Biorepository should establish the Material Transfer Agreements (MTAs) and any data use agreements, in collaboration with the other participating grantees for the CDP, as part of the Common Protocol. This is a primary repository for the CDP program; however, there may be other sites or DS studies that may use this biorepository. If that is the case, then the MTAs and data use agreements should also be done in collaboration with the PIs of those studies.

Do you expect this new web interface to also disseminate biospecimen requests to repositories or only query ability?

Yes. The specimens should be made available through the web interface. The query function is also available on the INCLUDE data hub. There will be cost coverage for sending samples and receiving samples.

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?

The INCLUDE Data Hub currently has a portal where you can access the metadata, phenotypic data, and genomic data. The intent is to provide a new function about specimens which will be linked to the biobanking website once ready. The expectation is to use the first year to prepare for the landing page of the website. Awardees should coordinate with the INCLUDE DCC to set up the linkage.

This page last reviewed on January 8, 2024