What is the purpose of having a central repository?
A central repository collects samples and data from significant NIDDK studies, simplifies access to samples, and ensures that samples are stored under uniform conditions. This allows for additional studies to be conducted, enhancing the value of the research. Similarly, reposited datasets can be maintained, queried, and reconfigured to facilitate new analyses after a study’s original data coordinating center closes. Another important goal of the repository is to allow cost effective and high quality processing of pediatric genetic samples.
What are the NIDDK Central Repositories?
The NIDDK Central Repositories are three separate contract-funded components that work together to store data and samples from significant, NIDDK-funded studies.
The first component is the Biosample Repository that
- gathers, stores, and distributes biological samples from studies
- works with investigators in new and ongoing studies as a real-time storage facility for archival samples
- collects and stores the entire sample collection from selected completed studies
The second component is the Genetics Repository that
- receives and processes blood samples, generally from pediatric study participants, to allow genetic analyses
- creates immortalized cell lines or cryopreserves nucleate cells for future immortalization, and prepares DNA from whole blood, cryopreserved cells and cell lines
The third component is a Database Repository that
- gathers, stores and distributes the incremental or finished datasets from studies
- helps active data coordinating centers prepare databases and incremental datasets for archiving and for carrying out restricted queries of the stored databases
- serves as a Data Coordinating Center and website manager for the NIDDK Central Repositories website
Who can submit samples and data?
Only significant NIDDK-funded studies designated by NIDDK will submit samples or data to the central repositories. In general, investigators funded through individual R01s will not be expected to submit samples and data.
Are completed or currently ongoing NIDDK-funded multi-site studies required to submit samples and data to the repositories?
NIH policy is that the unique resources developed through NIH funding are to be shared with the research community, to the extent that sharing of clinical data and materials is practical. Therefore, all current and complete multi-site NIDDK-funded studies should have a plan or should develop a plan for sharing data and samples that complies with current NIH and NIDDK policies. Wherever appropriate, the NIDDK Central Repositories should be used to facilitate sharing.
Is there any cost to investigators to send the samples or data to the repository?
Who can access stored materials?
All qualified investigators will be allowed access to the stored materials at the end of a pre-determined proprietary period.
What will be the proprietary period for stored samples and data?
The proprietary period for each study's materials will be mutually agreed upon by the study's Steering Committee and NIDDK. For multi-site clinical studies, NIDDK policy
defines this proprietary period in terms of specific study milestones.
Can an investigator retrieve samples stored in the repositories?
Yes, although the use of archival samples from a large study should be minimized in order to preserve the integrity of the collection for future use. Therefore, the study's Steering Committee and the NIDDK would need to approve requests for more than a minimal number of archived samples. However, studies will always have access to the samples needed to carry out assays that are part of the approved study protocol.
What provisions should be included about the repository in the informed consent for subjects?
NIDDK has developed model language for use in informed consents that describes the repository and explains what will happen to the samples and data that are collected. The most important point is that the repository will not accept any personal identifiers on samples or in the datasets. Your NIDDK Project Officer can provide you with a copy of the model language.
What subject or sample identification code will the repository use?
The repository can use the study's assigned ID for each participant. In situations where this would be inappropriate, because the ID contains potential personal identifiers, the study should assign a different, masked, identifier. The Database Repository will assign a unique prefix to the study or to each site within the study for use on the sample label or in the electronic manifest.
Does the NIDDK Repository maintain a Certificate of Confidentiality?
No. The Repository does not have a Certificate of Confidentiality because we do not accept any personal identifying information.
Who owns the samples submitted to the repository? Does the Institution submitting the samples maintain ownership or are they owned by NIDDK once they have been submitted?
The NIDDK Repository does not address its sample holdings in terms of "ownership", It is more a matter of control of the samples. The Repository is the custodian of samples from designated studies. The study group submitting the samples controls their distribution while studies are ongoing and during an agreed-upon proprietary period. Once the proprietary period ends, the Repository and the NIDDK Data Access Committee assume responsibility for distributing the samples in accordance with applicable NIH policies and procedures.