The National Institute of Diabetes & Digestive & Kidney Disease

Frequently Asked Questions About the NIDDK Central Repositories

• General
• Submitting samples to the Biosample Repository
• Submitting samples to the Genetics Repository
• Working with the Data Repository
• Accessing stored samples or data

General

1. What is the purpose of having a central repository?
   A central repository allows additional studies on samples and data collected in significant studies, enhancing the value of each study. It also ensures that samples are stored under uniform conditions, and simplifies access by other scientists to samples. Similarly, reposited datasets can be maintained, queried, and reconfigured to facilitate new analyses after the Data Coordinating Center closes. Another important goal of the repository is to allow cost effective and high quality processing of genetic samples.



2. 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. One component is the Biosample Repository, which gathers, stores and distributes biological samples from studies. The repository works with investigators in new and ongoing studies to serve as a real-time facility for storage of archival samples, and collects and stores the entire sample collection from selected studies that have been completed. The second component is the Genetics Repository, which receives and processes blood samples to allow genetic analyses. The Genetics Repository 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. The Database Repository is also responsible for helping active data coordinating centers prepare databases and incremental datasets for archiving and for carrying out restricted queries of the stored databases. Finally, the Database Repository will receive regularly updated data about sample inventories from the Biosample and Genetics Repositories and make that information available to ongoing studies in a customized format.



3. 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.



4. 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. Wherever practical, the NIDDK Central Repositories should be used to facilitate sharing.



5. Is there any cost to investigators to send the samples or data to the repository?
   No.



6. 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.



7. 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 is that this proprietary period be no longer than 2 years from accrual of the last sample or patient data.



8. Can an investigator retrieve samples stored in the repositories?
   Yes, although the use of archival samples from a large study should probably be kept to a minimum 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.



9. 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.



10. 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, an accession number will be assigned to each sample. The Database Repository will assign a unique prefix to the study or to each site within the study for use on the sample label.




Submitting samples to the Biosample Repository

11. Which samples should be sent to the Biosample Repository and when should those samples be sent?
    In general, the repository should be used to store samples that are not being used for the active conduct of the study. Whenever practical, part of each sample should be designated for the repository and shipped to the repository at the time of collection or sample processing. In general, the repository will not serve the day-to-day needs of active studies through extensive sample processing, aliquoting, and shipping aliquots to clinical labs or individual sites. However, the repository can aliquot and redistribute samples on a daily basis. In addition, the stored samples will be made available to the study if needed.



12. Can the Biosample Repository do aliquoting?
    Yes, the repository can aliquot samples.



13. Can the Biosample Repository serve as the primary receipt point for samples, processing, aliquoting and shipping samples out to various analysis laboratories?
    No. In general, each study should have its own plan for sample processing. This can involve a central receiving laboratory that processes and analyzes samples, and stores the samples needed for the planned analyses. Alternatively, studies may have the samples processed at the collection site.


However, the repository can serve as a central depot that receives aliquots from many study sites and then ships some aliquots to designated analysis facilities and stores others.


14. Can the Biosample Repository carry out sample processing or routine clinical analyses?
    No. The Biosample Repository is not intended to serve as a clinical laboratory.



15. Who will be in charge of the samples at the Biosample Repository?
    During the proprietary period, the study's Steering Committee will control access to the samples, and the Data Coordinating Center will work with the repository and be the primary contact with regard to the samples. However, once the proprietary period ends, the Database Repository will have the data associated with the samples, and will become the primary contact point with the regard to the samples.




Submitting samples to the Genetics Repository

16. Which samples should be sent to the Genetics Repository and when should those samples be sent?
    The Genetics repository will accept samples of whole blood that are shipped immediately after collection.



17. Can the Genetics Repository carry out molecular analyses of DNA and simple genetics tests?
    The Genetics Repository can process blood samples, cryopreserve lymphocytes, and extract DNA. The repository will use various assays to assess the quality of the DNA, including restriction enzyme digests and gel electrophoresis. In addition, the repository can carry out certain routine tests to check for familiality or paternity in a small subset of the samples.



18. Who will be in charge of the samples at the Genetics Repository?
    During the proprietary period, the study's Steering Committee will control access to the samples, and the Data Coordinating Center will work with the repository and be the primary contact with regard to the samples. However, once the proprietary period ends, the Database Repository will have the data associated with the samples, and will become the primary contact point with the regard to the samples.




Working with the Data Repository

19. What data should be sent to the Data Repository?
    In general, the repository should receive all the data being collected by the Data Coordinating Center, provided that the subject has consented to having his/her data included in the repository. However, no personal identifiers should be sent to the repository, and data may need to be transformed or anonymized in some way to ensure that no personal identifiers are reposited.



20. What interaction will the Data Coordinating Center have with the Data Repository before data are sent?
    The repository will work with the Data Coordinating Center during the study to prepare the data set for archiving. Repository personnel will consult with the Data Coordinating Center to develop appropriate documentation that is comprehensive enough to allow investigators not familiar with the data set to use it. In addition, the repository personnel will interact with the Data Coordinating Center to familiarize themselves with the database and its architecture in preparation for archiving. The Data Coordinating Center should plan to send incremental datasets to the repository on a regular basis. Finally, the Database Repository will work with Data Coordinating Centers of ongoing studies to provide customized views of regularly updated information about sample inventories in the Biosample and Genetics Repositories.



21. Should protected health information be sent to the Data Repository?
    In general, the repository should only get limited data sets as defined under HIPAA regulations. In some cases, repository personnel may provide advice to Data Coordinating Centers on how to transform or anonymized data to prevent transmission of protected health information.




Accessing stored samples or data

22. How does one gain access to the stored materials?
    Researchers who want to access the materials and data stored in the Central Repositories will submit an application to the NIDDK. Please see www.niddkrepository.org for details.



23. Who makes the decision about granting access to samples?
    A Sample Access Review Panel composed of external members established by the NIDDK will review all requests for access to repository materials. The requests will be judged on numerous criteria, including the qualifications of the researcher and the research environment, the significance and appropriateness of the proposed research, design of the proposed research and ethical considerations including consistency with the terms of the informed consent obtained from the subjects.



24. Is there a difference in consideration of requests for renewable (infinite supply) and non-renewable samples? Yes. Requests for renewable samples, such as DNA from immortalized cell lines or DNA that has been 'whole-genome-amplified', will be approved if the project for which they are being requested is judged to have a reasonable likelihood of achieving its stated aims. Requests for non-renewable samples, such as plasma or urine, will be approved only if judged to have high scientific merit and therefore require a complete scientific justification.



25. Under what conditions are samples distributed?
    In order to receive samples or data, the institution will have to sign a Usage Agreement with NIDDK (https://www.niddkrepository.org/niddkdocs/forms/Draft%20Data%20Use%20Agreement%20for%20Repository.doc). The agreement will include certification the project has IRB approval, that the investigators will only conduct the research consistent with the subjects' informed consent, and that researchers will not attempt to identify any individuals. In addition, the Agreement will forbid any redistribution of the materials by the investigator or institution.



26. Can non-U.S. investigators apply to use samples and data from the repository?
    Yes. In general, all applications will be judged without regard to the geographical location of the applicant, although it is conceivable that there will be certain non-renewable samples collected in specific studies that are restricted to U.S. investigators by the terms of the study or of the consent. At this time, there are no such samples.



27. Are there special provisions for samples collected by international consortia?
    For samples collected by international consortia, applications for use of samples and data will be considered regardless of the geographical location of the applicant institution or researcher. In addition, at least one member of the peer-review committee considering such applications will be from a non-U.S. institution.



28. During the proprietary period, while a study is ongoing, how do approved ancillary studies gain access to samples?
    Ancillary studies that are approved by the study's Steering Committee, must apply to the NIDDK for access to stored samples using the regular procedures. However, if the ancillary study has been funded through the NIH peer-review process, NIDDK may waive review by the Sample Access Review Panel. In such cases, NIDDK staff will review the request administratively for availability of requested samples, consistency with the informed consent, and human subjects research issues.