U.S. Department of Health and Human Services

Frequently Asked Questions for Grantees Providing Materials to the NIDDK Central Repository

General

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?

​No.


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.


For Grantees conducting studies that are required to submit materials to the Repositories: Submitting Samples to the Biosample Repository

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. In addition, the stored samples will be made available to the study if needed.


Can the Biosample Repository do aliquoting?

Yes, the repository can aliquot samples.


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.


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.


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.


For Grantees Submitting Samples to the Genetics Repository

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.  It is intended primarily to serve studies collecting samples from young children or those with low white counts, where it is impractical to extract more than a small amount of DNA from a blood sample.


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.


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.


For Grantees Submitting Data to the Data Repository

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 in some way to ensure that no personal identifiers are reposited.


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. 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.


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 data to prevent transmission of protected health information.


For Investigators Seeking Access to Stored Samples or Data

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.


Who makes the decision about granting access to samples?

Requests for non-renewable samples are submitted in a number of ways.  Applicants can submit an X01 grant application for access, but no funds.  In addition, the NIDDK often has other Funding Opportunity Announcements (FOAs) specifically aimed at encouraging use of reposited samples.  Relevant FOAs are listed at www.niddkrepository.org and NIDDK funding opportunities.
 
All applications are reviewed by a peer review panel and 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. For renewable samples (principally, DNA from cell lines and whole genome amplified DNA), requests are reviewed administratively by NIDDK staff.


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.


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/documents/). 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.


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.


Can commercial organizations apply to use samples and data from the repository?

Yes.  The data and sample request process is open to all organizations interested in using samples or data for research.


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.


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 Web-based request process at www.niddkrepository.org.