Who can submit data and specimens to NIDDK Central Repository?

In general, NIDDK supported clinical studies, including but not limited to clinical trials, prevention and control trials, and epidemiological studies, with significant programmatic involvement will have within the terms and conditions of their funding award a requirement to share and make available to the public the study data, and if applicable, a representative archival set of specimens for future research use. These studies may be eligible to deposit the data generated and a portion of the associated specimens into NIDDK-CR when conditions for submission are met. Other NIDDK-funded and non-NIDDK funded studies may also be eligible to deposit data and a representative archival set of specimens for future research use depending on the relevance of the collections to NIDDK’s mission, and the benefit to the broader scientific community. Studies may deposit data only, or data and specimens. More information can be found in the NIDDK-CR policy in Section 2.1. Researchers can also reach out to NIDDK-CR’s Support staff for additional information about eligibility and submission requirements.

Are completed or currently ongoing NIDDK-funded multi-site studies required to submit data and specimens to NIDDK Central Repository?

NIH policy is that scientific data (resources) generated in whole or part through NIH funding are to be shared with the research community, to the extent that sharing of 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 specimens with the broader scientific community that complies with current NIH and NIDDK policies. Wherever appropriate, NIDDK-CR or an NIDDK-approved repository should be used to facilitate sharing.

Are requestors of renewable or non-renewable specimens required to submit new data or specimens generated into NIDDK Central Repository?

In accordance with the signed user agreements, requestors seeking access to NIDDK-CR held resources may be required to submit materials generated or produced in the conduct of their Research Project to NIDDK-CR. All requestors are expected to manage the data as if the analyses were going to be eventually deposited back to the repository for sharing (i.e., with the necessary level of quality), although acceptance to deposit is not guaranteed and is at the discretion of NIDDK. At a minimum, requestors should provide an accompanying codebook/data dictionary and any documentation on procedures/analyses performed so future users will meaningfully understand and be able to use the resulting data.

I am an investigator with an NIDDK sponsored R01, is my grant eligible to deposit my data or specimens into NIDDK Central Repository?

Investigators funded by an R01 are encouraged to deposit and make resources available to the community via data type specific or generalist repositories adhering to NIH Data Management and Sharing (DMS) Policy and NIDDK DMS Guidance for selecting an appropriate repository. In general, investigators funded through individual R01s will not be eligible or expected to submit resources into NIDDK-CR. There are instances when an R01 grant that transitions to or from a larger multi-site study funded via a cooperative agreement, or is an ancillary study to a cooperative agreement, may be eligible to deposit resources into NIDDK-CR, if the resources generated via the cooperative agreement will be submitted to or are under the guardianship of NIDDK-CR. A list of possible repositories can be found on the External Links page.

Are there any costs associated with depositing resources in NIDDK Central Repository?

Studies eligible to deposit resources may do so at no additional cost to the contributing study, meaning, NIDDK-CR does not normally charge for the transfer and curation of data, or for the transfer and accessioning of specimens. Moreover, NIDDK-CR will cover the incoming shipping costs of the specimens (shipping boxes and waybill). NIDDK-CR does not cover costs associated with reconciling and prepackaging data for deposit, nor the costs associated with collection, processing, local storage, retrieval, sorting, and packaging specimens for transfer.

When are data and specimens expected to be publicly shared?

NIDDK Central Repository Resource Archival and Sharing Policy (NOT-DK-24-003) seeks to balance the interests of the contributing study investigators and those of the larger scientific community by setting defined timeframes for publicly sharing data and specimens. The periods for each study will be mutually agreed upon by the study leadership and NIDDK-CR in writing. NIDDK-CR policy requires a written protocol-level Resource Archival and Sharing Request before participants are enrolled that establishes submission and public sharing timeframes per NIH Data Management and Sharing Policy.

In alignment with NIH DMS policy, NIDDK-CR policies and procedures support initial and continuing access by the contributing study investigators, but not of prolonged and exclusive access, thus encouraging timely release and sharing of study generated resources. This should include both data and a corresponding set of specimens to be submitted and made available for access by the scientific community.

What data should be sent to NIDDK Central Repository?

Contributing studies should submit, with appropriate participant consent, all data collected, associated metadata, data attributes, and summary or analysis datasets. Data are to be submitted as defined in 45 CFR 164.514(e)(2) for limited data set format (LDS). NIDDK-CR has opted to receive data in LDS format because data are devoid of direct identifiers, although retain other elements permitted by HIPAA that allow NIDDK-CR to manage and share the data and associated specimens more responsibly over time. More information about data and documentation submission guidelines can be found under the Data Submission Guidance page.

What is a linking or linkage file? When should the linkage file be provided?

A linkage file is a list that associates (walks-through) the specimens with the relevant clinical data, and/or metabolomics, proteomics, sequencing, or genomics data, by matching the IDs that were used for the specimens to those that were used for the clinical data for all study participants. The linkage file and the key to decode information on the specimen labels is not normally shared with outside requestors and is held privately for internal NIDDK-CR use only. The linkage file should be provided by the contributing study at the time the clinical data are submitted to NIDDK-CR. When external investigators are approved for and provided access to data and/or specimens, NIDDK-CR will provide the linking information needed for combining NIDDK-CR study data with corresponding data in other repositories they have approved access for (e.g., dbGaP), or generate a customized linking file that matches the specific specimens received with the corresponding NIDDK-CR study data.

What interaction will the study have with NIDDK Central Repository to prepare data for archiving?

The Data Repository component will work with the contributing study team to prepare the data for archiving, and to develop appropriate documentation that is comprehensive and will allow investigators not familiar with the study data to use it.

Which specimens should be sent to NIDDK Central Repository and when should those specimens be sent?

The Biorepository component accepts a wide variety of specimen types with some of the most common being serum, plasma, urine, tissue, DNA, and stool. Eligible studies approved to submit specimens to NIDDK-CR should submit a representative archival set of specimens from all consented participants for future research use along with the specimen metadata and biological attributes. A representative archival set is defined as a set of specimens that includes a portion of every material type collected at every timepoint from every consented participant. Contributing studies are encouraged to submit the archival set at regular intervals during the active study period, determined by participant and specimen accrual rates, rather than at the end of the study. In general, the Biorepository should not be used to store specimens that are being used for the active conduct of the study to meet main study, sub-study, or ancillary study aims. The Biorepository does not serve as the primary repository to support the day-to-day needs of active or ongoing studies, with few exceptions. In rare instances, and as determined by NIDDK Program and Repository personnel, specimens stored at the Biorepository as part of the archival set may be made available to the contributing study if needed to meet study-related aims.

Who has oversight and decision-making authority of the specimens at NIDDK Central Repository?

For specimens held at the Biorepository component that are under the guardianship of NIDDK-CR, decisions related to access and release are governed by established NIDDK-CR policy, processes, and procedures, with NIDDK-CR and NIDDK Program staff participating jointly in the review of requests for access to resources and, when appropriate, subject matter experts. Additional information and review criteria considerations for the release of specimens can be found on the NIDDK-CR External Specimen Access Program page.

Can NIDDK Central Repository do aliquoting?

Yes, the Biorepository component can aliquot specimens as needed to preserve the collection. The Biorepository does not perform aliquoting for convenience, such as aliquoting specimens into multiple vials for shipment. If you are submitting specimens from an approved contributing study, we recommend that specimens be submitted in the lowest volume for future downstream analyses specified for the material type, to preserve specimen integrity by avoiding freeze-thaw cycles. If you are a requestor, there may be additional cost recovery charges associated with aliquoting and custom requests.

Can NIDDK Central Repository serve as the primary receipt point for specimens, processing, aliquoting, and shipping specimens to various analysis laboratories?

No. In general, each contributing study should have its own plan for specimen processing and storage during study conduct. This can involve a central receiving laboratory that processes, analyzes, or stores the specimens needed for the planned analyses. Alternatively, studies may have the specimens processed at the collection site and then batch shipped to the central receiving laboratory.

Can NIDDK Central Repository carry out specimen processing or routine clinical analyses?

The Biorepository component is not intended to serve as a clinical laboratory; however, it may be able to perform some routine quality and quantitative assays for specified material types and, when approved, other specialized services. Please contact NIDDK-CR Support staff for additional information.

What types of data and specimens are available for request?

A comprehensive list of studies available for request can be found on the Studies page of the NIDDK-CR R4R website. You may also search by specimen material types.

Do you have genotype data available? For which studies?

NIDDK-CR has limited genotype data available for request, but it does not normally hold raw genomic data. Genomic data generated from NIDDK-supported studies are made available through other repositories such as dbGaP and Gene Expression Omnibus (GEO). Phenotypic and clinical data associated with those studies may be available via dbGaP and NIDDK-CR. Datasets that are available from both dbGaP and NIDDK-CR may vary from each other. NIDDK-CR works with dbGaP to provide access to approved requestors of NIDDK studies in dbGaP without having to go through additional scientific review. However, requestors will be required to submit an application, upload their approved dbGaP Data Access Request (DAR), and sign a NIDDK-CR Data and Resources Use Agreement. Requestors may also need to submit additional documentation before data are released. A search via the NIDDK-CR R4R Studies page can be used to generate a list of studies with available genomic data in dbGaP.

What are renewable and non-renewable resources?

Renewable and non-renewable resources refer to the likelihood of regenerating the resource versus having a finite quantity. Generally, data resources are considered renewable, as are specimens generated from cell lines such as DNA. Non-renewable resources are those that cannot be regenerated including serum, plasma, urine, tissue, DNA (not from cell lines), and others that may eventually be depleted. Non-renewable resources may have a higher threshold for release.

What types of data are available in NIDDK-CR?

There are many different types of data available in NIDDK-CR, such as clinical phenotype data, clinical lab tests/results, continuous glucose monitoring, genotype/genetic data (e.g., allele data), survey data, specimen inventory data, qualitative data (e.g., interview transcripts), and images (e.g., MRI, CT scans, retinal photos). Users can find studies through faceted or keyword searches on the Studies page and learn more about the available data on the study overview pages.

Who can access stored resources?

Resources under the guardianship of NIDDK-CR are available to qualified researchers via the R4R site and may be limited by informed consent or applicable NIH or U.S. Government policy use restrictions. All interested researchers must have an institutional email address in order to create an NIDDK-CR account; personal emails are not permitted. The lead researcher submitting the request must be a permanent employee of the requesting institution and have oversight responsibility over the research team involved in the proposed project. Researchers must have an authorized institutional signatory official to execute a legally binding agreement with NIDDK. To maintain independent oversight, authorized signatories cannot be the same individual as the lead researcher requesting access.

Can the study group that collected the specimens retrieve some of the specimens stored in NIDDK Central Repository?

Contributing studies may be granted access to the specimens they submitted. For example, during the study period, NIDDK-CR may make an exception and allow the contributing study access to the archival set if those specimens are needed to meet study aims (aims that could not be accomplished otherwise). The use of the archival set of specimens from a contributing study should be minimized in order to preserve the integrity of the collection for future use. After the study is complete and the specimens are publicly available, contributing study investigators will go through the same request process as any other requestor.

Can non-U.S. researchers apply for access to data and specimens via NIDDK-CR R4R?

The data and specimen request process is open to all qualified investigators interested in using data or specimens for research. However, use of some resources may be restricted to U.S. researchers by the terms of the participants’ informed consent, or applicable NIH or U.S. Government policy use restrictions. Additionally, individuals affiliated with institutions located in countries of concern are prohibited from accessing resources. Please see NOT-OD-25-083 for more information.

Can commercial organizations apply for access to data and specimens via NIDDK-CR R4R?

The data and specimen request process is open to different organizations, including commercial organizations, interested in using data or specimens for research. However, use of some resources may be restricted to non-commercial entities or for non-commercial purposes by the terms of the participants’ informed consent. Additionally, organizations located in countries of concern are prohibited from accessing resources. Please see NOT-OD-25-083 for more information.

I am a student planning on using NIDDK-CR data for my thesis. Would I list myself as the Principal Investigator? How do I gain access to the resources?

NIH has released new guidance outlining requirements for accessing NIH controlled-access data to enhance data security and oversight. Under this guidance, data requests can only be made by researchers with the necessary credentials. To access NIDDK-CR controlled-access data, the Principal Investigator (PI) must be a permanent employee of the requesting institution, holding credentials at least equivalent to a tenured or non-tenure track professor (e.g., assistant, associate, full professor) at an academic institution, or a senior scientist at a non-academic institution. The PI must oversee others named on the Research Project who will access the data and be responsible for ensuring all data use complies with the terms of the NIDDK-CR Data and Resources Use Agreement (DUA) and institutional policies. Laboratory technicians, trainees, postdoctoral researchers, or graduate students do not have the required credentials and are not eligible to submit data requests. To gain access, you must identify a PI at your institution who meets the criteria to submit the request. The PI can then add you to the request under the “Other Researchers Under the PI” section of the request form.

Are there costs associated with requests for resources?

In general, resources are available at no or modest costs. NIDDK-CR may charge modest cost recovery fees associated with preparing and sending resources to requestors. More details on cost recovery practices are included under the question, ‘Is there a cost to obtain specimens?’

How do I obtain data via NIDDK-CR R4R?

For all data requests, interested researchers are encouraged to become familiar with the study collection by visiting the specific study page and browsing the study documents before submitting the request. This may facilitate the review process and reduce the number of iterations during the request process. Once requestors have decided whether the resources available can help answer their research question, the next step is to submit a Data Request. Please note that data requests must be submitted by a researcher who meets NIH eligibility criteria for accessing controlled-access data, that is, a permanent employee at their institution and with oversight responsibility for their research team.

The NIDDK-CR data request application will require a Research Project summary, which requestors will be able to complete by copying and pasting the relevant information from their protocol into the appropriate fields of the electronic application. They will also need to have IRB documentation specific to the proposed Research Project, addressed to the requestor, in order to complete and submit the application.

I still need access to the requested NIDDK-CR provided resources, how do I extend my access?

NIDDK-CR has streamlined the process to request an extension into a simple online form located within the Request on the Progress Report tab. Each year, requestors are asked to complete the online progress report and indicate whether they would like continued access to the requested resources. Following NIH guidelines, a new DUA will be signed annually after review and approval of the Progress Report. Failure to submit an annual progress report will result in termination of the Research Project and resource access discontinuation per the terms and conditions of the signed agreement.

I would like to request additional images to my approved request. What process should I follow?

To modify your request, including changes to the research team, expanding the aims of the approved research plan, requesting additional data (such as images), or combining the requested resources with outside sources not previously approved, you should submit a modification. To do this, use the “Modify Request” action within your “My Requests” dashboard to make the necessary edits to the request form. NIDDK will review and decide whether to approve the modification. Please note that some changes, like updates to the research plan or requesting additional resources, will require an updated DUA to be signed, even if you signed one recently.

Who makes the decision about granting access to specimens?

NIDDK has final decision authority for granting access to specimens under the guardianship of NIDDK-CR. For active studies, study leadership in collaboration with NIDDK will make a determination for granting access.

Is there a difference in consideration of requests for renewable (infinite supply) and non-renewable specimens?

Yes. Requests for renewable specimens, such as DNA from immortalized cell lines or DNA that has been 'whole-genome-amplified,' may be granted access if the project for which they are being requested is approved via the appropriate review process. Requests for non-renewable specimens, such as plasma or urine, may be granted through different pathways.

Access to renewable and non-renewable specimens with highly abundant, modestly depleting resources may be granted via an internal review process if the request is considered to have a reasonable likelihood of achieving the proposed research aims. Requests for more than modestly depleting non-renewable specimens require a full grant-like application and independent scientific merit review. All qualified investigators may request access by submitting a grant-like application to the NIDDK-CR External Specimen Access Program.

If we are working together with a contributing study investigator, would this affect our situation and chances of accessing the data?

Working with a contributing study team has no impact on NIDDK’s decision to approve a request. Each request is reviewed independently, and all information is considered. However, working with a contributing study investigator may pose additional requirements. For instance, any original investigator requesting resources must submit an IRB approval or exemption letter and cannot use a Not Human Subjects Research determination letter because the original investigator has the potential to access identifiable information in the original study.

While a study is ongoing, how do researchers gain access to specimens stored in NIDDK Central Repository?

Researchers may be able to apply directly to the study group to carry out an ancillary study. Ancillary studies that are approved by the study leadership for access to specimens stored in NIDDK-CR may then use the R4R web system to submit an ancillary specimen request. Requestors must be R4R registered users in order to complete and submit a request.

I would like to receive more of the specimens that I have requested or additional specimens. What process should I follow?

To request additional specimens or volumes for an ongoing Research Project, requestors should submit a new request by navigating to their “My Requests” dashboard and using the “Request Additional Resources” option next to the previously fulfilled request. This action will pre-populate the request form with information from the previous request using the request reuse functionality allowing requestors to make necessary changes to the research plan. Requestors should confirm the original request number is populated in the “Originating Request” field to ensure the subsequent request is linked to the original request and provide a justification for requesting additional resources. For an ancillary study, contact the study team directly to request access to additional specimens or volumes. NIDDK will make a final determination for the release of additional specimens or volumes.

How do I learn about the consent restrictions and permitted uses for study resources?

Researchers must consider any restrictions for use before submitting a request. The permitted uses for the resources are listed on each study page under the Resources Available on Request section. NIDDK has verified that all resources made available to the scientific community through NIDDK-CR have been consented for secondary and future research use, and carefully considers all requests against any informed consent restrictions for use prior to release.

How are specimen requests reviewed?

All requests are reviewed by NIH staff with scientific expertise, and administrative staff. There are different review pathways for specimen requests as described below.

• Administrative Reviews: Investigators seeking access to “modestly depleting” specimens, those that will deplete the specific specimens by less than 10%, and have funds to complete the proposed project, may be eligible for an internal administrative review process. These reviews are generally expedited, within 30 days of submission, and require additional documentation, such as proof of funding and ethics approval documentation, before proceeding with fulfillment.
• Full Reviews: Investigators seeking access to “moderately-depleting” specimens, meaning those that will deplete any specific specimen by 10%, but no more than 25% (also known as non-depleting specimens) and “significantly-depleting” or depleting, meaning those that will deplete the specific specimens by 25% or more, will require a full grant-like application. Please see the NIDDK-CR External Specimen Access Program page for more information. Complete applications are typically reviewed within 60 days of submission, and Access Letters are generated within 90 days. These Access Letters of approval are required to submit an Access Request in NIDDK-CR for specimen processing and fulfillment. Investigators planning to submit NIH or other grant applications for funding their study may undergo a shortened, secondary review after funding is secured if: (a) an Availability Inquiry report was included with the funding application, and (b) the outcome of the independent scientific review is included with the application package.

The funding opportunity I am interested in requires a letter of support from NIDDK-CR. Does NIDDK provide this type of letter?

Neither NIDDK nor the NIDDK-CR generally provide letters of support for grant applications. However, applicants interested in using NIDDK-CR resources to accomplish the aims of their research plan, especially those requiring access to NIDDK-CR stored specimens, should include an NIDDK-CR Specimen Volume and Impact Assessment Report (an impact report) with their grant applications in lieu of a letter of support. Please create an NIDDK-CR account if you do not have one already, and then submit an Availability Inquiry describing the specimens of interest. The NIDDK-CR support team will help finalize the inquiry and will provide an impact report that can then be submitted along with the grant application.

How do I obtain specimens?

• To request access to NIDDK-CR held specimens, all interested requestors must complete a two-phase request process. During the first phase, requestors submit an Availability Inquiry. Requestors interested in specimens will receive a volume and impact assessment report, usually with the intent to include the report in a grant application, such as an R01, or other funding mechanism. Grants do not need to be NIDDK-specific. NIDDK-CR Support staff will follow up with you after you submit your Availability Inquiry.
• Once the impact report is accepted, and you have secured funding and obtained an Access Letter (required for requests with a higher-than-modest impact on the repository’s inventory), you may move on to the second phase known as an Access Request using the Access Request button at the top of the Availability Inquiry page for release of the associated clinical phenotype data and specimen processing. Here, you will be asked to provide proof of funding, IRB approval, your research plan, and additional points of contact.
• Requestors may also be able to obtain access to specimens from active and ongoing studies held at NIDDK-CR in accordance with the contributing study’s ancillary sharing policies for specimens not otherwise available through the study’s biobank. To request access to specimens for an approved ancillary study, you must work with the parent study to submit an Ancillary request. NIDDK-CR Support staff will follow up with you after you submit your request.

Is there a cost to obtain specimens?

Per Section 301.h of the PHS Act (42 USC241(h)) and NIH Policy, NIDDK-CR charges modest amounts to requestors to recover costs of processing and handling. Cost recovery efforts assist with reimbursement of costs related to making specimens available to the scientific community. However, neither NIDDK nor NIDDK-CR charges users for the specimens themselves.

Requestors will be invoiced for specimen processing and handling according to the prices outlined on the NIDDK-CR Cost Recovery and Processing Times page; shipping is not included in the cost. This page also contains the policies for submitting payment, including a requirement that all requests over $5000, custom DNA requests, or international shipments pre-pay prior to the repository beginning preparation of the shipment.

How much does shipping cost?

Shipping costs are determined by multiple factors such as institution-negotiated courier rates, shipper types, and box dimensions and weight. Since these factors differ between institutions and requests, it is difficult to provide estimates. However, the NIDDK-CR Cost Recovery and Processing Times page outlines two common shipper types that requestors can use to obtain a shipping cost estimate from their courier (e.g., FedEx).

Once my request for specimens is approved, before pulling the specimens, will I be contacted regarding retrieval and shipment methods?

Yes, once NIDDK approves a request, requestors will need to sign a Data and Resources Use Agreement and approve the cost estimate. Any shipping questions or concerns can be brought up to the NIDDK-CR Support team during this time. NIDDK-CR Support team will also communicate if any discrepancies come up during the specimen pull that require requestor input.

Once my request for specimens is approved, how long will it take for me to receive the specimens?

Depending upon availability, a specimen request can take anywhere from 3 business days to over 3 months to fulfill. More information is found on the NIDDK-CR Cost Recovery and Processing Times page. The clock begins once the fully completed request is approved by NIDDK and an agreement is executed. Specimen turnaround time depends on many factors, including:

• Does the request require relabeling of vials?
• How many specimens are being requested?
• Do they need to be aliquoted?
• Are the specimens stored in one freezer or scattered in several freezers?
• Are specimens being pulled from -80C freezers or liquid nitrogen freezers?
• Where will the specimens be shipped?
• Does the request require payment by the recipient before the request may be processed?

I am unable to open a file (or data set) I received from the NIDDK Central Repository with my approved request, what do I do next?

If you are having issues opening a file or data set you received via NIDDK-CR R4R, contact NIDDK-CR Support staff through the ‘Comments’ tab of your request for assistance. You may also email NIDDK-CRsupport@niddk.nih.gov regarding any questions or issues with the resources received from NIDDK-CR.

If my only goal is to use a dataset to demonstrate the statistical methodology and I do not plan to draw any scientific conclusions using the dataset, do I need to go through the IRB process?

NIDDK-CR is a controlled access repository. Unless otherwise indicated on the study page, for any level of access to the data, you must have your institution's IRB or external IRB approval (or waiver), or ethics committee approval for international institutions. In addition, all requests must be accompanied by a description of the research that justifies the use of the resources, a research objective and design that describes your hypothesis and approach, an analysis plan that includes security safeguards for the data, and a research use statement to be made publicly available.

Is IRB clearance required for internal analysis in an organization, or is IRB clearance required only if the analysis will be published?

For any level of access to the data, you must have your institution’s Institutional Review Board (IRB) clearance or waiver. If you do not have an IRB, you must use an external IRB. Some institutions use ethics committee review boards, in which NIDDK will accept an approval or waiver. This IRB step is required whether or not you publish your findings. Since the data we offer is provided in Limited Datasets, devoid of direct identifiers, and there is no direct human-subject interaction, sometimes your IRB will make a determination of Not Human Subjects Research (NHSR) rather than provide IRB approval, exemption, or waiver. If your IRB documentation is not in English, you must provide an official, independent English language translation. Self-translations or translations via Google Translate will not be accepted.

I will have co-investigators working with me on the resources I am requesting. Does NIDDK need IRB approval from each co-investigator or their institution separately, or do you just need the IRB approval from the Principal Requestor's institution?

The lead requestor is responsible for obtaining IRB approval or a determination of NHSR from their institution’s IRB or an external IRB. Information submitted to the IRB should clearly describe the involvement and role of any co-investigators from the same or a different institution. When submitting the request for resources to NIDDK-CR, any co-investigators should be identified. Collaborators from other institutions who will have access to NIDDK-CR resources should be included under the “Independent Collaborators” section of the request form. Independent Collaborators (and their institution’s AOR) must sign their own agreement (a secondary agreement) for use of the resources. NIDDK-CR Support staff will initiate the primary and any secondary Data and Resources Use Agreements as appropriate.

On the DUA form, who should provide the Authorized Signature for my institution?

The Authorized Organization Representative (AOR) as defined by NIH is the individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. The AOR is also referred to as the authorized signatory or Signing Official (SO). Please see the NIH Grants Glossary page for additional details. The authorized person fulfilling this role may have any number of titles in your organization (e.g., a Manager, Officer, Director, Vice President, or Chief of contracts, grants, licensing, research administration, or sponsored programs for the institution). To strengthen data security measures, data management, and to allow for independent oversight, NIH will not allow individuals to occupy multiple key roles; that is, a PI may not serve as the AOR. Note: If registered with eRA Commons (not required), requestors must use the same authorized person (e.g., Grants Management Specialist) as listed in eRA Commons.

Our organization generally does not allow its employees to sign as a party to the agreement; can we remove the PI’s signature block?

No. Independent of whether the Requesting Institution does not allow its employees to sign as a party to an agreement when they are acting within the scope of their employment, the Principal Investigator (the Requestor) has distinct roles and responsibilities from those of the Requesting Institution, and their signature in the agreement attests to having read and understood those roles and responsibilities in the context of the request submitted to NIDDK-CR.

Can we request to modify the DUA, for example, by adding terms such as provisions for dispute settlements, non-waiver of privileges, and immunity clauses to meet the needs of our organization?

NIDDK-CR does not accept edits to the terms of the DUA, including the addition of unnecessary phrases or the addition and deletion of terms. Please reach out to NIDDK-CR support mailbox (NIDDK-CRsupport@niddk.nih.gov) with any additional questions regarding DUA language.

Under the “Requesting Institution” definition, it states that we would need to comply with all NIH/NIDDK policies for research participant protections. Where can we find these policies?

NIH/NIDDK policies for research participant protections are highlighted under the Human Research Protections: Compliance with Requirements section of the DUA. Additional policy requirements can be found in the NIDDK-CR Policy and on our website with links to relevant NIH policies.

Does the DUA statement, “The Requestor and Requesting Institution agree to retain control over the Data or Resources and further agree not to transfer these to any third parties not under the direct supervision of the Requestor or an approved Requestor’s Collaborator” limit our ability to publish our work, including results, analyses, summaries, etc.?

No. Requestors are strongly encouraged to publish their results promptly in peer-reviewed journals.

The DUA mentions the Requesting Institution’s obligation to follow IRB-approved informed consents. How do we know if the study’s informed consents impose any restrictions or limitations with secondary use that are applicable to the data requested?

The permitted uses for the resources based on the study’s informed consent are listed on each study page under the Resources Available on Request section. As part of the request submission and approval process, NIDDK-CR assesses the alignment of the proposed research with the permitted uses specified by the requested study’s informed consent documents and conveys any applicable restrictions to the Requestor.

Can Materials generated be used for research or publication purposes at the end of the project period? The DUA language seems to limit this to a 5-year period and for policy and regulatory compliance purposes.

The 5-year limit is on the Resources obtained from the repository in that the Requestor and Requesting Institution may retain minimum Resources obtained under the Research Project for a period not to exceed five (5) years after completion of the Research Project, as required for policy and regulatory compliance. At the end of this period, the Requestor and Requesting Institution agree to manage Resources as required in the DUA.

What does “pre-competitive mean” in Data and Resources distributed through the Repository mechanisms should be considered pre-competitive?

This term of access promotes collaboration to achieve maximum public benefit and establishes that the resulting data should continue to be shared openly.

The DUA states that data must be aggregated to a minimum of 10 participants; however, our research project has smaller sample sizes. Will we be able to publish our results?

NIDDK-CR understands that not all datasets are created equal, and there may be a grouping of smaller sizes depending on the source data. NIDDK-CR has processes in place to evaluate any added risk to participants as part of the manuscript and public release clearance process. When necessary, as part of the clearance process, NIDDK-CR consults a biostatistician who evaluates potential added risks to the study participants with smaller groupings and may ask the Requestor to make edits before the manuscript is submitted for publication. As a reminder, the DUA specifies that requestors are to submit their manuscripts to NIDDK-CR for clearance no later than 30 days prior to submission to a journal.

If I produce a manuscript using NIDDK data and/or specimens, am I required to acknowledge this?

Researchers producing manuscripts and other works (abstracts, presentations) using NIDDK-CR provided data and/or specimens are required to acknowledge the use of the repository and the contributing study resources. NIDDK-CR recommends use of data availability statements and Digital Object Identifiers (DOIs) when acknowledging use of resources. Study-specific acknowledgements may be required with some of the data/specimen sources.

Why should I use a Digital Object Identifier (DOI) when citing a study?

A DOI is unique and persistent making it ideal for citing resources. URLs are not permanent and can hinder future research reproducibility when links are inactive or route to unknown pages. NIDDK-CR uses DataCite to register DOIs, increasing NIDDK-CR resource discoverability, accessibility, and reusability. The study DOI and citation guidance can be found on each study’s overview page.

What information should I provide if a journal submission requires a data availability statement?

NIDDK-CR provides specific language for requestors to use as data availability statements. This statement should be used in any published works to inform readers that the research data associated with the published work are available and can be accessed through NIDDK-CR. Study specific language can be found on a study’s overview page, below the dataset citation information. Contributing studies that have deposited data into NIDDK-CR should include a data availability statement in any published works. Requestors that have accessed data through NIDDK-CR must include a data availability statement in any published work, to include any new materials generated under their Research Project and where new materials are deposited (NIDDK-CR or other repository).