Key Dates

Related Announcements

• April 1, 2024 - Notice of Update to National Institute of Diabetes and Digestive and Kidney Disease Central Repository (NIDDK-CR) Cost Recovery Policy. See Notice NOT-DK-24-011
• September 21, 2022 - Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data.  See Notice NOT-OD-22-214.
• September 21, 2022 - Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data.  See Notice NOT-OD-22-213.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
• October 29, 2020 - Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan. See Notice NOT-OD-21-014.
• October 29, 2020 - Final NIH Policy for Data Management and Sharing. See Notice NOT-OD-21-013. 
• August 27, 2014 - NIH Genomic Data Sharing. See Notice NOT-OD-14-124.

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The purpose of this Notice is to rescind NIDDK Data Sharing Policy (July 2013) and NIDDK Repository Usage Policy (March 2015) and introduce NIDDK Central Repository Resource Archival and Sharing Policy that aligns with timelines and requirements and expectations of the NIH Data Management and Sharing Policy and NIDDK Data Management and Sharing Guidance. This Notice applies to select grant applications and awards that involve human subject research and are eligible to submit project-generated resources to NIDDK Central Repository (NIDDK-CR) and secondary researchers who request access to NIDDK-CR held resources. This Notice also applies to all resources held under the guardianship of NIDDK-CR and users (direct and indirect) of NIDDK-CR program and its Resources for Research (R4R) website platform(s), including projects that submit resources to NIDDK-CR and secondary research directly resulting from the use of NIDDK-CR resources.

NIDDK-CR policy aligns with NIH Data Management and Sharing (DMS) Policy and NIDDK DMS Guidance to promote the management and sharing of scientific data generated from NIH-funded or conducted research. Failure to comply and abide by the NIH DMS Policy or NIDDK-CR policy may impact future NIDDK funding decisions or the use of NIDDK-CR held resources.

All users, including submitters and requestors, are expected to comply and abide by applicable NIH, NIDDK, and NIDDK-CR policies, practices, and procedures. Projects eligible or planning to submit resources to NIDDK-CR and who have submitted grant applications for receipt dates on or after January 25, 2023, are expected to comply with NIH DMS Policy and NIDDK DMS Guidance for public sharing of scientific data. Individuals interested in accessing resources held under the guardianship of NIDDK-CR are expected to abide by the terms and conditions of NIDDK-CR Data and Resources Use Agreement (DUA) and any use limitations set forth by the study participants’ informed consent. All NIDDK-CR R4R users must abide by the User Code of Conduct.

Additional information about NIDDK-CR expectations, submission and access request guidelines, and preservation practices can be found on the NIDDK-CR website.

Purpose of the NIDDK Central Repository

NIDDK-CR supports the storage and sharing of study-generated resources (biospecimens and data) from active and completed clinical studies with significant NIDDK programmatic involvement, and other clinical studies deemed to be of considerable scientific value to the broader scientific community (NIDDK-funded or supported, and under certain circumstances non-NIDDK funded), including secondary research directly resulting from the use of NIDDK-CR held resources. NIDDK-CR is a fundamental component of and essential to the fulfillment of NIDDK’s mission to engender public trust and seek maximal benefit from the resources collected from multi-center and large single-center clinical studies in which NIDDK, study investigators, and participants have invested considerable efforts. Data and biospecimens from these well-characterized studies constitute an important scientific resource, and the full value of these resources can only be realized if they are made available promptly for use by other researchers. NIDDK Central Repository Resource Archival and Sharing Policy defines relevant aspects of the program operations, resource management, user terms of engagement, and governance structure. All resources transferred to and shared via NIDDK-CR are held under the guardianship of NIDDK-CR and the custodianship of NIDDK through a set portion of the resource life-cycle as specified per policy, with an established preservation strategy.

More detailed information and the complete NIDDK Central Repository Resource Archival and Sharing Policy can be found at NIDDK-CR website or NIDDK Policies for Clinical Researchers.

Overview of the NIDDK Central Repository Policy

The NIDDK Central Repository Resource Archival and Sharing Policy aligns with the timelines and requirements and expectations for scientific data set forth in the NIH Data Management and Sharing Policy. NIDDK-CR policy does not supersede the Final NIH DMS policy (NOT-OD-21-013) or the legal requirements to submit composite results to clinicaltrials.gov per the Final Rule for Clinical Trials Registration and Results Information Submission, or other applicable NIH Policies and federal Regulations..

Harmonization with NIH Data Management and Sharing Policy

Projects that intend or are required to submit resources to NIDDK-CR must submit a written, protocol level, Resource Archival and Sharing Request to NIDDK-CR for approval before enrollment of the first study participant. The written request to onboard a protocol must align with NIH DMS Policy and NIDDK DMS Guidance and include timelines for submitting and publicly sharing data and biospecimens per NIDDK-CR submission and sharing schedules. Information in this request should expand and be consistent with the information provided in the approved Data Management and Sharing Plan associated with an NIH award, as applicable. Prior to submitting a Resource Archival and Sharing Request, recipients should ensure that the information provided is consistent with the content of the approved Data Management and Sharing Plan. As a reminder, the Resource Archival and Sharing Request does not supersede the requirement to submit and update the NIH DMS plan as needed and when appropriate per  NOT-OD-23-185.

Inquiries

Please direct all inquiries to:

Rebecca Rodriguez, Ph.D.
Office of Clinical Research Support
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
Telephone: 301-451-0323
Email: rebecca.rodriguez2@nih.gov