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                    NIDDK Data Management & Sharing
                    NIDDK Guidance for Writing a DMS Plan

    Related Topics
        NIDDK Data Management & Sharing
        NIDDK Guidance for Writing a DMS Plan
                NIDDK DMS Tools & ResourcesNIDDK Guidance for Writing a DMS Plan
    The National Institutes of Health (NIH) Data Management and Sharing (DMS) policy expects that researchers maximize
the appropriate sharing of scientific data. The DMS Plan should describe how the scientific data generated will be
managed and shared. NIH has outlined six elements that should be included in each submitted DMS Plan. The
Writing
a Data Management & Sharing Plan
section of sharing.nih.gov describes each of the recommended elements.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) provides Institute-specific DMS
Guidance, which builds upon the NIH guidance, for the following DMS Plan Elements:
Data Type
    Related Tools, Software, and/or Code
    Standards
    Data Preservation, Access, and Associated Timelines
    Access, Distribution, or Reuse Considerations
    Oversight of Data Management and SharingData Type
NIDDK expects investigators will:
Detail the types of data that will be generated.
    Data should be managed at the individual level (experiment, cell, animal, participant), whenever
        possible.
        If the data type is at an aggregate/population level (e.g., z-stack images), a description of
        the aggregation
        method/process should be provided. (See
        “DMS Plan Element: Access, Distribution, and Reuse Considerations”
        section for more information about depositing/sharing aggregate data.)
    Specify data types that are governed by additional policies, for example:
    Genomic data are subject to the Genomic Data Sharing (GDS) policy and the DMS policy.
        (See NOT-OD-22-198.)
        Human subjects’ data must be handled in a way that is consistent with protecting research
        participant privacy.
        (See NOT-OD-22-213.)
        All other policies governing human subjects research must be adhered to.
        (Refer to the intramural
        research guidelines as needed.)
    Indicate any data types that will not be shared and include a justification.Additional Requirements:
In the event that
    another
    applicable policy
    has more detailed expectations than that of the DMS policy (e.g.,
    GDS policy,
    requirements in the Notice of Funding Opportunity [NOFO], other NIH policies), the
    investigator is required to comply with the more detailed policy.
    Clinical data guidelines (e.g.,
    Privacy Protection,
    Human
    Data Sharing, and
    Health Insurance Portability and Accountability Act
    [HIPAA], when applicable)
    must be followed in addition to all DMS policies and human research
    policies, as appropriate.Related Tools, Software, and/or Code
NIDDK expects investigators to list and describe custom code or software used to
    generate the scientific data, and to share the raw data and results used to validate
    the software for reproducibility purposes and to maximize data reuse after sharing.
    NIDDK strongly encourages the use of open-source software/algorithms/resources for the data
    management and analysis.
    Should investigators choose to use proprietary software/algorithms/resources,
        NIDDK requires the rationale and justification for their use to be included
        in the DMS Plan.
    NIDDK expects that all open-source code/software/tools used to develop the published
    or submitted dataset are shared at the time of data submission or publication.
    GitHub or Docker images are resources that may allow easy bundling of datasets
        with their associated code/tools for processing.
    NIDDK expects that raw data and intermediate data accompanying the scientific data are
    shared at the time of data submission or publication.
    Any novel analytic pipelines or workflows must be shared, with appropriate
    documentation, to enable another investigator to recreate the analysis.Standards
Data Standards
Data standards relate to how data are organized, documented, and formatted. Data standards, vocabularies,
ontologies, and terminologies for a proposed study are dependent on the data types being collected.
NIDDK expects that investigators will use data standards widely accepted within the community. Additionally,
NIDDK strongly encourages the use of data standards that may promote the
creation of machine-readable datasets.
Investigators may choose to utilize existing NIH CDE resources; for example, the
    NIH CDE Repository.
    Specific NOFOs may require the use of certain data standards. Investigators should review
    the NOFO closely and ensure the DMS Plan reflects the required standard(s).
    Investigators should describe the data standards that will be applied for each data type
    to be collected.More information on how to document data standards and metadata for different data types in a DMS plan can be found on the DMS Plan Worksheet and DMS Plan Examples. Additional examples of metadata and data standards to aid in addressing this element are available in the Tools and Resources page.
Metadata
Metadata is information about the data itself that provides context to interpret, analyze, or combine the
study data and may also make study data more findable. The specific metadata and associated documentation
for a proposed study will vary by scientific area, study design, type of data collected, and characteristics
of the dataset. Metadata can include methodology and procedures used to collect the data, data labels,
definition of variables, and any other information necessary to reproduce and understand the data.
Investigators are expected to describe the anticipated metadata to be submitted with datasets.
Datasets should have appropriate metadata to enhance their FAIRness (see
    Wilkinson et al. [2016]
    for more details).
    Metadata should be sufficient such that investigators reusing the dataset can reproduce the findings.
    NIDDK strongly recommends the use of machine-readable metadata, such as through use of the
    Center for Expanded Data Annotation and Retrieval (CEDAR)
    Workbench,
    when practical.
    The Data and Metadata
    Standards Examples for DMS Plans tool provides several illustrative examples of data standards
    and metadata schema relevant to NIDDK research.Data Preservation, Access, and Associated Timelines
Desired Repository Characteristics and Selection
Investigators must indicate the repository(ies) where the scientific data generated will be archived.
    NIDDK expects that investigators will select repositories that meet the NIH desirable
        characteristics of data repositories.
        If an investigator plans to utilize a repository that does not meet such characteristics, a
        justification must be included.
    Investigators need to consider the type of data they will be submitting when selecting a repository. A
    short justification of the choice of repository for each data type must be included.
    NIDDK strongly encourages investigators to consider the following factors when selecting a repository:
    NOFO specified repository (ies).
        Organism, domain, or data type-specific repositories.
        Whether controlled access to data is required (e.g., for protection of human subjects’ privacy).
    Studies may generate various types of data from a given individual (e.g., genomic and metabolomic data
    from a single participant).
    NIDDK does not recommend submitting the same data to multiple repositories; rather, different
        data types should be submitted to data type- or domain-specific repositories and linked through
        appropriate metadata to facilitate findability and reuse.
        Investigators are encouraged to submit data to data type-specific repositories (e.g., database
        of Genotypes and Phenotypes [dbGaP] and Metabolomics Workbench [MetWB]) when appropriate, taking
        advantage of data type-specific quality control and metadata schema in each repository.
        The NIH
        Generalist Repository Ecosystem Initiative (GREI) is intended to supplement
        domain-specific data repositories. If an investigator chooses to submit all data to a generalist
        repository rather than one or more data type-specific repositories, a justification must be
        provided.
    Submission to repositories which only hold metadata or summary data (such as ClinicalTrials.gov, Accelerating Medicines Partnership in Type 2 Diabetes [AMP]-T2D,
    and AMP Common Metabolic Diseases [AMP-CMD]) **do
    not fulfill**the desirable characteristics under the DMS policy, nor do they meet the
    NIDDK expectation for sharing of primary data. In these cases, primary data should be submitted to a
    repository that complies with DMS policy requirements.
    Requirements for study registration and submission of summary data to ClinicalTrials.gov remain
        in effect. (See NOT-OD-16-149)Repositories and tools to find repositories
dkNET - lists repositories used by
    NIDDK-supported researchers
    NIH-supported
    repositories
    Generalist Repositories
    NIDDK Central Repository
    Additional resources to help in "Selecting a
    Repository"Data Preservation and Submission Timelines
Per NIH policy, investigators must state in the DMS Plan when their data will be shared, and how long
    the data will be available. NIDDK expects investigators to provide additional information on the
    following, as applicable:
    Investigators must comply with any timeline for data sharing or longevity of availability,
        or instructions specified in the NOFO or the NIH Grants Policy Statement on retention of data.
        (See the HHS Office of Research Integrity's
        tutorial
        on retention of data.)
        Investigators must indicate repositories chosen and the longevity of data preservation to
        demonstrate that these policies are sufficient.
        Consider scientific value and impact over cost when deciding data availability timeframe.
    Investigators must preserve their data for a time period and in a manner that is consistent with
    all applicable human subjects research regulations.
    Required registration and reporting for clinical research with ClinicalTrials.gov, as described
        underNOT-OD-16-149,
        remain in effect.
        Human subjects research involving personal identifiable information (PII) and protected health
        information (PHI) under HIPAA require External
        link retention for 6 years, but some states have additional regulations and time
        periods. When such a policy exists, the investigator will be expected to comply with it.**Additional considerations:**
Journal policies may include requirements and time frames for data availability. They may range from 3
    years to more
    than 10 years
    (eLife,
    Nature,
    JBC),
    with 5-6 years being the most common.
    **Note:** Data retention is separate and distinct from any secondary use preservation
    timelines, which are covered in the next element.Access, Distribution, or Reuse Considerations
Investigators must address these topics in the DMS Plan when the research will involve human participants:
Provide an explanation of how patient privacy will be protected.
    Repository selection should be done with the consideration
        for human data privacy.
        The investigator is expected to include a statement on measures taken in the study and by
        the repository to address re-identification risk.
    Informed consent
    Whether consent allows for re-use of data, and any limitations on the scope of data re-use.
        Use of machine-readable informed consents is encouraged whenever possible.
        A copy of the consent form may be provided, or a statement that the investigator is willing
        to share the consent document with NIDDK in the future.
    Controlled access
    NIDDK encourages investigators to make their data as openly available as possible.
        When controlled access is required, such as to protect the privacy of human participants,
        investigators should explain the process needed to access the data.NIDDK strongly encourages the sharing of individual level data wherever possible.
When individual-level data will not be shared (i.e., when data are aggregated), a
    justification must be included in the DMS Plan.
    Investigators are encouraged to utilize Global Unique Identifiers (GUIDs) whenever possible to link
    participants in multiple studies, taking appropriate steps to minimize re-identification risk.In the event that
another
applicable policy
has more detailed expectations than that of the DMS policy, the investigator is required to comply
with the more detailed policy.
Specific guidance for the Intramural Research Program (IRP) program Office of Intramural Research
    (OIR) includes the following:
    IRP human data sharing
        OIR
        guidance and
        policy.
        **IRP investigators should meet all extramural requirements as well.**
    Genomic Data Sharing (GDS) requirements
    (NOT-OD-22-198)
    may apply simultaneously with the new DMS policy.
    Clinical data guidelines and human subjects’ data must be handled appropriately as detailed in
    NOT-OD-22-213
    and other policies governing human subjects research.Oversight of Data Management and Sharing
Investigators must describe how compliance with the approved DMS Plan will be monitored and the intended frequency of oversight review. The institutional official or designee (title and role) who will be responsible for oversight of compliance with the accepted DMS Plan must be included.
    Adherence to the plan could impact future funding decisions for that institution, thus the responsible party may be at the institution level. The institutional official or designee is confirming that practices/procedures are in place to monitor that the investigator has established and is adhering to the DMS plan.Any updates to the DMS Plan need to be approved by NIDDK. Therefore, NIDDK expects that
    investigators will work proactively with the Program Officer assigned to their application through
    their institutional official (or with the Scientific Director’s office for NIDDK intramural
    investigators)
    to obtain review and approval of modifications when any changes or updates to the DMS Plan are
    needed. (See NOT-OD-23-185 for how to request revisions to an approved DMS Plan.) Examples that may require updates to the DMS Plan may include, but are not limited to,
    the following:
    The type(s) of data generated change(s).
        A different data repository(ies) is(are) chosen for submission.
        Adjustments to the sharing timeline.
    NIDDK requires investigators to include an update on progress made toward fulfillment of the DMS
    activities during the progress report(s), including the final progress report. More details on
    adherence to the approved DMS Plan are provided
    by
    NIH.
    NIDDK strongly encourages the use of a persistent identifier, such as a Digital Object
    Identifier (DOI), when data are submitted, in the progress reports, and in all related
    publications.Ready to see an example plan? Visit the NIDDK
DMS Tools and Resources page
The information will be updated as additional policy or guidelines are established and as new resources are
released.
        Last Reviewed November 2023 Contact Us
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