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NIH Data Management and Sharing Policy

Guide to Complying With the 2023 NIH Data Management and Sharing Policy

Overview of Resources

Resources for creating an NIH-compliant Data Management and Sharing Plan (DMS Plan) include:

Overview of a DMS Plan

The NIH suggests that a DMS Plan be approximately two pages and include the following six elements, as outlined in their Supplemental Information:

  1. Data Type
    • Briefly describe the scientific data to be managed and shared.
    • Summarize the types (for example, 256-channel EEG data and fMRI images) and amount (for example, from 50 research participants) of scientific data to be generated and/or used in the research. Descriptions may include the data modality (e.g., imaging, genomic, mobile, survey), level of aggregation (e.g., individual, aggregated, summarized), and/or the degree of data processing.
    • Describe which scientific data from the project will be preserved and shared. NIH does not anticipate that researchers will preserve and share all scientific data generated in a study. Researchers should decide which scientific data to preserve and share based on ethical, legal, and technical factors. The plan should provide the reasoning for these decisions.
    • A brief listing of the metadata, other relevant data, and any associated documentation (e.g., study protocols and data collection instruments) that will be made accessible to facilitate interpretation of the scientific data.
  2. Related Tools, Software, and/or Code
    • Indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software. If applicable, specify how needed tools can be accessed.
  3. Standards
    • Describe what standards, if any, will be applied to the scientific data and associated metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation).
  4. Data Preservation, Access, and Associated Timelines
    • Give plans and timelines for data preservation and access, including the name of the repository(its) where scientific data and metadata arising from the project will be archived.
    • When the scientific data will be made available to others and for how long. Identify any differences in timelines for different subsets of scientific data to be shared. 
      • Note: the NIH encourages scientific data to be shared as soon as possible, and no later than the time of an associated publication or end of the performance period. The NIH also encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community 
  5. Access, Distribution, or Reuse Considerations
    • Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to:
      • Informed consent
      • Privacy and confidentiality protections consistent with applicable federal, Tribal, state, and local laws, regulations, and policies
      • Whether access to scientific data derived from humans will be controlled 
      • Any restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or anticipated agreements
      • Any other considerations that may limit the extent of data sharing. Any potential limitations on subsequent data use should be communicated to the individuals or entities (for example, data repository managers) that will preserve and share the scientific data. The NIH IC will assess whether an applicant’s DMS plan appropriately considers and describes these factors.
  6. Oversight of Data Management and Sharing
    • Indicate how compliance with the DMS plan will be monitored and managed.