UW Research

November 17, 2023

NIH Data Management and Sharing Policy Requirements and Resources

UPDATE: Changes to an approved Data Management and Sharing Plan (DMS Plan) requires timely submission of a prior approval request via the Prior Approval Module in eRA Commons. For more information review the NIH NOT-OD-23-185

The NIH Data Management & Sharing Policy (DMS Policy) has some significant impacts for NIH proposals submitted for due dates on or after Jan. 25, 2023.

Does this Policy Apply to My Research Project?

Determine if the proposed research is subject to the DMS policy.

This DMS Policy applies to all NIH funded research which results in the generation of scientific data. Carefully review the Funding Opportunity Announcement (FOA) for any specific institute or center requirements.

Data Management & Sharing Plan Requirement

Develop a Plan for managing and sharing scientific data. Attach the DMS plan in the Other Plans section within FORMS-H as part of your NIH applications. NIH has an optional DMS Plan format available.

  • Review NIH guidance for Writing an up to two page DMS Plan and the NIH DMS Policy FAQs
    • We encourage researchers to review UW libraries resources and use the DMPTool and templates to prepare their DMS Plan.
      • Watch a recorded DMPTool Training from the Network of National Libraries of Medicine.
  • The Plan should cover 6 recommended elements
    • Addressing Oversight of Data Management and Sharing: 
      • The Proposal PI is required to monitor and manage the DMS plan, with at least yearly examination and oversight of data sharing and storage at the time of the RPPR, to ensure compliance with NIH DMS guidelines. The UW Office of Sponsored Programs verifies the inclusion of the DMS plans with new proposals. Any changes to the DMS plan will be communicated to NIH by the PI through the Office of Sponsored Program as required.
      • Sample language: Lead PI _[name]_, ORCID: _[ORCID ID]_, will be responsible for the day-to-day oversight of lab/team data management activities and data sharing. Broader issues of DMS Plan compliance oversight and reporting will be handled by the PI and Co-I team as part of general [campus(es)] stewardship, reporting, and compliance processes.
  • Considerations for specialized datasets, data privacy, and human subjects protections:
    • Applications subject to both the DMS Policy and the Genomic Data Sharing (GDS) Policy will submit a single Plan. See NOT-OD-22-198 for details and other considerations.
    • Human subjects participant data protections: Informed Consent, De-identification, Certificate of Confidentiality
    • Any restrictions on sharing: Regulatory restrictions (e.g. HIPAA, GDPR), Tribal laws, policies and Tribal sovereignty, ethical considerations

UW Libraries Resources

Our UW Libraries host a variety of Research Data Management resources that may help with developing a data management plan and more. We urge you to review UW Libraries information for relevant resources that may help with this policy:

Identify Methods/Approaches and Repositories

The UW Libraries has information on Selecting a Data Repository that includes a list of repositories.

Proposal Budget Costs

Proposal budgets may include requests for estimated funds needed for data management and sharing activities. These should include all allowable costs for data management & sharing for all data types.

  • Label as Data Management and Sharing Costs
  • Address in budget justification; for proposals using the modular budget format, include these costs under Additional Narrative Justification
  • Must be incurred before end of the project period
  • Review information on Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data
  • Cost Examples:
    • Curating & formatting data for transmission to & storage in a selected repository for long-term preservation & access, including de-identifying data
    • Preparing metadata to foster discoverability, interpretation, and reuse
    • Preserving & sharing data through established repositories, e.g. data deposit fee

What are some things to know about budgeting for NIH data storage and data management? 

  • NIH NOT-OD-23-161 Application Instruction Updates – Data Management and Sharing (DMS) Costs

What about Changes to the DMS Plan?

Pre-Award Changes to DMS Plans

  • If NIH requires changes, applicants will be notified via Just-in-Time (JIT)
  • Revisions should be submitted as part of the JIT response (e.g. via OSP to Grants Management Specialist (GMS) or in eRA Commons)
  • Defer to the instructions from NIH GMS

Post-Award Changes to DMS Plans

Any changes to an approved Data Management and Sharing Plan (DMS Plan) requires timely submission of a prior approval request via the Prior Approval Module in eRA Commons.

For more information review the NIH NOT-OD-23-185:Prior Approval Requests for Revisions to an Approved Data Management and Sharing (DMS) Plan Must be Submitted Using the Prior Approval Module.

When are Data Expected to be Shared?

Data are expected to be shared no later than time of publication of findings or the end of an award whichever is earlier.
Review resources from the UW Libraries: Publishing and Sharing Research Data.

Resources

  • 10/20/2023 – Updated links including  NOT-OD-23-185, removed outdated registration link
  • 7/25/2023 – updated UW Libraries registration link
  • 2/08/2023 update – NIH DMS Policy FAQs link added & adding to narrative for modular budgets
  • 1/06/2023 update – Addressing Oversight of Data Management and Sharing
  • 12/15/2022  update – DMPTool recorded training link
  • 10/11/2022 initial publication