NIH Data Management and Sharing

Starting January 25, 2023, the National Institutes of Health (NIH) will require all researchers seeking grant funds that result in the generation of scientific data to:

• Submit a two-page data management and sharing plan as part of the funding application. The plan must outline how their scientific data and accompanying documentation will be managed and shared.
• Submit a data management and sharing plan as part of the grant application process.
• Maximize the appropriate sharing of scientific data generated from NIH-funded or conducted research in the plan, with justified limitations or exceptions.

For more details about the new data management and data sharing policy, read the NIH Scientific Data Sharing one page guide: The Who, What, Where and When of the NIH Data Management and Sharing (DMS) Policy (PDF)

• Develop a Data Management Plan (DMP)

  A Data Management Plan (DMP) is a document that outlines best practices in data management and how you will apply these practices in the course of your grant or project.

  The following elements must be addressed in your plan:

  • Data Type - Include the type of data and estimated amount of data being generated. Use general terms and descriptions about data modality (e.g. imaging, genomic, mobile, survey), how the data is aggregated and processed.
  • Related Tools, Software and Code - Indicate if specialized tools are needed to reproduce your research and how they can be accessed.
  • Standards - An indication of what standards 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).
  • Data Preservation - The name of the repository, where scientific data and metadata will be archived. For more information see NIH Repositories for Sharing Scientific Data.
  • Access and Timelines - A description of how the data will be made available and what unique persistent identifiers (PID) you will use to support reporting out on your progress and outputs. Provide the timeframe with the expectation that the data should be made available as soon as possible.
  • Access, Distribution, or Reuse Considerations - Including informed consent, privacy and confidentiality protections like de-identification and Certificates of Confidentiality, any data use agreements or licensing limitations.
  • Oversight of Data Management and Sharing - How and when the data management plan will be monitored and managed, and by whom (e.g. , titles, roles).

  Taken from: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html

• DMP Templates and Samples
  Using the DMP tool to create and manage all your DMPs will help you stay organized.
  Use your OKEY credentials to login.
  NIH has provided a variety of sample plans on their website.
• Tools for Developing your DMP
  • DMP Tool – This is an open-source, online application that helps researchers create data management plans (DMPs). The DMP Tool provides a click-through wizard for creating a DMP that complies with funder requirements. It also has direct links to funder websites, help text for answering questions, and data management best practices resources.
  • DMP Checklist for Researchers.docx - This checklist from the working group on NIH DMSP guidance addresses the required elements in the NIH DMS Policy effective January 25, 2023.
  • DMP Self-Assessment Questionnaire - This comprehensive questionnaire from Purdue University can help researchers think about all the different aspects of the research data lifecycle that should be addressed in a data management plan.
  • Guidelines for an effective DMP - The ICPSR guideline provides a 21-page document that includes templates, a list of recommended elements to be included in DMP.
  • NIH Tool - Repositories for sharing Scientific Data -  In general, NIH does not endorse or require sharing data in any particular repository, although some initiatives and funding opportunities will have individual requirements. Overall, NIH encourages researchers to select the repository that is most appropriate for their data type and discipline.
• Budgeting

  Any costs necessary to carry out the DMSP can be included as a line item in the budget. Additionally, the budget justification must include a short synopsis of the DMSP. The budget justification will justify any costs associated with long term storage of the data for which you are requesting the sponsor to pay. While completing this portion of the DMSP, please reference the NIH provided lists of allowable and unallowable costs.

   

  Note that all allowable costs submitted in budget requests must be incurred during the performance period (before the end of the grant), even for scientific data and metadata preserved and shared beyond the award period. For instance, if a DMS plan proposes preserving and sharing scientific data for 10 years in an established repository with a deposition fee, the cost for the entire 10-year period must be paid before the end of the period of performance.

   

  For further assistance, please reference the NIHM Data Archive (NDA) cost estimation tool. 

   

  DMS costs must be listed as a direct cost in section F. Other Direct Costs of the R&R Budget form, specifically identified as “Data Management and Sharing Costs,” and should be included in the budget justification. For modular budgets, the costs for data management need to be justified as an additional narrative justification.

  Please be aware peer reviewers may comment on the appropriateness of the budget justification as part of the unscored budget section. Your entire DMSP is only reviewed by the Program Officer.

   

  If you do not need funds because you have the active storage space, data curation expertise and/or are depositing the data and/or metadata into a free federal repository recommended by NIH, your justification will address the areas below and state, “no funds are needed to support DMS.”

• Data Sharing

  Where to share your data:

  Consent is absolutely required if you are conducting research with human subjects, even if data will be de-identified. Please reference the NIH's guidance on privacy protections and AI/AN populations. Please do not share your data if doing so would violate privacy protection or applicable laws.To improve the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data, the NIH recommends sharing datasets through established data repositories. See Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research for more detailed information.

   

  When to share your data:

  Your data should be accessible as quickly as you are able. Additionally, you can use relevant requirements and expectations (i.e. data repository policies, award record retention requirements, or journal policies) to determine when to make your data sets available.The NIH requires that you share your data when you publish your work or before your performance period ends, whichever comes first, regardless of journal or repository policies.
• Leveraging LabArchives for Data Sharing

  OSU CHS provides LabArchives Electronic Lab Notebooks (ELN) to all personnel and students. Scientific data can be organized in a designated notebook, to separate it from the ELN and shared using one of the data publishing workflows available within the ELN.  Metadata can be added as an entry on the page containing the scientific data to be shared.  This may include methodology and procedures, protocols, data labels, definitions, or any other information that will aid in reproducing and understanding the data.  Further, when publishing data via the ELN with the creation of a DOI, additional metadata can be added to include authors, grant or funding IDs, and ORCID.  A DOI is created and assigned to the shared data as a permanent digital identifier that can be referenced elsewhere and provides a link back to the data.  Once published with the DOI, the scientific data is publicly available to anyone with access to the DOI. More information about LabArchives can be found here.

• Training Resources
  • Video: ICPSR Introduction to Data Management Plans - 13 minutes
  • Video: GREI Collaborative Webinar Series on Data Sharing in Generalist Repositories
  • Video: Understanding the New NIH Data Management and Sharing (DMS) Policy - 90 minutes
• Frequently Asked Questions
  Start by viewing this informative list of FAQ's from NIH.
• Compliance & Institutional Oversight

  NIH expects researchers and institutions to implement data management and sharing practices as described in their approved Plan. Once the grant has been awarded, the Data Management and Sharing Plan becomes part of the award's terms and conditions. Non-compliance may result in:

  • Additional terms and conditions to the award
  • Cancellation of the award
  • The potential to affect future funding decisions

   

  When in doubt, ask your NIH program official. They are well-versed in the requirements for the plans and can help assist you with interpretations of specific institute rules and your specific circumstances.

   

  Responsibility for overseeing the implementation of DMSPs is flexible with the NIH policy. Although the specifics may vary depending on the project, the following general responsibilities apply:

  • Overall responsibility is attributed to the PIs who are required to ensure the execution of DMSP.
  • The consistency of sharing of data concerning human subjects between the DMSP and informed consent is ensured by the IRB.
  • PIs and OSU CHS Office of Research ensure the correct data use agreements are established before sharing sensitive data.