Data Management Plans: NIH Data Sharing Policy

University Libraries Subject Librarians

Grant Writers

Final NIH Policy for Data Management and Sharing Released October 29, 2020; Effective January 25, 2023
NOT-OD-21-013

Previously, the NIH only required grants with $500,000 per year or more in direct costs to provide a brief explanation of how and when data resulting from the grant would be shared.

In NIH's view, all data should be considered for data sharing. Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.

The 2023 policy is entirely new. Beginning in 2023, ALL grant applications or renewals that generate Scientific Data must now include a detailed plan for how you will manage and share data during the entire funded period. This includes information on data storage, access policies/procedures, preservation, metadata standards, distribution approaches.

The term Scientific Data is defined in the policy as "The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens."

You must provide this information in a data management and sharing plan (DMSP).

The Data Sharing Plan follows the Research Plan Section and does not count toward the page limit.

The DMSP will be assessed by NIH Program Staff (though peer reviewers will be able to comment on the proposed data management budget). The Institute, Center, or Office (ICO)-approved plan becomes a Term and Condition of the Notice of Award.

See NIH's Data Sharing and/or our NIH Public Access Library Guide pages for full details.

NIH encourages the use of established, subject-specific repositories. To select a repository relevant to your data consider:

1. Is there a specific NIH repository named in the funding announcement?
2. Is there a data repository specific to your discipline?
3. If not, is there a general data repository you can use? 
4. The MOspace campus digital repository is another option.  It’s best suited for small datasets in readily available formats such as Excel, PDF, or Word that can be shared under a Creative Commmons BY-NC-ND License

For additional guidance, see NIH supplemental information on Selecting a Repository 

In a supplemental document of two pages or less, address the following six sections:

1. Data Type: Briefly describe the scientific data to be managed, preserved, and shared, including:
2. Related Tools, Software and/or Code: An indication of whether specialized tools will be needed to access or manipulate the shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software.
3. 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). If the discipline of the research does not have a shared approach to data structures, the Plan may indicate that no consensus data standards exist for this scientific data and metadata.
4. Data Preservation, Access, and Associated Timelines: Plans and timelines for data preservation and access, including (a) specific repository or repositories where data will be shared (see tab on the left on repositories); what persistent identifier or other indexing tool will be provided to find and access the data; and when data will become available and for how long it will stay available.
5. Access, Distribution, or Reuse Considerations: Any limits that will be placed on access, and why the limits are expected to be placed.
6. Oversight of Data Management and Sharing: Indicate how and on what schedule the DMS Plan will be monitored and managed, and by whom.

See Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan for a detailed description of these Elements.

Sample Plans:  https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-for-data-management-and-sharing/writing-a-data-management-and-sharing-plan#sample-plans

Budget

Costs to execute the DMSP can be included in the budget as a line item and a brief summary of the DMSP must be provided in the budget justification. Allowable costs include labor for data curation, preservation, de-identification, and more. The NIH has a provided a list of allowable and unallowable costs.

Any costs related to complying with the policy must be paid for up-front during the performance period. For example, costs for long-term data preservation must be budgeted for in the proposal and paid before the end of the grant. You may find the NIMH Data Archive (NDA) cost estimation worksheet or the publication Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data useful.