Research Guides: Research Data Management: NIH Data Management & Sharing Policy

Additional NIH Data Management & Sharing Policy Resources

For a broader overview on the policy changes: Data Management & Sharing Policy
Guidance to determine which of the following NIH policies apply to your particular project: Which Policies Apply to My Research?
Additional information on selecting an appropriate repository: Selecting a Data Repository
More information on data sharing related costs may be requested in an application for funding: Budgeting for Data Management & Sharing
For more on what constitutes scientific data: Research Covered Under the Data Management & Sharing Policy
For more information on the data types to be shared under the GDS Policy: Data Submission and Release Expectations
FAQs for the NIH Policy for Data Management and Sharing

What is the New NIH Data Management & Sharing Policy?

In October 2020, the National Institutes of Health (NIH) issued the Final NIH Policy for Data Management and Sharing, emphasizing the importance of good data management practices and establishing the expectation for the appropriate sharing of scientific data generated or collected from NIH-funded or conducted research, with justified limitations or exceptions.

On January 25, 2023, the new policy will come into effect for any NIH-funded research (regardless of the research grant budget size) that generates scientific data.

This new policy also establishes a requirement that applicants must submit a Data Management and Sharing Plan for any NIH-funded or conducted research that will generate scientific data, including:

Competing grant applications that are submitted to NIH for the January 25, 2023 and subsequent receipt dates.
Proposals for contracts that are submitted to NIH on or after January 25, 2023.
NIH Intramural Research Projects conducted on or after January 25, 2023.
Other funding agreements (e.g., Other Transactions) that are executed on or after January 25, 2023, unless otherwise stipulated by NIH

NIH DMS and Genomic Data Sharing Policies

Human and Genomic research advances our understanding of factors that influence health and behavior, with its data treated as a vitally important shared resource and valuable tool that benefits the scientific community and general public. Here are some considerations to make before and while conducting research in accordance to the DMS Policy and the Genomic Data Sharing (GDS) Policy:

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
All data used or generated as part of a grant must be managed, but not all data should be shared. You should not share data if doing so would violate privacy protections or applicable laws.
If you are conducting research with human subjects, you must incorporate consent during the data management and sharing process, even if data will be de-identified.
If you are conducting research with any restrictions on sharing, such as Regulatory restrictions (e.g. HIPAA, GDPR), Tribal laws, policies and Tribal sovereignty, or ethical considerations, you must secure appropriate agreements with tribal authorities before using and sharing that information.

6 Core Elements to Include in a Data Management and Sharing Plan

Following the outline in the NIH Guide Notice Supplemental Policy Information: Elements of an NIH Data Management and Sharing Plan, DMS Plans should address the following recommended elements and are recommended to be two pages or less in length.

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1.) Data Type:

Briefly describe the scientific data to be managed and shared:

Summarize the types and amount of scientific data to be generated and/or used in the research. Descriptions may include the data modality , level of aggregation, 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 that will be made accessible to facilitate interpretation of the scientific data.

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2.) Related Tools, Software, and/or Code:

Indicate whether specialized tools are needed to access or adapt shared scientific data to support replication or reuse, as well as the name(s) of the needed tool(s) and software. If applicable, specify how these tools can be accessed.

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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).

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4.) Data Preservation, Access, and Associated Timelines:

Give plans and timelines for data preservation and access, including:

The name of the repository where scientific data and metadata arising from the project will be archived.
How the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools.
When the scientific data will be made available to other users and for how long. Identify any differences in timelines for different subsets of scientific data to be shared.

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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 that will preserve and share the scientific data.

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6.) Oversight of Data Management and Sharing:

Indicate how compliance with the DMS Plan will be monitored and managed.