NIH Data Management and Sharing Policy (DMSP)

NIH Data Management and Sharing Policy (DMSP)

New NIH Funding Requirement Starting January 25

Beginning in January 2023, Final NIH Policy for Data Management and Sharing (NOT-OD-21-013) will require researchers to include a data management and sharing (DMS) plan in funding applications. In preparation for the policy implementation, NIH has launched a Scientific Data Sharing Website.

The Final DMS Policy applies to all research, funded in whole or in part by NIH, that results in the generation of scientific data. This includes competing grant applications and proposals for contracts that are submitted to NIH on or after the January 25, 2023, submission deadline. The DMS Policy does not apply to research and other activities that do not generate scientific data, including training, infrastructure development, and non-research activities.

Once a grant has been awarded, the DMS Plan becomes part of the award's terms and conditions. NIH expects researchers and institutions to implement data management and sharing practices as described in their approved Plan. Compliance with the DMS Plan, including any updates, may be reviewed during regular reporting intervals.

Applicability

The DMS Policy applies to all research that generates scientific data, including Research Projects, some Career Development Awards, SBIR/STTR, and Research Centers. The DMS Policy does not apply to research and other activities not generating scientific data, including Training Grants, Fellowships, Construction (C06), Conference Grants, Resource (Gs), and Research-Related Infrastructure Programs. 

Explore these NIH Introductory Webinars outlining the new requirements.

A visual explanation of the 6 elements of an NIH DMSP

Source: The University of Alabama at Birmingham

 

Researchers will be required to submit a DMS plan at the time of application to the funding NIH Institute, Center, or Office (ICO) that outlines how scientific data and related metadata will be managed and shared, including any potential restrictions or limitations.

Below are the six required elements and some details on how to address them. NIH has published a Data Management and Sharing Plan Elements Guide which you can read for more information.

Select an element below to learn more about it
DMSP Plan Required Elements
  • Element 1: Data Type
    Element 1: Data Type

    Summarize the types and estimated amount of scientific data expected to be generated in the project. 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. Briefly list 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.

    Related Resources:

  • Element 2: Related Tools, software, and code
    Element 2: Related Tools, software, and code

    State whether specialized tools, software, and/or code are needed to access or manipulate shared scientific data, and if so, provide the name(s) of the needed tool(s) and software and specify how they can be accessed.

  • Element 3: Standards
    Element 3: Standards

    State what common data standards, if any, will be applied to the scientific data and associated metadata to enable interoperability of datasets and resources, and provide the name(s) of the data standards that will be applied and describe how these data standards will be applied to the scientific data generated by the research proposed in this project. If applicable, indicate that no consensus standards exist.

  • Element 4: Data Preservation, Access, and Associated Timelines
    Element 4: Data Preservation, Access, and Associated Timelines

    Provide the name of the repository(ies) where scientific data and metadata arising from the project will be archived. Describe how the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools. Describe when the scientific data will be made available to other users (i.e., no later than time of an associated publication or end of the performance period, whichever comes first) and for how long data will be available.

    Related Resources:

  • Element 5: Factors affecting access, distribution, or reuse of scientific data, controlled access and privacy considerations
    Element 5: Factors affecting access, distribution, or reuse of scientific data, controlled access and privacy considerations

    NIH expects that in drafting Plans, researchers maximize the appropriate sharing of scientific data. Describe and justify any applicable factors or data use limitations affecting subsequent access, distribution, or reuse of scientific data related to informed consent, privacy and confidentiality protections, and any other considerations that may limit the extent of data sharing. State whether access to the scientific data will be controlled (i.e., made available by a data repository only after approval). If generating scientific data derived from humans, describe how the privacy, rights, and confidentiality of human research participants will be protected (e.g., through de-identification, Certificates of Confidentiality, and other protective measures).

    Related Resources:

    • See the Principal Investigator Human Subjects Items to Consider When Developing the DMS Plan (below)
    • UCCS DMPS Awareness Handout
    • UCCS IRB SOPs (Find the most recent procedures in the SOPs under Manuals and Operating Procedures)
  • Element 6: Oversight of Data Management and Sharing
    Element 6: Oversight of Data Management and Sharing

    Describe how compliance with this Plan will be monitored and managed, frequency of oversight, and by whom at your institution (e.g., titles, roles). This element refers to oversight by the funded institution, rather than by NIH. The DMS Policy does not create any expectations about who will be responsible for Plan oversight at the institution. At UCCS, the PI and their team are responsible for oversight and compliance with their DMSP.

In addition, researchers proposing to generate scientific data derived from human participants will need to describe how privacy, rights, and confidentiality of human research participants will be protected.

This article Ten simple rules for maximizing the recommendations of the NIH data management and sharing plan by Sara Gonzales Matthew B. Carson, and Kristi Holmes provides 10 key recommendations for creating a DMSP that is both maximally compliant and effective.

 

Principal Investigator Human Subject Items to Consider When Developing the DMS Plan

  • Review NIH Sharing Data from Human Participants
  • Consider what factors might limit data sharing
    • Informed consent that will not permit or limits scope of sharing or use. Projects are expected to include data sharing requirements in consent forms to the extent possible.
    • Privacy or safety of research participants would be compromised and available protections are insufficient.
    • Explicit federal, state, local, or Tribal law, regulation or policy prohibits disclosure.
    • Restrictions imposed by existing or anticipated agreements with other parties.
  • Consider how research participant data will be shared.
  • Consider how research participants will be informed their data will be shared (i.e., de-identified using HIPAA de-identification standard or identifiable. This is managed by the research team.)
  • When submitting an NIH funded proposal to the UCCS IRB include your DMS plan to the IRB for general awareness. Please note the IRB may ask some follow-up questions or make requests to ensure the DMS plan follow federal regulations and campus policies.
  • If using Genomic Data, review NIH Genomic Data Sharing Policy.

If you have questions about sharing human subjects data or the IRB application process, please reach out to the IRB@uccs.edu.

 

Data Management and Sharing Plan FAQs

How do I budget for my DMSP?

If you have specific questions about budgeting for the DMSP, please reach out to osp@uccs.edu

Allowable Costs: Unallowable Costs:
  • Curating data
  • Developing supporting documentation
  • Formatting data according to accepted community standards, or for transmission to and storage at a selected repository for long-term preservation and access
  • De-identifying data
  • Preparing metadata to foster discoverability, interpretation, and reuse
  • Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation
  • Preserving and sharing data through established repositories (ex: data deposit fees). If proposing multiple repositories, costs associated with each may be included
  • Note: Personnel (salary and fringe) effort specific to DMS must be included as part of the DMS Costs line item in the detailed R&R budget. (If a modular budget, it must be detailed in the Additional Narrative Justification). 
  • Infrastructure costs that are included in institutional overhead (for instance, Facilities and Administrative costs) 
  • Costs associated with the routine conduct of research, including costs associated with collecting or gaining access to research data. 
  • Costs that are double charged or inconsistently charged as both direct and indirect costs 
When should I share my scientific data?

Scientific data should be shared as soon as possible, but no later than the time of a publication of findings in a peer-reviewed journal OR at the end of the award, whichever comes first. The publication date is considered to the be when the article is first available via print or electronic format. Does a pre-print article trigger this requirement? No, this requirement is only applicable to a published, peer-reviewed article. Scientific data that wasn't published should be shared by end of award, so then pre-print data may be required if data is not published by end of award.

What if I want to make changes to my DMSP after it's been approved?

If an award is made, the approved DMS Plan will become a term and condition of the award and the PI is responsible for managing and sharing data as described in the DMS Plan. During the funding period, compliance with the Plan will be determined by the NIH Institute or Center.

Effective October 12, 2023, prior approval requests must be submitted through eRA Commons by a UCCS approved signing/authorized official. These requests must be submitted at least 30 days in advance of the requested change. Please contact osp@uccs.edu as soon as possible if you believe you need to make changes to your DMS Plan. To learn more, see NIH's announcement for DMS Plan Prior Approval Capability.

Prior approval from the NIH Program Officer along with the revised DMS Plan are required when the following changes occur to the plan:

  • New Scientific Direction
  • Change in Data Repository
  • Timeline Revision
How to submit a Research Performance Progress Report (RPPR)?

Compliance with the Plan, including any Plan updates, may be reviewed during regular reporting intervals (e.g., at the time of the annual RPPR). Please contact osp@uccs.edu when submitting a NIH RPPR.

Resources

UCCS and CU Resources

NIH Resources

Other Resources

    DMPTool - Provides templates that can be used in developing Data Management Plans for grant applications to U.S. federal funding agencies (this tool may produce a document that is beyond the page limit)
  • OSF Working Group on DMSP Guidance - Includes policy readiness checklist for librarians and researchers and other resources