NIH Data Management and Sharing Policy

NIH has issued a Data Management and Sharing Policy (DMSP) that seeks to promote the sharing of scientific data generated from NIH funded or conducted research. This DMSP will affect a proposal’s entire lifecycle, generating requirements from proposal preparation through award management. The DMSP is effective for all proposals submitted on or after January 25, 2023, subject to the requirements of the NIH Application Guide and Instructions.

See policy details for NOT-OD-21-013.

To implement this policy, NIH will now require the inclusion of a Data Management Sharing (DMS) Plan in relevant proposals. The plans must outline the methods which will be employed to ensure proper data management and sharing practices. In addition, NIH will also allow certain costs related to data management implementation, if properly documented.

 

Human Subjects Research Considerations

When the proposed research will involve collection of new human participant data or use of previously collected data, some important issues should be considered, including:

  • Consent for use of previously collected data
  • Fully informing research participants about data sharing plans
  • Appropriate de-identification of data before submission to a repository
  • Identifying data that should be subject to controlled access
  • Implications of sharing data that is covered by a certificate of confidentiality
  • Ensuring the data management and sharing plan, IRB protocol, and informed consent are congruent

The UT Human Research Protection Program (HRPP) provides guidance about these considerations and others. For general information about this program at UT Austin, see Human Subjects Research.

Human Subject Research Consideration for NIH Data Management (PDF)

 

Requirements

Not every proposal submitted to the NIH is required to submit a DMS Plan. Proposals that must submit a DMS Plan are those in which the research results in the generation of scientific data, defined as data 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.

DMS Policy extends to the following types of NIH activity:

  • Research Projects
  • Some Career Development Awards
  • Research Centers
  • Small Business SBIR/STTR

DMS Policy does not extend to:

  • Training
  • Fellowships
  • Construction
  • Conference Grants
  • Resources
  • Research-Related Infrastructure Programs

A full listing can be found on NIH’s website: NIH Activity Codes subject to DMS Policy.

 

Implementation Details

NIH has released NOT-OD-22-189 which outlines the implementation requirements for those proposals which must submit a DMS Plan. This notice also serves to provide information on the management of the DMS Plan once a proposal is awarded. Below are details regarding the DMS Plan implementation, by proposal/award stage.

Data Management & Sharing Plan (DMS Plan)

  • Proposals must include a new DMS Plan which addresses six elements, as required by NIH.
  • Recommended not to exceed two pages.
  • Genomic Sharing Plans should be described within this DMS Plan.
  • Attachment should be uploaded as “Other Plan(s)” in the PHS 398 Form within the Grants.gov form set in UTRMS.
  • The “Resource Sharing Plan” attachment field should not be used for this document.

Allowable Budgeting

  • Budget is allowable to implement the DMS Plan if:
    • Costs are related to curating data and developing supporting documentation
      • Curating data
      • Developing supporting documentation
      • Formatting data according to accepted community standards
      • De-identifying data
      • Preparing metadata to foster discoverability, interpretation, and reuse
      • Local data management consideration, such as unique and specialized information infrastructure necessary to provide local management and preservation (e.g. before deposit into established repository)
      • Preserving and sharing data through established repositories, such as data deposit fees (including multiple repositories)
    • Costs are related to preserving and sharing data through established repositories
    • Costs must be reasonable, allowable, and allocable
    • Costs must be incurred during the period of performance, even those that are included for the preservation of scientific data and metadata beyond the award period
  • Genomic data management costs are allowable

Budget Preparation in Submission Package

  • Budget must be identified in a single line item for R&R Budget as “Other – Data Management and Sharing Costs” and be separate from all “other” costs in budget
  • If no costs are anticipated, budget of “$0” should be included
  • For R&R Budgets, a detailed budget justification must include these costs in a section identified as “Data Management and Sharing Justification”
  • Modular budgets must use the Additional Narrative Justification to discuss the DMS Plan costs. It is recommended to provide no more than half a page of justification for this cost item
  • Subaward Budgets:
    • DMS costs for each subaward must be listed as a single line item on the R&R Subaward Budget (F. Other Direct Costs, 8-17 Other)
    • If no DMS costs are anticipated on the subaward, the line item is not required (Do not enter $0). This is only applicable for the R&R Subaward Budget
    • *Note* A DMS cost line item is still required for the parent applicant’s R&R budget, even in circumstances when neither the parent nor the subawards will be requesting funds (A $0 request for the parent R&R budget)

Unallowable Costs

  • Infrastructure costs included in Facilities & Administrative Costs (IDC)
  • Costs associated with the routine conduct of research, including:
    • Costs associated with collecting or otherwise gaining access to research data (such as data access fees)
  • Costs may not be charged as both direct and indirect costs

Just in Time Process

  • Should the submitted DMS Plan need additional information or not meet the requirements, NIH may request a revised DMS Plan be submitted through the Just in Time (JIT) process via eRA Commons.

Notice of Award

  • DMS Plan will be a part of the award, included as a term and condition of funding.
  • Recipients are expected to comply with the requirement of the DMS Policy and ensure DMS Plan is implemented within the project. Failure to comply can include the following:
    • Additional terms and conditions placed upon the award
    • Termination
    • Future funding decisions can be impacted by failure to comply

Award Compliance

  • Updates to the DMS Plan as changes occur must be submitted to the Program Officer
  • Updates are also allowable via the submission of the Research Performance Progress Report (RPPR).
  • Data should be made accessible no later than the time of the associated publication or the end of the performance period of the award
    • If a no-cost extension is granted, data should be made accessible no later than the time of the associated publication or the end of the no cost extension, whichever comes first

Resources

The University of Texas Libraries

The University of Texas Libraries Research Data Services provides, through an external host, a DMP Tool to assist researchers in the creation of Data Management Plans. For additional information, please see the UT Libraries Research Data Services page.

OSP Training

The Office of Sponsored Projects has compiled resources that discuss this new policy and how it will be applied throughout the lifecycle of a sponsored project. The PowerPoint below highlights key requirements and best practices in the implementation of a Data Management and Sharing Plan.

Pre- and Post-Award Requirements for NIH Data Management and Sharing Policy (PDF)

Additional Resources

NIH Optional Data Management and Sharing Plan Format Page
NIH FAQs on the 2023 Data Management and Sharing Policy