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Final NIH Policy for Data Management and Sharing

NIH Notice: Final NIH Policy for Data Management and Sharing (NOT-OD-21-013)

What is the new Data Management and Sharing (DMS) policy in brief?

  • The final NIH DMS Policy requires submission of Data Management and Sharing Plans and compliance with NIH Institute, Center, or Office-approved Plans. It also emphasizes the importance of good data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. Non-compliance may affect future NIH funding decisions. 

How will it be implemented?

  • Inclusion of a new “Other Plans” field in the SF424 application package
  • Compliance with the plan as part of the terms and conditions of the award
  • Implementation of the plan as described in the proposal and approved by NIH
  • Review of compliance with the plan as part of regular progress reports

How does this differ from the previous requirement to submit a Resource Sharing Plan?

  • As indicated in the notice on Implementation Details, previously required data sharing plans and genomic data sharing plans will no longer be attached in the Resource Sharing Plan of the Forms-H, SF424 application. The expanded DMS Plan incorporates those details but requires additional detail, as specified in the policy and the SF424 application package guidelines.

When does the DMS Policy take effect?

  • The DMS Policy is effective for proposals submitted on or after January 25, 2023.

What proposals are affected?

  • All NIH proposals that generate scientific data, regardless of funding level (research projects, career development awards, SBIR/STTR, research centers)

What data are to be shared?

  • 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.
    •  All data must be managed, but not all data generated is to be shared. However, NIH expects researchers to maximize sharing of appropriate data.
    • Researchers have the responsibility to determine both what constitutes their scientific data and to propose how they will maximize appropriate sharing of that data, including identification of data that will not be shared along with justifications for these determinations.
  • Exclusions include:
    • Data not necessary for or of sufficient quality to validate and replicate research findings
    • Laboratory notebooks
    • Preliminary analyses
    • Completed case report forms
    • Drafts of scientific papers
    • Plans for future research

What are elements of the DMS Plan?

  • Two-page plan (preview of this format page) covering six sections:
    • Data type – summary of types and estimated amount of data to be generated; data modality, level of aggregation, degree of data processing
    • Related tools, software, code needed to access and manipulate data (e.g., open source, fee-based, from research team)
    • Data standards – standards to be applied to scientific data and metadata
    • Data preservation, access, timelines – data repository to be used, persistent unique identifier, and indication of when and how long data will be available
    • Access, distribution, reuse considerations – description of factors for data access, distribution, or reuse
    • Oversight of data management – compliance monitoring, management, frequency, responsible individual for oversight

What special considerations for sharing data from human participants or with intellectual property are expected?

  • Consistency with privacy, security, and proprietary issues
  • Consideration of factors affecting access, distribution, or reuse of data that are related to Informed consent, privacy and confidentiality (i.e., de-identification, Certificates of Confidentiality, and other protective measures); applicable federal, Tribal, state, and local laws, regulations, policy

Where are data expected to be shared?

What is the timeline for sharing?

  • Data sharing is expected no later than the time of publication or end of grant period, whichever occurs earlier.
  • In the event of a no-cost extension, data sharing is expected no later than the time of publication or end of the extension period, whichever occurs earlier.

What costs may be charged to the grant?

  • Curation fees, data repository fees incurred during the project period – proposed as direct costs indicated as “Data Management and Sharing Costs” with budget justification

How will the DMS Plan be reviewed?

  • NIH program staff will assess DMS Plans to ensure the specified elements have been adequately addressed and to assess the reasonableness of the plan. Any issues will be resolved through standard Just-in-Time procedures, including potentially a revised DMS Plan.
  • Peer reviewers will not be provided with the separate DMS Plan attachment.
  • During peer review, reviewers may comment on the reasonableness of the requested costs in the budget based on information in the budget justification, which will contain a brief description of the DMS Plan, but these comments will not impact the score.

Where can I find detailed information/resources or FAQs?

Is there a tool to help develop the NIH DMS Plan?

  • The Research Data Services at UK webpage, hosted by UK Libraries, provides a link to DMPTool, a user-friendly resource providing templates and guidance on creating data management plans aligned with agency guidelines, as well as a brief visual tutorial.
  • Log in access to DMPTool is via the user’s UK linkblue username and password.

Where can I access NIH training on the DMS Policy?

  • NIH’s two-part webinars on the New Data Management and Sharing Policy
  • PDO workshop upon request (PDO@uky.edu)

Where can I access sample DMS Plans?

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