Agency Update: NIH Releases Final Data Management and Sharing Policy

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As part of its ongoing work to standardize and promote the sharing of data generated from biomedical research, the National Institutes of Health (NIH) published its final NIH Policy for Data Management and Sharing (DMS) on October 29, 2020.  The final policy is the culmination of several recent efforts from NIH in this space, including the release of a draft DMS policy in November 2019.  The new policy incorporates feedback gathered from the NIH grantee community on that draft policy as well as Requests for Information (RFIs) issued in 2016 and 2018.  The effective date for this policy is January 25, 2023, giving researchers slightly more than two years to prepare to incorporate the agency’s expectations into their research programs.

The final DMS policy, which applies to all NIH-funded research, includes two major components: 1) the submission of a DMS plan for all extramural grants, contracts, and other funding agreements at the time of application submission, and 2) an expectation of compliance with that plan throughout the course of the project.  The timing of DMS plan submission is a major change from last year’s draft policy, which required researchers to submit a DMS plan ‘Just-in-Time,’ in the later stages of the proposal review process.  According to NIH, the purpose of moving up this timeline for developing and submitting a DMS plan is so that “data management and sharing [is] recognized to be an integral component of a biomedical research project, rather than an administrative or additive one.”

Other significant attributes of the final DMS policy relate to the following areas:

  • Clarifying Expectations for Sharing Scientific Data: While the policy does not create an explicit requirement to share all scientific data, NIH hopes that by requiring researchers to submit a plan, researchers will begin to prospectively integrate data sharing into their normal research practices, as appropriate given any applicable ethical, legal, or technical factors.
  • Definition of “Scientific Data”: The final policy notes that data should be “of sufficient quality to validate and replicate research findings,” in contrast to the draft policy which simply stated that data shared should be “necessary to validate and replicate research findings.”  The final policy also removes the expectation to digitize scientific data from the definition outlined in the draft policy.
  • Assessment of Plans: NIH program staff will assess the merit of submitted data plans.  Peer reviewers may comment on proposed budgets for DMS plans, but these comments will not impact a proposal’s overall score.
  • Consistency of Data Sharing Expectations Across NIH: The new DMS policy will represent the minimum requirements for DMS across the agency, and individual Institutes and Centers (ICs) may request additional and/or more specific information from their applicants.
  • Data Derived from Human Research Participants: The policy does not introduce any new requirements for protections of human research participants, and notes that existing laws and policies such as the Common Rule, Certificates of Confidentiality, and the NIH Genomic Data Sharing Policy continue to apply.
  • Timing of Expected Data Sharing: The final policy states that data should be “made accessible as soon as possible, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first.”  NIH does not provide an explicit timeline on how long data should remain available, but instead provides a “framework for helping researchers think through a minimum time period for data availability” in its supplemental notices.
  • Location of Shared Data: NIH “strongly encourages the use of established repositories to the extent possible,” and provides supplemental guidance on selecting an appropriate repository.

To further assist researchers in understanding and applying the final DMS policy to their work, NIH has released supplemental guidance on elements of a DMS plan, allowable costs for DMS, and selecting a repository for data resulting from NIH-funded research.  The agency also plans to provide and update frequently asked questions and other information for the NIH community to assist in implementation prior to the 2023 implementation date.

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