NIH Issues Data Management and Sharing Policy

NIH 2023 Data Management & Sharing Policy

The NIH has issued the Data Management and Sharing (DMS) policy, effective Jan. 25, 2023, in order to promote the sharing of scientific data. Under the DMS policy, the NIH expects that investigators and institutions will (i) plan and budget for the managing and sharing of data; (ii) submit a DMS plan for review when applying for funding; and (iii) comply with the approved DMS plan.

The DMS Plan must be submitted as part of the funding application or proposal and NIH staff will review for acceptability and may request modifications prior to the award. Approval is also required by the funding institute. DMS Plans are not included in the scored peer review process unless specifically noted in the Funding Opportunity Announcement, although related budget items will be considered.

Key Concepts:

Scientific Data is 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.

  • Scientific data includes any data needed to validate and replicate research findings.
  • Scientific data does not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects such as laboratory specimens.

The DMS Policy applies to all research that generates scientific data, including:

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

The DMS Policy does not apply to research and other activities that do not generate scientific data, including:

  • Training (T)
  • Fellowships (Fs)
  • Construction (C06)
  • Conference Grants (R13)
  • Resource (Gs)
  • Research-Related Infrastructure Programs (e.g., S06)

Proprietary Data

  • Under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive, effective May 2, 2019, SBIR and STTR awardees may withhold applicable data for 20 years after the award date, as stipulated in the specific SBIR/STTR funding agreement and consistent with achieving program goals. SBIR and STTR awardees are expected to submit a Data Management & Sharing Plan per DMS Policy requirements.
  • When dealing with the private sector, issues can arise if as data sharing is limited by restrictions imposed by licensing limitations. In such instances, investigators should discuss this with proposed collaborators early in the process to avoid agreements that prohibit or unnecessarily restrict data sharing. If a restriction is deemed warranted, the NIH will evaluate the justifications of the investigators.

As both the awardee and the institution are expected to adhere to the approved plan as a term and condition of the award, the OVCR is working to provide a repository with templates and other such guidance. You will hear more from them in the coming weeks.

Please reach out to me with any questions or requests for trainings/discussion for your area.

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