NIH has issued the Data Management and Sharing (DMS) Policy (effective January 25, 2023) to promote the sharing of scientific data. Sharing scientific data accelerates biomedical research discovery, in part, by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies.
This policy applies to all research meeting these criteria regarding of funding level:
- Is funded or conducted in whole or in part by NIH
- Results in the generation of scientific data
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 does not apply to research and other activities that do not generate scientific data.
Examples include: Training (Ts), Fellowships (Fs), Certain non-research Career Awards (e.g. KM1), Construction (C06), Conference Grants (R13), Resources (Gs), Research-related Infrastructure programs (e.g., S06) and non-research activities.
Applicants will be required to submit a two-page data management and sharing plan and to comply with that plan.
- Submission of an official Data Management and Sharing (DMS) Plan as part of all applications for funding beginning January 25, 2023.
- Compliance with the DMS Plan approved by the funding NIH Institute, Center, or Office. The approved plan becomes a part of the terms and conditions of the grant. Compliance will be monitored at regular reporting intervals by the funding NIH Institute, Center or Office and may factor into future funding decisions.
- The policy does not require researchers to share data per se but expects them to maximize their data sharing. NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data.
- It allows investigators to request funding for personnel costs or other fees related to data management and sharing activities; however, the money must be spent during the grant’s award period.
- Grant reviewers will see the data management plan and can comment on the budget, but plans are not used to determine the grant’s scientific merit.
DMS Plans should maximize appropriate sharing.
Justifiable ethical, legal, and technical factors for limiting sharing include:
- Informed consent will not permit or limits the scope of sharing or use
- 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 are imposed by existing or anticipated agreements with other parties
Reasons NOT generally justifiable to limit sharing:
- Data are considered to small
- Researchers anticipate data will not be widely used
- Data are thought not to have a suitable repository
Data type: Identify the data to be preserved and shared
Related tools, software, code: Tools and software needed to access and manipulate data
Standards: Standards to be applied to scientific data and metadata
Data preservation, access, timelines: Repository to be used, persistent unique identifier, and when/how long data will be available
Access, distribution, reuse considerations: Description of factors for data access, distribution, or reuse
Oversight of data management and sharing: Plan compliance will be monitored/managed and by whom
An optional Data Management and Sharing Plan format page will be provided to assist applicants with the preparation of this attachment. A preview version of this format page is available now. A final fillable version will be available by Fall 2022 and instructions will be incorporated into the NIH Application Form Instructions. Use of this format page is recommended, but DMS Plans generated using other approaches (e.g. DMPTool) will be accepted. DMS Plan is uploaded to application in the Research Plan Section (#11. Other Plans)
System developed by the University of California Curation Center of the California Digital Library, offers templates for creating data management plans. Rutgers is an institutional member and is available from the list of institutions. The system walks you through requirements for specific funding agencies. Allows you to work in sequence or jump around, save drafts, and export text files. Rutgers University Libraries offers resources to assist with creation.
NIH will monitor compliance with Plans over the course of the funding period during regular reporting intervals (e.g., at the time of annual Research Performance Progress Reports (RPPRs)). Steps include:
- Approved DMS Plan becomes a Term and Condition of Award
- Grantee reports progress of approved DMS Plan in RPPR
- NIH reviews compliance annually
Failure to comply with DMS Plans may result in the NIH ICO adding special Terms and Conditions of Award or terminating the award. If award recipients are not compliant with Plans at the end of the award, noncompliance may be factored into future funding decisions.
For contracts, noncompliance with the DMS Plan will be handled in accordance with the terms and conditions of the contract and applicable Federal Acquisition Regulation (FAR).