NIH Data Management and Sharing (DMS) Policy: Overview

NIH Data Management and Sharing Policy
Effective January 25, 2023

Applies to:

Effective January 25, 2023, the NIH Data Management and Sharing (DMS) Policy applies to all research that meets these criteria:

• Is funded or conducted in whole or in part by NIH
• Results in the generation of scientific data

Research activities covered by the DMS Policy include the following regardless of funding level:

• Extramural competing grant applications submitted to NIH for January 25, 2023 and subsequent receipt dates.
• Extramural proposals for contracts submitted to NIH on or after January 25, 2023.
• Intramural research projects conducted on or after January 25, 2023.
• Other funding agreements executed on or after January 25, 2023, unless otherwise stipulated by NIH.
• Examples: Research Projects, Certain 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. 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.

NIH's complete list of NIH activity codes subject to the DMS Policy.

"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."

Source: https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policy/research-covered-under-the-data-management-sharing-policy

Policy Requirements:

Applicants will be required to submit a two-page data management and sharing plan and to comply with that plan.

1. Submission of an official Data Management and Sharing (DMS) Plan as part of all applications for funding beginning January 25, 2023.
2. 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.

Additional Details:

• 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

Source: FAQ for 2023 Data Management and Sharing Policy - https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56549

• Data type: Identify the data to be preserved and shared
• Related tools, software, code:  Tools and software needed ot 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

Sources:

• Reference slides download from August 11, 2022 Understanding the New NIH Data Management and Sharing Policy Webinar
• Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (Release Date: 10/29/2020)

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).

Sources:

• FAQ for 2023 Data Management and Sharing Policy - https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56553
• Reference slides download from August 11, 2022 Understanding the New NIH Data Management and Sharing Policy Webinar

For more details about the NIH DMS Policy, consult links to the central portal, final policy, implementation details, FAQ, and policy supplemental information below:

For further assistance:

If you would like assistance creating your data management plan or did not find the agency information you needed here, please contact us at dataplan@listserv.unc.edu. We provide guidance and resource referrals to help UNC faculty, staff and students with data management and developing their data management plans.

UNC federally funded researchers, for in-depth review and assistance creating your data management plans in compliance with federal requirements, contact UNC's Research Data Management Core for assistance.

For further assistance:

If you would like assistance creating your data management plan or did not find the agency information you needed here, please contact us at dataplan@listserv.unc.edu.