NIH Data Management and Sharing Policy

Effective January 25, 2023

Overview

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

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

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.
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
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
NIH DMS Plan Format Page
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)

Sample Plans
NIH has provided sample DMS Plans as examples of how a DMS Plan could be completed in different contexts, conforming to the elements. These sample DMS Plans are provided for educational purposes to assist applicants with developing Plans but are not intended to be used verbatim. Each PI’s DMS Plan must reflect their specific situation for a given data set.

Note that the sample DMS Plans provided below may reflect additional expectations established by NIH or specific NIH Institutes, Centers, or Offices that go beyond the DMS Policy. Applicants will need to ensure that their Plan reflects any additional, applicable expectations (including from NIH policies and any ICO- or program-specific expectations as stated in the FOA).

DMP Tool
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.

For assistance with creating a DMS plan, contact Rutgers University Libraries.
For some programs and types of data, the NIH may require the use of particular data repositories. For others, researchers are encouraged to select a repository appropriate for their discipline or the type of data generated. If no appropriate field-specific repository is available, researchers may consider a general or institutional data repository. For assistance selecting a repository, please contact Rutgers University Libraries.

Explore Data Repository Options
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).

Monitoring of and compliance with the Data Management and Sharing Plan (DMSP) is the responsibility of the project’s Principal Investigator (PI). The plan is implemented and managed by individuals working under the direction of the PI. The PI of the proposal will make the plan available to all personnel involved in the project and is responsible for ensuring faithful adherence to the DMSP and revising the plan annually as the research project evolves (see NOT-OD-24-175).

Rutgers Research and Sponsored Programs (RSP) unit within the Office for Research verifies the inclusion of the DMSP in new proposals and that updates regarding the plan are included in the annual report (RPPR). Any changes to the DMSP will be communicated to NIH by the PI through RSP as required. NOT-OD-24-176

PIs must work with the Research and Contract Services unit within the Office for Research to ensure the correct data use agreements are established before sharing sensitive data.

For projects involving human-derived data that qualifies as human subjects research, the DMSP is part of the IRB-approved protocol and deviations from the plan are reportable to the IRB per standard reporting practices. The consistency of sharing of data concerning human subjects between the DMSP and informed consent is ensured by the HRPP/IRB.
Process for Submitting Prior Approval Requests

If DMS Plan revisions are necessary (e.g., new scientific direction, a different data repository, or a timeline revision) Plans should be updated by recipients and reviewed and approved by the NIH ICO. All requests for NIH awarding ICO prior approval must be submitted by the Authorized Organization Representative (Signing Official (SO) role in eRA Commons) at least 30 days in advance of the requested change, and the currently approved DMS Plan remains in effect for the award until the request is approved by the funding NIH ICO.

In the Prior Approval Module, recipients must Select “Prior Approval – Other Request” and follow the instructions provided to complete the required entry. This functionality may only be used for revised DMS Plan prior approval requests.

The request must be submitted by a Signing Official.

Prior Approval – Other Request Instructions
- Description: Enter “DMS Plan Revision” (without quotations).
- Effective Date: Enter the effective date of the requested changes.
- Justification Document: Provide the rationale and justification for the requested changes.
- Budget Document: Provide if the revised DMS Plan impacts the budget. Include information for current and future budget periods. Note: This is not a supplement request.
- Other Supporting Documents: Attach the revised DMS Plan.
All uploaded documents must be in PDF format.

See NOT-OD-23-185