NIH 2023 Data Management and Sharing Policy (DMS Policy)

What's new about the 2023 NIH Data Management and Sharing Policy?

The National Institutes of Health (NIH) has issued a new Policy for Data Management and Sharing effective January 25, 2023. This new policy will require that ALL new and competing proposals/renewals that generate Scientific Data, regardless of funding level, include a detailed plan for how the data will be managed and shared during the entire funded period. The NIH Data Management and Sharing Plan (DMSP) is similar to what other funders/sponsors call a Data Management Plan (DMP).

The DMSP (or DMS Plan) will be reviewed and assessed by NIH Program Staff (though in certain scenarios, peer reviewers may comment on the DMS Plan or proposed budget for data management and sharing. It should be noted that these comments will not impact the score). The Institute, Center, or Office (ICO)-approved plan becomes a Term and Condition of the Notice of Award.

**The DMS Policy does not apply to research and other activities that do not generate scientific data, for example: research training, fellowships, infrastructure development, and non-research activities.

Featured Resources:

What does this mean now?

For due dates on or after January 25, 2023, ALL new and competing proposals/renewals that will generate Scientific Data must include a DMSP.

The term Scientific Data is defined in the policy as "The recorded factual material 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."

Initial Steps

  1. Determine whether this NIH policy applies to you: If you are uncertain about whether this policy applies to your research, then please visit NIH’s page Research Covered Under the Data Management & Sharing Policy for more information.
  2. Set your timeline: If you have an active NIH award going up for renewal with a receipt date of January 2023, or if you are planning to submit an NIH proposal in 2023, then developing a DMSP should be a high priority, especially if you are working with external collaborators as it may take time to set up appropriate data procedures or agreements.
  3. Read through this page: Start to familiarize yourself with the updated Policy (including the supplements). Attend November’s Research Administration Hot Topics session, and other upcoming topic area sessions, to learn more about the policy and ask questions.
  4. Evaluate your own project and data management practices. Review your own project and data management practices relative to the policy (see the NIH-provided supplements below), especially around documenting existing practices and developing new ones to address the increased emphasis on data sharing and administrative oversight.
  5. Review campus data services. Evaluate whether available campus data resources and services meet your needs, and consider costs you may need to budget for, such as labor for data cleaning and documentation (see NIH-provided supplement on allowable costs).

What should be included in my Data Management and Sharing Plan?

The DMSP must include the following essential Elements and may not exceed two pages:

  • Data Type
  • Related Tools, Software, and/or Code
  • Standards
  • Data Preservation, Access, and Associated Timelines
  • Access, Distribution, or Reuse Considerations
  • Oversight of Data Management and Sharing.

Plans should be updated throughout the award.

See Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan and Writing a Data Management & Sharing Plan for a detailed description of these Elements.

To draft the plan itself, we recommend the DMPTool (log in with your CNET ID via Single Sign On/SSO) using the “NIH Forthcoming 2023” DMSP template. Additional guidance for completing each section will be added to the DMPTool.

You may opt to use the Data Management and Sharing Plan Format Page template.

What does this mean at proposal stage?

For due dates on or after January 25, 2023, ALL new and competing proposals/renewals that will generate Scientific Data must include a DMSP.

  • The Data Management Sharing Plan will be included in the “Other Plan(s)” field of the NIH FORMS-H application forms as a single PDF attachment:
    • PHS 398 Research Plan
    • PHS 398 Career Development Award Supplemental Form
  • The requested direct costs to support the activities proposed in the DMS Plan must be indicated as “Data Management and Sharing Costs” as follows:
    • R&R Budget Form: single line item in section F. Other Direct Costs
    • PHS 398 Modular Budget Form: as text embedded within the Additional Narrative Justification
  • A brief summary of the DMS Plan and a description of the requested Data Management and Sharing Costs must be included within the Budget Justification attachment:      
    • R&R Budget Form: single line item in section F. Other Direct Costs
    • PHS 398 Modular Budget Form: as text embedded within the Additional Narrative Justification

These changes will be implemented with application form packages identified with a Competition ID of "FORMS-H" and associated application guide instructions. Additional details will be incorporated into the NIH Application Form Instructions by Fall 2022.

What does this mean at Just-In-Time (JIT) stage?

If more information for the Data Management and Sharing Plan (DMSP) is needed after proposal submission and the Plan was not approved by NIH, then applicants will be notified that more information is needed at JIT stage. Applicants must communicate with their Program Officer and/or Grants Management Specialist to resolve any issues with the DMSP that prevent the funding IC from approving the DMSP. Additionally, this may also require an institutionally approved and revised DMSP prior to submission to the sponsor.   

What does this mean at award stage?

At award stage, recipients must comply with the version of the Data Management and Sharing Plan (DMSP) that was approved by the funding NIH Instituted or Center (IC). However, DMSPs may be updated during regular reporting intervals as part of the annual Research Performance Progress Report (RPPR) process. Any changes to the DMSP must be approved by the funding NIH IC.

When do I need to submit my Data Management and Sharing Plan (DMSP)?

  • Extramural (grants): as a single PDF attachment to the “Other Plan(s)” field on the PHS 398 Research Plan or PHS 398 Career Development Award Supplemental Form. Additionally, a brief summary and associated costs should be submitted as part of the Budget and Budget Justification (see Budgeting for Data Management and Sharing and NDA Cost Estimation Tool).
  • Extramural (contracts): as part of the technical evaluation
  • Intramural: determined by the Intramural Research Program
  • Other funding agreements: prior to the release of funds

NIH Guidance & Resources:

This information is the complete NIH 2023 Policy (NOT-OD-21-013) including related announcements, summary, and discussion.

This page informs the extramural research community of implementation details for the NIH Policy for Data Management and Sharing (DMS Policy) affecting grant and cooperative agreement applications submitted for receipt dates on or after January 25, 2023.

This page describes NIH’s effort to reduce the burden of duplicative reporting expectations and intent to inform the research community of its intent to establish a single Plan submission requirement for research subject to both the NIH Genomic Data Sharing Policy (GDS Policy) and the NIH Policy for Data Management and Sharing (DMS Policy). This implementation update will take effect for Plan submission due dates on or after January 25, 2023.

These FAQs are intended to help clarify the implementation of the NIH DMS Policy and will be updated on an ongoing basis.

This information is intended to help researchers choose data repositories suitable for the preservation and sharing of data.

This information outlines categories of allowable NIH costs associated with data management and sharing to assist individuals and entities subject to the final NIH DMS Policy.

This information is intended to help researchers choose data repositories suitable for preserving and sharing data (i.e., scientific data and metadata). Deposit in an established, quality data repository generally improves the data's FAIRness (Findable, Accessible, Interoperable, and Re-usable).

This is information on privacy considerations when sharing human research participant data. This information is not intended to provide a guide for compliance with regulatory requirements, nor is it establishing binding rules for NIH awardees, but instead provides a set of principles, best practices, and points to consider for creating a robust framework for protecting the privacy of research participants when sharing data.

This page describes considerations and best practices for the responsible and respectful management and sharing of AI/AN participant data under the DMS Policy. This Supplemental Information was developed in response to Tribal Nations’ input received through Tribal Consultation and public comments from AI/AN organizations and community members, researchers, institutions, data providers and users, research participants, infrastructure developers, and others to further promote culturally respectful and effective research partnerships.

This document provides guidance, points to consider and sample language for informed consent documents of research studies which plan to store and share data and/or biospecimens for future use.

NIH activity codes included

NIH’s sharing policies

Resources and training opportunities for NIH sharing policies

NDA Data Submission Cost Estimation Tool

Outlines the data sharing related costs that may be requested in an application for funding

FAQ's

  • Does RedCap typically count as a data repository? Or does the data need to be moved to a publicly available space? No, at this time RedCap is not considered a data repository. Yes, the data needs to be accessible.
  • What is the definition of ‘data’? What types of data must be deposited and shared? The Policy requires plans for “Scientific Data” Scientific Data is defined by the NIH as follows: "the recorded factual material 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 do 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.
  • When should I upload data? At the end of a study? Annually?  
    When/how data is stored and the timelines are all elements of the plan. The NIH understand that different research and programs will have different needs and timelines. Additional info about timing of data sharing: “NIH encourages scientific data to be shared as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. NIH also encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.” https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-for-data-management-and-sharing/writing-a-data-management-and-sharing-plan
  • Is there a standard approach UChicago is taking for data use agreements for us now that all of our data must be available? In the past, I have had to explore DUAs on a case-by-case basis. Perhaps we can streamline this now? At this time, there is no plan to amend the DUA process. The URA Contracts Team will continue to leverage DUA templates such as those provided by the FDP to make this as streamlined for Researchers. Please route your DUA in AURA Agreements.
  • Can you comment on the Human Subjects issues regarding sharing data for purposes potentially that go beyond, or perhaps even against, the aims and goals of the research they agreed to participant it?  Is this meant to be an opt in in the consenting process? Per NIH: “NIH expects that researchers will take steps to maximize scientific data sharing, but may acknowledge in Plans that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent.  Foreseeable limitations should be described in DMS Plans. Per the supplemental information “Elements of an NIH Data Management Sharing Plan,” a compelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH. Potential examples of justifiable factors include:
    • informed consent will not permit or will limit the scope or extent of sharing and future research use
    • existing consent (e.g., for previously collected biospecimens) prohibits sharing or limits the scope or extent of sharing and future research use
    • privacy or safety of research participants would be compromised or place them at greater risk of re-identification or suffering harm, and protective measures such as de-identification and Certificates of Confidentiality would be insufficient
    • explicit federal, state, local, or Tribal law, regulation, or policy prohibits disclosure
    • restrictions imposed by existing or anticipated agreements (e.g., with third party funders, with partners, with repositories, with Health Insurance Portability and Accountability Act (HIPAA) covered entities that provide Protected Health Information under a data use agreement, through licensing limitations attached to materials needed to conduct the research)
    • datasets cannot practically be digitized with reasonable efforts

    Examples of reasons that would generally not be justifiable factors limiting scientific data sharing include:

    • data are considered to be too small
    • data that researchers anticipate will not be widely used
    • data are not thought to have a suitable repository

    See the FAQ “If researchers are reusing existing, shared data to generate new datasets, are they expected to reshare the primary data they incorporated into their new analysis?” for more information on the DMS Policy’s expectations for sharing primary data accessed during the course of a study.

    NIH respects and recognizes Tribal sovereignty and American Indian and Alaska Native (AI/AN) communities’ data sharing concerns, and NIH has proposed additional considerations when with working with Tribes in the draft supplemental information on “Responsible Management and Sharing of AI/AN Participant Data.””

  • I assume the data have to be de-identified.  This means, for example, no dates, right? It depends and should be addressed in your plan. De-identified data may list the year.
  • Many journals now require a complete data set for publication. Can they be considered a repository? This would not typically be considered a repository.
  • Will there some wording to add to our consent forms to reveal this to participants, and do we have to adjust existing consent forms? We have started to involve the UChicago IRB offices, and we are working on language related to the policy. In regards to consent forms specifically, it is possible that language may be added to or revised for consent forms by IRB as they deem necessary and in compliance with the policy.
  • Does the 2023 DSMP requirement apply to *non-competing* renewals of existing projects or projects submitted for deadlines prior to Jan 25, 2023? No, it does not apply to non-competing renewals.
  • It would be super helpful for those of us in our early to mid career to have a "consult" service for setting up a data sharing plan when preparing new grant submissions. Thank you for the feedback. It is recommended to email datasharing@uchicago.edu as a starting point for assistance with preparing your DMSP.
     
  • Implementation Details for the NIH Data Management and Sharing Policy

This page informs the extramural research community of implementation details for the NIH Policy for Data Management and Sharing (DMS Policy) affecting grant and cooperative agreement applications submitted for receipt dates on or after January 25, 2023.

**Please frequently check back here and at the following pages for updates: Scientific Data Sharing and the Notices of NIH Policy Changes.