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NIH Data Management and Sharing Policy

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

On January 25, 2023, the National Institutes of Health (NIH) Data Management and Sharing Policy was implemented.

NIH is implementing an updated format for Data Management and Sharing Plans (DMSPs) effective May 25, 2026 (NOT-OD-26-046). While the underlying 2023 NIH Data Management and Sharing Policy remains unchanged, this new format reflects NIH’s broader effort to reduce administrative burden and improve consistency in how plans are written, reviewed, and monitored.  

All NIH grant applications or renewals that generate scientific data will need to use this new Data Management and Sharing Plan format. This format includes answering yes/no questions on your intentions to share scientific data to be generated in the proposed research, and asks for brief descriptions of the data to be generated, in what repository data will be shared, and any justifications for limiting sharing. Researchers must provide this completed format document to NIH at the time of proposal submission. 

The DMSP is assessed by NIH program staff as part of your grant application. Reviewers also have access to this document. The NIH Institute, Center or Office (ICO)-approved plan is important because it becomes a term and condition of award if you are awarded your grant.

While this new format will allow you to more quickly complete the data management and sharing plan requirements for NIH proposals, it does NOT preclude the need for thought and consideration on actions required at the outset of a research project to allow for data sharing later in the project. Without this consideration, you may not be able to meet the data sharing terms and conditions of your award. NIH could hold this against you in future proposals.

The 2023 NIH Data Management and Sharing policy supersedes the NIH Data Sharing Policy of 2003, but does not supersede other NIH research sharing policies, including the Genomic Data Sharing (GDS) Policy.

A data management and sharing plan (DMSP) must be submitted as part of the funding application for all new and competing NIH proposals/renewals that generate scientific data. See the above NIH policy definition for scientific data.

High-level first steps for researchers:

Taking the following six steps will prepare you for accurately completing the new Data Management Sharing Plan format and being well-positioned to execute your research data management and sharing actions when the time comes.

  1. Determine your personal timeline. If you, the researcher, plan to submit an NIH proposal or if you have an active NIH award up for renewal, then developing a DMSP is a high priority. This is especially important if you are working with external collaborators, as it may take time to agree on data management and sharing plans. 

  2. Read through this webpage to familiarize yourself with the changes and with the policy, including the supplements.

  3. Familiarize yourself with the FAIR principles. The FAIR data principles are guiding principles NIH used in creating this new policy. These principles are used to make datasets more findable, accessible, interoperable, and reusable.

  4. Assess your own project and data management practices relative to the policy’s requirements and recommendations.

  5. Review available data resources including campus data services (e.g., computing, storage, consulting) and assess whether these resources will meet your needs. For Virginia Tech sponsored data storage and computing options and associated services, including services through Google and Microsoft, consult the IT Service Catalog. Most of the relevant entries in the catalog can be found under Research Services & Technologies, Servers, Storage, & Cloud, and Software & Computing Devices sections.

  6. Consider costs you might need to budget for tasks such as data cleaning, documentation, and sharing. For more information on budgeting, see the NIH-provided supplement on allowable costs and the section below titled “How do I budget for data management and sharing?”

University Libraries at Virginia Tech provides on-campus data management planning tools and assistance, to help you create an effective and comprehensive data management and sharing plan.

The new NIH Data Management and Sharing Policy requires a plan for maximizing the sharing of scientific data while acknowledging factors (legal, ethical, or technical) that may affect the extent to which data can be shared.

If you are conducting human subjects research, the informed consent process must make participants aware of how data collected from them will be shared and how data will be de-identified. The consent form should be as explicit as possible in informing research participants about what will happen with their data. NIH provides guidance on creating consent language that allows for future data use.

NIH and Virginia Tech recognize that not all human subjects data can be shared openly, even if de-identified. Sharing de-identified, individual-level data can create risks of identification of research participants if not done properly. As a starting point, consider openly sharing aggregate data only, or data underlying the figures in publications or presentations.  

If you are conducting research with American Indian, Alaska Native, or Indigenous populations, you must secure appropriate agreements with tribal authorities before using and sharing that information.

Where do I share my data?

NIH recommends sharing datasets through established data repositories to improve the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data, but does not dictate a particular repository for data sharing.

NIH supports many data repositories, and your data might or might not be appropriate for an NIH repository. Researchers should also consider data repositories supported by other organizations, both public and private.  

University Libraries administers the Virginia Tech Data Repository and associated curation services to assist Virginia Tech researchers in meeting this policy. The Virginia Tech Data Repository also has online guidance on sharing human participants data generated in the course of Virginia Tech research.

For more information, see Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research.

When do I need to share my data?

NIH requires researchers to share their data when they publish their work or before their performance period ends, whichever comes first. In general, researchers should make their data accessible as soon as possible. 

How do I prepare my data for sharing?

Regardless of which repository researchers use, the Virginia Tech Data Repository guidance on Preparing Data for Deposit (not specific to this repository) can be useful in preparing their data for sharing.

In sharing data with some access restrictions, researchers should work with the Privacy and Research Data Protection Program to create a data use agreement (DUA).

The most significant change in the NIH Data Management and Sharing Policy implementation is the shift from the previous narrative-based plan covering six elements (NOT-OD-21-014) to a structured format with Yes/No questions (Q1-3, Q5, and Q7) requiring explanations only for “No” responses or when sharing will be limited. 

While this simplifies the writing process, it also shifts the focus toward clear commitments and compliance rather than descriptive planning.

University Libraries at Virginia Tech provides on-campus data management planning tools and assistance. These tools will help you consider your project data management comprehensively such that you are in a good position to complete and commit to your answers in this new DMS Plan format.

Figure 1 shows a preview of the new DMS Plan (DMSP) format to be used, followed by a breakdown of how to approach each question.

Figure 1: Preview of the new DMS Plan format to be used:
NIH Data Management and Sharing Plan Format Page (OMB Clearance Pending)

Q1. Maximum appropriate sharing of data

From NIH DMS Policy FAQ B.5: “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.”

You should generally answer “Yes,” meaning data will be shared as openly as possible and as restricted as necessary. If sharing is limited (e.g., controlled access), provide justification in Q4.

Q2: Timing of data sharing

Data must be shared by the earlier of:

  • Publication, or 

  • End of the performance period (including no-cost extensions) 

Answer “Yes” unless specific exceptions apply (e.g., SBIR/STTR or patent considerations)

Q3. Data availability duration

This refers to whether data will remain available according to repository policies. In practice, this means selecting a repository that meets:

  • NIH retention expectations (≥ three years)

  • Institutional policies - five years for Virginia Tech

  • Journal requirements

The Virginia Tech Data Repository and most NIH-recommended repositories meet these criteria, so “Yes” is typically appropriate. 

Q4. Justification for limiting sharing of data (200 words maximum)

Use this section to explain any restrictions on sharing, including ethical, legal, or technical reasons. Refer to FAQ B.5 (What are the justifiable reasons for limiting sharing of data).

NIH considers certain reasons appropriate for limiting data sharing, such as:

  • Participant privacy and confidentiality risks 

  • Informed consent does not permit sharing

    • This particular limitation should lessen as new funded projects include consent forms where public sharing is addressed 

  • Legal or regulatory constraints 

  • Technical challenges that cannot be reasonably addressed 

In contrast, the following are not considered justifiable reasons:

  • The dataset is small 

  • The data are not expected to be widely used 

  • A suitable repository is not readily identified 

Justifications should clearly describe the specific risks and constraints that prevent data sharing.

Q5. Human participant protections

An answer of “Yes” confirms compliance with NOT-OD-22-213: Protecting Privacy When Sharing Human Research Participant Data. A “No” response would indicate non-compliance with this notice, so investigators should familiarize themselves with how to follow this notice and plan accordingly. 

“Not Applicable” is an appropriate response for research not involving human participants.

Q6. Data type and repository table (100 words maximum)

Proposal writers must list:

  • Data types, including species and modality (e.g., human scRNA sequencing data, mouse flow cytometry data, etc.)

  • Associated repositories where these data types will be made publicly available

NIH allows flexibility (“if known”), so include expected data types and refine later during RPPR if needed.

Figure 2: Question 6 of the new 2026 DMS Plan format requiring a data type and repository table

For selecting a suitable data repository for your data types, refer to the section above “What do I need to know about data sharing?”, subsection “Where do I share my data?”

Q7. Genomic Data Sharing (GDS) Policy compliance
This question applies to studies subject to the NIH Genomic Data Sharing (GDS) Policy (e.g., large-scale human genomic data). It asks whether data will be shared in a NIH-designated repository according to GDS timelines and whether you will meet the expectations of the Institutional Certification requirements outlined in the GDS policy (NOT-OD-14-124).

Similar to Q5, this question is intended to confirm awareness and compliance with an existing NIH GDS policy. In most cases, the appropriate response is “Yes” if your study falls under the GDS Policy. A “No” response would require justification in Q4 and may indicate non-compliance.

In limited cases, a “No” response may be appropriate, such as when:

  • The informed consent does not permit broad genomic data sharing (e.g., legacy datasets) 

  • Legal or regulatory restrictions limit data sharing (e.g., state laws or international regulations) 

  • Tribal or community governance policies restrict deposition in external repositories 

  • There is a high risk of re-identification that cannot be adequately mitigated 

  • Institutional Certification requirements cannot be met due to consent or data use limitations 

These scenarios should be clearly justified in Q4.

As you develop your Data Management and Sharing Plan, make sure you do not include hypertext (e.g., hyperlinks and URLs) in the DMS Plan attachment. NIH emphasized this in Reminder: NIH Policy on Use of Hypertext in NIH Grant Applications.

NIH allows researchers to budget for certain costs associated with data management and sharing. These are described in Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing. More information about allowable costs is provided by NIH guidance Budgeting for Data Management and Sharing. If  researchers are including institutional services and tools in your their DMSP, the associated costs should be included.

Any costs related to complying with the policy must be paid for up-front during the performance period. For example, costs for long-term data preservation must be budgeted for in the proposal and paid before the end of the grant. The NIHM Data Archive cost estimation worksheet is useful for budget planning.

To think comprehensively about budgeting for data sharing within your proposal, consider these questions derived from the Council of Government Relations Readiness Guide. NIH also provides a set of useful FAQs on Budgeting and Costs; see their FAQ page, section F.

An important notice regarding budgeting was released on August 1 2023: NOT-OD-23-161: NIH Application Instruction Updates Data Management and Sharing (DMS) Costs

In part, this notice says "Effective for applications submitted for due dates on or after October 5, 2023, NIH will no longer require the use of the single DMS cost line item. NIH recognizes that DMS costs may be requested in many cost categories. Therefore, in line with our standard budget instructions, DMS costs must be requested in the appropriate cost category, e.g., personnel, equipment, supplies, and other expenses, following the instructions for the R&R Budget Form or PHS 398 Modular Budget Form, as applicable."

Per Virginia Tech Policy 130015 "Ownership and Control of Research Data, Results, and Related Materials" it is the responsibility of the researcher (the Principal Investigator or co-Investigators) to steward and share their data appropriately. Thus researchers have primary responsibility for oversight of data management and sharing plans (DMSPs). Researchers can report on execution and updating of data management and sharing activities through the annual Research Performance Progress Report (RPPR).

Other university units (e.g. under “Where can I get help” on this page) provide researchers with data management and sharing guidance and support, and can be delegated responsibility for actions within written DMSPs. These units should be made aware of these potential responsibilities prior to proposal submission. If these units are not made aware, they may not be able to meet these delegated responsibilities when the time comes.

Researchers must comply with the ICO-approved plan and document compliance in reports such as the annual Research Performance Progress Report (RPPR). Non-compliance may result in enforcement action from the NIH such as an addition of special terms and conditions to the award and termination of the award. Non-compliance might also affect future funding decisions. If researchers make changes to their submitted plan, their new plan must be re-approved.

University Libraries Data Services
dataservices@vt.edu
- Help understanding details of the NIH requirements and how to meet them
- Completing the DMSP
- Depositing open access data in Virginia Tech Data Repository
- General data management and sharing plan writing workshops
- Referrals for other research data management assistance or consulting resources

Human Research Protection Program
irb@vt.edu
- Research support in meeting ethical and regulatory responsibilities when conducting research with human subjects
- IRB protocols
- Consent form review

Privacy and Research Data Protection Program
prdp@vt.edu
- Formulating data plans, data security measures, privacy protection
- Creation of data use agreements (see appropriate tab) - Controlled and regulated storage and compute
- Advice on data de-identification

Office of Sponsored Programs
osp@vt.edu
- Proposal submission
- Budgeting and costs
- Meeting terms and conditions of NIH awards

Office of Research and Innovation
- Communication and outreach materials for faculty, staff, and administrators regarding the new NIH policy

NIH definition of scientific data

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.

NIH definition of scientific data

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.