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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.

After January 25, 2023, all NIH grant applications or renewals that generate scientific data must include a robust and detailed plan for how researchers will manage and share data during the entire funded period. This includes information on data storage during a project, access policies/procedures, data preservation after a project is completed, metadata standards, and sharing approaches. Researchers must provide this information to NIH in a data management and sharing plan (DMSP) at the time of proposal submission. The DMSP is similar to what other funders call a data management plan (DMP).

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.

This policy supersedes the NIH Data Sharing Policy of 2003, but does not supersede other NIH research sharing policies. Plans for sharing genomic data as expected by the Genomic Data Sharing (GDS) Policy are to be described in the DMSP submitted at the time of proposal submission, and not in a separate GDS Plan or at Just-in-Time.

 

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 for January 25, 2023, and subsequent receipt dates. See the above NIH policy definition for scientific data. 

High-level first steps for researchers:

  1. Determine the 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. Also consider costs you might need to budget for tasks such as data cleaning, documentation, and sharing. For more information, see the NIH-provided supplement on allowable costs and budgeting for data management and sharing.
     

To avoid duplication of effort, if your research requires IRB approval, you can include your completed data management and sharing plan in place of the “Data Management Plan” section of Virginia Tech's IRB protocol template

University Libraries at Virginia Tech provides on-campus data management planning assistance and campus resources, including advice on creating an effective and comprehensive data management and sharing plan.

If you plan to generate scientific data, you must submit a data management and sharing plan to the funding NIH ICO as part of the budget justification section of the application for extramural awards. This will be part of your grant submission package. Your plan should be a maximum of two pages and must include the following elements:

  • 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

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

Complete your NIH data management and sharing plan using this NIH-provided template. This template is available with additional useful guidance through DMPTool. DMPTool also provides a web interface for creating these plans. Log into DMPTool using VT Single Sign-On (e.g. PID and password). For additional data management planning resources, refer to University Libraries resources.

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 & TechnologiesServers, Storage, & Cloud, and Software & Computing Devices sections.

Be sure to budget for data management and sharing resources as needed.

As you develop your Data Management and Sharing Plans, make sure you do not include hypertext (e.g., hyperlinks and URLs) in the DMS Plan attachment. NIH emphasizes this in DMS Plan Tip: Leave the Hypertext at Home.

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.

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. They can also use relevant requirements and expectations such as data repository policies, award record retention requirements, and journal policies to decide when to share your data sets.

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).

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. 

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. To avoid possible issues when reporting progress, researchers should ensure that their submitted plan contains enough detail for the program officer to be able to evaluate compliance.

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
- Writing 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
- 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.