NIH Data Management and Sharing Policy

The NIH Data Management and Sharing Policy

Prior to January 2023, the NIH only required grants with $500,000 per year or more in direct costs to provide a brief explanation of how and when data resulting from the grant would be shared.

The 2023 policy requires ALL grant applications or renewals that generate Scientific Data must include a robust and detailed plan for how you will manage and share data during the entire funded period. This includes information on data storage, access policies/procedures, preservation, metadata standards, distribution approaches, and more.  You must provide this information in a data management and sharing plan (DMSP). The DMSP is similar to what other funders call a data management plan (DMP).

The DMSP will be assessed by NIH Program Staff (though peer reviewers will be able to comment on the proposed data management budget). The Institute, Center, or Office (ICO)-approved plan becomes a Term and Condition of the Notice of Award.

What do I need to do?

A DMSP must be submitted as part of the funding application for all new and competing proposals/renewals that generate Scientific Data. 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. 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."

High-level first steps

1. Determine your personal timeline. If you have an active NIH award going up for renewal with receipt date of January 2023, or if you are planning to submit an NIH proposal this year, 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/agreements. 
2. Read through this webpage to familiarize yourself with the changes and with the policy itself (including the supplements) and the NIH Data Management & Sharing Policy Overview.
3. Familiarize yourself with the FAIR principles (Wilkinson et. al, 2016). The FAIR (findable, accessible, interoperable, reusable) data principles are the guiding principles the NIH has used in creating the new policy. 
4. Assess 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 (e.g., computing, storage, consulting) and assess whether they will meet your needs. Also consider costs you may need to budget for such as labor for data cleaning and documentation (see the NIH-provided supplement on allowable costs).

If your research requires IRB approval, UA's IRB may ask for information contained in your DMSP. Therefore, it is strongly recommended to draft your DMSP prior to seeking IRB approval .

What do I need to submit as a part of my funding proposal?

Your plan should be two pages or fewer and must include these 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. For additional resources, refer to How to Get Started Writing a DMP. 

See a UA-specific example on the examples page. NIH has provided several examples. Note that these samples are not intended to be used as templates and their use does not guarantee approval by NIH. 

NIH has also developed an optional DMS Plan format page that aligns with the recommended elements of a DMS Plan.  Important: Do not include hypertext (e.g., hyperlinks and URLs) in the DMS Plan attachment.

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To draft the plan itself, we recommend the DMPTool (log in with NetID) using the NIH template. A self-paced DMPTool training is also available.

Budget

Costs to execute the DMSP can be included in the budget as a line item and a brief summary of the DMSP must be provided in the budget justification. Allowable costs include labor for data curation, preservation, de-identification, and more. The NIH has a provided a list of allowable and unallowable costs and has extensive information on the NIH DMSP FAQ page under "F. Budget/Costs".  

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. You may find the NIHM Data Archive (NDA) cost estimation worksheet or the publication Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data useful. See also the FASEB DataWorks! guide to Budgeting: Estimating Costs for Data Management and Sharing Plans.

Some services provided by the University are free of charge while others are not. While free services do not need to be included in the budget, please consider contacting the managing office prior to including them in your DMSP (e.g., repositories). See the following section for what kinds of services and tools are available to you. 

Common DMSP Issues

• Inconsistent usage of the six DMSP elements. Solution: use a tool/template to draft the plan
• Conflicting information in different parts of the plan. Solution: proofread the plan, request a review of your plan from data management support staff in the Library (see below).
• Vagueness in sharing details. Solution: be precise with details including what data will be generated vs shared, how much and in what format, the name of the repository(ies) where it will be shared and exactly which data will be shared where. Sharing by request is not acceptable as a sharing solution.   
• Not providing sufficient justifiable reasons for not sharing. Solution: not sharing data is allowable but a clear justification must be provided. 
• Insufficient mention in the budget for DMS plan activities. Solution: account for all costs, including personnel time.
• Over reliance on generalist repositories. Solution: look for a disciplinary repository first (NIH maintains a list). Use a generalist repository (like ReDATA) only when there isn't a suitable disciplinary repository. This can be justified by stating the lack of suitable repository in the DMSP.

Source: Federal Demonstration Partnership (FDP) Data Management and Sharing (DMS) Town Hall #3, December 14, 2023. [Youtube]

What institutional tools and services are available to me for compliance during my grant?

Data Sharing

Unlike NIH's prior policies, the new 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 it can be shared. See the definition of Scientific Data above for what is in scope for sharing.

If you are conducting research with human subjects, you must incorporate consent during the data management and sharing process, even if data will be de-identified. 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. See the NIH's guidance on privacy protections and AI/AN populations

Compliance and Institutional Oversight

NIH DMSP Assessment 

Your DMSP will not be seen by peer reviewers. NIH program staff will assess your plan and may request changes during the JIT process. The community has prepared a scoring rubric that may be used to evaluate your plan (this rubric is intended to assist researchers in preparing plans and for officers reviewing plans but is not an official NIH document).

If you make changes to your submitted plan, your new plan must be re-approved by NIH. the process varies depending on if the change is made pre-award or post-award.  Follow the guidelines in the NIH Policy NOT-OD-23-185 Prior Approval Requests for Revisions to an Approved Data Management and Sharing (DMS) Plan Must be Submitted Using the Prior Approval Module

Institutional Oversight

The NIH policy is flexible on who is responsible for overseeing the implementation of DMSPs. While the specifics may vary depending on the project, generally speaking

• PIs are ultimately responsible for ensuring the DMSP is executed.
• HSPP/IRB is responsible for ensuring that the sharing of data pertaining to human subjects is consistent between the DMSP and informed consent.
• PIs and Sponsored Projects and Contracting are responsible for ensuring appropriate data use agreements are in place before sharing sensitive data.
• If a PI choses to deposit data into UA's ReDATA repository to comply with the data sharing aspects of the DMSP, prior to making the data public, the repository is responsible for ensuring the data can be shared. The repository will collect an attestation from the PI that data has been deidentified (where applicable), and that proper consents and permissions have been obtained to share the data. Additionally, the repository will coordinate with the HSPP/IRB, Native Peoples Technical Assistance Office, or other offices as appropriate.
• If applying to NIDDK or NICDR, please contact Research Development Services for special guidance prior to completing section 6 of the DMSP. New

Compliance Monitoring

You must comply with the ICO-approved plan and document that compliance in the annual Research Performance Progress Report (RPPR). Non-compliance may result in enforcement action from the NIH such as

• Addition of special terms and conditions to the award
• Termination of the award

Non-compliance may also affect future funding decisions. To avoid possible issues when reporting progress, ensure that your submitted plan contains enough detail for the program officer to be able to evaluate compliance.

The NIH anticipates that beginning with RPPRs submitted on or after October 1 2024, a series of standard questions will be added to include updates on the status of data sharing, repositories and unique identifiers for data that have been shared. The questions themselves have not yet been made available. New 

Where can I get help?

More Information:

• Final NIH Policy for Data Management and Sharing (2023)
• FAQs for the NIH Policy for Data Management and Sharing (DMS Policy)
• Supplemental Information: Elements of an NIH Data Management and Sharing Plan (2023)
• Supplemental Information: Allowable Costs for Data Management and Sharing (2023)
• Supplemental Information: Selecting a Repository for Data Resulting from NIH-Supported Research 
• Supplemental Information: Protecting Privacy When Sharing Human Research Participant Data 
• Supplemental Information: Responsible Management and Sharing of American Indian/Alaska Native Participant Data 
• Informed Consent for Secondary Research with Data and Biospecimens Guidance and sample language.

For more information from the UA Libraries, see Data Management Resources