NIH Data Management and Sharing Policy

DMS Plans should be included within the “Other Plan(s) field on the PHS 398 Research Plan or PHS 398 Career Development Award Supplemental Form as indicated in the Application Instructions. Hyperlinks are not permitted in the DMS Plan attachment. Including them could lead to an application being withdrawn from consideration.

Developing and Formatting Plans

NIH recommends the plan be two pages or less and must include these 6 key elements:

• Element 1: Data Type
• Element 2: Related Tools, Software, and/or Code
• Element 3: Standards (ex: data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation)
• Element 4: Data Preservation, Access, and Associated Timelines
• Element 5: Access, Distribution, or Reuse Considerations
• Element 6: 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 the NC State University Libraries Data Management resource page and access other NC State University resources on the Research Education Researcher Resources webpage. 

NIH has provided Sample Plans for how a DMS Plan could be completed in different contexts, conforming to the elements described above. 

To draft the plan itself, we recommend the DMPTool. To access the DMPTool, log in with your Unity ID and password and select NIH as the funder which will launch the NIH-GEN DMS Plan 2023 template. Additional guidance for completing each section of the template will be added to the DMPTool on a rolling basis.

FDP NIH DMS Pilot templates are now available in DMPTool for any individual needing to create an NIH DMS Plan. Individuals using DMPTool to create a DMS Plan will now see three options when selecting NIH as the primary funding organization.

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 (see NOT-OD-23-161). To request funds toward DMS costs, investigators should include:

• DMS costs 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.
•  Specify estimated DMS cost details within the “Budget Justification” attachment of the R&R Budget Form or “Additional Narrative Justification” attachment of the PHS 398 Modular Budget Form, pursuant to the instructions. The recommended length of the justification should be no more than half a page (see Application Instructions for details). 

The budget justification should expand upon the activities proposed in the DMS Plan that will incur costs. Be sure to include:

• a brief summary of the type and amount of scientific data to be preserved and shared
• the name of the established repository(ies) to be used; and
• general cost categories

Clearly indicate what portion of the DMS costs are being proposed by the prime recipient vs. any subrecipients. Specify the subrecipient’s F&A on their direct DMS costs in that breakdown. 

Investigators whose research projects are also subject to the Genomic Data Sharing (GDS) Policy should also include requested costs for genomic data management and sharing (see NOT-OD-22-198).

Forms-H guidance requires “0” be entered in the R&R Budget, with a justification detail provided that states, “No costs for data management and sharing are requested” if no costs are requested.

NIH has provided guidance on what costs related to data management and sharing are allowable and unallowable. The associated costs will depend on the type of research and data involved in your proposal.

The NC State University Libraries provide many resources free of charge. While free services do not need to be included in the budget, please consider contacting the managing office prior to including them in your DMS Plan (e.g., repositories). See the following section for what kinds of services and tools are available to you.

Reasonable, allowable costs may be included in NIH budget requests for:

• Curating data
• Developing supporting documentation
• Formatting data according to accepted community standards, or for transmission to and storage at a selected repository for long-term preservation and access
• De-identifying data
• Preparing metadata to foster discoverability, interpretation, and reuse
• Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (for example, before deposit into an established repository).
• Preserving and sharing data through established repositories, such as data deposit fees. 
• If the Data Management & Sharing (DMS) plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.

Note: All allowable costs submitted in budget requests must be incurred during the performance period, even for scientific data and metadata preserved and shared beyond the award period. For example, costs for long-term data preservation must be budgeted for in the proposal and paid before the end of the grant. A review of the NIMH Data Archive (NDA) cost estimation worksheet or the publication Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data may be helpful in determining the costs associated with data management and sharing.

Budget requests must NOT include:

• Infrastructure costs that are included in institutional overhead (for instance, Facilities and Administrative costs) 
• Costs associated with the routine conduct of research, including costs associated with collecting or gaining access to research data. 
• Costs that are double charged or inconsistently charged as both direct and indirect costs

Note: Please keep in mind if you are planning to budget services provided at NC State University, those services or rates need to comply with the University Regulation 10.05.09, to be an approved service center rate that can be applied to a federal sponsor/project. 

For additional guidance on how and where to include these costs in both the Modular or R&R Budget and their associated justifications, please see below also found at sharing.nih.gov, Budgeting for Data Management and Sharing. 

Datasets should be shared through established data repositories to improve the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data.

NIH has recommended a number of relevant repositories for use, however, your data may or may not be appropriate for an NIH repository. You should also consider data repositories supported by other organizations, both public and private. Not all of these repositories offer free services. 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 and NC State University’s Library’s guide to Data Repositories. The NC State University Libraries is an Institutional Member of the Dryad Digital Repository, a platform that makes research data discoverable, freely reusable, and citable.

The 2023 NIH DMS Policy requires data to be shared with a publication or before the period of performance ends, whichever comes first.

Generally, data should be made accessible as soon as possible.

Program staff at the proposed NIH Institute or Center (IC) will assess DMS Plans to ensure the elements of a DMS Plan have been adequately addressed and to assess the reasonableness of those responses. Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.

During peer review, reviewers will not be asked to comment on the DMS Plan nor will they factor the DMS Plan into the Overall Impact score, unless sharing data is integral to the project design and specified in the Funding Opportunity Announcement (see NOT-OD-22-189).

Note: If the DMS Plan cannot be approved as provided in the application, applicants will be notified that additional information is needed. This will occur through the Just-in-Time (JIT) process. If needed, applicants should submit a revised DMS Plan. Refer to NIH Grants Policy Statement Section 2.5.1 Just-in-Time Procedures for additional guidance.

The ICO-approved plan will be incorporated as a term of award and compliance will be required. Compliance with the approved plan will be monitored through 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. 

NIH recognizes that plans may need to be updated or revised over the course of a project for a variety of reasons:

• The research is moving in a new scientific direction
• A more appropriate data repository becomes available
• The data-sharing timeline shifts

The funding NIH ICO will need to approve all changes to the Plan.

Effective October 12, 2023 any changes to an approved Data Management and Sharing Plan (DMS Plan) (for funded awards subject to the Final NIH Policy for Data Management and Sharing (DMS) Policy) requires the recipient to submit a timely formal prior approval request to the funding NIH Institute, Center, or Office (ICO). This notice also informs the community that recipients must submit these requests through the Prior Approval Module in eRA Commons (see NOT-OD-23-185).

Instructions for submitting through the Prior Approval Module: 

• 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.  

Uploaded documents must be in PDF format.

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. The currently approved DMS Plan remains in effect for the award until the request is approved by the funding NIH ICO.

It is the PI’s responsibility to update the Plan to reflect any changes. Submission of the request for changes in the eRA Commons  Prior Approval Module should be initiated by submitting a PMR request type “Other”.

At NC State University, institutional oversight is managed by the PI, College Research Office, and Sponsored Programs and Regulatory Compliance Services as follows:

Principal Investigators’ responsibilities include:

• creating a DMS plan to include with the proposal submission, as applicable.
• identifying any sensitive data generated or utilized during the course of the project and coordinating with the College Research Office and Sponsored Programs and Regulatory Compliance Services to put appropriate controls and procedures in place.
  • all NIH-sponsored IRB protocols will undergo annual renewal approval by the NC State IRB office. As a part of the annual process, NC State researchers will submit an update to their approved IRB protocol regarding DMS Plan items. The IRB will provide an approval renewal letter for submission to NIH.
• monitoring compliance with the approved DMS Plan, including identifying appropriate professional staff to help implement the approved plan.
• reporting on examination and oversight of data sharing and storage at least annually to meet the Research Performance Progress Report (RPPR) requirement.
• identifying any changes to the DMS plan and working with the College Research Office and Sponsored Programs and Regulatory Compliance Services to communicate the changes to NIH through the Prior Approval Module in eRA Commons.

College Research Offices responsibilities include:

• ensuring a data management plan is submitted at proposal stage, when applicable.
• confirming compliance with the plan is addressed in any subsequent RPPR submitted.
• collaborating as necessary with Sponsored Programs and Regulatory Compliance Services.

Sponsored Programs and Regulatory Compliance Services responsibilities include:

• negotiating and executing data use agreements for sensitive data as applicable.  
• ensuring consistency between DMS plan and applicable data use agreement terms, communicating any off-cycle changes to the approved DMS Plan to NIH 

Specifically, IRB responsibilities include:

• ensuring that the sharing of data pertaining to human subjects is consistent between the DMS Plan and informed consent.