Data Management and Sharing Plan - NIH

NIH expects researchers to maximize the appropriate sharing of scientific data, taking into account factors such as legal, ethical, or technical issues that may limit the extent of data sharing and preservation.

A DMSP must be submitted as part of the funding application for all new and competing proposals/renewals that generate Scientific Data for January 25, 2023, and subsequent receipt dates. 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 timeline. If you have an active NIH award going up for renewal, 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. Become familiar with the policy and the related resources provided by the NIH including the application instructions. 

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. Determine which NIH data-sharing policies apply to your research.

• This Data Management and Sharing Policy applies to all research that generates scientific data, including research projects, some career development awards, small business awards (STTR/SBIR), and research centers.
• Data Management and Sharing Plan vs. Resource Sharing Plan

5. Assess your project and data management and sharing practices relative to the policy, especially around documenting existing practices and developing new ones to address the increased emphasis on data sharing and administrative oversight. Determine whether there are any limitations on sharing your data and be prepared to address these limitations in the DMSP. Look at whether your IRB protocol submission will need to be updated in light of data-sharing expectations.

6. Review campus data services (e.g., computing, storage, consulting) and assess whether they will meet your needs. Also, consider costs you may need to include in the budget, such as labor for data cleaning and documentation (see the NIH-provided supplement on allowable costs).

• resources from the UMB Institute for Clinical & Translational Research
• resources from the UMB Health Services and Health Sciences Library
• resources from the UMB School of Pharmacy

NIH repositories for sharing data

Data repository finder tool

NHLBI-specific policy

DMS Plan Blank Format Page - NIH has developed an optional format that aligns with the recommended elements of the DMSP.

The DMSP should address the following recommended elements and are recommended to be two pages or less in length:

• 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.

NIH resource on Elements to Include in a Data Management and Sharing Plan

DMP Tool:  The DMPTool is an online system that helps you create data management plans compliant with funder guidelines. To log in to the tool, go to DMPTool.org and log in by (1) clicking Sign In, and (2) selecting the institutional login option. You can then log in with your UMB credentials.

UMB Policy Regarding Ownership, Management, and Sharing of Research Data

Costs to execute the DMSP can be included in the budget. Include a brief justification of the proposed activities proposed in the DMSP that will incur costs. Allowable costs include labor for data curation, preservation, de-identification, and more.

Any costs related to complying with the policy must be paid for during the performance period. For example, costs for long-term data preservation may be budgeted for in the proposal and paid before the end of the grant.

NIH instructions

NIH application form instructions - search for Special Instructions for Applications Submitted with a Data Management and Sharing (DMS) Plan

NIH NOT-OD-23-161:  NIH Application Instruction Updates – Data Management and Sharing (DMS) Costs

NIMH resource

National Academies resource

You must comply with the NIH-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.

If you make changes to your submitted plan, your new plan must be re-approved by NIH. The approval process depends on whether the change is made pre-award or post-award.

PIs will be ultimately responsible for ensuring that the project team complies with the DMSP as proposed, for reporting on compliance in the annual RPPR, and for initiating prior approval requests for changes to the DMSP.

HRPO/IRB will be responsible for ensuring that the sharing of data pertaining to human subjects is consistent between the DMSP and informed consent.

PIs and SPA will be responsible for ensuring appropriate data use agreements (DUAs) are in place before sharing sensitive data. The request for a DUA must be initiated by the PI.

For a data-intensive project, consider including a data manager on the project team to oversee data collection, storage, and sharing.

Consider the following:

• Who will initiate requests to execute DUAs?
• Who will oversee compliance with each DUA?  
• Who will ensure that data are deidentified (when relevant)?
• Who will work with CITS or your School IT to ensure the secure transmission of data?

Work with your School IT and CITS to discuss cloud storage, data transmission, and other data services to assess whether and how their data services will meet your needs.

Establish what data need to be managed and by whom (see the definition of Scientific Data above or in the policy). NIH expects that data are of sufficient quality to validate and replicate research findings. NIH expects researchers to maximize the appropriate sharing of scientific data, taking into account factors such as legal, ethical, or technical issues that may limit the extent of data sharing and preservation.

Of the data being collected, which datasets would be subject to additional privacy controls? Who will manage such controls? Who will have access?

If you have a Data Use Agreement, ensure that the agreement allows for de-identified data sharing and/or sharing of derived datasets, if possible.

If your research involves human subjects, ensure that consent forms contain appropriate language that will allow de-identified data sharing.

• NOT-OD-22-213 - Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data
• NIH resource for developing informed consent language in research studies where data and/or biospecimens will be stored and shared for future use.

You will need to share your data when you publish your work or before your award performance period ends, whichever comes first. In general, you should make your data accessible as soon as possible. You can also use relevant requirements and expectations such as data repository policies, award record retention requirements, or journal policies, to decide when to share your data sets.

The policy does not state specific requirements for how you share your data. When you share your data, you should address the NIH’s goal of making data as accessible as possible. The NIH expects all shareable data to be made available, whether associated with a publication or not. 

All data used or generated as part of a grant must be managed, but not all data should be shared. You should not share data if doing so would violate privacy protections or applicable laws. 

Changes to an approved Data Management and Sharing (DMS) Plan must be submitted using the Prior Approval Module in eRA Commons. 

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) require the recipient to submit a timely formal prior approval request to the funding NIH Institute, Center, or Office (ICO). These prior approval requests are submitted through the Prior Approval Module in eRA Commons. Emails and other communications are not acceptable.

eRA Commons Prior Approval – Other Request Instructions

• 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.  

All uploaded documents must be in PDF format.

The request must be submitted by a Signing Official in Sponsored Programs Administration (SPA).  Contact the SPA Proposals Team with any questions about the process.