Data Management and Sharing Plan - NIH

The NIH Data Management and Sharing policy will be implemented for the January 25, 2023 proposal deadline and subsequent receipt dates for all new and competing proposals/renewals for projects that generate Scientific Data. This page will be updated as information and resources are made available.

What's new about this policy?

Previously, 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 is entirely new. Beginning in 2023, ALL grant applications or renewals that generate Scientific Data must now 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? Initial steps to consider

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.

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).

Guidance and Resources

NIH repositories for sharing data

Data repository finder tool

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

Budget guidance

Costs to execute the DMSP can be included in the budget as a line item. 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 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.

NIH instructions

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

NIMH resource

National Academies resource

Compliance

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.

Oversight

PIs will be ultimately responsible for ensuring that the project team complies with the DMSP as proposed, and for reporting on compliance in the annual RPPR. SPA will review the RPPR prior to submission.

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.

Additional suggestions and resources for writing your DMSP

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.

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.