Research Administration

The policy is effective for all NIH funding mechanisms submitted or beginning on or after January 25, 2023. Anyone who has NIH-funded research that generates scientific data is expected to comply with the data management and sharing policy. This is typically research projects, some K awards, small business SBIR/STTR awards and research centers. 

If your research project generates scientific data, and that project is funded by the NIH in whole or part, you will be expected to comply as a condition of your award. 

Scientific Data

The policy defines scientific data 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."

Examples of scientific data include:

• Single-cell RNA sequencing of immune cells in an HIV study
• Electrophysiological recordings and fMRI images in a rodent model of PTSD
• Step activity in a wearable device study of cardiovascular health

Scientific data do not include data not necessary for or of sufficient quality to validate and replicate findings. Also excluded from the policy are 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. 

See also
NIH Data Sharing: Research Covered by the 2023 Data Management & Sharing Policy

The data management and sharing plan must be included as part of your award application, and can be no longer than 2 pages. (An optional data management and sharing plan format page is included in the list of Format Pages and is incorporated into updated FORMS-H application instructions). 

Your plan needs to describe how you will manage scientific data that is collected, and how you intend to make that data available to other research teams. Once approved by the agency's scientific program staff, the plan becomes part of the terms and conditions of your award, and you are required to follow it as written. Any changes will require approval from the program staff. 

UTMB subscribes to the DMP Tool that helps you write your plan with ease. 

Elements of a Data Management and Sharing Plan

Data Type

The description of the data to be preserved and shared. Summarize the types of data you are collecting and the amount that will be generated. You also need to specify which data will be preserved and shared. The NIH does not expect you to preserve and share ALL scientific data generated. You need to decide which scientific data to preserve and share based on the ethical, legal and technical factors. Such factors include informed consent conditions, privacy or safety of participants, contractual exceptions or explicit laws that prohibit disclosure.

While there are some limitations, the expectation is that your plan will be designed to maximize appropriate sharing.

Related Tools, Software, and/or Code

Your plan needs to include the related tools, software and/or code that are needed to access or manipulate the shared data. This supports the reuse or replication of data. Include the names of the needed tools and software, and how to obtain these resources.

Standards

You must outline the data standards you apply to the data and associated metadata, such as data formats, dictionaries, identifiers, definitions and other documentation.

Data Preservation, Access & Associated Timelines

You need to include the name of the repository you will use to archive the data, and how the data will be found and identifiable. 

When considering a repository, you want to consider the following criteria:

• Unique persistent identifiers
• Long-term sustainability
• Metadata
• Curation and quality assurance
• Free and easy access
• Broad and measured reuse
• Clear use guidance
• Security and integrity
• Confidentiality
• Common format
• Provenance
• Retention policy

Once you identify a repository, your plan will need to include a timeline of when the scientific data will be made available and how long it will be available.

When selecting a repository, be sure to check out the SPARC website. It is a free tool that will help guide you through selecting the repository most appropriate for your research and budget. NIH also has a list of more than 70 NIH-supported repositories.

The NIH encourages scientific data to be shared as soon as possible, but no later than the time of publication or end of performance period, whichever comes first. It should be available for as long as you anticipate it being useful to the larger scientific community.

Access, Distribution, or Reuse Considerations

include any factors related to informed consent, privacy and confidentiality, any applicable laws or regulations, and any other factors limiting the extent to which your data can be shared. Any exclusions of data must be justified and that justification must be included in the plan.

Oversight of Data Management & Sharing

This section spells out the details relating to how you manage and monitor the data you collect, and ensure that sharing happens according to the timeline you have set.

See also
NIH Data Sharing: Writing a Data Management & Sharing Plan
How to Use the DMP Tool

While being part of your award application, the data management and sharing plan is not part of your peer review process. It is reviewed and approved by the agency's scientific program staff. However, the budget for implementing your plan is considered as part of the application by the study panel. It will be reviewed to ensure it is appropriate with your project.

When budgeting your data management and sharing costs, consider that allowable direct costs include:

• Curating data/developing supporting documentation
• Repository costs
• Local data management considerations
• 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
• 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.)

These costs must be incurred during the performance period of the award.

See also
NIH Data Sharing: Budgeting for Data Management & Sharing

UTMB subscribes to the DMP Tool, a resource that helps guide you through creating your data management and sharing plan. Use your UTMB log in credentials to access the resource.

NIH Data Sharing (nih.gov)

How to Use the DMP Tool

Complying with the NIH Data Management and Sharing Policy

AAMC Report: Institutional Strategies for the NIH Data Management and Sharing Policy

AAMC Data Management and Sharing website

Research Covered Under the Data Management & Sharing Policy | Data Sharing (nih.gov)

FAQ on Scientific Data ( Frequently Asked Questions (FAQs) | Data Sharing (nih.gov))

Data Management & Sharing Policy Overview | Data Sharing (nih.gov)

FAQ on Justifiable Reasons to Limit Data Sharing ( Frequently Asked Questions (FAQs) | Data Sharing (nih.gov))

Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf (nih.gov)

Sharing Data From Human Participants ( Data Sharing Approaches | Data Sharing (nih.gov))

FAQ on Reusing, Existing Shared Data ( Frequently Asked Questions (FAQs) | Data Sharing (nih.gov))

Writing a Data Management & Sharing Plan | Data Sharing (nih.gov)

Data Management and Sharing Plan Format Page ( NIH Forms & Applications | grants.nih.gov)

Selecting a Data Repository | Data Sharing (nih.gov)

Repositories for Sharing Scientific Data | Data Sharing (nih.gov)

FAQ on When to Share Data: Frequently Asked Questions (FAQs) | Data Sharing (nih.gov)

FAQ on Data Sharing Timelines When a No Cost Extension is Granted: Frequently Asked Questions (FAQs) | Data Sharing (nih.gov)

Budgeting for Data Management & Sharing | Data Sharing (nih.gov)

NOT-OD-22-189: Implementation Details for the NIH Data Management and Sharing Policy

FAQ on Noncompliance: Frequently Asked Questions (FAQs) | Data Sharing (nih.gov)

Which Policies Apply to My Research? | Data Sharing (nih.gov)

NIH Institute and Center Data Sharing Policies | Data Sharing