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Research Data Management: New 2023 NIH Data Sharing Policy


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Overview of 2023 NIH Data Management and Sharing Policy

The National Institutes of Health (NIH) has issued a Final NIH Policy for Data Management and Sharing to promote the sharing of scientific data. Starting on January 25, 2023, NIH requires researchers to submit a plan outlining how scientific data from their research will be managed and shared. The policy also establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. 

The new policy requires submission of a 2-page (max) Data Management and Sharing Plan (DMSP) describing the following:

  1. Data type
  2. Related tools, software, and/or code
  3. Standards
  4. Preservation, access, and associated timelines 
  5. Access, distribution, and reuse considerations
  6. Oversight of data management and sharing

NIH has provided supplemental resources to help the research community prepare for the new policy. These include: 

Choosing a Data Repository

NIH strongly encourages the use of established repositories for preserving and sharing scientific data. Prioritize your search for a repository according to the following criteria:

  1. Check the FOA (Funding Opportunity Announcement) or NIH Institute, Center, Office (ICO) policy for particular data repositories (or sets of repositories) to be used to preserve and share data.
  2. If no data repository is specified by the FOA or ICO policy, researchers are encouraged to select a data repository that is appropriate for the data generated from the research project. 
    • Primary consideration should be given to data repositories that are discipline or data-type specific to support effective data discovery and reuse. For a list of NIH-supported repositories, visit Repositories for Sharing Scientific Data.
    • If no appropriate discipline or data-type specific repository is available, researchers should consider a variety of other potentially suitable data sharing options: 
      • Data repositories, including generalist repositories (such as UC's Dryad data repository) that make data available to the larger research community, institutions, or the broader public. 
      • Small datasets (up to 2 GB in size) may be included as supplementary material to accompany articles submitted to PubMed Central (instructions).
      • Large datasets may benefit from cloud-based data repositories for data access, preservation, and sharing.

FAQ for NIH 2023 DMS Policy

For additional background, also view NIH's FAQ about the new policy.

General Data Sharing 

NIH promotes data sharing as a way to accelerate biomedical research discovery, enable validation of research results, provide access to high-quality data, and promote data re-use for future studies.

Request a consultation  for NIH data policy and data management-related questions, or email Data Curation Librarian Wasila Dahdul (wdahdul@uci.edu) for assistance. A template with guidance and sample language is also available to help researchers write NIH-compliant plans (see Box to right)

NIH strongly encourages researchers who work with sensitive topics and/or populations to address data sharing in the Informed Consent process. Researchers should also pay special attention to their de-identification process to ensure that all identifying information has been fully removed. Finally, researchers should consider depositing their data in restricted access repositories that require data use agreements and research plans in order to access the data.

While sharing data can lead to scooping, this is very rare. If you are worried about scooping you may want to hold off publishing your data until your associated publication is ready to be published. Some repositories have a "private for peer review" option which allows you to make your data available to peer reviewers but not fully publish your data until the article has been accepted.

 

NIH 2023 Data Sharing Policy 

The final NIH 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. 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.” Even those scientific data not used to support a publication are considered scientific data and within the final DMS Policy’s scope.

No. NIH prefers that scientific data be shared and preserved through repositories rather than kept by a researcher and provided upon request.

NIH program staff will assess the DMS plans but peer reviewers may comment on the proposed budget for data management and sharing.

NIH encourages the use of established repositories. To select a repository relevant to your data consider:

  1. Is there a specific NIH repository named in the funding announcement?
  2. Is there a data repository specific to your discipline?
  3. If not, is there a general data repository you can use? Consider using the Dryad digital repository 
For additional guidance, see NIH supplemental information on Selecting a Resository 

 

A standard specifies how exactly data and related materials should be stored, organized, and described. In the context of research data, the term typically refers to the use of specific and well-defined formats, schemas, vocabularies, and ontologies in the description and organization of data. However, for researchers within a community where more formal standards have not been well established, it can also be interpreted more broadly to refer to the adoption of the same (or similar) data management-related activities, conventions, or strategies by different researchers and across different projects.

NIH encourages scientific data be shared as soon as possible, and no later than time of an associated publication or end of the performance period, whichever comes first.

Allowable costs can include:

  1. data curation and developing documentation (formatting data, de-identifying data, preparing metadata, curating data for a data repository)
  2. data management considerations (unique and specialized information infrastructure necessary to provide local management and preservation before depositing in a repository)
  3. preserving data in data repositories (data deposit fees)
For additional information, see NIH supplemental information on allowable costs 

 

The NIH has said that NIH Program Staff will be monitoring compliance with the policy during the funding period. “Noncompliance with Plans may result in the NIH ICO adding special Terms and Conditions of Award or terminating the award. If award recipients are not compliant with Plans at the end of the award, noncompliance may be factored into future funding decisions.” See full NIH FAQ for more details 

Templates and Sample Plans

Sample Plans

  • NIH has provided Sample DMS Plans that apply to different research contexts and NIH ICOs. 

Templates

Webinars on the new policy

Learn more about the new 2023 NIH data policy and resources available through UCI Libraries.

Writing a Data Management and Sharing Plan for NIH, UC Love Data Week, February 2023
Presented by Wasila Dahdul (UCI) and Ariel Deardorff (UCSF)
View recording and materials via Box

Managing and Sharing Data for NIH Projects, UC Love Data Week, February 2023
Presented by Wasila Dahdul (UCI), Derek Devnich (UCM), Ho Jung Yoo (UCSD), Reid Otsuji (UCSD)
View on Vimeo

The New 2023 NIH Data Management and Sharing Policy. November 2022, hosted by the School of Medicine, Office of Research. 

Webinar recordingSlides

Need more help?

Request a consultation for NIH data policy and data management-related questions, or email Data Curation Librarian Wasila Dahdul (wdahdul@uci.edu) for assistance.

Resources

The DMPTool is a free resource that helps researchers create data management plans (DMPs) necessary to meet institutional and funding agency requirements. It provides customized templates for creating DMPs that guide researchers in addressing data-related requirements. 

Dryad is a curated digital repository that makes a wide variety of data types accessible, reusable, and citable. Researchers can submit their datasets independently or as part of a manuscript submission for its partner journals.

Click here for more info on publishing your data with Dryad