2025 Federal Administration Transition Information & Resources - This will be updated as new information is available.

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NIH Data Management and Sharing Policy guidance

On January 25, 2023, the National Institutes of Health (NIH) will require the submission of a Data Management and Sharing Plan (DMS) with new proposals for projects generating scientific data. Note that this new policy does not apply to:

 

  • Training (T)
  • Fellowships (Fs)
  • Construction (C06)
  • Conference Grants (R13)
  • Resource (Gs)
  • Research-Related Infrastructure Programs (e.g., S06)
  • Start planning now for the selection of the appropriate repository for data sharing and secondary uses.
  • Note that non-compliance with this new requirement for a DMS plan could result in your proposal not moving forward for scientific review
  • Resources and support are available through the Lane Library. 

The information below is for NIH-sponsored PI and their research teams, and staff responsible for supporting sponsored research. 

What are the new NIH requirements?  

From January 25, 2023, the National Institutes of Health (NIH) will require all new proposals that involve the generation of scientific data to include a 2-page Data Management and Sharing Plan (DMS). This information must be provided in  a new “other Plan(s)” attachment field in the PHS 398 Research Plan form. Applicants must attach the DMSP/DMP in this new field in FORMS-H applications.

The plan must include six elements (as specified in NOT-OD-21-014): 

  1. Data Type
  2. Related Tools, Software, and/or Code
  3. Standards
  4. Data Preservation, Access, and Associated Timelines
  5. Data Access, Distribution, or Reuse Considerations
  6. Oversight of Data Management and Sharing

Getting Assistance

The VPDoR, School of Medicine, and a community of Stanford-led teams are partnering to coordinate support for principal investigators and research teams across campus who are preparing new proposals for the coming funding cycle. 

Resources are available to Principal Investigators and research teams that will be affected by these changes. 

How should I prepare?

Researchers who foresee submitting new proposals for data-generating studies should start planning now, by prioritizing the following: 

  • Selection of the appropriate repository for data sharing and secondary uses; 
  • Planning for curation, deposit, local management, preservation, and sharing of data (if applicable). This includes building the costs of these activities into project budgets.  (Information regarding categories of allowable costs can be found here.) 
  • Preparing to draft a DSMP/DMP (Data Sharing and Management Plan/Data Management Plan) to be included in submissions on or after 1/25/23. DMPs must account for human subjects protections and privacy. If your project involves data derived from human participants, it is paramount that researchers uphold six operational privacy principles in developing the plan and throughout the project: 
  1. Proactive assessment of protections
  2. Clear communication of data sharing and use in consent forms
  3. Considerations of justifiable limitations on data sharing
  4. Institutional review of the conditions for data sharing
  5. Protections for all data used in research
  6. Remaining vigilant regarding data misuse 

Where do I find information to help me estimate repository costs?

Costs depend on the repository selected and the size of the data sets to be stored.  NIH provides a list of approved domain-specific and generalist repositories. In addition, Stanford provides DMP consultation services to assist in creating a budget for your data management needs and free archival of data in the Stanford Digital Repository, which meets or exceeds NIH repository requirements. 

The National Academies of Science Engineering and Medicine have posted resources to help researchers forecast biomedical data sharing costs.

Is there guidance on designating data for ‘controlled access’ v ‘openly without access restrictions?

Yes.  The Policy provides points to consider factoring into controlled access decisions.

Are there tips and guidance for generating high-quality metadata, preparing files for sharing, and documentation? 

Yes. Through the Generalist Repository Ecosystem Initiative (GREI), the NIH Office of Data Science Strategy has created a publicly available webinar series on repository sharing best practices. 

What about data curation resources?

In addition to DMP data management services provided by the Stanford University Library and Lane Library, the following external links describe curation and archival services using various cost and delivery models including:

See this chart comparing generalist repositories.

What resources are available to help me?

  • If you have questions about the policy’s provisions concerning privacy, security, or ELSI (ethical, legal, or social implications), please e-mail Scott Edmiston scotted@stanford.edu
  • The Lane Library in the School of Medicine has created a resource guide accessible to anyone interested in gaining better knowledge on the process.
  • The Stanford Data Farm is a research tool built on the Redivis platform enabling a host of features aligned with NIH requirements, such as persistent identifiers, logging/auditing, governance, privacy, security, and secure analytics for a variety of structured and unstructured data types.

Additional sources of information and assistance: 

We continue to monitor the changes and encourage you to stay connected to the Research Administrators in your schools for additional updates. 

David Studdert, LL.B., ScD

Senior Associate Vice Provost for Data Resources and Professor of Health Policy and of Law

 

Cindy Kiel 

Associate Vice Provost for Research Policy and Integrity

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