RESEARCH DATA MANAGEMENT SERVICE GROUP
Comprehensive Data Management Planning & Services

National Institutes of Health

What is required?

The NIH requires a two-step process as part of its data policy:

  1. A data sharing plan is required with the grant proposal for all proposals over $500,000. Some NIH programs and program policies require a data sharing plan regardless of award amount.*
  2. Dataset(s) supporting funded research should be deposited in an appropriate data repository as described in the data management plan.​

* As of January 25, 2023, a data management and sharing plan will be required for all research generating scientific data.

What do I need to submit as part of my proposal?

  • Each project proposal must include a Data Management and Sharing Plan (DMS) outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations. 

What is a data management and sharing plan (DMS)?

Data management and sharing plans should explain how scientific data generated by research projects will be managed and which of these scientific data and accompanying metadata will be shared. NIH encourages data management and sharing practices to be consistent with the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles and reflective of practices within specific research communities.

Researchers planning to generate scientific data are required to submit a plan to the funding NIH ICO as part of the Budget Justification section of the application for extramural awards, as part of the technical evaluation for contracts, as determined by the Intramural Research Program for Intramural Research Projects consistent with the objectives of this Policy, or prior to release of funds for other funding agreements.

If Plan revisions are necessary (e.g., new scientific direction, a different data repository, or a timeline revision), Plans should be updated by researchers and reviewed by the NIH ICO during regular reporting intervals or sooner. Plans from NIH-funded or conducted research may be made publicly available and should not include proprietary or private information. (See Final NIH Policy for Data Management and Sharing)

For some programs and data types, NIH and/or NIH Institutes, Centers, or Offices (ICOs) have developed specific data sharing expectations (e.g., scientific data to share, relevant standards, repository selection, timelines) that apply and should be reflected in a Plan. When no additional NIH and/or NIH ICO data sharing expectations apply, the NIH recommends addressing all Elements of an NIH Data Management and Sharing Plan, and the plan may include the following:

  1. Data Type: Briefly describe the scientific data to be managed, preserved, and shared.
  2. Related Tools, Software and/or Code: An indication of whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software.
  3. Standards: An indication of what standards will be applied to the scientific data and associated metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation).
  4. Data Preservation, Access, and Associated Timelines: Plans and timelines for data preservation and access, including repositories, how data will be findable, and when it will be available.
  5. Access, Distribution, or Reuse Considerations: NIH expects researchers to maximize the appropriate sharing of scientific data generated from NIH-funded or conducted research, consistent with privacy, security, informed consent, and proprietary issues. Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data.
  6. Oversight of Data Management and Sharing: Indicate how compliance with the Plan will be monitored and managed, frequency of oversight, and by whom (e.g., titles, roles).

When do I need to share my data? 

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. NIH encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.

Where can I deposit my data? 

There is currently no designated NIH repository for data, however a number of programs and center data sharing policies do specify repositories.

The NIH encourages deposit into repositories that support effective data discovery and reuse, and provides guidance for Selecting a Repository for Data Resulting from NIH-Supported Research, as well as lists of recommended repositories:

Researchers should discuss their plan for preservation of access to data resulting from the project in their Plan.

How do I submit? 

Before submitting your data to your chosen repository, you will need to ensure you've completed these steps.

  • De-identify your data if appropriate.
  • Put your data in an open, machine-readable file format such as .csv.
  • Document the dataset thoroughly in a separate readme.txt file, and/or create metadata according to the scheme required by your chosen repository.
  • Obtain a DOI or other permanent identifier for the dataset from your chosen repository.
  • Follow the upload instructions for your chosen repository.

See our Best Practices topics for help with these steps, or contact us for help.

Are there any compliance requirements?

  • Research proposals without a Plan will not be considered for funding. 
  • Failure to provide updates in grant reporting may result in an enforcement action, including additional special terms and conditions or termination of the award, and may affect future funding decisions.  
  • Failure to deposit data after the end of the funding period may negatively influence future funding opportunities. 

More information

Implementation

The NIH Data sharing policy went into effect in 2003; the latest update was on October 29, 2020. 

 

Page last updated Nov 2020