Forthcoming NIH Data Management and Sharing Policy

Posted on by Anna Sackmann

On January 25, 2023, the National Institutes of Health (NIH) will implement a new Data Management and Sharing Policy. The Library Data Services Program and Research Data Management Program have several resources to help you adapt to the new policy, including extensive guidance and suggested language for writing a plan. Additionally, the DMPTool, which is free for UC Berkeley users and supported by the Library Data Services Program, walks grant applicants through the plan requirements. We will be offering four drop-in workshops designed for researchers this fall. Please register using for the workshops using the links below:

 

 

The NIH is a leader in implementing data management plans and was the first federal granting agency to do so with their 2003 NIH Sharing Policy. In the years since, the agency developed two genomic data sharing policies (2008 and 2014), and addressed data sharing in clinical trials in 2016. The new data sharing policy builds on their existing data management requirements and is broadly sweeping with the goal to maximize the “…sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions.” 

 

The new policy will apply to all research funded (in whole or in part) by the NIH that produces scientific data. It will apply to grant applications submitted on or after January 25, 2023. The NIH 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…” Please note that the NIH definition of scientific data does NOT include the following: 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.

 

There are a few aspects that set the new NIH DMSP apart from current policy:

  • Plans will outline how data and metadata will be managed over the course of the project and which of these data will be shared.
  • Grant applicants will need to include details about software or other tools that were used to analyze the data.
  • If generating data derived from human participants, plans will need to outline how confidentiality, privacy, and rights of those individuals will be preserved.
  • Plans must include a selected repository or repositories where the data will be preserved along with a timeline for sharing the data (either as soon as possible, no later than the time of an associated publication, or at the end of performance period if there is no associated publication). 
  • Updates to plans over the course of the project will be reviewed by the NIH ICO (institute, center, or office) during regular reporting intervals.
  • Data management costs may be added to the grant budget including data curation and developing documentation (e.g., formatting data, de-identifying data); data management considerations (e.g., unique and specialized information infrastructure necessary to provide local management and preservation before depositing in a repository); preserving data in data repositories (e.g., data deposit fees).
  • Compliance with plans will be measured during the funding period at regular reporting intervals.

 

Please see our list of frequently asked questions. For additional information about the policy, please see the NIH page on Data Management and Sharing Policy. 

Many thanks to Elliott Smith, Michael Sholinbeck, and Erin Foster for all of their expertise and contributions!

If you have any questions or need additional support, please email librarydataservices@berkeley.edu.