By: Pamela Shaw, Biosciences & Bioinformatics Librarian

Since 2003, the National Institutes of Health (NIH) has created policies for data sharing and management, and these policies have been revisited, revised, and updated as the biomedical data landscape has changed. In 2019, the NIH released its draft of a data management and sharing policy. After a period for public comment and NIH review, the final NIH Policy for Data Management and Sharing was released on October 29, 2020.

• Effective date: The policy will take effect for all proposals submitted or executed on or after January 25, 2023 (depending on proposal type)
• Scope: the policy applies to all research funded or conducted – in whole or in part – by the NIH
• Requirements: NIH awardees must submit a Data Management and Sharing plan that outlines how data and metadata will be shared, accounting for restrictions and limitations; compliance with the awardee’s proposed plan
• Page limit for plan: two pages
• Where, in the proposal, the plan should be included:
  • In the Budget Justification section for extramural awards
  • In the technical evaluation (performed by NIH-ICO staff) for contracts
  • Submitted prior to release of funds for other funding agreements
• Repository selection: The NIH encourages the use of “established repositories” for sharing data
  • Consider using DigitalHub, the repository for Northwestern Feinberg School of Medicine’s scholarly and research products. See our guide on “Getting Started with DigitalHub"; for a quick step-by-step process for uploading datasets. Also check out the guide’s information on “Research Data Sharing with DigitalHub” for helpful tips and links.
• Considerations for human subjects data: Little has changed for human subjects data requirements. Investigators are required to follow rules for protecting privacy, rights, and confidentiality previously outlined in the NIH’s 2014 Genomic Data Sharing (GDS) Policy, 2015 Intramural Research Program Human Data Sharing Policy, and 45 CFR 46
• Timeline requirements for sharing and preserving data:
  • NIH-funded data should be made “accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first.”
  • Timelines for how long to make shared data available are less specific, subject to considerations for the value of the shared data and repository or journal requirements. The NIH will provide a framework to assist researchers in determining the minimum sharing time period.
• All plans will be reviewed by the appropriate NIH Institute, Center or Office (NIH-ICO), though peer reviewers may supply comments that can inform NIH-ICO review.

More details are available in the policy, available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html

We encourage all Feinberg investigators to familiarize themselves with the final policy, and begin practice of writing good data management and sharing plans before the effective date of the policy. Galter Library offers classes and guides to help Feinberg researchers manage and share their data effectively. Data Librarian Sara Gonzales also provides expert guidance and advice in good data practice, including consultation on writing data management plans.