NIH Issues Final Data Sharing Plan, Effective in 2023

A year after releasing a draft version, NIH on Oct. 29 announced a final data management and sharing policy, but it will not be required of grant applications until January 2023. The policy calls for submission of a plan for data management “outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations.” It also requires investigators to comply “with the awardee’s plan as approved” by NIH. In addition, NIH released three related notices that offer information on the elements of a plan, what costs are allowable, and recommendations “to help researchers choose data repositories suitable for the preservation and sharing of data.”

According to a summary by the Association of American Medical Colleges (AAMC), a data plan “ must be submitted at the time of grant application, which is a change from the earlier proposal for ‘Just-in-Time’ submission (after completion of peer review but prior to funding). The final policy adds the concept of data quality, stating that data should be ‘of sufficient quality to validate and replicate research findings,’ and removes language that indicates that a response of ‘to be determined’ is an acceptable part of a data management and sharing plan,” AAMC said. Additionally, NIH “clarified expectations around when data should be shared. Updating language from the draft policy that data should be made accessible ‘in a timely manner,’ the final policy states that data should be accessible ‘no later than the time of an associated publication, or the end of the award/support period, whichever comes first.’” NIH is keeping a provision in the draft policy that allows “ various NIH institutes, centers, and offices [to] supplement the NIH policy with additional requirements for grantees,” but added in the final policy that the agency wants to “promote consistency on key policy provisions and will further address these concerns during the policy implementation period.”

Link to all NIH data sharing plan notices

Link to AAMC summary