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NIH Releases Final Policy on Data Management and Sharing

October 30, 2020

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CONTACTS
Anurupa Dev, Lead Specialist, Science Policy
Heather Pierce, Sr. Director, Science Policy & Regulatory Counsel

The National Institutes of Health (NIH) issued its final policy on data management and sharing on Oct. 29 for data generated from NIH-funded or conducted research. The policy has a two-year implementation period and will go into effect on Jan. 25, 2023.

Accompanying the policy, the agency also released three related notices containing supplemental information on elements of a data management and sharing plan, allowable costs, and repository selection.

In a statement, NIH Director Francis Collins, MD, PhD, noted that the policy “establishes the baseline expectation that data sharing is a fundamental component of the research process, which is in line with NIH’s longstanding commitment to making the research it funds available to the public.”

A policy to promote scientific data sharing has been under development at the NIH for several years. The AAMC previously responded to the agency’s proposed provisions for the policy [see Washington Highlights, Dec. 13, 2018] as well as the draft policy [see Washington Highlights, Jan. 10]. The AAMC additionally commented on desirable characteristics of repositories for managing and sharing data [see Washington Highlights, Mar. 13], the responses to which were used to inform the supplemental materials released by the NIH.

The final policy makes some changes in response to feedback obtained through the public comment period, as detailed in the guide notice. Similar to the draft policy, the final policy does not mandate data sharing, but rather establishes a requirement for submission of and compliance with a data management and sharing plan. This 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.

The agency has also 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.”

The draft policy stated that various NIH institutes, centers, and offices may supplement the NIH policy with additional requirements for grantees. In response to feedback that these varying expectations would be challenging for the research community, the NIH has stated in the final policy that they intend to promote consistency on key policy provisions and will further address these concerns during the policy implementation period.

In a blog post, NIH Associate Director for Science Policy Carrie Wolinetz, PhD, wrote that the policy is intended to strike “a balance between reasonable expectations for data sharing and flexibility to allow for a diversity of data types and circumstances.”

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