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AMIA urges NIH to dramatically revise draft data management and sharing policy to maximise value of scientific data -

The American Medical Informatics Association (AMIA) recently warned the National Institutes of Health (NIH) that its proposed data management and sharing policy would be detrimental to data-driven discovery and lead to increased compliance burdens for researchers. The organisation provided dozens of recommendations for how the draft should be revised to better reflect FAIR (Findable, Accessible, Interoperable, and Re-usable) data principles, better leverage data to advance retrospective and observational research, and strengthen the reproducibility of all NIH-funded projects.

In October 2018, the NIH issued a Request for Information (RFI) on Proposed Provisions of a Draft Data Management and Sharing Policy for NIH Funded or Supported Research, which gave stakeholders a preview of how the NIH was looking to update its 15-year-old existing NIH Data Sharing Policy. AMIA submitted comments in December 2018 encouraged by NIH efforts to update the 2003 data sharing policy and noted that ‘quality data management and sharing plans are prerequisite to achieve the vision of FAIR data principles and such a scope should be the long-term goal of the NIH policy.’ AMIA also noted that a key deficiency in the existing policy was that grant applications are not scored on the quality of their data sharing plans. This has led to suboptimal and incomplete sharing plans, and likely has contributed to so-called ‘data silos’ and increased scrutiny over whether and how NIH-supported research data is made available to other researchers and the broader public.

Nearly a year later, in November 2019, the NIH issued a follow-up Request for Public Comments (RFC) on a DRAFT NIH Policy for Data Management and Sharing and Supplemental DRAFT Guidance. A side-by-side comparison of the 2018 and 2019 proposals reveal very few substantive changes, despite structural changes to carve out 2018 policies as 2019 guidance documents. This prompted AMIA to issue a preliminary statement November 12, 2019, voicing disappointment with the second iteration. Upon closer examination, AMIA identified several critical issues with the proposed data management and sharing policy (DMSP).

Specifically, the NIH policy continues to undervalue the importance of data management and sharing as an essential part of modern research. It envisions a two-page plan developed after a project has been chosen to receive funding, perpetuating a check-the-box exercise that will only make the task of managing ever-growing volumes of data more difficult. The draft policy also positions individual NIH Institutes, Centers, and Offices (ICOs) to develop their own specific DMSPs without adequate instruction on key tenets to follow.

AMIA recommended the NIH revise its draft DMSP to achieve three core goals - Optimise scientific data once generated; incentivise improvements in data management and sharing practices; and coordinate disparate Institute, Center, and Office policies. To achieve these goals, AMIA recommended that the NIH finalise an NIH-wide DMSP over the course of three years that positions NIH ICOs to develop their own requirements, subject to approval by the NIH Office of Data Science Strategy and the Office of Science Policy.

AMIA also encouraged the NIH to take a stronger leadership position in establishing guardrails for ICOs by requiring ICOs to factor the quality of grantees’ Plans into the overall impact score through a peer-review process for those grants that are supported at high levels or focused on programmatic priorities; identify and incentivise deposition of scientific data in endorsed depositories and knowledgebases; and establish graduated Plan requirements based on funding levels, subject to the aforementioned NIH review.

Last, AMIA recommended the NIH establish a funding policy for data management and sharing activities that earmarks a percentage (at least 5 percent) of a grant award for such activities, rather than merely allow for such activities to be included in NIH budget requests.

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