AMIA Urges NIH to Revise Proposed Data Management, Sharing Policy

The American Medical Informatics Association (AMIA) is recommending that NIH dramatically revise its data sharing and management proposal to maximize the value of scientific data.

In October 2018, NIH issued a request for information to update its 15-year-old existing NIH Data Sharing Policy. In December that same year, AMIA submitted comments to NIH in support of an expansive update to the institute’s data sharing policy.

At the time, AMIA 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 has likely contributed to “data silos” as well as scrutiny about how NIH-supported research data is made available to other researchers and the public.

In November 2019, NIH issued a follow-up request for information on its data sharing and management policy. A comparison of the 2018 and 2019 proposals reveal very few changes, AMIA noted.

“We fear these proposals will increase researcher burden and reinforce data silos,” said AMIA Vice President of Public Policy, Jeffery Smith, MPP. “Given recent advances in computing power and storage capacity, the NIH must use this policy to facilitate new data-driven discoveries, continuous learning, and breakthroughs in treatment.”

AMIA stated that specifically, the new proposed policy continues to undervalue the importance of data management and sharing as an important part of modern research. The policy envisions a two-page plan developed after NIH has chosen to fund a project, which AMIA believes will perpetuate a check-the-box exercise that will make managing ever-increasing volumes of data more challenging.

The draft policy also positions individual NIH Institutes, Centers, and Offices (ICOs) to develop their own specific data management and sharing policies (DMSPs) without comprehensive instructions on key rules to follow.

“It is imperative that the NIH view scientific data as the principle result of scientific research – not the conference presentation or journal publication describing the data,” said Patricia C. Dykes, PhD, RN, FAAN, FACMI, AMIA Board Chair and Program Director of Research at the Brigham and Women’s Center for Patient Safety, Research, and Practice.

“As the world’s largest funder of biomedical research, the NIH must craft a policy that leverages scientific data as a strategic asset.”

To address these issues, AMIA recommended that NIH revise its proposed policy to achieve three main goals. These include optimizing scientific data once generated, incentivizing improvements in data management and sharing practices, and coordinating disparate ICO data management and sharing policies.

To achieve these goals, AMIA recommended that NIH finalize a pan-NIH DMSP that positions ICOs to develop their own requirements, subject to approval by the NIH Office of Data Science Strategy and the Office of Science Policy. Additionally, AMIA said that NIH should take a stronger leadership position in establishing guardrails for ICOs.

NIH should also implement the new DMSP over the span of three years, AMIA suggested, requiring grant proposals subject to the existing policy (i.e. grants over $500,000 per year) to comply initially, while giving grants of lesser amounts additional time to comply.

AMIA also advised NIH to establish a funding policy for data management and sharing activities that reserves a certain percentage of a grant award for such activities, instead of allowing these activities to be included in NIH budget requests.

Going forward, it will be critical for NIH’s data management and sharing policy to drive new discoveries and facilitate novel medical research, AMIA said.

“Everything we value from scientific research follows from the right analysis of data, so the NIH must take the position that good data stewardship is an essential component of the scientific enterprise, rather than a ‘just-in-time’ afterthought or byproduct of the ‘real’ research activities,” the organization stated.

With these recommendations, AMIA aims to help NIH better leverage data for research and reproducibility.

“The opportunity inherent in this policy is to organize, categorize, and manage scientific data for retrospective and observational research, and to make publicly funded scientific data appropriately findable, accessible, interoperable, and reproduceable, or FAIR,” AMIA concluded.  

“A robust DMSP is necessary to optimize these investments so that new discoveries can be identified across these programs and so that all NIH-funded research can add to our national strategic asset of life sciences and biomedical data. As mentioned in our previous comments, AMIA has numerous experts that can be made available to NIH policymakers and our offer to assist still stands.”