The National Institutes of Health (NIH) recently released a draft policy for data management and sharing, asking for public comment. One of the first public reactions —from the American Medical Informatics Association (AMIA) — was an expression of disappointment. In a statement, Douglas Fridsma, M.D., Ph.D., AMIA’s president and CEO, said the policy represents “a step backwards at a time when there is exponential growth in the amount of scientific data for research and the need to leverage large data sets to advance cures for disease.”
Last year NIH put out request for information (RFI) on potential key elements that could comprise a future NIH data management and sharing policy. As Carrie D. Wolinetz, Ph.D., NIH’s associate director for science policy, noted in a blog post, most commenters supported data sharing and the importance of prospectively planning for where, when, and how scientific data should be managed and shared. “There were, however, concerns about how one policy could fit all sizes and types of data across the biomedical research universe as well as potential burden on the research community,” she wrote.
In an e-mail exchange with Healthcare Innovation, Jeff Smith, AMIA’s vice president of public policy, explained further why the organization expressed disappointment with the draft policy. “The plan delegates a good deal of responsibility to Institutes and Centers, but this is really a continuation of the status quo and an inadequate position from which to coordinate and lead – as the NIH data sharing policy should do,” he said, adding that NIH’s approach will actually lead to much more variation in data sharing plans across the entire NIH portfolio. “This is where a ‘check-the-box’ mentality will come into play,” Smith said. “Data sharing will be seen as a red-tape exercise without much (if any) benefit from sharing, assuming the data sharing across projects is even remotely consistent and coordinated.”
He said the draft plan may be a response to negative feedback from bench/field researchers who see data sharing as a burden “because it’s ancillary to the hypothesis testing and it usually happens after the experiment has been conducted.”
The draft plan says that data sharing plans could be submitted at “Just-in-Time” and reviewed by NIH program staff, “which reduces applicant burden because only those applicants likely to be funded would submit plans.”
Smith said this means that rather than having to submit a data sharing plan as part of the proposal, it can be cobbled together once a decision to fund has been made and it means that grant managers at NIH (not subject-matter expert reviewers) will review. “We see submission of a plan as part of the proposal as a no-brainer and a fallback position from our chief recommendation to have them scorable elements of submitted proposals,” he said. The proposal also states that data sharing plans can’t be more than two pages long.
AMIA was “incredibly surprised” that the draft policy didn’t go further, Smith said, “especially when you look back over the last few years and you study the RFIs they’ve fielded on Strategies for NIH Data Management, Sharing and Citation and the RFI on metrics to asses value of repositories,” he said, “not to mention the Data Science Strategy and NLM Strategy and the high-level NIH STRIDES initiative. The PCORI data sharing policy is miles beyond what the NIH has proposed, which added to our surprise. We figured the NIH would have more wherewithal on the subject than PCORI.”
I asked Smith if NIH could still make changes to the final rule based on responses to the draft. He said yes. “We’ll be making the case that the persistence of data silos and lax compliance with ClinicalTrial.gov reporting necessitates a smarter and better approach. Several years ago, several senators, including Warren and Biden, were fierce critics of data silos. I imagine there are others who share their concerns.”
