Mark Phillips and Bartha M. Knoppers in the Journal of Law, Medicine and Ethics: “Open science has recently gained traction as establishment institutions have come on-side and thrown their weight behind the movement and initiatives aimed at creation of information commons. At the same time, the movement’s traditional insistence on unrestricted dissemination and reuse of all information of scientific value has been challenged by the movement to strengthen protection of personal data. This article assesses tensions between open science and data protection, with a focus on the GDPR.
Powerful institutions across the globe have recently joined the ranks of those making substantive commitments to “open science.” For example, the European Commission and the NIH National Cancer Institute are supporting large-scale collaborations, such as the Cancer Genome Collaboratory, the European Open Science Cloud, and the Genomic Data Commons, with the aim of making giant stores of genomic and other data readily available for analysis by researchers. In the field of neuroscience, the Montreal Neurological Institute is midway through a novel five-year project through which it plans to adopt open science across the full spectrum of its research. The commitment is “to make publicly available all positive and negative data by the date of first publication, to open its biobank to registered researchers and, perhaps most significantly, to withdraw its support of patenting on any direct research outputs.” The resources and influence of these institutions seem to be tipping the scales, transforming open science from a longstanding aspirational ideal into an existing reality.
Although open science lacks any standard, accepted definition, one widely-cited model proposed by the Austria-based advocacy effort openscienceASAP describes it by reference to six principles: open methodology, open source, open data, open access, open peer review, and open educational resources. The overarching principle is “the idea that scientific knowledge of all kinds should be openly shared as early as is practical in the discovery process.” This article adopts this principle as a working definition of open science, with a particular emphasis on open sharing of human data.
As noted above, many of the institutions committed to open science use the word “commons” to describe their initiatives, and the two concepts are closely related. “Medical information commons” refers to “a networked environment in which diverse sources of health, medical, and genomic information on large populations become widely shared resources.” Commentators explicitly link the success of information commons and progress in the research and clinical realms to open science-based design principles such as data access and transparent analysis (i.e., sharing of information about methods and other metadata together with medical or health data).
But what legal, as well as ethical and social, factors will ultimately shape the contours of open science? Should all restrictions be fought, or should some be allowed to persist, and if so, in what form? Given that a commons is not a free-for-all, in that its governing rules shape its outcomes, how might we tailor law and policy to channel open science to fulfill its highest aspirations, such as universalizing practical access to scientific knowledge and its benefits, and avoid potential pitfalls? This article primarily concerns research data, although passing reference is also made to the approach to the terms under which academic publications are available, which are subject to similar debates….(More)”.
