All or Nothing: The False Promise of Anonymity

Abstract

In early 2016, the International Committee of Medical Journal Editors (ICMJE) proposed that responsible sharing of de-identified individual-level data be required for clinical trials published in their affiliated journals. There would be a delay in implementing this policy to allow for the necessary informed consents to work their way through ethical review. Meanwhile, some researchers and policy makers have conflated the notions of de-identification and anonymity. The former is a process that seeks to mitigate disclosure risk though careful application of rules and statistical analysis, while the latter is an absolute state. The consequence of confusing the process and the state is profound. Extensions to the ICMJE proposal based on the presumed anonymity of data include: sharing unconsented data; sharing data without managing access, as Open Data; and proposals to sell data. This essay aims to show that anonymity (the state) cannot be guaranteed by de-identification (the process), and so these extensions to the ICMJE proposal should be rejected on governance grounds, if no other. This is not as negative a position as it might seem, as other disciplines have been aware of these limitations and concomitant responsibilities for many years. The essay concludes with an example from social science of managed access strategies that could be adopted by the medical field.