Implementing values-based governance for a new bioresource model

Abstract

We are pleased to be given the opportunity to read and respond to the peer commentaries on our ‘regulatory soup’ essay by Bartha Knoppers2 and Shawn Harmon. Knoppers frames her response as a dichotomy between regulation and collaboration, and emphasizes the role of patient/participant/public engagement as the key to ensuring that precision medicine and its associated infrastructure operates appropriately. In contrast, Harmon focuses on regulatory tools that may be employed to ensure that ‘innovations are timely, widely affordable, safe, and effective’. In particular, he draws attention to the ways in which ‘responsible research and innovation’ and ‘legal foresighting’ can be used as tools for developing ‘values-based regulation’. Both peer commentaries focus particularly on biobanking and data sharing. Here we reflect on developments in this field since ‘regulatory soup’ was written. We pay particular attention to our work with colleagues at the Centre for Law and Genetics at the University of Tasmania, Australia and our collaborative endeavors with like-minded scholars in other jurisdictions, some of whom also co-authored the regulatory soup essay. Coincidentally our work incorporates many of the ideas expressed in both peer commentaries, with a particular focus on collaborative engagement, identification of values, reflexivity and evidence-based review. We end with a practical example of how we have used these values-based approaches to create a governance framework for a new type of bioresource in Tasmania.