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Implementing values-based governance for a new bioresource model

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Nicol, D ORCID: 0000-0002-6553-2839, McWhirter, R ORCID: 0000-0002-9409-8074 and Dickinson, J ORCID: 0000-0003-4621-1703 2017 , 'Implementing values-based governance for a new bioresource model' , Journal of Law and the Biosciences, vol. 4, no. 2 , pp. 404-411 , doi: 10.1093/jlb/lsx007.

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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.

Item Type: Article
Authors/Creators:Nicol, D and McWhirter, R and Dickinson, J
Keywords: precision medicine, biobanking, public engagement, values based regulation
Journal or Publication Title: Journal of Law and the Biosciences
Publisher: Oxford University Press
ISSN: 2053-9711
DOI / ID Number: 10.1093/jlb/lsx007
Copyright Information:

The Author 2017. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) http://creativecommons.org/licenses/by-nc-nd/4.0/

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