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Presidential Commission for the Study of Bioethical Issues
Request for Comments on Synthetic Biology

Presidential Commission for the Study of Bioethical Issues www.bioethics.gov/

The challenge for synthetic biology (and for other innovative life-science based technologies) is to engage productively with stakeholders and to devise governance systems for the technology that will guard against foreseeable risks, while enabling developments that could be societally beneficial and safe. The appropriate risk governance of innovative technology needs to be informed by an understanding of how governance and engagement approaches interact with innovation processes. We define an ‘appropriate’ approach to risk governance as one that is enabling of innovation, minimises risk to people and the environment, and balances the interests and values of all relevant stakeholders (Tait, 2007).

This approach to the risk governance of innovative technology is based on our research in three key areas: (i) science and innovation strategies in public and private sector organisations; (ii) regulation and governance of new technology; and (iii) public and stakeholder perspectives. Interactions among these three areas determine which scientific research and development is commercialised, which products are developed, and which companies and industry sectors – and even which countries – are able to participate in and benefit from product development (Wield, 2008).

Policymakers and regulators hold the key to many of these outcomes and may be seen as shapers of, rather than responders to, scientific developments and public and stakeholder responses. Based on our independent integrated analysis of these interactions and their outcomes in terms of societal benefits delivered or foregone, we summarise our findings for the Commission as potential policy and regulatory guidelines for the risk governance of synthetic biology.