Synthetic biology ethics: managing risks without limiting benefits

Synthetic biology has the potential to address global issues, such as clean energy and affordable vaccines, but it also carries potential risks. Policy makers are currently faced with the challenge of regulating this emerging science and a new US report has made recommendations for minimising risks without restricting progress based on five ethical principles.

Synthetic biology applies engineering techniques to the design and build of biological systems with new or specialised functions. The ability to synthesise vaccines, drugs, biofuels and crops could help meet several global needs, but there are concerns about the human and environmental risks from engineering 'life' to serve our own purposes. In 2009, scientists created the world's first self-replicating synthetic (human-made from chemical parts) genome in a cell of a different species. This triggered huge media and public interest and the response highlighted the need for policy makers to develop strategies while policy is still ahead of this emerging science.

The report was conducted by the US Presidential Commission for the Study of Bioethical Issues who engaged with a range of people, including scientists, engineers, faith-based ethicists and the general public, to identify five ethical principles relevant to emerging technologies. It proposed several recommendations to ensure each principle was met.

Public Beneficence aims to maximise public benefits and minimise public harm. To promote this principle, the report recommended evaluating current public funding of synthetic biology activities and study proposals to ensure research is conducted on behalf of the public. There should also be efforts to encourage scientists to share information with each other in order to promote innovation.

Responsible Stewardship is an obligation to act for those who cannot represent themselves, such as children and future generations. The report recommended identifying an agency to coordinate governmental approach to synthetic biology. The agency would lead discussions between different parts of government with a stake in synthetic biology to ensure that policy makers have adequate information and to harmonise strategies across government. It would also direct an ongoing review of the ability of synthetic organisms to replicate in the natural environment and ongoing risk assessments of the release of synthetic organisms. The coordinating agency would also ensure dialogue at an international level and the ethical education of medical and research communities.

Promoting Intellectual Freedom and Responsibility ensures that excessive restriction does not inhibit new benefits. The report suggested supporting a culture of individual and corporate responsibility with self-regulation by the research community. This would be monitored to determine if additional steps should be taken to encourage accountability. It also stressed the importance of ensuring risk assessments outside of intuitional research settings and the `amateur´ or 'do-it-yourself' research community.

Promoting Democratic Deliberation embraces the debate of opposing views and participation by citizens. The report recommends encouraging exchange of views between different interest groups, such as scientists, policy makers, religious groups and civil society groups. It also proposes the use of clear and accurate language rather than sensationalist terms, such as 'creating life' and 'playing God'. Educational activities around synthetic biology could also help ensure the public can make informed choices.

Promoting justice and fairness. The report suggested that strategies should be developed to guarantee that neither risks nor benefits of synthetic biology are unfairly distributed to certain groups or populations. This could involve developing guidelines and voluntary recommendations to assist manufacturers.
Source: Presidential Commission for the Study of Bioethical Issues, Washington D.C. (2010) New Directions - The Ethics of Synthetic Biology and Emerging Technologies. Downloadable from www.bioethics.gov/documents/synthetic-biology/PCSBI-Synthetic-Biology-Report-12.16.10.pdf

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