tems—capabilities that may ultimately be used for applications in manufacturing, food production, and global health. Even though research has largely been limited to work at the molecular or cellular level, governments and industries worldwide are investing significant resources in synthetic biology research and product development.

Synthetic biology—unlike any research discipline that preceeds it—has the potential to bypass the less predictable process of evolution to usher in a new and dynamic way of working with living systems. Thus, while synthetic biology is still a nascent area of research, it has attracted significant attention. Many questions, however, remain:

•  What solutions can synthetic biology realistically offer for today’s global challenges?

•   How may we best prepare researchers for work in synthetic biology?

•  What are the commercial, industrial, and medical possibilities for synthetic biology?

•  What ethical and social concerns does synthetic biology raise, and how can they be addressed locally or collectively?

•  How should we best engage the public to enable understanding of the promise and risks of this emerging field?

•  What intellectual property, patent, sharing and ownership arrangements will best allow synthetic biology to advance?

•  How should synthetic biology be regulated, and what form should any oversight or governance frameworks take?

•  Does synthetic biology pose new biosafety and biosecurity concerns, and if so, how may they be addressed effectively?

Stakeholders around the world are grappling with such questions. In the United States, for instance, the President’s Commission for the Study of Bioethical Issues has identified essential principles and recommendations for the purpose of guiding ongoing research in synthetic biology.2 And, in response to advances in synthetic biology, the National Institutes of Health has revised its guidelines on recombinant DNA3 based upon the National Science Advisory Board for Biosecurity’s consideration of synthetic biology in the context of dual use research.4

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2 Anita L. Allen, Henry R. Silverman Professor of Law and Professor of Philosophy, University of Pennsylvania Law School and a member of the Presidents’ Commission, discussed the commission’s recommendations at the Shanghai symposium. See page 22 of this report.

3 Department of Health and Human Services, National Institutes of Health March, 2013. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Online at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html (accessed March 27, 2013).

4 National Science Advisory Board for Biosecurity (NSABB), April 2010. Addressing Biosecurity Concerns Related to Synthetic Biology: Report of the National Science Advisory



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