Synthetic Biology Interdisciplinary Challenge 2
What are the significant differences, if any, between risk assessment capacity and religious analyses of the moral permissibility for synthetic biology applications and other biotechnology applications?

Challenge Summary
The Hastings Center, one of several bioethics think tanks, recently announced that it is doing a study on ethical issues in synthetic biology, noting that “this rapidly advancing technology raises ethical questions about benefits and harms that have not been thoroughly addressed.” But because synthetic biology is a part of the continuum of research in the broad field of biotechnology, most of the ethical and policy issues it might raise are at least somewhat familiar.  The challenge is to identify those issues, if any, that are quantitatively or qualitatively different for this field.

Synthetic biology is not limited to engineering specific changes in existing naturally occurring cells and organisms.  Rather, it is predicted to be capable of constructing powerful and problematic organisms from scratch. When researchers announced that they had synthesized the deadly and virulent polio virus for the purpose, they said, of showing how easy it would be to construct new bioweapons from off the shelf materials scientists and ethicists were alarmed and the National Academies initiated a study on ways to prevent the destructive use of biotechnology.  The familiar safety issues raised by biotechnology were now qualitatively altered to include bioterrorism, leading to extended discussions about scientific freedom versus the asserted need to prohibit some forms of research or to censor some forms of scientific communication.

More generally, risk assessment is a generic problem for all new technologies.  In the area of biotechnology, early experiments were the subject of vociferous public debate, leading a few jurisdictions to ban the work entirely within their borders.  Even where permitted, it was accompanied by extraordinary safety measures and enhanced oversight.  Much of this was due to a combination of factors the novelty of recombinant DNA techniques (which was the impetus for the unprecedented Asilomar Conference, during which time a diverse audience of nearly 150 biologists and other scientists, physicians, and lawyers met to draw up voluntary guidelines to ensure the safety of recombinant DNA technology); the concerns about new traits or organisms escaping from the controlled environment and affecting flora and fauna on a large scale; the fear that it would be a temptation to undue tinkering with nature; and the prospect of altering the economics of agriculture.  Synthetic biology’s predicted capacity to expand the range of organisms that can be constructed may make risk assessments so complex that current methodologies will prove inadequate.  In discussing the benefits and potential risks associated with the creation of synthetic organisms, scientists should take care to use language that is direct but not inflammatory.

Another long-running debate concerns intellectual property and the status of elements of living systems, such as gene sequences or altered organisms.  For decades, U.S. law has granted patent rights for these products of biotechnology research and innovation, but whether this has achieved the goals of the patent system incentivizing investment, inducing open disclosure, and speeding technological advances has been debated unrelentingly since the first patent was granted for an altered bacterium.  Recently the debate has intensified, with a legal challenge to the patents held by Myriad Genetics that are used for testing BRCA mutations that may increase a person’s risk of breast and ovarian cancer.  Certainly the prospect of modular elements allowing a wider range of people to participate in the construction of new organisms may change the way the patent system’s incentives actually function, and may lead to rethinking the use of patents in this area.

More dramatic, however, is the fact that synthetic biology represents the ability to construct artificial life forms.  The sheer ability to construct a living organism is a fundamental break with history of the human species, one that may lead to profound questioning of deeply held religious and cultural beliefs about the origins and meaning of life.  As one observer noted wryly, “God has competition.”  If life is not a mystery but rather a predictable consequence of combining elements of the material world, it bespeaks a mastery over creation that has led to deep distress in public debates surrounding IVF in the 1980s and cloning in the 1990s.  It taps into fundamental divisions among major world religions in their views on the proper domain of human activity, and it even affects notions of human exceptionalism, whether in the context of debates on evolution or speculation about life on other planets.  But the extent to which these debates are changed as one moves from cloning to synthetic biology is not yet understood.

Bioethics is not a discipline aimed at slowing or stopping scientific inquiry and technological progress.  It is, however, a discipline that aims to begin with accurate science, incorporate emotional and political realities into debates, and use political and moral philosophy to guide us to more carefully reasoned arguments about whether and when a technological application is good or bad, and when a governmental response is or is not justified.

Key Questions

• What are the significant differences, if any, in risk assessment capacity for synthetic biology applications as opposed to other biotechnology applications? 
• Do current regulatory structures and ethical analyses adequately capture the uncertainties associated with synthetic biology?
• What are the significant differences, if any, in religious analyses of the moral permissibility or implications of creating life synthetically, as opposed to the use of cloning or IVF?
• What is the current state of thinking about the net effects of granting intellectual property rights over engineered organisms? 
• Is this analysis affected by introducing synthetic biology into the discussion?
• What can be learned from Asilomar?