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IDR Team Summary 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



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IDR Team Summary 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 ex- isting 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 viru- lent 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 bioter- rorism, 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 tech- nologies. In the area of biotechnology, early experiments were the subject of vociferous public debate, leading a few jurisdictions to ban the work 19

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20 SYNTHETIC BIOLOGY 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 agri- culture. Synthetic biology’s predicted capacity to expand the range of organ- isms 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 organ- isms. 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 disclo- sure, 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 con- sequence 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

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IDR TEAM SUMMARY 2 21 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 clon- ing 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 capac- ity for synthetic biology applications as opposed to other biotechnology ap- plications? 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 op- posed to the use of cloning or IVF? • What is the current state of thinking about the net effects of grant- ing intellectual property rights over engineered organisms? Is this analysis affected by introducing synthetic biology into the discussion? • What can be learned from Asilomar? Reading Ahuja A. Life is just a bowl of petri. The Times 2 July 2007: http://www.timesonline.co.uk/ tol/comment/columnists/article1895_26.ece. Accessed online 13 May 2009. Berg P. Meetings that changed the world. Nature 18 September 2008:http://www.nature. com/nature/journal/v455/n7211/full/455290a.html. Accessed online 28 July, 2009. Charo RA. Are we playing God? Or playing human? The Washington Post 12 August 2001: B01. Henkel J, Maurer S. Presentation. On the economics of synthetic biology: Is openness feasible?: http://www.syntheticbiology3.ethz.ch/proceedings/Henkel%20Maurer%20- %20On%20the%20economics%20of%20SB%20SB3.0%202007-06.pdf. Accessed online 13 May 2009. Herrera S. Preparing the world for synthetic biology. Technol Rev MIT 2005:http://www. technologyreview.com/articles/05/01/issue/herrera20105.asp?p=1. Accessed online 13 May 2009.

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22 SYNTHETIC BIOLOGY National Research Council. Biotechnology research in the age of terrorism. Washington, D.C: National Academies Press 2004: http://books.nap.edu/openbook.php?record_ id=10827&page=R1. Accessed online 13 May 2009. Nisbet MC, Lewensten BV. Biotechnology and the American media: The policy process and the elite press. Science Communication 2002;23(4):359-391: Abstract available http:// scx.sagepub.com/cgi/content/short/23/4/359. Accessed online 28 July 2009. Tierney J. Are scientists playing God? It depends on your religion. New York Times 20 November 2007:http://www.nytimes.com/2007/11/20/science/20tier.html. Accessed online 26 May 2009. IDR Team Members • John E. Burris, Burroughs Wellcome Fund • Gregory Dewey, Keck Graduate Institute • Sarah E. Evans, U.S. Department of State •  Joseph Francis, State University of New York Downstate Medical School • Wendell Lim, University of California, San Francisco • Ichiro Matsumura, Emory University School of Medicine • Kristala L.J. Prather, Massachusetts Institute of Technology • Deboleena Roy, Emory University • Jan A. Witkowski, Cold Spring Harbor Laboratory • Laurie Zoloth, Northwestern University • Lynne R. Peeples, New York University IDR Team Summary By Lynne R. Peeples, Graduate Science Writing Student, New York Univrsity The Interdisciplinary Research (IDR) team, comprising 13 scientists and bioethicists, considered ethical and policy issues at the National Acad- emies Keck Futures Initiative Conference on Synthetic Biology in 2009. The team concluded that synthetic biologists should heed the accumulated wisdom from decades of advances in biotechnology and remain alert to new developments as the field progresses. A number of policies and regulations are already in place to prevent both safety and ethical lapses in the application of recombinant DNA technology. The challenge for this team was to identify those issues, if any, which were quantitatively or qualitatively different for synthetic biology. Is there anything special about this emerging field?

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IDR Team SUMMARY 2 23 The IDR team thoughtfully concluded that, at this early stage in the field’s development, synthetic biology currently poses no unique problems that previous cutting edge advances in science have not. However, the team recommended that it deserves the same level of careful attention. They believe the new discipline should borrow from the existing regulatory frameworks to protect the public and allow the science to proceed, for now. New approaches to ethics training, risk assessment, monitoring and public communication should be developed along the way to address the innova- tions of a burgeoning discipline. Risks and Benefits Many existing technologies lie along the biotechnology continuum, such as the genetic modification of organisms for agriculture, assisted re- production, and the capacity to sequence the human genome. These have already spurred the exploration of a range of questions about ethics and regulatory policy. Synthetic biology is another incremental step forward on that con- tinuum. And, like its precursor technologies, the risks and benefits can be categorized as intentional and unintentional—requiring regulations to keep sensitive tools, techniques, and resources out of the hands of bad people and harmful products from getting out of the laboratory. To that end, similar oversight should be applied to both the final products and processes used in their manufacturing. Regulation should continue to be based primarily on products’ properties, suggested the team, regardless of how they are made, or what percentage of natural and synthetic components are involved. If a toxic or otherwise dangerous creation results from synthetic biology, it should be regulated just like any other hazard- ous material. The team acknowledged, however, that the blurred border between natural and synthetic properties, and the potential for products of synthetic biology to evolve, could complicate intellectual property frame- works in the future. Precautionary interventions are necessary throughout the production process. Again, policies already in place could be used as guidelines for im- proved ethics training for students and scientists; monitoring of key tools, techniques and resources to keep tabs on who is doing what with the tech- nology and where; maintaining academic journal standards that scrutinize submitted papers for security implications; and proper disposal of lab waste. The team could not agree, however, whether synthetic organisms should

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24 SYNTHETIC BIOLOGY include self-destruct mechanisms to prevent uncontrolled spread in the environment. The issue of self-evolvability was also raised, but consensus was not reached as to whether future synthetic biology products could pose unique risks if they evolved at an unprecedented pace and in unexpected directions. Because developments in technology during recent decades are now routinely used not only in high tech laboratories but in high school class- rooms, the tools that can be used for experiments in synthetic biology are widely available. A doctoral degree in science isn’t necessary to know how to mix and match genes. Some scientists suggest building new organisms with genetic blocks may be easier than brewing your own beer—or could even be done while drinking that brew. So, in addition to academic scientists, high school students and do-it-yourself garage labs have the potential to create synthetic organisms. The team was unable to agree whether these amateur scientists could, or should, be closely monitored and subject to regulation. The team recommended that funding agencies continue to support the study of ethical issues related to new science by setting aside about 5 percent of all grant money for examining these and many more issues that could arise—from risks to humans and the environment to possible limitations on its applications imposed by public wariness of the field. Public Perception and Cultural Context Public perception will continue to play a major role in the way people respond to news about progress in synthetic biology. The popular media frequently reminds us—and often exaggerates—the risks associated with manipulating nature. The villain in a recent episode of the popular televi- sion show, CSI Miami, is an ear of genetically engineered corn; the plot of Jurassic Park was based on genetic engineering gone awry. While these kinds of portrayals may not accurately reflect the truth, scientists must communicate with the public to alleviate apprehensions that will inevitably arise. People frequently fear what they don’t understand. Natural compounds may sound more benign than artificial ones even though the most harmful toxins are completely natural. The team recom- mends allocating resources toward risk assessment and communication to ensure the public has the right facts, and that the benefits of the new sci- ence—from its potential in curing diseases to creating new renewable fuel sources to cleaning up environmental messes—are presented along with theoretical or real risks.