Summary and Conclusions

Executive Summary

Synthetic biology is becoming the dominant term in describing an innovative multidisciplinary field with both promising scientific benefits and important ethical issues at the same time. The surge of interest in engineering living systems is largely due to a reduction in gene sequencing and synthesis costs as well as the completion of the human genome project and developments in automation techniques.

Although the term has been abundantly used for almost a decade, there is no consensus on a definition for synthetic biology. Different practical approaches to synthetic biology research and engineering emanate from different disciplines, resulting in an almost intangible characterization. An attempt by the European Commission to describe synthetic biology resulted in the following working definition: “Synthetic Biology is the engineering of biological components and systems that do not exist in nature and the re-engineering of existing biological elements; it is determined on the intentional design of artificial biological systems, rather than on the understanding of natural biology”.

The goals in synthetic biology range from creating an open source registry for standardized biological parts (initiated by the Massachusetts Institute of Technology ) to environmental control, development of pharmaceuticals and renewable fuel production. There are two main practical approaches involved in pursuing such goals. The bottom-up approach starts by creating synthetic biological systems out of partially artificial components, whereas the top-down approach reduces existing life forms down into its individual components.

Now that research has enabled to change individual biological components, focus lies on constructing complex networks in single-cell and multi-cellular systems. Recently realized accomplishments include the development of nonnative behaviors such as bi-stability, oscillations, bio-sensing and spatial-pattern formation. Furthermore, as the capabilities of synthetic biology advance, applications within biotechnology, pharmaceutics, environment, information technology and renewable energy will emerge.

The issues concerning synthetic biology are partially acknowledged by the scientific community. Unfortunately different stakeholders usually raise only a limited number of concerns, dependent on personal interest or due to insufficient data or unfamiliarity. The concerns that typically appear in literature include bio-safety, bio-security and intellectual property rights. Topics concerning attitude towards life, reductionism, transparency and public involvement that are relatively hard to address but nonetheless important, do not obtain the attention they deserve. Therefore we have propose different frameworks of the major ethical issues involved in synthetic biology, which can function as a potential reference for regulation and policy making. The different road maps illustrate a rough division of the main ethical issues in synthetic biology, differences between physical and non-physical harms in emerging technologies, ethical considerations from a synthetic biology practitioner's point of view and the connection between evolution, life, reductionism and the bottom-up approach in synthetic biology research.

The undervalued but key ethical issues in synthetic biology are mainly concerning reductionism and the bottom-up approach of creating living systems. Issues concerning safety, security and handling of intellectual property rights should mostly be related to politics not ethics. Although these topics need good regulation, ethics does not play a major part there. Instead there should be more focus on questions concerning life, specifically the reductionist (top-down) approach towards understanding life, and the bottom-up approach towards creating life. The reductionist approach in general, is a method to understand complex systems by understanding its subsystems, in synthetic biology specifically the molecular level is targeted to see how biological systems work. In the bottom-up approach systems are pieced together to give rise to bigger systems, as can be done in biology with genetic engineering principles. What happens if the reductionism approach will eventually show us what life is all about? What happens when humans can create living systems? We cannot foresee if research in synthetic biology will be able to reach those goals but since the scientific community is getting closer en closer to the foundation of living systems, these questions become much more important.

We have evaluated these omitted topics and reflected on them quantitatively by carrying out and analyzing a survey amongst 60 supervisors (and advisors) and 168 students, participating in the 2009 International Genetically Engineered Machine competition. The aim was to raise awareness on these particular subjects. Moreover, the collection of many opinions from this particular scientific community contributes to understanding synthetic biology, to see how ethical issues are perceived and to recognize which concerns should be addressed in regulating synthetic biology.

Conclusions from the survey

The first few questions were introductory to the main ethical issue: whether the reductionist approach in biology has any effect on our current perception of life and if so, how. The questions meddle with traditional and established viewpoints.
It seems that the possible negative effects of the pursuit of understanding life (the devaluation of life) are not a reason to stop research, mostly because people argue that the value of life cannot be changed (but might even be enhanced) by understanding the mechanisms of life. A majority of 90% would not pull back from fundamental research on the principles of living matter even if the the value of life cannot be secured.
Modifying organisms by the using genetic engineering tools should be available because of the (possible) benefits that it carries along, as outlined by the majority of the group. Only a small group is worried about the consequences that these techniques might have when meddling with evolution. Although the techniques are well studied, the complexity of DNA and the translation system are not yet completely understood and should make researchers use genetic engineering with care, and only apply it for beneficial purposes. A risk/benefit assessment could help identifying when these techniques should be applied.

One of the biggest contributors to synthetic biology research and possibly one of the most controversial researchers in (synthetic) biology is Craig J. Venter. His project on creating a minimal genome is groundbreaking and raises a lot of questions, primarily by media machinery. Whether the research of Venter is new or not is a difficult question, the surveyed group does not have a universal answer. Reasons for that can include that more specific knowledge on his research is needed, and that it is hard to define when an approach or technique is typically new. Nevertheless, the technical challenges that Venter faces are acknowledged.
Although he is pushing the technology as far as it goes, over 80% does not believe that Venter is playing God by creating life artificially. Nevertheless, the majority also thinks that the public will perceive the research as controversial, thinking that Venter is trying to create new life forms. A relatively large minority of think that the public will presume that he is only putting biological components together. An important point is to focus on the importance of proper communication in order to inform the public objectively. Using statements such as "playing God" might draw the wrong attention.

Amongst the main issues in synthetic biology are bio-safety and bio-security. Both the dangers of errors and terrors are addressed in the survey, as well as the attitude towards risk-taking in this emerging field of science.
The majority acknowledges the possibility of the production of a biological system containing some hazardous error and most believe there is regulation needed to prevent this. 34% does not see this possibility as a real thread and think either that there is sufficient regulation already, or just does not fear this at all. It is hard to say whether new regulations can overcome the unforeseeable problems that come with synthetic biology. An issue in respect to safety is the emergence of DIY biology, which can increase the risk of errors significantly.
Most people acknowledge the risk of synthetic biology principles being used for terrorist purposes, but in contrast to the previous question, there are much more people that think new regulation will not be the answer, mostly because they have the feeling that if terrorist want to use synthetic biology as a means to their own ends, they will find a way of doing that anyway. Nevertheless the plurality of the group believes that enforcing additional policies can minimize this risk.
Synthetic biologists are generally careful. Only a very small group can be described as optimistic and fearless, whereas the plurality would conduct additional research to minimize any risks. Moreover, the majority thinks that the public is even more fearful and risk-averse than researchers are. They believe that the public first wants proof that a certain project is safe, before pursuing any goals. Furthermore, the influence of communication between researchers and the public on risk assessment is important.

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