Team:Potsdam Bioware/Safety Ethics

Safety & Ethics

Safety Assesment

Our iGEM project requires only the handling of the non-pathogenic, non-adherent Escherichia coli K12 and B strains and the well-established filamentous phage. Both, the bacteria and the phage are commonly used chassis in laboratories and pose no risk when handled according to the mandatory rules. As all of us are well briefed about laboratory safety and biohazard regulations we follow these at all times. In Germany, work with genetically modified organisms is regulated by the ‘Law on Gene Technology’ (Gesetz zur Regelung der Gentechnik, GenTG). According to these rules, the responsible governmental authorities of the state of Brandenburg have been notified about our work. Following these rules, there should not be a significant danger neither to the environment nor to team members.
The most important issues we discussed are the consequences of the error-prone PCR we use to modify our parts. We tried to estimate the chances of generating highly toxic proteins. Surveying the literature, we found several reports about natural variants of microviridins and one rational mutational study, but no reports on toxic effects. As cyanobacteria can also produce toxic compounds (non-ribosomal peptides named microcystins) toxicity testing is well established in the cyanobacteria research community, and obviously, testing did not identify toxic effects. Therefore, we assume that our mutations will not have any hazardous effects. Additionally, the obtained, constructed, and planned plasmids contain only previously described parts without any known risk potential. Therefore, as far as we can foresee, our constructed BioBricks will not have or trigger any toxic effects or be critical in any way for the environment. This means that only a negligible risk arises from our used methods and constructs to the environment, the public and the team members. Last but not least, we do not see any particular danger of abuse or other security threat of our work, since it is specifically addresses scientific questions. It is our goal that the health of mankind and the environment benefit from our research.

Safety Questions

1. Would any of your project ideas raise safety issues in terms of: researcher safety, public safety, or environmental safety?
   • No, our project is not raising any of these safety issues.
2. Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues? If yes, did you document these issues in the Registry? how did you manage to handle the safety issue? How could other teams learn from your experience?
   • No, our BioBrick parts or devices are not going to raise any safety issues.
3. Is there a local biosafety group, committee, or review board at your institution? If yes, what does your local biosafety group think about your project? If no, which specific biosafety rules or guidelines do you have to consider in your country?
   • In Germany, work with genetically modified organisms is regulated by the ‘Law on Gene Technology’ (Gesetz zur Regelung der Gentechnik, GenTG). According to these rules, the responsible governmental authorities of the state of Brandenburg have been notified about our work. Our work was classified as biosafety level 1.
4. Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?
   • So far biosafety assessment is primarily based on the characterization of wild-type devices or systems. For synthetic biology these rules should be extended to better represent the variations made by synthetic biology approaches. In addition to the continuous evaluation of safety and security, a section on technological impact assessment should be added.

Ethics

Why Ethics?

Synthetic Biology is not only a current topic in the science community. A look through published articles in papers e.g. the Guardian [1], abstracts from governmental institutions [2] and a large amount of webblogs [3] regarding the latest developments in this new field, strengthen the impression of a general interest.

The reasons for this development are sure a combination of different factors. With the possibilities of the modern web and media people have the chance to understand science and communicate about new results. A general interest for information is forming with a new generation. The typical image of a researcher in a ivory tower has been replaced by lighthouses of knowledge, which interact with the society.

Former mistakes, where few decided in which amount and time manner new results in research are used e.g. the usage of nuclear power, are not imaginable in the age of information. These social trends forces science to take on a dialogue with society about the use of new research results, application and commercialization. We tried to think about these certain issues by holding a lecture on this topic, resulting into a field of forces for synthetic biology and a survey to reflect the opinion of the German politics.

Seminar: "From engineer to creator: a controversy"

On the 5. July 2011 the iGEM Team Potsdam hosted a lecture about ethics in the field of synthetic biology. As guest speaker we were able to welcome Prof. Dr. Ralf Stoecker, professor of philosophy at the University of Potsdam and also member of the board of the Academy for Ethics in Medicine. This lecture was not only for the iGEM Team itself, but for all students with different field of study. Through advertisement in different departments a audience with different background was the result. Starting with a general overview in the history of philosophy regarding the metaphysics of morals and the example of Immanuel Kant, Prof. Dr. Stoecker tried to explain the difficulty of ethics in modern times.

Kant started to think about general ideas concerning actions of humans a priori [4]. Philosopher often try to adapt these moral principles to certain specific cases. Nowadays they are confronted with the problem of a fast development in science and new applications. It is not any more possible to think first about a general principle and then adapt these to the new results. Today the society often needs an answer to a moral problem in short time, because the applications are needed or will be commercialize anyway. One can then try, to extract from the concrete problem e.g. synthetic biology in medicine general principles. This way is part of the applied philosophy.

To represent this current problem in finding a ethic view on synthetic biology, Prof. Dr. Stoecker suggested a field of forces, where different positive and negative effects pull at the decision to use synthetic biology in research for new applications. In conclusion, the ethic or moral decision for a new case in not determined by higher general principles. It is a combination and weighing of different positive and negative aspects.

We tried to find relative clear examples for advantages and disadvantages of synthetic biology. One should always remind himself, that the different aspects have different weight for each individual. While the iGEM competition is a good example for advantages of synthetic biology e.g. new applications and teaching of new knowledge, Miller and Selgelid [5] show in their paper, that new applications in biology also can used for military use . The „lone operator” scenario by Tucker and Zilinkas [6] is also a good example for possible biosafety problems. In this unlikely scenario one professional researcher follows his own terrorist goal. Still these examples show disadvantages which one has to consider, when trying to make his decision.

Literature

[1] McKie, R. (2003), 'Fluorescent fish' give the green light to GM pets, The Observer, Sunday 15
[2] Balmer, A. and Martin, P., (2008), Synthetic Biology Social and Ethical Challenges, Institute for Science and Society University of Nottingham
[3] Maynard, A. (2008), Synthetic biology, ethics and the hacker culture, on http://2020science.org/2008/06/13/8613-synthetic-biology-ethics-and-the-hacker-culture/ (12.09.2011)
[4] Kant, Immanuel. Foundations of the Metaphysics of Morals. Trans. Lewis White Beck Standard edition of Königliche Preussische Akademie der Wissenschaften. Berlin, 1902–38.
[5] Miller S. and Selgelid, M., (2006), Ethical and philosophical consideration of the Dual-use dilemma in the biological sciences. Centre for Applied Philosophy and Public Ethics, Australian National University and Charles Sturt University, Canberra, Australia
[6] Tucker, J.B., Zilinskas, R.A., (2006), The promise and perils of synthetic biology, The Atlantis news, spring 2006
[7] Habermas, J. (2003): The Future of Human Nature. Cambridge (UK), Malden/MA: Polity

Survey

In Germany, synthetic biology is a barely considered and scarcely conducive field of research. At times when companies like Celera Corporations on a basis of synthetic biology earns more than 150 Million US $ per year, the German government didn’t promote one specific research and development project in the field of synthetic biology until now .

In order to determine the general consensus on synthetic biology we generated a survey about the opinion of the members of the German parliament. The aim of this survey was to figure out what the members of the parliament think about “synthetic biology” and how the future of synthetic biology in Germany might look like.

Survey: File:Survey.pdf

• 1. How would you assess your knowledge about Synthetic Biology?
• 2. Research in the field of nutrition:
  • a. How would you assess the potential of Synthetic Biology?
  • b. How would you assess the risk of Synthetic Biology?
• 3. Research in the field of healthcare and medicine:
  • a. How would you assess the potential of Synthetic Biology?
  • b. How would you assess the risk of Synthetic Biology?
• 4. Research in the field of energy:
  • a. How would you assess the potential of Synthetic Biology?
  • b. How would you assess the risk of Synthetic Biology?
• 5. Would you support an enhanced promotion of Synthetic Biology?

This survey was sent to 637 members of the German parliament. 15 Members answered and 10 of them attended the survey. The participation was around 2,22 percent.

The survey said that the members of the parliament believe in a high potential of synthetic biology in the area of healthcare, medicine and energy research. In the field of nutrition, they do not expect to significant improvements through synthetic biology researches. The members of the parliament classified the risks of research in the field of synthetic biology as average.

This survey also shows a positive trend for the enhancement of research in the field of synthetic biology by the German government. Mainly the members of the parliament regard the field of healthcare, medicine and energy research as having great potential for the future of synthetic biology.

Statement of the German government

In Germany synthetic biology is considered as a new field of research in the biotechnology. It is based on biotechnology and genetic engineering and has the aim to generate new biological systems with accurately defined abilities.

In the near future, the resulting knowledge will be used in various research sectors such as biofuel or pharmaceutics. In spite of the possible potential of this field of research more and more people warn against potential risk of misusing of this new knowledge.

On this account, it is necessary to take care of this new technique in a social and political way, so that it would be possible to use the enormous prospects and potentials and to assess the possible risks of misusing. In this context, the German parliament required the government for a statement on this topic.

In response to the German parliament question on the position of the German government to “perspective and position of the government of synthetic biology”, the German government gave a statement to this topic :

(cited from “Antwort der Bundesregierung auf die Kleine Anfrage der Abgeordneten René Röspel, Dr. Ernst Dieter Rossmann, Dr. Hans-Peter Bartels, weiterer Abgeordneter und der Fraktion der SPD – Drucksache 17/4898 – Stand und Perspektiven der Synthetischen Biologie“, 22.03.2011, translated by iGEM-Team Potsdam)

The government’s expectations of this new field of research primarily relate to the benefit of environmental protection, energy research, development of new chemical products and renewals in biomedical science and pharmaceutical industry. However, the synthetic biology is still in its infancy. For this reason, it is not possible to evaluate the date when the first renewals will be established.

The military research in the field in relation to the protection against infectious agents will not be excluded in the future. However the risks which are associated with the abuse of this technology for terrorist acts were classified as low, because of the existence of naturally occurring pathogen. The research and development work in the area of synthetic biology is subject to the gene technology law, the foreign trade law and the weapons of war control law, wherefore there are no additional need for legislative or regulatory action.

The government monitored the opinion-forming process related to this field and established a temporary position at the ZKBS (Zentrale Kommission für die Biologische Sicherheit) to monitor the development of synthetic biology and support the ZKBS for risk assessment in this field. On international level the EU established the Knowledgebased Bio-Economy Collaborative Working Group (KBBE-NET CWG) which analyzes the possible potential of synthetic biology.

In the last 5 years, the German government invests in this field of research 709.000 € for social and ethical accompanying research and 450.000 € in innovation and technology analysis. But until now, the government didn’t promote a specific research and development project in the field of synthetic biology. By comparison, in the last 5 years the USA provides 430 Mio $ for this field of research. The same applies to the government of Great Britain who spending 30 Mio € for public research in this field.