Before analyzing the ethical aspects of synthetic biology, it seems important to clearly define this new area of biology.
Synthetic biology is a new field of research in biology which mixes science and engineering. It focuses on the conception and the construction of new reliable functions through the creation of biological systems or the re-engineering of organisms which already exist. The singularity of synthetic biology compared to traditional biology is about engineering live beings to have a predictable behavior. In order to do so, scientists focus on optimizing existing biosynthetic pathways or creating new ones while bypassing or suppressing inefficient pathways in order to increase productivity.
Three different approaches exist in synthetic biology:
✵ The metabolic engineering of the living beings by using biobricks (DNA sequences whose functions and assembly conditions are known). The biobricks are free of access on the WEB and can be synthesized on request.
✵ The production of minimal genomes and simplified organisms where new functions can be added to realize a task. This approach is often used for the optimization of existing processes.
✵ The synthesis of a whole synthetic genome that will be inserted in existing cell hosts or in synthetic cells. This field of synthetic biology may help scientists to understand how living organisms are created.
The organisms which come from these approaches can be used in both industrial applications (for example to produce drugs, biofuels, biomass or biopesticides) and in basic research as tools like biosensors (E. chromi - Team Cambridge, 2009) or against pollution (Physco Filter - Team TU-Munich, 2013). With these new tools emerging from synthetic biology, many possible fields conducting to different experiments in science permit the intellectual and technical expansion. Bioethics is necessary to prevent researcher about its ethical limits.
The advances in biotechnology techniques also lead to dangerous possible applications causing a general fear of modified organisms by the public. They may be afraid of the organisms that can be created by synthetic biology, afraid that these organisms will somehow grow out of our control or have unexpected properties and will become dangerous for humanity. Our iGEM team observed this while talking to the general public on the streets of Bordeaux. For more information, look at our Cap Sciences section on this page.
In order to limit this fear, the question of transparency is important for scientists. Besides publishing his results, the researcher has to be able to explain his research process and the challenges of the project by stating the explored and the ignored areas. The general audience has to be able to understand his whole scientific approach. Results found, thanks to this approach, contribute to the production of new knowledge and innovation that could be shared to the general public. It is also important for the researcher to analyze his results, looking at the possible negative impacts of his research and estimating the safety and environmental risks and as well the ethical problematic. However, the researcher cannot be the only one in charge of the safety and ethics of his research.
Creating guidelines and a legal framework is essential for safety reasons and to reassure the general public. In Europe, there is no law specifically concerning synthetic biology but synthetic biology is framed by common biology laws. In France, the first laws concerning bioethics were put in place in 1994.  Before, general laws existed but did not deal with the particular ethical aspects which come from biology and using living organisms. On the 1st of July, the law n°94-548 presents guidelines for data processing in medical research. This updated the law n°78-17 (1978) relative to informatic and big data processing in all fields of research. Quickly after, on the 29th of July 1994, two laws were put in place: law n° 94-653 and 94-654 which deal with respecting the human body and products which come from the human body. These laws cover the protection of patients which was then introduced in the Civil code, organizational rules in medical sectors and guidelines to be put in place to protect people involved in medical research programs. In march 2002, patient rights are put in place and certain end of life guidelines are discussed. Futile medical care is banned. Ethic committees set up by the European Union also exist to complement these laws for example, the European Commission, the European Group on Ethics in Science and New Technologies, the Inter-service Group on Ethics and EU policies, and the Executive Management for Research and Innovation
Specifically concerning synthetic biology, a European project called SYNBIOSAFE approved by the European Commission has focused on ethics and safety of synthetic biology. In 2012, it published an article concerning the bioethical and biosafety attentions in iGEM competitions. These two types of frameworks help the researcher to answer to many ethical questions in the clearest way possible. Therefore, not only law may limit synthetic biology. Aspects concerning Politics, Economy, and Philosophy could influence the bioethics questions.
On the 29th of July, Savandara and Charlotte had the possibility to meet with Mr Jacques Faucher, doctor, priest and founder of the regional Ethics commitee "l'Espace Bioéthique Aquitain". Mr FAUCHER generously accepted to come to our lab at the European Institute of Chemistry and Biology (IECB) in order to talk to us about the importance of bioethics in the field of synthetic Biology.
When Mr Potter, American oncologist and surgeon, invents the word ethics in the 1970's and writes his book Bioethics: a bridge to the future he pioneers the questions to come asking himsef questions which go beyond medecine such as: does life have a future on this planet? Questions which have lead to the conclusion that not everything that can be done should be done. Since the modification of a plant's genome or of a unicellular organism's genome is tolerated, what about the human genome? In other words, are there barriers to put on living organisms? Should we have the right to experiment on humans in order to widen our knowledge on the human body? In the case of human clinical trials, ethical aspects are judged on the quality of the scientific protocol. It would not be ethical to use humans as tests if researchers are not certain to have exploitable results. Furthermore, the question of consent also needs to be adressed. While we cannot ask an animal or a plant for their consent, ethical commites insist on having a proof of consent in the European Union. This is particularly important since Anglo-Saxon scientific reviews refuse to publish papers if the have not been approved by an ethics commite. We can ask ourselves if the importance researchers give to Bioethics is truly personal or if they do not regard it as only constraint for publication.
When it comes to bacteria however, what point of view do we have? Humans generally have a vision of the world which is anthropocentric, we consider ourselves superior to other organisms. For example, during the Nuremberg trials against Nazi doctors, Carl Brandt (health minister and part of the German military) was sentenced for having lead experiments on humans in concentration camps believing that he was superior to them. When do these acts become wrong? Recently, in China, certain tests are being done on human embryos. Where should we draw the line for embryonic therapy? In Europe, questions of ethics slows down research on such topics but in Asia, research seams to be without limits.
In sciences, the question of intellectual property is recurrent. Concerning synthetic biology, all of the objects used can be patented. Among these are genes, plasmids, biobricks, genetic circuit broads, software modeling of mechanisms etc. However, these aren't necessarily considered as dicoveries which we can define as a revelation of what was previously unknown, but already exist. Indeed, the scientific discovery is supported by publications which are in free access for who wants it. So, we can consider it is a part of the common knowledge, ownerless. However, the creation is a process or a product which brings a solution for a particular problem. So it is a new element, previously a lacking element. An invention is supported by a patent.
In our case, in synthetic biology, the invention can be a whole organism, a gene or a DNA sequence. The National Consultative Ethics Committee (CCNE) tries to delimitate these processes by making it impossible to take ownership of organisms which already exist making sure that a discovery doesn’t become an invention. Also, the patentability of an element won’t be possible when it was extracted of its natural environment to live in a synthetic environment, or an element which was reproduced in a synthetic environment, but already naturally being.
Here, it is a polemical subject because in synthetic biology, we are making “organic inventions”. So, there is a question: “Is it acceptable to be a living being’s owner?” “What about an interior component of it?” In this last case, who does the element belong to, the organism or at that one who modified it?
With the emergence of synthetic biology, the definition of living may be modified. Indeed, in this field, researchers can generate or modify the genome of an existing organism, insert a whole artificial genome in an existing organism or create a new artificial organism. We can wonder if these modifications made by humans will not have an impact on the nature of the organism. Can we consider that an organism is living if it has been totally or partially created artificially? Synthetic biology regards the “objects” which are created as living beings because they are built from the cell, the basic unit of life. They have the property of self-organization and identical or similar self-replication to those of natural living beings. So we can considerate that they are “alive”?
With these "new" organisms, a living being may be considered as simple and easy to create. Once decoding the DNA of a organism is understood, synthetic biology is able to do everything with a bacteria, a yeast or animals bigger, thinking that are like "machines". But is it ethical to consider life as a tool, which we do in the iGEM competition? What is the limit between an ethical scientific project and an unethical scientific project.
All of these ethical considerations made us think about our project Cur'd Vine. First, it is important to us that our project was related with transparency, so that uninitiated people can apprehend our scientific approach. Our Wiki, in free access on the WEB, allows us to clearly and concisely expose all the thinking steps which governed our Cur’dVine project. It also allows us to share our knowledge and results to as many people as possible. New iGEM teams or other researchers could use our results to continue our project. Furthermore, our implication in annex projects such as Cap Sciences, making street interviews about GMO's or high school presentations about synthetic biology, is a sign that we have constantly tried to democratize synthetic biology to the general public and helped us to consider the profits and risks. Without being paranoiac, we have to think of all potential dangers that our molecule may create.
Will this molecule be able to create new diseases? Can it break the flora equilibrium for example through effects on bees in the region and creating the proliferation of chinese hornets? We can also ask ourselves questions concerning it's effects on humans. Since curdlan is technically a sugar biopolymer, would it increase the sugar level in wine? These are questions which can be asked by the general public and which might cause them to be frightened of our project. This is why we have taken into consideration these questions and tried to answer them in the best way possible which are resumed in our next section which deals with safety.
 : 5e avis sur la biologie de synthèse. Comité consultatif commun d'éthique pour la recherche agronomique. INRA - CIRAD.(2014)
 : La révision des lois de bio-éthique.