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Team:Victoria Australia/Ethics
From 2009.igem.org
With the biological lighting system that we are creating, we have considered ethical issues that arise for Synthetic Biology where there are distinct advantages in our project, most notably: The dangers of gene technology (control of the system), the dangers of creating artificial life, intellectual property (IP) and gene patenting.
The dangers of creating artificial life and the dangers of gene technology (control of the system):
Decent statement on fears and dangers of propagating systems and genes “escaping” into the environment needed here to introduce the issues.
Our project eliminates the risks of propagation – cell-free systems are non-replicating and non-propagating; i.e. it's principally just the genetic circuit and ancillary nucleotides, amino acids, supporting enzymes and energy exchange systems. Therefore there is a limited circuit life dependent entirely on depletion of the system, creating a level of control, hence a great reduction in the risk of making ‘life’ or introducing a replicating system into the environment. For these reasons cell-free systems are not currently legislated by the Australian Office of the Gene Technology Regulator, though technically they can be using plasmids which themselves are capable of transfer and hence may pose an actual risk.
In our system our plasmids are dependent on a phage polymerase for transcription, so only infected prokaryotes pose a suitable threat of zoonotic transfer in terms of viable recombinant protein being produced. As a result there is less of a concern with unintentional release as not only can the system not survive and replicate, but there is reduced risk of the plasmid creating viable recombinant protein production in the environment without a specific recombination event.
The system we have chosen is based on waste products from everyday use such as a lysate from grass clippings to control the production and switching on and off of the proteins. Aside from positive environmental aspects, this system can be regarded as GRAS (Generally Regarded As Safe). Indeed, a preferred test system was to use a non-toxic wheat germ extract.
Importantly, gene transfer is far less likely if we decouple the system, whereby transcription occurs in one reaction, and the actual machine is a genetic circuit comprising only translation and using RNA in the feed stock. In this system there is less selective processes due to the requirement of integration by reverse transcription. Furthermore, RNases are endemically present in all areas of our environment, including transfer in the air and dust particles, and so RNA comprising a recombinant protein of interest is even less likely to survive, get into the cell intact, and/or integrate into a genome. Lastly, GFPs are known to be non-toxic as seen in fluorescent dogs, cats, mice, rats and frogs from scientific investigations.
IP and gene patenting: way not enough – need to describe current gene/patenting laws and then make our position clear.
We have put forward material to advance Synthetic Biology and retained IP material in hand to develop ourselves. Patent protection varies from case to case. DNA is patentable when it has been isolated, purified, or modified to produce a new form not found in nature. In relation to our project, we had isolated the yellow fluorescent protein, purified it and modified it via Polymerase chain reaction to produce a new recombinant blueberry protein. However this invention is not newly discovered and therefore not patentable and judging from our research on the matter, was not a patent form previous papers.
Some patents have been granted for fragments of DNA. That presents the problem of someone trying to patent a larger fragment or gene that contains the already patented sequence. Awareness has been raised as to whether the user will need to obtain a license from the first inventor or whether they can obtain the patent without the first patent holder's permission. This is likely to arise in the near future and will most likely be resolved in courts designated to hear patent actions. Modified bacteria are patentable as they do not occur naturally in nature. Our research involved the use of bacteria being E.Coli, however, not modified, hence these patenting laws do not apply.
