Team:KU Leuven/Human Practices/Ethics/Normative/Biosecurity

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    <h3>Biosafety</h3> </a>
     <p>Health and Ecological impact</p>
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    <h3>Biosecurity</h3>
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     <p>You are here!</p>
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    <h3>Justice</h3> </a>
     <p>Commercialisation?</p>
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  <h3>General View</h3>
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    <p align="center"><b>Ethical issues arise particularly from dangers of using synthetic lethal and virulent pathogens for terrorist attacks, bio-war, or maleficent uses (‘garage terrorism’, ‘bio-hacking’), particularly if knowledge and skills on how to produce such pathogens are freely available.</b><p/>

    <p align="justify">The next major ethical topic that we need to address is biosecurity. “Ethical issues arise particularly from dangers of using synthetic lethal and virulent pathogens for terrorist attacks, bio-war, or malicious uses (‘garage terrorism’, ‘bio-hacking’), particularly if knowledge and skills on how to produce such pathogens are freely available. Not only are protocols available <a href="http://openwetware.org/wiki/Main_Page">online</a>, iGEM actively promotes an open source system where ‘Bricks’ are added to the registry and can be ordered by other teams. Applications of synthetic biology for such purposes include the production of biological weapons, such as new and/or modified pathogenic viruses or bacteria as well as synthetic organisms engineered to produce toxins. The literature on bio-war and the use of bioengineering for bio-defence, bio-offence and terrorism shows the potential of this technology, which may be amplified by synthetic biology” (EgE, Opinion no. 25., 2009).<br/>
Biosecurity is a trending topic in recent literature: how to best guide this young science to safekeep the public from harm without stifling the possibilities for new discoveries is a matter of great debate. (Bennet G. al., 2009) (Hayden E. C., 2009) (Kelle A., 2009) (Erickson B., 2011) (Falkow S., 2012)<br/>
In a world where ‘bio-hackers’ will be able to perform synthetic biology in their own garage, the limits of registering and licensing tools will be tried. Therefore <b>we strongly advocate early intervention at the educational level by providing opportunities for open ethics discussions and fostering individual and institutial responsibility</b>. Our hope is for a community that goes beyond the mere sharing of knowledge. We would like to work towards a society where the public is well-informed, actively involved, and thus capable of self-regulation. Such a society will feel responsible for it members. This view is inspired by the concept of intellectual freedom and responsibility and regulatory parsimony, put forward by several bio-ethics committees (the Presidential  Commission for the study of Bioethical issues. 2010) (Gutmann A., 2011) (EgE, Opinion no. 25., 2009). The iGEM competition  in which we participate provides an ideal platform for this endeavour since it is a competition for undergraduates.<br/>
On the other hand this does not make the need for external regulation superfluous. In our opinion however an active participation of the scientists will lead to a better acceptance of the need for external evaluation. Regulations are best made in dialogue with scientists and using their active participation (Yearley S., 2009). <b>As such, ethics will no longer be about an outsider telling others what they can and cannot do, but instead rooted from within the scientific community. </b><br/>
It however remains true that a single, maliciousperson with access to the right knowledge and equipment still poses a serious threat to the general public. This is extended by the fact that some intended and unintended dual purposes can be foreseen but others not (EgE, Opinion no. 25., 2009).This makes the matter of responsibility so complicated and is the reason why it would be unwise to let just one institution -be it the scientists themselves or one outside regulatory organ- carry the full responsibility. Regulatory oversight is therefore also seen as necessary in the EU and US such as for example a screening infrastructure for genetic sequence providers (EgE, Opinion no. 25., 2009 )( the Presidential  Commission for the study of Bioethical issues. 2010).</p>
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    <p>The US Presidential Commission for the study of Bioethical issues text on synthetic biology</p>
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    <h3>Dual use dilemma</h3>
    <p align="center"><b>Mitigating the risk for wrongful use as much as possible is and remains a legislative problem. We are convinced that an effective regulation can be found in dialog with the scientific community and that there is broad willingness to play a constructive role in this debate.</b><p/>
    <p align="justify">Concerning our project we will limit ourselves to the impact of our project on biosecurity, this leads us to the dual use dilemma. This dilemma arises as a consequence of the fact that one piece of research sometimes has the potential to be used for bad as well as good purposes. A recent example is the H5N1 “affair”.  A research group wanted to study which mutations could make the Avian H5N1 flu virus transmittable between mammals. They did this generating the required genome themselves. This led to a passionate dialog about biosafety, biosecurity and bioterrorism which eventually led to a self-imposed moratorium on further research (Falkow S., 2012). The whole is an ethical dilemma since it is about promoting good outcomes in the context of the potential for also causing harm. It is also agovernmental dilemma as these strains van threaten the security and health of their citizens (Miller S., Selgelid S. J., 2007). <br/>
The intended consequence of our system is to shift balances in the environment to favour the predation of aphids and to prevent them from thriving in order to increase crop revenue. Dual use would in this case be an effect on non-target organisms or in a non-target environment that is detrimental to the respective ecosystem. The further defining of these dual use situations is yet another reason to perform risk assessments and long term field studies.<br/>
It is regrettably so that even with these studies every possible dual use scenario cannot be foreseen. Mitigating the risk for wrongful use as much as possible is and remains a legislative problem. We are convinced that an effective regulation can be found in dialog with the scientific community and that there is broad willingness to play a constructive role in this debate.
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Bennett G., Gilman N., Stavrianakis A., Rabinow P. (2009). From synthetic biology to biohacking: are we prepared?. Nature biotechnology 1109-1111.<br/>
Erickson B., Singh R., Winters P. (2011). Synthetic Biology: regulating industry uses of new Biotechnologies. Science, 333(6047), 1254-1256.<br/>
Falkow S. (2012). The lessons of Asilomar and the H5N1 ‘affair’. mBio. 3(5):e00354-12. doi:10.1128/mBio.00354-12<br/>
Gutmann A. (2011). The ethics of synthetic Biology: Guideline Principles for Emerging Technologies. Hastings Center Report 41, (4), 17-22.<br/>
Hayden E. C. (2009). Keeping genes out of terrorists’ hands. Nature, 461, 22.<br/>
Kelle A. (2009). Synthetic biology and biosecurity. EMBO reports. S23-S27<br/>
Miller S., Selgelid S. J. (2007). Ethical and Philosophical Consideration of the Dual-use Dilemma in the Biological Sciences. Sci Eng Ethics, 13, 523–580.<br/>
The Presidential  Commission for the study of Bioethical issues. (2010). New directions: the Ethics of synthetic Biology and Emerging Technologies.<br/>
Yearley S. (2009). The ethical landscape: identifying the right way to think about the ethical and societal aspects of synthetic biology research and products. J. R. Soc. Interface, S559-S564.<br/>
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