Team:Freiburg/Safety/safety

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<p id="h1">Safety</p>
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<p id="h1">Safety & Security</p>
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<p>At the beginning we formed a group of teammembers who concerned themself with human practice and safety issues. We contacted different experts such as Joachim Boldt, Deputy Head at the Department of Medical Ethics and the History of Medicine, and in terms of safety and environment the Stabsstelle Sicherheit (deputy of safety), which gave us kindly advises for our human practice plans and safety aspects. These meetings and contacts were extremely helpful to ensure that our plans were reasonable. To have an impression of our public outreach, please visit our <a id="link" href="https://2013.igem.org/Team:Freiburg/HumanPractice">Human Practice</a> or <a id="link" href="https://2013.igem.org/Team:Freiburg/Safety/engineering_life">Ethical Discourse</a> page.</p>
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<p id="h2">Declaration of Intent</p>
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<p> Hereby we, iGEM Team Freiburg 2013, state, that all the DNA constructs used, as well as our mammalian cell lines, were solely utilized for laboratory work. The cells provided us a well-established model system for scientific research, which is similarly utilized by thousands of other academic institutions around the world. Notably, in none of our experiments we used stable integration of DNA-sequences into our host cell genomes and therefore, have not created genetically modified human cells. We purposely avoided the utilization of viruses as DNA-donors, and instead, were strictly relying on transient PEI-transfections in every approach. As Cas9 - the heart of our toolkit - was also mutated to a non-cutting DNA-binding device from the very start of the uniCAS project, the risk of off-target mutagenesis in our mature HEK-293T, HeLa, CHO-K1 or NIH/3T3 cultures was efficiently reduced to a minimum.</p>
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<p id="h2">Biosafety & Biosecurity</p>
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<p id="h2">Safety </p>
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<p>Concerning biosafety and biosecurity, DNA constructs used in this work as well as the genetically modified cells are thought for laboratory work. They should not be able to harm any organism. Even if our DNA constructs are taken up by organisms there is no risk to the environment as the constructs do not transfer any pathogenicity factors or biological fitness advantages. It is a tool for scientific research and it shouldn't be possible to use our system for malicious purposes. Our main protein, dCas9 and its related RNAs, are originating from a pathogen (Streptococcus pyogenes). This bacterium is classified, according to German regulations, to be safety level 2. As we are only dealing with a protein and RNAs, which are not described as a part of any pathogenic or toxic factor of this bacterium, they can be considered as harmless. This is in accordance to German regulations for biotechnology and the German safety forms. An up-scale of this system would not raise any additional dangers and could be performed under S1 conditions as our small-scale approaches. This is also in accordance to German safety regulations.
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<p>At the beginning of our project, it was deliberately intended to strictly work on a transient experimental scale. This was due to our intention to firstly test for the possibility to regulate and control endogenous processes and to classify off-target effects. Accordingly, we never stably integrated our dCas9 or RNAimer constructs into a human cell genome and did not have to use randomly integrating retroviruses. In regard to biosecurity concerns, our uniCAS toolkit is exclusively useful and intended to act as tool for laboratory research, so purposes to release uniCAS-transfected cells into the environment could on the one hand be judged senseless but also futile. Furthermore, it is worth mentioning that our project doesn’t involve expression of any toxins or pathogenic proteins - whereby secondary risks could be excluded from our project.</p><br>
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<p>Nevertheless our main protein, dCas9 and also its related RNAs, originated from a pathogenic bacterium (<i>Streptococcus pyogenes</i>). This procaryote is classified, according to German regulations, to be safety level 2. We were solely operating with the protein and RNAs vectors - originally distributed from addgene -, which to date have not been described as a part of any pathogenic or toxic activities of this bacterium, they could be considered as nonhazardous. An up-scale of this system would not raise any additional dangers and could be performed under S1 conditions as our small-scale approaches. This is in accordance to German regulations for biotechnology and safety. For a detailed look on our Safety explanations and official forms, please have a look on our <a id="link" href="https://2013.igem.org/Team:Freiburg/Safety">safety page</a>.</p><br>
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<p id="h2">General Security</p>
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<p>Most of all new technologies and methods bring benefits but also risks with them. Therefore, we asked several Freiburgian experts from different biological and medical fields for their opinion - regarding research, ethics and safety. Especially in the context to our project and in regard to multiple gene regulation in general, we received a broad range of optimist but also critical <a id="link" href="https://2013.igem.org/Team:Freiburg/HumanPractice/experts">commentaries</a>.</p><br>
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<p>Exemplarily, we intend to point out some key reflections on the topic, which resulted from an interview with Brain expert <a id="link" href="https://2013.igem.org/Team:Freiburg/HumanPractice/experts#Holzschuh">Dr. Jochen Holzschuh</a> from the Freiburg Department of Developmental Biology.</p>
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<p id="ethikzitat"><font size="5">“</font>... even when considering the highest risks, it is not an alternative to stop research ...<font size="5">“</font></p><p id="ethikzitat"><font size="5">“</font>... as a scientist who creates a certain knowledge, responsibility does not stop at the end of his or her own work - instead, the duty of observing the usage of this knowledge by other scientists arises ...<font size="5">“</font></p>
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<p id="ethikzitat"><font size="5">“</font>… a scientist can never stay objective in regard to his own project. Thus, safety judgements always need to be developed with non-involved experts ...<font size="5">“</font> </p>
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<p>There have been different methods for regulation of genes before. Hence, we did not set up a totally new branch of research, which would have implied new safety issues. But nevertheless, we engineered the CRISPR/Cas system, and thereby gave rise to the opportunity of a more complex type of gene regulation - because it is now possible to simultaneously target and therefore regulate multiple genes at once. Still <a id="link" href="https://2013.igem.org/Team:Freiburg/HumanPractice/experts#Hess">Prof. Dr. Wolfgang Hess</a> confirmes that:</p>
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<p id="ethikzitat"><font size="5">“</font>… considering ethics and biosafety: it’s „just“ another tool to do things that have been done before, expect for the complexity …<font size="5">“</font></p>
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<p>One question in our interviews dealt with the problem which security aspects can be seen in regard to laboratory or environment while using our toolkit. Most of the experts emphasized that we did not use any viruses or stable transductions as described above.
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For more information about the ethical background of our project and the expert opinions on that controversial topic, especially the medical point of view, visit our <a id="link" href="https://2013.igem.org/Team:Freiburg/HumanPractice/ethics">ethics page</a>.</p>
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Latest revision as of 03:39, 29 October 2013


Safety & Security

Declaration of Intent

Hereby we, iGEM Team Freiburg 2013, state, that all the DNA constructs used, as well as our mammalian cell lines, were solely utilized for laboratory work. The cells provided us a well-established model system for scientific research, which is similarly utilized by thousands of other academic institutions around the world. Notably, in none of our experiments we used stable integration of DNA-sequences into our host cell genomes and therefore, have not created genetically modified human cells. We purposely avoided the utilization of viruses as DNA-donors, and instead, were strictly relying on transient PEI-transfections in every approach. As Cas9 - the heart of our toolkit - was also mutated to a non-cutting DNA-binding device from the very start of the uniCAS project, the risk of off-target mutagenesis in our mature HEK-293T, HeLa, CHO-K1 or NIH/3T3 cultures was efficiently reduced to a minimum.

Safety

At the beginning of our project, it was deliberately intended to strictly work on a transient experimental scale. This was due to our intention to firstly test for the possibility to regulate and control endogenous processes and to classify off-target effects. Accordingly, we never stably integrated our dCas9 or RNAimer constructs into a human cell genome and did not have to use randomly integrating retroviruses. In regard to biosecurity concerns, our uniCAS toolkit is exclusively useful and intended to act as tool for laboratory research, so purposes to release uniCAS-transfected cells into the environment could on the one hand be judged senseless but also futile. Furthermore, it is worth mentioning that our project doesn’t involve expression of any toxins or pathogenic proteins - whereby secondary risks could be excluded from our project.


Nevertheless our main protein, dCas9 and also its related RNAs, originated from a pathogenic bacterium (Streptococcus pyogenes). This procaryote is classified, according to German regulations, to be safety level 2. We were solely operating with the protein and RNAs vectors - originally distributed from addgene -, which to date have not been described as a part of any pathogenic or toxic activities of this bacterium, they could be considered as nonhazardous. An up-scale of this system would not raise any additional dangers and could be performed under S1 conditions as our small-scale approaches. This is in accordance to German regulations for biotechnology and safety. For a detailed look on our Safety explanations and official forms, please have a look on our safety page.


General Security

Most of all new technologies and methods bring benefits but also risks with them. Therefore, we asked several Freiburgian experts from different biological and medical fields for their opinion - regarding research, ethics and safety. Especially in the context to our project and in regard to multiple gene regulation in general, we received a broad range of optimist but also critical commentaries.


Exemplarily, we intend to point out some key reflections on the topic, which resulted from an interview with Brain expert Dr. Jochen Holzschuh from the Freiburg Department of Developmental Biology.

“... even when considering the highest risks, it is not an alternative to stop research ...“

“... as a scientist who creates a certain knowledge, responsibility does not stop at the end of his or her own work - instead, the duty of observing the usage of this knowledge by other scientists arises ...“

“… a scientist can never stay objective in regard to his own project. Thus, safety judgements always need to be developed with non-involved experts ...“

There have been different methods for regulation of genes before. Hence, we did not set up a totally new branch of research, which would have implied new safety issues. But nevertheless, we engineered the CRISPR/Cas system, and thereby gave rise to the opportunity of a more complex type of gene regulation - because it is now possible to simultaneously target and therefore regulate multiple genes at once. Still Prof. Dr. Wolfgang Hess confirmes that:

“… considering ethics and biosafety: it’s „just“ another tool to do things that have been done before, expect for the complexity …“

One question in our interviews dealt with the problem which security aspects can be seen in regard to laboratory or environment while using our toolkit. Most of the experts emphasized that we did not use any viruses or stable transductions as described above. For more information about the ethical background of our project and the expert opinions on that controversial topic, especially the medical point of view, visit our ethics page.

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