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Team:Freiburg/Safety/safety
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<p id="h1">Safety</p> | <p id="h1">Safety</p> | ||
| - | <p id="h3"> | + | <p id="h3">Declaration of Intent</p> |
| - | <p> Hereby we 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 | + | <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">Safety</p> | <p id="h2">Safety</p> | ||
| - | <p>At the beginning of our project it was deliberately intended | + | <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> |
<p>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 the 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 regulations. 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. For a detailed look on our Safety aspects, please have a look on our <a id="link" href="https://2013.igem.org/Team:Freiburg/Safety">safety page</a>, where you can find our safety forms.</p> | <p>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 the 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 regulations. 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. For a detailed look on our Safety aspects, please have a look on our <a id="link" href="https://2013.igem.org/Team:Freiburg/Safety">safety page</a>, where you can find our safety forms.</p> | ||
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| + | <p>As all new tools and methods come with risks and benefits, we asked several experts in the fields of biology and medicine for their opinion regarding research, ethics and safety - especially in context to our project and multiple gene regulation in general.</p> | ||
<p>The consulted experts all agreed that | <p>The consulted experts all agreed that | ||
Revision as of 02:28, 29 October 2013
Safety
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.
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 the 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 regulations. 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. For a detailed look on our Safety aspects, please have a look on our safety page, where you can find our safety forms.
As all new tools and methods come with risks and benefits, we asked several experts in the fields of biology and medicine for their opinion regarding research, ethics and safety - especially in context to our project and multiple gene regulation in general.
The consulted experts all agreed that
“[…] even when considering the highest risks, it is not an alternative to stop research [...]“ (Dr. Jochen Holzschuh).
He continues
„[...] 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.“
This means that on the one hand scientists are responsible to watch scientific development but also stay in dialog with society and politics about their research.
Taking a more objective view on our own project, we agree with Dr. Jochen Holzschuh’s opinion:
“[…] moral and safety judgements always need to be developed with non-involved experts […].”
For a detailed overview about our expert interviews see the quotations on our expert opinion site.
There have been different methods for regulation of genes before and we did not create a new field of research which would have implied new safety issues. But nevertheless we engineered the CRISPR/Cas system, and thereby give the opportunity for a more complex gene regulation because it is now possible to target different DNA sites simultaneously and therefore regulate multiple genes at once. Still Prof. Dr. Wolfgang Hess confirmed 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 ethic page.
