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Team:Caltech/Safety
From 2014.igem.org
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| Link to our team's safety form. | |||||||||||||
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One of the questions are team asked was: if we were to design an inter species drug to treat diabetes, how feasible would it be to test and distribute?After considering this idea, we came across questions regarding the safety of this approach. We contacted the Caltech Safety Office to consider the steps we would have to take to test it. First, we would want to test our drug on animals. To do this, we would have to adhere to the IACUC guidelines for animal testing. This link describes the procedures necessary. Next, we would want to test it on humans. For that, we would need to adhere to the IRB guidelines. Not only do we need to follow IRB guidelines, but we also need to follow FDA guidelines. Their regulations can be found at the FDA's website for guidelines regarding clinical trials.
| This approach does address our question. However, it makes it seem like a trivial process, when it, in reality, would be very time consuming to perform. Since we were unsuccessful in creating our circuit design in E. coli, this approach did not influence our science project, since it is a distant step in the process. However, an actual research group or biotech company working on a project similar to this over a much longer time scale (e.g. 8 years) will almost certainly encounter these concerns and have to account for them accordingly. Other teams can follow these steps if they design a successful circuit in E. coli using insulin. |
Please visit our Materials and Methods section to view the standard protocols we followed over the summer. | | |||||||||
