Team:Caltech/Safety

From 2014.igem.org

(Difference between revisions)

Revision as of 22:00, 17 October 2014

Home

Team

Official Team Profile

Project

Parts

TXTL Promoter Characterization

Notebook

Safety

Attributions

Safety
Link to our team's safety form.

W.M. Keck Engineering Laboratories

Our Lab Space

Our lab is located on the 1st floor of W. M. Keck Engineering Laboratories. We have our own tabletop centrifuge and thermal cycler, as well as a 37°C incubator, a -20°C freezer, and a 4°C freezer. We share the -80°C freezer with the rest of the Richard Murray lab.

Safety Regarding Policies and Practices

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.

Procedures

Please visit our Materials and Methods section to view the standard protocols we followed over the summer.

@@ Line 89: / Line 89: @@
 <tr> <td bgColor=#000000 colspan = 3> <font color = "white"> <font size = +2> <center> Safety Regarding Policies and Practices </center> </font> </td>
-<tr> <td> 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. The link, https://iacuc.caltech.edu/submission, describes the procedures necessary. Next, we would want to test it on humans. For that, we would need to adhere to the IRB guidelines, which can be found here: https://irb.caltech.edu/protocols. Not only do we need to follow IRB guidelines, but we also need to follow FDA guidelines. Their regulations can be found at <a href="http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm#FDARegulations">the FDA's webpage</a> for guidelines regarding clinical trials.
+<tr> <td> 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. <a href="https://iacuc.caltech.edu/submission">This link</a> describes the procedures necessary. Next, we would want to test it on humans. For that, we would need to adhere to <a href="https://irb.caltech.edu/protocols">the IRB guidelines</a>. Not only do we need to follow IRB guidelines, but we also need to follow FDA guidelines. Their regulations can be found at <a href="http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm#FDARegulations">the FDA's website</a> for guidelines regarding clinical trials.
 <p>
-This approach does address our question. However, it makes it seem like a trivial process, when, 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. Other teams can follow these steps if they design a successful circuit in E. coli using insulin.
+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 <i>E. coli</i>, 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.