Safety Form

 
1. Are you planning to do any of the activities listed below?
a.Using organisms from Risk Group 3 or 4
b.Using parts from an organism in Risk Group 4
c.Releasing or deploying a genetically modified organism outside the lab
d.Testing your product on humans (including yourselves)
2. Please read over iGEM’s White List. (https://responsibility.igem.org/guidance/white-list)Will your team use any organisms or parts not on the whitelist, or do any activities not on the whitelist?
3. Are you planning to do any of the activities mentioned above that require advance permission from iGEM?
a.Working with animals or samples from animals (in iGEM, “animals” are vertebrates, like rats or fish, and higher-order invertebrates, like octopus and bees)
b.Bringing a product of a genetically modified organism outside the lab
c.Conducting laboratory experiments using human samples, such as blood, DNA, other bodily specimens, and health or psychological outcomes
d.Using parts or organisms obtained from anywhere other than a trusted commercial or institutional supplier
e.Biasing the inheritance frequency of a genetic marker in an organism’s progeny, i.e. creating a gene drive
f.Increasing risks from antimicrobial resistance, such as by using novel resistance factors
4. Are you collecting any data about people, such as their opinions, quotations, medical history, gender, behavior, attitudes, or concerns?
(For good reasons, many countries require formal approval for Human Subjects Research, as well as consent procedures for participants. You may need formal permission from a Research Ethics Committee, Institutional Research Board, or equivalent. Remember compliance with relevant laws and regulations is a requirement for participation in iGEM.)
5. Does your project involve lab work and your team has plans to access lab space?
6. Please upload a photo or two of your lab showing the relevant safety features. Available file formats: .png, .jpg, .webp
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7. What is the biosafety level of your work space?
8. Which work areas will you use / are you using to handle biological materials?
9. Describe the goal of your project: what is your engineered organism (or other synthetic biology product, system, or tool) supposed to do?
Good example answers:
-Our bacteria will be engineered to interact with human cells. They will detect tumor cells that express biomarkers for liver cancer. They will use invasin to enter the tumor cells, and then secrete apoptin to kill the tumor cells.
-Our algae will receive gases high in CO2. We will increase their expression of Photosystem II proteins to make them absorb more CO2 from the gas.
10.  Will you be engineering whole organisms, including viruses and cell lines in your project?
11. Please explain in more detail how your project will be conducted without engineering an organism.
12. Will you use any other organisms in your project? List organisms, including genus, species, and strain.
13. As part of your project, are you planning to make / have made new parts or substantively changed existing parts in the Registry?
14. Could any of your parts be hazardous on their own and/or in the context of your project?
15. What experiments will you do with your organisms and parts?
Example answers:
-Our bacteria is meant to live on plant leaves, so we will test them on tobacco (Nicotiana benthamiana) in a lab greenhouse.
-We want to use a protein from ants, but its sequence is unknown. So we will capture ants (Camponotus spp.) to extract DNA and RNA to find the sequence of the protein we want.
-Our bacteria need to interact with human cells for a medical application. We will test them in human cell culture using the HEK293 cell line.
-We are interested in a RNA-binding protein expressed in Kluyveromyces lactis. We have found the sequence in a paper and will have it synthesized by a commercial provider.
-Our project will not involve experiments with organisms or parts. We will run digital directed evolution experiments to identify a candidate receptor binding protein for our fungicide.
16. Are you using some kind of hazardous chemicals in your project?
17. What kinds of chemicals are you using in your project?
18. If you selected any of the hazardous kinds of chemicals above, please list the specific chemicals you are using.
19.  Is your team using or planning to use an Artificial Intelligence (AI) tool(s) for the development of your project?
20. Which category of AI tool(s) are you using or planning to use for your project?
21. What risks, if any, do you foresee arising from the use of these AI tools in your project? What measures will you take to identify and mitigate these risks?
22. Are there any hazards presented by the organisms, parts, chemicals, or experiments you described in Q9-21?
23.  Imagine that, in the future, your project was fully developed into a real product that real people could use. How would people use it?
24. Please describe how your project would be used in the real world.
25. If you were permitted, would the continued development of your project require release beyond containment?
26. Briefly, describe what experiments, tests, or final uses would need to take place outside of laboratory containment. Include any institutional approval processes or national regulations that you are aware you would need to comply with. (1-3 sentences)
27. Have people on your team had a conversation (within your team or with someone outside the team) about how any of the bad outcomes below might relate to your project?
28. Considering the future use(s) and conversations from the previous questions, do you think your project could potentially lead to any of the bad outcomes listed above?
29. If your project were fully developed, could any of your engineered organisms or parts spread autonomously in the environment?
30. Describe these strategies and why you chose them
31. Please select which cohort you belong to.
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