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Revision as of 18:50, 15 August 2017

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Safety Form

This form is for you to tell us all about your project, the organisms/parts you are using, the potential risks of your project, and what you are doing to reduce those risks.

  • We encourage STUDENTS, instead of instructors, to complete this form.
  • You will need an Instructor or PI to sign and submit this form before the Giant Jamboree.
  • As you type, this form will remember your answers - you do not need to click "Submit" until Parts 1-5 have been completed.

Deadlines

If you will not be able to complete this form before the deadline, please email us (safety AT igem DOT org) and tell us about your situation.

Complete by Friday, June 30, 2017

  • Part 1: Contact
  • Part 2: About our Lab
  • Part 3: About our Project
  • Note: you do not need to click "Submit". The form will automatically save your responses.

Complete by Monday, October 2, 2017

  • Part 4: New Parts
  • Part 5: Sign Off submitted by the Instructor or PI

NOTE

Complying with the safety requirements is a condition of competing at iGEM - that includes providing all the information in this form by the relevant deadlines.
Failure to do so can lead to immediate disqualification from the competition and referral to the Responsible Conduct Committee.

Safety Form

Team Selection

Please choose a team

This form has been submitted.

You can unsubmit the form if you wish to make further edits.

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1.- Contact Information

Name

Email

Note

It is your responsibility to demonstrate that your work is safe. The easiest way to do this is through a well-researched and comprehensive safety form.

2.- About our Lab

This part of the form is for you to tell us about your laboratory space and your safety equipment. If you need help, please consult your faculty advisor or laboratory manager. You can also read the Safety page and the Risk Groups page for basic information about different types of biology labs.

1. Please upload a photo or two of your lab to the iGEM 2017 server (include your team name in the file name), preferably showing the relevant safety features and paste the link here:




Biosafety Level

2. What is the Safety Level of your lab? [Help about Risk Groups and Safety Levels]

Note

iGEM teams should not use Risk Group 3 or 4 organisms, and they should not work in Safety Level 3 or 4 labs. If you are planning to work at Safety Level 3 or 4, contact safety (AT) igem (DOT) org right away!!




Work areas

3 Which work areas do you use to handle biological materials? Please check all that apply.




Biosafety Training

4. Have your team members received any safety training yet?

  • Yes, we have already received safety training.
  • We plan to receive safety training in the future:
  • We will not have safety training:

Note

For the purposes of iGEM, biosafety and biosecurity training covers the procedures and practices used to manage risks to your team, colleagues and institution, communities and the environment - from accidents or deliberate misuse of your projects. All team members are expected to be aware of these risks and to work to manage them

5. Please briefly describe the topics that you learned about (or will learn about) in your safety training.

  • Lab access and rules (including appropriate clothing, eating and drinking, etc.)
  • Responsible individuals (such as lab or departmental specialist or institutional biosafety officer)
  • Differences between biosafety levels
  • Biosafety equipment (such as biosafety cabinets)
  • Good microbial technique (such as lab practices)
  • Disinfection and sterilization
  • Emergency procedures
  • Transport rules
  • Chemicals, fire and electrical safety
  • We will not have safety training:

6. Who provided your safety training? Did you get training from multiple people?

  • University biosafety office
  • Departmental specialist
  • PIs/instructors
  • Other



Oversight

7. Who is responsible for the safety of biology labs at your institution? What are the guidelines for laboratory biosafety? Please give a link to these guidelines, or briefly describe them if you cannot give a link.

8. In your country / region, what are the laws and regulations that govern biosafety in research laboratories? Please give a link to these regulations, or briefly describe them if you cannot give a link.




Uncertainties

9. Are there any areas where you have encountered uncertainties concerning institutional, regional, national or international rules and regulations and whether they are relevant to your lab and/or work?

10. Do you think the design of current regulations is sufficient to ensure safe and ethical practices?

(If not, how else could you approach the design? We’re interested in your ideas for strategies that could be used to promote safe and ethical practices as it becomes easier to engineer biology (i.e. monitoring people or information, building safety into the design of equipment, etc). Can you think of any useful examples from other fields?)

3.- About our Project

This part of the form is for you to tell us about your primary project idea, what organisms and parts you will use and what your project will do. We know that iGEM teams often change project topics during the summer. When you change your primary project idea, please update this form to tell us about your new idea! If you are still working on multiple project ideas by June 30, you may choose one to describe on this form, or you may tell us about other ideas in the "Further Comments" section.




Project Overview

11. How will your project work?

Describe the goal of your project: what is your engineered organism supposed to do? Please include specific technical details and names of important parts. (Even though your project might change, please describe the main project idea you are working on right now. See the example answers for help.)



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 gasses high in CO2. We will increase their expression of Photosystem II proteins to make them absorb more CO2 from the gas."

Bad example answers (not enough detail):

"We are engineering E. coli to cure liver cancer."

"Climate change is a very important problem. Our algae will reduce CO2 emissions and fight climate change."






Future applications

12. How would your project be used in the real world?

Imagine that your project was fully developed into a real product that real people could use. How would people use it? Check all appropriate boxes and expand in the comments section. (Note: iGEM teams should not release modified organisms into the natural environment.)


  • (Examples: library of standardized promoters, system for communication between cells)

  • (Examples: reporter strain for measuring the strength of promoters)

  • (Examples: cells that make a flavor chemical for food, cells that make biofuel)

  • (Examples: cells that clean your clothes, bread made with engineered yeast)

  • (Examples: cells that guard against pests, engineered rice plants, cells that promote growth of crop plants)

  • (Examples: a bio-sensing strip with cells that detect arsenic)

  • (Examples: cells that remove pollution from lakes, engineered forest trees that can resist drought)

  • (Examples: anti-cancer bacteria, bread made with engineered yeast, engineered rice plants)

  • (Examples: bacteria that live on Mars)


13. What safety or ethical risks would be involved with such a use?




Specific risks

14. Does your project include the use of gene drives?


  • STOP: Gene Drives are not allowed in iGEM projects without a special exception from the Safety Committee. For more information see the Safety Policy page and the White List. Please contact the Safety Committee by emailing safety AT igem DOT org

Note

For the purposes of iGEM, a gene drive includes Cas9 (and other endonucleases, such as dCas9 and Cpf1) integrated into the genome (including through the use of gRNA) of a sexually reproducing eukaryotic organisms (including organisms that reproduce both sexually and asexually, such as yeast) and/or the use of a drive to impact the progeny.



15. Does your project include the use of animals?


  • STOP: The use of animals is not allowed in iGEM projects without a special exception from the Safety Committee. For more information see the Safety Policy page and the White List. Please contact the Safety Committee by emailing safety AT igem DOT org


16. Does your project include the use of anti-microbial resistance factors? For more information see the Safety Policy page and the White List.

  • If you cannot provide such a reference you will need to complete a check-in form for this part.

  • You will need to complete a check-in form for this part.

Note

For the purposes of iGEM, anti-microbial resistance factors are genetic sequences, or any other factor, that can increase an organism's resistance to drugs or therapeutics used to control them. This includes genes known to confer resistance to antibiotics or antiviral drugs.




Parts and organisms not on the Whitelist

17. Does your project include parts or organisms not on the Whitelist.?


  • STOP: Before you acquire or use any organism/part that is NOT on the Whitelist, you must submit a Check-In form. Check-Ins allow the iGEM Safety Committee to help you ensure that you will work safely with these riskier organisms/parts. The Safety Committee will base its review on the information you provide – please provide as much information as possible and use references as appropriate.

Note

Some organisms and parts present risks beyond what is ordinary for lab work in synthetic biology. As your project progresses, you should consider the risks presented by each organism and part you plan to use.




Chassis

18. What is your chassis organism?

Check all species you are genetically modifying in your project.

Note

For the purposes of iGEM, a chassis is the organism in which you are putting your parts, or which you are modifying in your project. Many teams will use a common lab organism as a chassis. Some teams may use a more exotic organism. Some project may not involve a chassis.

Comments:




Other organisms (or parts from them)

19. Besides your chassis, do you plan to use any other organisms (or parts from them)?

What organisms, and what experiments will you do? Please explain briefly. Please include the names of species / cell lines / strains. This includes the origins of parts taken from other organisms, even if they are being synthesized rather than isolated from nature – you need not include any parts already in the registry.



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 is synthesized by a provider.”






Uncertainties

20. Are there parts of your project which you think may have ethical, safety or security concerns that are not fully covered by current rules and standards?



21. Who have you worked with to resolve any uncertainties or gaps in how you ensure the safety of your project and how difficult have they been to contact?

Note:

Beyond this point, no more is required for the June 30th deadline. No need to click submit or fill in more information

4.- New Parts

This part of the of the form is for you to tell us about the parts you have developed during your project. It summarises information that might already have been submitted through check-in forms. Please visit this page to download a blank copy of the spreadsheet for this question. (If you need a CSV version instead of XLSX, visit this page.) Complete the spreadsheet. Include all new or highly modified protein coding parts that you are using. If you submitted a Check-In for an organism or part, you should still include it in this spreadsheet. You may omit non-protein-coding parts (except if they are known virulence factors – you should undertake a literature search to determine if they are), and you may omit parts that were already in the Registry if you are using them without significant modifications. For more information on virulence factors see the Safety Policy page and the White List. Please contact the Safety Committee by emailing safety AT igem DOT org

Click here to show/hide instructions for completing the spreadsheet

Remember to change the filename of your spreadsheet! Put your team's name in place of "TeamName".

  1. Species name (including strain): For an organism, give the scientific name of the species. Include a strain name or number (such as "K-12" for E. coli K-12) if there is one. For a part, give the name and strain of the organism that the part originally came from.
  2. Risk Group: Give the Risk Group of the organism in column A. You may use a categorization according to your home country, according to the USA, or according to the WHO. If the organism falls into an 'in-between' or special category such as 2+ or 2-Agricultural, explain this category in the Notes column. If you cannot find any Risk Group categorization for this organism, write "N/A" and explain in the Notes column. (Multicellular organisms generally do not have a Risk Group.)
  3. Risk Group Source: Cite the source from which you obtained the Risk Group information. See Risk Group Guide for recommended sources. If you got the information from the Canadian PSDS, from the NIH Guidelines, or from the DSMZ catalogue, you may simply write "PSDS", "NIH", or "DSMZ". Otherwise, please give a web link or a full citation for your source.
  4. Disease risk to humans?: Does this organism cause any disease in humans? If yes, what disease does it cause?
  5. Part number/name: For a part: If it has a Registry part number (like BBa_XXXXX), write that number. If it has no Registry part number, give a short name for the part. (For example: "Actin", "Alcohol Dehydrogenase".) For a whole organism, leave this column blank.
  6. Natural function of part: For a part: Briefly describe what the part does in its parent organism. (If it is an enzyme, what reaction does it catalyze? If it is a receptor, what molecules does it bind to? Etc.) For a whole organism, leave this column blank.
  7. How did you acquire it?: Describe how you acquired the organism/part. If you have not acquired it yet, describe how you plan to acquire it. (For example: did you receive the part DNA from another lab? Did you order the part DNA from a synthesis company? Did you use PCR to isolate the part from genomic DNA of its parent organism? Did you order the cell line from a company?)
  8. How will you use it?: Describe how you are using the organism/part in the lab. (For example: "This organism is our chassis." "This part senses when the cells are exposed to glucose." "This organism is the source for a part that we are isolating by PCR." "This part produces the toxin which our bio-sensor is designed to detect.")
  9. Notes: Use this column to give any additional information that is necessary.

-- Please do not change the "Destination Filename"! [File:TeamName Safety2017 Spreadsheet.xls]

You may upload multiple versions of your spreadsheet, using the same Destination Filename. The wiki software will keep track of different versions, and list them in chronological order.

Click here to VIEW your spreadsheet


5.- Sign Off

Only a team Instructor or PI may submit the Safety Form.

Instructors/PIs, please read the form you are submitting, and confirm that all its information is correct. By checking the "I Agree" box and clicking the "Submit" button, you are certifying that the Final Safety Form accurately describes the activities of your team and that they have worked in conformity with relevant international, national, local and institutional laws, rules and regulations and that the parts used comply with the competitions rules and regulations, including on open access. We are using the "I Agree" box in lieu of a signature with paper and pen.

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