Safety

From 2013.igem.org

(Difference between revisions)

Revision as of 15:35, 9 August 2013

iGEM 2013 SAFETY

iGEM treats the safety of participants and the public and protection of the environment as top priorities. To this end, iGEM has adopted a three level review process that challenges participants to address the safety, security and environmental implications of their work.

Adobe Reader
Please complete these forms using [http://get.adobe.com/reader/ Adobe Reader]. Your advisor will need to sign the forms electronically and Adobe Reader has an option to do so.

iGEM 2013 SAFETY Instructions

All iGEM 2013 teams must complete this form:

iGEM 2013 Basic Safety Form

Teams working with parts or organisms that are risk group 2 or greater must complete this form for each part of organism:

iGEM 2013 Biosafety form Part 2

All iGEM 2013 Software teams must complete this form:

[Software form - Released ~12/13th August 2013]

Forms must be completed and emailed to the correct mailing list below for your region by the 30th of August 2013

Safety Form Resources

In order to complete these forms and submit them to iGEM, you will need to know a few things about the organisms you are working with. More specifically, you will need to know the Risk Group (and corresponding Biological Safety Level) for the organisms and some of the parts you are working with. Here are some sites that should help you find out the Risk Group for your organisms and parts.

Risk Group Table

We have created a Risk Group and Biological Safety Level quick reference table. Use this table to help determine which BSL you should be using for a specific RG organism.

Organism Risk Group classification:

[http://www.absa.org/ American Biological Safety Association] The ABSA has a searchable database of orgnisms that give the risk froup for many differnt regions.

[http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Toc351276291 National Institutes of Health Risk Group Definitions]. This appendix of the NIH guidelines lists the Risk Group classification for organisms and gives examples of RG2, RG3 and RG4.

[http://www.australiagroup.net/en/biological_agents.html The Australia Group] List of Biological Agents for Export Control. This page lists all the organisms that can't be used in iGEM due to their pathogenicity and control over the transport of the DNA. You shouldn't use any organisms on this list as you can't send us the DNA.

Lab biosafety:

[http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf World Health Organization Laboratory biosafety manual]. The WHO biosafety manual should help you determine the classification of your lab if you don't know it.

Information on completing the safety forms

For help in completing safety requirements, please watch these two videos:

Stage 1

First, all teams must fulfill local requirements for review and approval of projects by university institutional biosafety committees, where available. iGEM will defer to approvals and waivers granted by local biosafety committees when documentation is provided. All teams should seek guidance and information from their university's biosafety committees or other appropriate local groups.

Note: Standards for review vary from nation to nation and university to university. You will need to check local university documents and websites for requirements.

Stage 2

Due August 30th, 2013: Second, all teams must complete the Basic Safety Page by August 1, 2013. The Safety Page is your team’s primary location for discussing potential safety, security and environmental implications of your project and for describing your team’s plans for addressing risks. If you are only using parts from the official iGEM Distribution Kit and/or parts derived from Risk Group 1 organisms, this completes your safety requirements. The Safety Resources List contains links to resources that will help you assess and address risks.

Stage 3

Due August 30th, 2013: Third, is your team is planning to use an organism, or a part from an organism, that is rated above Risk Group 1 (RG1)? Are you planning to use any mammalian cells or parts? If YES to either of these questions, then you must complete a Beyond the Basics Form. If you decide to work with an above-RG1 or mammalian organism later, please complete the Beyond the Basics Form at that time. Some teams working on projects raising the most serious potential safety issues may be asked to complete an in-depth biosafety assessment form.

Some organisms and parts are exempt from this requirement. Exemptions are listed at the beginning of the iGEM Biosafety Part 2.

Are you unsure if this requirement applies to you? To learn more about what risk groups and biosafety levels (BSL) are assigned to organisms you are working with, start by consulting the Safety Resources List. For further help, please speak with your team's faculty advisor, consult the WHO Laboratory Biosafety Manual [PDF], contact the Safety Committee at safety@igem.org, or consult your own national or institutional standards.

The Risk Group and BioSafety Level system is used in many countries, but other classification schemes exist. In particular, some countries have Risk Group 4 as the least dangerous organisms. The Beyond the Basics form is for anything more dangerous than the least-dangerous category. You may use your own national standards or World Health Organization (WHO) standards to determine whether you must complete the Beyond the Basics Form.

Safety Policies:

The Safety Committee must be able to communicate with your team's faculty advisor about any safety concerns for your project. If your advisor cannot be reached, you may be subject to restrictions at the Jamboree.

No organism rated Risk Group 3 or 4 may be used as a chassis.

Genetic parts from Risk Group 3 or 4 organisms may only be used if you submit a Beyond the Basics Form and receive approval from the Safety Committee. We STRONGLY encourage you to find substitutes for these parts from RG1 or RG2 organisms.

Any project that is intended to cause harm to the environment, or to human health, will be disqualified.

If there are significant discrepancies between your safety forms and your Jamboree presentation, you may be subject to restrictions at the Jamboree.

If you have any questions regarding issues of safety, security, and iGEM, please do not hesitate to contact the Safety Committee at safety [AT] igem [DOT] org.

@@ Line 1: / Line 1: @@
-{{TOCRight}}
+==iGEM 2013 SAFETY ==
+<div id="sub_wrapper">
-*** iGEM teams please note - These are example questions provided for you to think about some of the aspects of safety in iGEM. We are updating them and will post the safety form that you need to complete for iGEM 2013 in the beginning of August. ***
+<div class="main_item" style="text-align:left; font-size:100%; width: 750px; padding-left:75px; margin-bottom:-35px;">
+<table style="padding-bottom: 30px;">
+<tr>
+iGEM treats the safety of participants and the public and protection of the environment as top priorities. To this end, iGEM has adopted a three level review process that challenges participants to address the safety, security and environmental implications of their work.
-<p>Before answering these questions on your team Safety page, be sure to read the [https://igem.org/Safety  Safety in iGEM] page. and the FAQ section below.</p>
+<br>
+<html>
+<img src="https://static.igem.org/mediawiki/igem.org/1/19/Adobe-reader-logo.png" width="30" height="30"> <a href="http://get.adobe.com/reader/"> Adobe Reader </a>
+</html>
+<br>
+ Please complete these forms using [http://get.adobe.com/reader/ Adobe Reader]. Your advisor will need to sign the forms electronically and Adobe Reader has an option to do so.
-<p>For iGEM 2013, teams are asked to detail how they approached any issues of biological safety associated with their projects. Specifically, teams must consider and provide answers to the questions below: </p>
+==iGEM 2013 SAFETY Instructions==
+====All iGEM 2013 teams must complete this form: ====
-===Why does iGEM ask teams to address safety questions and screen projects? ===
+* [https://static.igem.org/mediawiki/2013/2/20/IGEM_2013_Basic_Safety_Form.pdf iGEM 2013 Basic Safety Form]
-iGEM safety questions and screening procedures are designed:
-*To protect team members as they work in their labs, iGEM institutions, the general public and the environment
-*To encourage team members to consider safety, health, security, and environmental implications of their projects, both within and beyond the scope of iGEM competition.
+====Teams working with parts or organisms that are risk group 2 or greater must complete this form for each part of organism:====
-===iGEM Safety Questions===
+* [https://static.igem.org/mediawiki/igem.org/7/71/IGEM_Biosafety_Form_Part_2.pdf iGEM 2013 Biosafety form Part 2]
-====1. Would any of your project ideas raise safety issues in terms of:====
-*researcher safety,
-*public safety, or
-*environmental safety
-=====Guidance:=====
+====All iGEM 2013 Software teams must complete this form:====
-There are three recommended steps in addressing this question.
-#To start, please list organisms you are using and organisms from which your parts are derived, indicating the risk group or biosafety level for each.   For help, see Table 1 and 2 of the [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf World Health Organization (WHO) Laboratory Biosafety Manual].  You are welcome to use your national standards if you prefer.  If national standards do not use the WHO 1-4 scale, please provide a link to an explanation of your standards.
-#Then consider risks to team members, publics and environment if the project goes according to plan.  Please describe risks posed by lab equipment and chemicals as well as biological parts and organisms.   How are you addressing these issues in project design and lab work?   Have you received biosafety training and other laboratory safety training?  If so, please briefly describe the training.
-#Then consider risks to team members, publics and environment if the project does not go according to plan.   What are risks if safety measures such as containment procedures go wrong and organisms or parts are released?   What are risks to security from malicious misuse?    How are you addressing such risks?
+* [Software form - Released ~12/13th August 2013]
+====Forms must be completed and emailed to the correct mailing list below for your region by the 30th of August 2013====
+https://static.igem.org/mediawiki/2013/5/59/Safety_forms_lists.png
 ----
-====2. Do any of the new BioBrick parts (or devices) that you made this year raise safety issues? If yes, ====
-*Did you document these issues in the Registry?
-*How did you manage to handle the safety issue?
-*How could other teams learn from your experience?
-=====Guidance:=====
+==Safety Form Resources==
-Please reference the biosafety level of parts.  If you are working with anything other than a BSL1 organism, take extra care with this question. Your nation regulates handling and transfer of pathogens and parts associated with pathogenicity.  For a list of regulated organisms, see the [http://www.australiagroup.net/en/biological_agents.html Australia Group website].
+In order to complete these forms and submit them to iGEM, you will need to know a few things about the organisms you are working with. More specifically, you will need to know the Risk Group (and corresponding Biological Safety Level) for the organisms and some of the parts you are working with. Here are some sites that should help you find out the Risk Group for your organisms and parts.
+[https://2013.igem.org/Safety/Risk_Group_Table <b>Risk Group Table</b>]
-----
+We have created a Risk Group and Biological Safety Level quick reference table. Use this table to help determine which BSL you should be using for a specific RG organism.
-====3. Is there a local biosafety group, committee, or review board at your institution? ====
-*If yes, what does your local biosafety group think about your project?
-*If no, which specific biosafety rules or guidelines do you have to consider in your country?
-=====Guidance:=====
+<b>Organism Risk Group classification: </b>
-The iGEM Safety Committee is not a substitute for national and local university institional biosafety committees
-# Does your university have a Biosafety Committee or equivalent? Please provide a link to regulations and local requirements.
-# Is your project in compliance with national regulations and university requirements?
-# If you are working with any organisms or parts requiring containment arrangements above BSL 1 or equivalent, have you consulted with your Institutional Biosafety Committee regarding your project?
+* [http://www.absa.org/ American Biological Safety Association] The ABSA has a searchable database of orgnisms that give the risk froup for many differnt regions.
+*[http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Toc351276291 National Institutes of Health Risk Group Definitions]. This appendix of the NIH guidelines lists the Risk Group classification for organisms and gives examples of RG2, RG3 and RG4.
+* [http://www.australiagroup.net/en/biological_agents.html The Australia Group] List of Biological Agents for Export Control. This page lists all the organisms that can't be used in iGEM due to their pathogenicity and control over the transport of the DNA. You shouldn't use any organisms on this list as you can't send us the DNA.
+<b>Lab biosafety:</b>
+* [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf World Health Organization Laboratory biosafety manual]. The WHO biosafety manual should help you determine the classification of your lab if you don't know it.
 ----
-====4. Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering? ====
+==Information on completing the safety forms==
+For help in completing safety requirements, please watch these two videos:
+<html>
+<tr>
+<iframe width="560" height="315" src="//www.youtube.com/embed/ou6RJrBr3R8" frameborder="0" align="center" allowfullscreen></iframe>
+<br>
+<iframe width="560" height="315" src="//www.youtube.com/embed/5a25Z46ZFfA" frameborder="0" allowfullscreen></iframe>
+</tr>
+</html>
+===Stage 1===
+First, all teams must fulfill local requirements for review and approval of  projects by university institutional biosafety committees, where available. iGEM will defer to approvals and waivers granted by local biosafety committees when documentation is provided. All teams should seek guidance and information from their university's biosafety committees or other appropriate local groups.
+* Note: Standards for review vary from nation to nation and university to university. You will need to check local university documents and websites for requirements.
+===Stage 2===
+Due August 30th, 2013: Second, all teams must complete the Basic Safety Page by August 1, 2013. The Safety Page is your team’s primary location for discussing potential safety, security and environmental implications of your project and for describing your team’s plans for addressing risks. If you are only using parts from the official iGEM Distribution Kit and/or parts derived from Risk Group 1 organisms, this completes your safety requirements. The Safety Resources List contains links to resources that will help you assess and address risks.
+===Stage 3===
+Due August 30th, 2013: Third, is your team is planning to use an organism, or a part from an organism, that is rated above Risk Group 1 (RG1)? Are you planning to use any mammalian cells or parts? If YES to either of these questions, then you must complete a Beyond the Basics Form. If you decide to work with an above-RG1 or mammalian organism later, please complete the Beyond the Basics Form at that time. Some teams working on projects raising the most serious potential safety issues may be asked to complete an in-depth biosafety assessment form.
+* Some organisms and parts are exempt from this requirement. Exemptions are listed at the beginning of the iGEM Biosafety Part 2.
+* Are you unsure if this requirement applies to you? To learn more about what risk groups and biosafety levels (BSL) are assigned to organisms you are working with, start by consulting the Safety Resources List. For further help, please speak with your team's faculty advisor, consult the WHO Laboratory Biosafety Manual [PDF], contact the Safety Committee at safety@igem.org, or consult your own national or institutional standards.
+* The Risk Group and BioSafety Level system is used in many countries, but other classification schemes exist. In particular, some countries have Risk Group 4 as the least dangerous organisms. The Beyond the Basics form is for anything more dangerous than the least-dangerous category. You may use your own national standards or World Health Organization (WHO) standards to determine whether you must complete the Beyond the Basics Form.
+===Safety Policies: ===
+* The Safety Committee must be able to communicate with your team's faculty advisor about any safety concerns for your project. If your advisor cannot be reached, you may be subject to restrictions at the Jamboree.
+* No organism rated Risk Group 3 or 4 may be used as a chassis.
+* Genetic parts from Risk Group 3 or 4 organisms may only be used if you submit a Beyond the Basics Form and receive approval from the Safety Committee. We STRONGLY encourage you to find substitutes for these parts from RG1 or RG2 organisms.
+* Any project that is intended to cause harm to the environment, or to human health, will be disqualified.
+* If there are significant discrepancies between your safety forms and your Jamboree presentation, you may be subject to restrictions at the Jamboree.
+If you have any questions regarding issues of safety, security, and iGEM, please do not hesitate to contact the Safety Committee at safety [AT] igem [DOT] org.
-=====Guidance:=====
+</tr>
-This is an open-ended space for you to consider and suggest ways of improving safety or safety awareness at iGEM and beyond.   Some iGEM teams have offered ideas (and sometimes full projects) to limit gene flow, to create software for screening pathogens, and to reduce reliance on antibiotic resistant markers.   Other iGEM projects have discussed concerns that might arise if the project succeeded and became widely used, as commercial product or other means of distribution.   Some iGEM projects have discussed risks that might materialize if the knowledge generated or methods developed were to become more widely available.
+__NOEDITSECTION__