SAFETY POLICIES

As it is at the forefront of what is technologically possible, iGEM also comes across important policy issues on a continuing basis. In 2018 iGEM has clarified its positions on:

• Do not release
• Human experimentation
• Gene drives
• Anti-microbial resistance
• Use of animals
• Use of parts from risk group 4 organisms
• deletion as modifications

Do Not Release Policy

iGEM teams often do projects that have an immediate practical application. But within the context of the iGEM competition, wet-lab projects should remain at an experimental stage. iGEM teams should not release or deploy any genetically modified organisms, or the products of genetically modified organisms, outside the lab.

For more details, please visit our Do Not Release Page.

No human experimentation

iGEM projects are meant to remain at the experimental stage. Testing your product on humans (including yourselves) is strictly prohibited. It is considered a breach of the do not release policy.

Engineered organisms you make, or their products, should not come into direct contact with humans. If you can demonstrate something you have produced has no modified organisms on or in it, then a waiver may be possible. Please contact safety AT igem DOT org setting out what you would like to do, and why you believe that there will be no modified organisms present. You need permission from the Safety and Security Committee before any of your product comes into contact with humans.

In the past, some teams have wanted to use samples from humans (swabs, feaces, blood, etc.). This is possible but must comply with both institutional/national rules and iGEM's safety and security rules and policies. A team wanting to use specimens from humans would need to provide evidence of relevant institutional or national reviews. In accordance with the White List, a team would also need to submit a Check-in form to the Safety and Security Committee before using human samples. The Safety and Security Committee are unlikely to grant permission to use samples from vulnerable populations (such as minors/children, prisoners, pregnant women or fetuses).

In many cases social science research (such as surveys) also requires pre-approval from review boards. Teams are reminded that compliance with iGEM's safety and security rules are a requirement for participation. One of those rules is that any experiment with human subjects (including non-invasive experiments, such as surveys), must comply with all rules of the institution/country. Copies of national guidelines, for many countries, may be found here. Because of the time it can take to fill out forms and receive ethical approval, teams are strongly advised to begin the approval process as soon as possible.

Outside of the competition, any experimentation involving humans will be closely regulated. You would need permission from regulators. Even after the competition is over, we strongly suggest you speak to your institution about the rules governing the use of humans in research.

Gene drives

Policy discussions around gene drives center around whether they should be released into the environment and under what safety provisions should research be carried out. iGEM has a strict do not release policy – this applies to gene drives as well as any other projects. On the use of gene drives as research tools in iGEM projects, the policy is:

Gene Drives are not allowed in iGEM projects without a special exception from the Safety Committee.

Teams will need to convince the Safety Committee that:

• There will be no environmental release - This is existing iGEM policy for all projects and not just on gene drives.
• That the project is safe - iGEM has adopted an adaptive risk management approach for gene drives. The Safety Committee will evaluate your project proposals with reference to host organism (chassis), modifications (including any associated parts) and containment measures. Teams should make use of the published Framework for the Risk Assessment and Management of Gene Drive Technology in Contained Use.
• Your team is implementing and adhering to the measures proposed by Akbari et al in “Safeguarding gene drive experiments in the laboratory”
• Your team has notified the Safety Committee that you are considering or planning to use gene drives in your project and you and your faculty advisor have participated in a mandatory conference call with experts on drives and on safeguards.
• Any orders for commercially produced genetic material placed by your team must be screened for regulated sequences.
• None of your parts submitted to the registry contain a functional gene drive – a drive in a single part will not be accepted and this can have implications for medal criteria.

Further reading

• Di Carlo et al - Safeguarding CRISPR-Cas9 gene drives in yeast, Nature biotechnology 33 (12): 1250-1255. doi:10.1038/nbt.3412. http://dx.doi.org/10.1038/nbt.3412
• Netherlands - Gene drives : Policy report, National Institute for Public Health and the Environment,
• Germany - Position statement of the ZKBS on the classification of genetic engineering operations for the production and use of higher organisms using recombinant gene drive systems - English German
• United Kingdom - HSE Biological Agents eBulletin, March 2016

Anti-microbial resistance (AMR)

Resistance to important drugs is an increasing challenge to human and animal health. It has led to high level discussions at the United Nations General Assembly, a commitment to address this issue by world leaders and an action plan from the World Health Organization. As part of its commitment to safe and responsible research and innovation, iGEM has clarified its position on this important issue.

iGEM recognises that some AMR-related sequences are common research tools and pose little public health risk. iGEM also realises that other AMR-related sequences could pose a public health risk. For example, the World Health Organization has identifies a series of Highest Priority Critically Important Antimicrobials and maintains a list of Critically Important Antimicrobials. As a result, iGEM will continue to accept AMR-related parts into the registry, but any part containing sequences connected to anti-microbial resistance not in common research use will be flagged. Such parts will not be included in the distribution kit and explicit permission for use from iGEM (via a check in form) will be required to get access to the part. To get permission, the Safety Committee will evaluate the project proposals with reference to host organism (chassis), modifications (including any associated parts) and containment measures.

Use of animals in iGEM projects

Different parts of the world have different governance measures for the oversight of use of animals in research. Relevant values are not universal and regulatory oversight measures may not be present. As an international competition, iGEM teams come from many different regulatory environments. As the projects attempted by teams becomes more sophisticated and accomplish more, there is an increasing focus on demonstrating a proof of concept. In recent years, a growing number of teams have used animal in their projects.

iGEM is clarifying its position on the use of animals in projects:

• Consistent with the safety and security rules, teams planning to use any multicellular organisms (animals, plants, insects, etc.) not on the White List need permission from the Safety and Security Committee. Teams should submit a check-in form before using any plant or animal to tell us about any risks associated with your work and how you will be managing them.
  
  
• Teams planning to use vertebrates (e.g. rats, mice, guinea pigs, hamsters), or higher order invertebrates (e.g. cuttlefish, octopus, squid, lobster) must also submit an Animal Use Form to tell us about why you need to use them. (You will still need to submit a check-in form to tell us about any risks associated with your work and how you will be managing them.)

In addition to any institutional or national approvals required for the use of animals, teams will need to persuade the Safety and Security Committee of their need to use animals by using the Animal Use form. Teams will need to make a case based on the three R's:

1. Replace – whenever possible alternatives to animal models should be used. Teams must be ready to explain why no alternative approaches were possible.
2. Reduce – if animals are to be used, the fewest possible needed to accomplish the goal of the research should be used. Teams must show they are using the appropriate number of animals to power their study.
3. Refine – animal research must use methods that minimize or alleviate pain, suffering or distress and enhance animal welfare. This includes appropriate housing, environment, stimulation, and feeding of animals.

All teams wanting to use vertebrates (e.g. rats, mice, guinea pigs, hamsters), or higher order invertebrates (e.g. cuttlefish, octopus, squid, lobster) in their project must make use of the Experimental Design Assistant made available by the UK National Centre for the 3Rs. This is a free online tool designed "to guide researchers through the design of their experiments, helping to ensure that they use the minimum number of animals consistent with their scientific objectives, methods to reduce subjective bias, and appropriate statistical analysis". Teams will need to upload the diagram report made by the tool in the Animal Use form. Teams will also be asked to upload any approval paperwork and evidence of institutional review by an animal use committee (e.g. Institutional Animal Use and Care Committee in the US or China, or Ethics Advisory Board in the European Union).

To help make the case for using animals, teams should look carefully at the Key Concepts in the Guide for the Care and Use of Laboratory Animals produced by the US National Academies of Science (also available in Chinese. There are also lots of different online resources made available by the UK National Centre for the 3Rs. There are also new guidelines for ethical review of animal welfare in China. We have also provided an example of a complete and compelling animal use form.

Further reading

• World Organization for Animal Health - Use of animals in research and education in the Terrestrial Animal Health Code
• US National Institutes of Health Anima study proposal, including a sample animal study proposal.
• Canadian Council on Animal Care - Guidelines on choosing an appropriate end point in experiments using animals for research, teaching and testing
• Charan & Kantharia - How to calculate sample size in animal studies?, Journal of Pharmacology & Pharmacotherapeutics, 2013;4(4):303-306.
• Festing & Altman - Guidelines for the Design and Statistical Analysis of Experiments Using Laboratory Animals, ILAR Journal, Volume 43, Issue 4, 1 January 2002, Pages 244–258
• Naud - Statistical Justification of Animal Numbers Used in Research and Teaching, University of Vermont
• NC3Rs, BBSRC, Defra, EPSRC, MRC, NERC, Wellcome Trust and other AMRC charities - Responsibility in the use of animals in bioscience research: Expectations of the major research council and charitable funding bodies

Use of parts from Risk Group 4 organisms

In many parts of the world, the highest risk group of any organism or part being used will determine the type of biosafety precautions needed for the work. This means if you are using a part or sequence (or synthesised genetic material with the same sequence) from an organism that needs a BSL4 laboratory, the work should only be undertaken in such a facility. iGEM teams are NOT allowed to use ANY part from a Risk Group 4 organism.

Some parts from Risk Group 2 and 3 organisms are permitted - more information can be found on the White List.

Deletions as modification

Some regulators around the world have concluded that deleting sequences from an organism does not result in a modified organism. Other regulators do consider these techniques to result in a modified organism. For the purposes of iGEM, and in particular for the do not release policy, iGEM considers any alteration to a sequence (including deletion) to be covered by its safety rules.