As it is at the forefront of what is technologically possible, iGEM also comes across important policy issues on a continuing basis. In 2017 iGEM has clarified its positions on:
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 no 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 - The Safety Committee will evaluate your project proposals with reference to host organism (chassis), modifications (including any associated parts) and containment measures.
- 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.
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.
- 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 models in their projects. iGEM is clarifying its position on the use of animals in projects:
When considering the use of animals in iGEM projects, teams should reflect on three core principles:
- Replace – whenever possible alternatives to animal models should be used. Teams must be ready to explain why no alternative approaches were possible.
- Reduce – if animals are to be used, the fewest possible needed to accomplish the goal of the research should be used.
- Refine – animal use must be for a specific purpose and the rationale behind their use, the protocols to be used, and how that use will further scientific knowledge all need careful consideration. Animal welfare must also be given due consideration.
Teams will need to present their considerations based on the 3R principles and request permission in advance from the Safety Committee to use animals in their projects. Evidence of an institutional review, for example by an Animal Care and Use Committee, will allow the Safety Committee to fast track its evaluation. Teams unable to provide such evidence can use a check-in form to provide detailed information about their planned use of animals and why they cannot accomplish similar results in another way.
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.