As it is at the forefront of what is technologically possible, iGEM also comes across important policy issues on a continuing basis. iGEM has clarified its positions on the topics below.
Failure to meet any of these requirements and policies can lead to immediate disqualification from the competition and referral to the Responsible Conduct Committee.
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).
For the purposes of iGEM, human experimentation includes but is not limited to the unique contributions of an individual including , blood, DNA, other bodily specimens, and health and psychological outcomes.
Human subjects research
Surveys, interviews, focus groups, and public engagement
There are many ways that you need to be careful with how you interact with humans in your project even if you are not collecting or experimenting with biomedical samples from humans. iGEM teams often engage with communities to understand broader social concerns, much of which involves talking with people, collecting information, analyzing it, and presenting it before judges at the Jamboree and on your wikis. This type of human subjects research is social science research.
In many cases social science research (such as surveys, interviews, focus groups or as part of public engagement) requires pre-approval from review boards at your local institution, and must comply with national guidelines. This oversight is designed to ensure ethical and responsible research, including issues such as informed consent, privacy and data protection, as well as protection of vulnerable populations⇗.
It is iGEM’s policy that all human subjects research conducted by teams must be done in accordance with relevant laws and regulations, as well as any institutional rules or guidance. Teams must demonstrate their awareness of these laws, regulations, rules and guidance, as well as their adherence to them. Teams are reminded they must attest to compliance via their safety forms.
Copies of national laws, regulations and guidelines, for many countries, may be found here ⇗. Many universities have an internal “Institutional Review Board” (IRB) or “Research Ethics Committee” (REC) that is responsible for approving human subjects research at that institution. Because of the time it can take to fill out forms and receive IRB/REC approval (often weeks or months), teams are strongly advised to begin the approval process as soon as possible.
Demonstration of adherence to institutional policies should be seen as minimum requirements, and we expect teams to go above and beyond in demonstrating their commitments to responsible and ethical conduct. For example, for teams that do not have established review committees at their institutions (e.g. some community lab teams), we expect them to consult with the international and national policies and other resources and experts linked on the Safety Hub and Human Practices Hub (see the ‘How to Succeed’ section of the Hub).
- World Health Organization, Ethical standards and procedures for research with human beings⇗.
- World Health Organization, International ethical guidelines for health-related research involving humans (Chinese, English, Japanese, Russian, Spanish, Ukrainian, etc)⇗.
- World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects⇗.
- US Department of Health and Human Services, International Compilation of Human Research Standards⇗.
- The College of New Jersey, International Human Subject Research Resources⇗.
- Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans⇗.
- Health Canada, Ethics resources⇗.
- Millum, Canada’s new ethical guidelines for research with humans: a critique and comparison with the United States⇗, Journal of the Canadian Medical Association, 2012 Apr 3; 184(6): 657–661.
- Example:University of Waterloo, Does my data collection activity require ethics review?⇗.
- Example:University of Waterloo, Research with human participants⇗.
- National Health Commission, Ethics Approval Protocol of Biomedical Research Involving Human Subjects (in Chinese). ⇗
- People's Republic of China, Human Genetic Resources Management Regulations of PRC (in Chinese). ⇗
- European Union, Ethics for researchers: Facilitating Research Excellence in FP7. ⇗
- European Union, Science with and for Society - Research Ethics Policy". ⇗
- Example:INSERM (French National Institute of Health and Medical Research), Research on Human Subjects". ⇗
- UK Research Integrity office, Research involving human participants, human material or personal data. ⇗
- NHS Health Research Authority, Is my study research decision tool. ⇗
- Example:University of Cambridge, Working with human participants: ethical approval and data protection. ⇗
- National Institutes of Health, Human Subjects in Research: Things to Consider. ⇗
- Department of Health and Human Services, Human Subject Regulations Decision Charts. ⇗
- National Institutes of Health, Decision Tool: Am I Doing Human Subjects Research?. ⇗
- Example:University of Southern California, Is your project human subjects research, or not?. ⇗
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.
The purpose of a gene drive is to bias the inheritance frequency of a genetic marker in an organism’s progeny. For the purposes of iGEM a gene drive includes a gene or genes for recombinases or endonucleases (such as Cas9, Cpf1 ⇗, HEG, TALEN, ZFN ⇗) site-specifically integrated into the genome of a eukaryotic organism. These must be accompanied by a mechanism, such as a guide RNA ⇗ (gRNA) in the case of Cas9, directing their site specificity if this is not already inherent in the protein sequence (as in the case of a ZFN). The recombinase or endonuclease used may be Cas9, Cas12a/Cpf1, or any other engineered or natural variant. All organisms capable of sexual reproduction are included. This also encompasses organisms such as yeast which reproduce mainly asexually (see exclusions below).
- Genomic integration must be specific to the site targeted ⇗ by the endonuclease, or a reasonable chance must exist for this to occur. Random insertion of the endonuclease (for example by lentiviral vector) does not constitute a gene drive.
- Work in somatic cell lines (i.e. non-germline) that are unable to reproduce sexually or evolve into the organism they are derived from is excluded. Examples of somatic cell lines include HEK293 and BV-2.
- Di Carlo et al - Safeguarding CRISPR-Cas9 gene drives in yeast ⇗ Nature biotechnology 33 (12): 1250-1255. doi:10.1038/nbt.3412. https://dx.doi.org/10.1038/nbt.3412 ⇗
- Netherlands - Gene drives : Risk assessment method for gene drives ⇗, National Institute for Public Health and the Environment,
- 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 ⇗
- 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, including some of great public health importance. For example, several of the antimicrobials on the World Health Organization's list of Critically Important Antimicrobials ⇗ are also common selection markers. iGEM also recognises that there are risks that scientific or engineering activities, if not being carried out responsibly, could increase resistance to these important medical countermeasures. iGEM is committed to enabling the most exciting and important science and engineering, whilst managing associated risks. As a result, iGEM is working to minimise its use of resistance factors for antimicrobials of critical importance to public health. iGEM is reviewing the use of resistance factors in parts used in the competition. iGEM will continue to accept AMR-related parts into the Registry, but any part containing sequences connected resistance to anti-microbials on WHO's list will be flagged.
Any team wanting to conduct experiments likely to alter the risk in their host institution will need to submit a Check-In form to obtain permission from the Safety and Security Committee BEFORE they carry out their research. This includes the introduction of anti-microbial resistance factors into human, animal, or plant pathogens, the use of resistance factors other than those in common use in the institution, or conferring resistance for an antimicrobial not previously conferred to that organism (for example, conferring vancomycin resistance to a bacteria that has never been made resistant in the past). See the White List for details of what needs to be Checked-In. To get permission, the Safety and Security 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, or social insects such as bees or American or German cockroaches) 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.)
For the purposes of iGEM, use of animals includes using noninvasive and invasive experimentation with live animals, animal food studies, and any procedure resulting in the death of an animal, or harvesting any part of animal for study. Any part of an animal acquired through a third party must also be approved by the reviewing committee.
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 ⇗:
- 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. Teams must show they are using the appropriate number of animals to power their study.
- 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 explain in detail how they have addressed the 3Rs. One easy way to do that is to use 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 (please choose the North America based Team Example from the drop down list).
- If a project involves the use of a vertebrate or higher order invertebrate, then it is covered by the policy and the team MUST request permission in advance from the SSC (via an Animal Use Form);
- If a project outsources, to a third party, animal experiments involving vertebrates or higher order invertebrates, then it is covered by the policy and the team MUST request permission in advance from the SSC (via an Animal Use Form);
- If a project uses parts from a vertebrate or higher order invertebrate killed for their project, then it is covered by the policy and the team MUST request permission in advance from the SSC (via an Animal Use Form);
- If a project uses parts from a vertebrate or higher order invertebrate killed for other research purposes, even if the animals were killed by other researchers, or would otherwise be disposed of, then it is covered by the policy and the team MUST request permission in advance from the SSC (via an Animal Use Form). This includes companies commercially providing animal parts for use in research. The use of parts from animals already being used in research is an important factor for REDUCING the use of animals in research and should be discussed in the relevant part of the form;
- If a project involves the use of animal parts obtained from a food supplier, such as a butcher, then it is not covered by the policy but teams should still follow iGEM’s guidance for working with samples from outside the lab
- Some projects are closely connected to other research in their host lab or other institutions. Some of this research outside of iGEM involve animal experiments. In these cases, if teams want to use the results of these animal use experiments, they will either (i) need to have complied with iGEM’s animal use policy and obtained permission in advance for these experiments from the SSC; or (ii) reference the data appropriately as having been provided to them.
- World Organization for Animal Health - Use of animals in research and education ⇗ in the Terrestrial Animal Health Code
- US National Institutes of Health Animal 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 ⇗
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.