If you want to use animals in your iGEM project, start planning now
Animals are used in research for many different purposes, including as models for the human body and as test subjects for food or medicine intended for animals. Past iGEM teams have wished to more fully demonstrate a proof of concept for their projects through experiments with animals such as rats, mice, fish, and bees.
Unfortunately, one of the most common reasons that teams are disqualified from the iGEM Competition is for violations of our Animal Use Policy. The policy requires that teams get approval from the Safety & Security Committee using an Animal Use Form before beginning experiments involving animals or animal samples. Teams often underestimate the difficulty of getting their experimental plan approved or do not realize that their work falls under the policy. In this post, we will try to help you figure out whether you need to submit an animal use form, and if so, how to get it approved.
iGEM’s Animal Use Policy doesn’t just cover experiments with live animals done by your team. It also covers samples taken from live animals, feeding live animals with a product produced by your team, animal use outsourced to a third party, including other researchers, and any work that required an animal to be killed for your project (e.g. tissue samples obtained from another lab at your institution).
Does my team need to get permission to use animals?
The majority of the projects in the iGEM competition do not require animal use. In 2021, only 7 teams submitted an application to use animals, and only 1 team was granted permission. In 2018, the year with the greatest number of applications, only 2% of teams submitted applications (7 in total).
The use of animals in iGEM projects
| Began process | Submitted application | Granted permission | |
|---|---|---|---|
| 2018 | 15 | 7 (2%) | 1 |
| 2019 | 8 | 6 (2%) | 2 |
| 2020 | 5 | 1 (1%) | 1 |
| 2021 | 9 | 7 (2%) | 1 |
The Animal Use Policy covers work with vertebrates (e.g. rats, mice, guinea pigs, hamsters, amphibians, and fishes) or higher order invertebrates (e.g. cuttlefish, octopus, squid, lobster, bees, or American or German cockroaches). You will need to get permission if you plan to do any of the following:
Experiments with live animals done by your team
Samples taken from live animals (e.g. saliva, hair, blood, feces)
Feeding live animals with a product produced by your team
Animal use outsourced to a third party, including other researchers
Any work that required an animal to be killed for your project (e.g. tissue samples obtained from another lab at your institution)
How can my team get permission?
If you want to use animals in your iGEM project you will need permission in advance from the Safety and Security Committee, by submitting both a Check-In Form and an Animal Use form.
On top of the other rules you have to follow, if you want to use animals in your iGEM project you will need permission in advance from the Safety and Security Committee.
Before iGEM grants permission, you will need to show you have all relevant institutional or national permissions. Most teams will need to follow other rules and seek other permissions to get to work with animals. For example, teams may need approval from an institutional animal use committee. In other cases, your work may be covered by approvals already obtained by your instructors or PI. Experts at your institution should be able to help you follow local rules and get all the permissions you need.
To get permission from iGEM, you will need to submit both a Check In Form and an Animal Use Form.
Check-In Form
The Check-In Form addresses the containment and safety aspects of your plans. Any team planning on using multicellular organisms (which includes all animals) must show us they have identified any risks from their plans and will manage those risks appropriately. You will probably need to tell the Safety and Security Committee about how you will prevent multicellular organisms from escaping from the lab.
Animal Use Form
The Animal Use Form justifies your work and addresses the welfare of the animals (defined as vertebrates and higher-order invertebrates). We take the use of these animals very seriously. Any team ready to use these animals in their project should be ready to justify it, not only to our community but to the rest of the world. You will need to share a detailed plan of what you intend to do, including any specialized facilities and extra training. These forms go through a two stage review: first by an animal use specialist; and then by our own Safety and Security Committee. It usually takes more than one revision of an animal use form to get permission from our reviewers – and that can take a lot of time!
How do we justify using vertebrates or higher order invertebrates?
To justify plans involving vertebrates or higher order invertebrates, teams will need to explain how they have considered replacing, reducing, and refining the use of animals.
Replace
Alternatives to animal models should be used whenever possible. 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.
These 3 R’s are a common approach for seeking permission to use animals and underpin rules in Asia, Europe, and North America, for example.
It can take months to get animal use permission from iGEM. Most teams must submit multiple iterations of their plans. Plan ahead! It will not be possible to get permission in the last few days before the wiki freeze. Photo by David Clode on Unsplash.
What happens if we use animals and don’t get permission in advance?
Unfortunately, this is the most common reason that teams are fully disqualified from the iGEM competition. That means these teams do not qualify for any awards or medals, and their wiki may even be removed from the iGEM website. All of their effort comes to nothing.
Teams that fail to use a Check-In Form to get permission to work with lower order invertebrates or other multicellular organisms can face partial disqualification. Judges may be asked to proceed as if the team had not done the experiment or activity. This means the results will not count towards medal criteria or for awards. Again, work without permission is effectively wasted energy!
Disqualifying a team or their results is never an easy decision for the Safety and Security Committee. We want you to succeed, and part of our motivation for writing this post is that we hope we do not have to disqualify any team this year for unauthorized animal use!
Teams must get permission to work with animals before beginning their work. Unfortunately, failure to get permission ahead of time is the most common reason that teams are fully disqualified from the iGEM competition. Photo by Alexandr Gusev on Unsplash.
What are the most common problems with animal use forms?
Some of the most common problems with the Animal Use Forms we see are:
Teams underestimate how long it takes – it can take months to get animal use permission from iGEM. Most teams must submit multiple iterations of their plans. Plan ahead! It will not be possible to get permission in the last few days before the wiki freeze. We appreciate teams reaching out to us at safety [AT] igem [DOT] org as soon as they think they may want to use animals.
Teams fail to look carefully at the animal use policy – we provide as much information as we can on what the rules are, what we expect, and how teams can get the permissions they will need to use animals in their projects. From the answers we get in the forms, it is clear that many teams do not look carefully at the guidance we provide.
Teams do not provide enough detail – remember that you are justifying the use of animals to the world. You will need to explain clearly and in detail how you have reflected on the 3R’s (Replace, Reduce, Refine). We will work off the assumption that if you cannot fully justify your work, you are not ready to do it. We provide a model answer to help teams understand what full justification looks like (to see the model answer, go to the Animal Use Form page, select Team Example and the form “example-animal-use”.)
Teams ignore power calculations – The aim is not to use as few animals as possible (because this is always 0). It is to use the smallest number of animals possible to prove whatever it is you are trying to prove. There are well established standards on how to calculate this number. You will find links to key resources in the Animal Use Policy.
Examples of successful animal use in iGEM projects
Despite all these challenges, it is possible to use animals in iGEM projects. We know some projects can develop during the competition to the point where animal use can be justified. Here are a few examples of teams that got permission to use animals.
Ultimately, the team wanted to develop a probiotic to be administered to wild bee populations in sugar water. The probiotic was intended to help the bees more easily break down harmful pesticides in their environment. As part of their project, the team wanted to observe wild bee behavior around different designs of ‘bee feeders’ to identify the optimum design. The team did not plan to feed the bees their engineered probiotic. The team explained how they would carry out their experiments, and address nutritional shortcomings in sugar water. They also consulted with institutional and national experts on experimenting with bees. It took 2 iterations of their Animal Use Form to get approval to run their animal experiment.
Ultimately, the team wanted to develop a probiotic to be administered to wild bees. The engineered bacteria would grow in the gut of the bees and express an enzyme known to break down the insecticide imidacloprid. This insecticide had been connected to Colony Collapse Disorder, which was decimating wild bee populations. The team built the engineered bacterial system and showed it produced and excreted the intended enzyme in vitro. They justified their plans to test their engineered system on bees in a contained space. The team demonstrated a statistically relevant increase in the survival rate of bees exposed to their engineered bacteria. It took 5 iterations of their Animal Use Form over 3 months to get approval to run their animal experiment.
Ultimately, the team wanted to develop a novel detection system for colon cancer. Their engineered bacteria would grow in the human gut and bind to cancerous cells. The cancer would then be cheaply, easily and non-invasively detectable via ultrasound. They also considered engineering their bacteria to start to treat the cancer. After demonstrating that the individual components of their system worked in vitro, the team successfully persuaded the Safety and Security Committee that they were ready to try their system in vivo with mice. The team had institution approval for this work and provided documentary evidence. Their expert reviewer noted how comprehensive their answers were and how well they explained how the animal experiments fit into their plans. It took 3 iterations of their Animal Use Form over 3 months to get approval to run their animal experiments.
Cover images clockwise from top left: Bee by leandro fregoni on Unsplash, Fish by David Clode on Unsplash, Rat Photo by Alexandr Gusev on Unsplash, Jellyfish Photo by Jeffrey Hamilton on Unsplash
