Team:Crete/Safety


Overview

Safety and security, both inside and outside the lab, were a major concern for the iGEM Crete team. From the biosafety insurance to the establishment of the GDPR principles, we thoughtfully planned every aspect of our project and received all the necessary training and guidance. Our team believes that safe working conditions are a key element of responsible research and we wanted to make sure that we would follow the safety code of practice during this year’s iGEM lifecycle. Here you can find our Safety Form.

Lab Safety

For the needs of our project, our team implemented its experiments in two different laboratories. The majority of these were carried out in a biosafety level 1 laboratory (BSL-1), located at the university. Experiments conducted in a BSL-1 require no special equipment and the permitted materials pose zero or only a low risk to healthy adults and present minimal potential danger to laboratory personnel and the environment. All members who participated in the conduct of the experiments received the appropriate training, were informed about the safety regulations, and were also given a demonstration of the safety measures when being inside the laboratory. The final part of our experiments, especially the immunization check in mice, was carried out in a BSL-2 laboratory. The Foundation of Research and Technology, FORTH, is located next to our university and had the noble kindness to grant us the appropriate laboratory for this specific process. In the following picture, the basic rules in the laboratories of each biosafety level are briefly discussed.

Additional COVID-19 Rules

In addition to the Covid-19 regulations imposed by the Greek government and the University of Crete, our team decided to implement further rules inside lab spaces to solidify everyones’ health. iGEM Crete was recruited in October and we already knew that there was a potential lockdown coming up soon. The lockdown in Greece was introduced on November 7th and we continued working safely, adjusting our meetings via zoom calls. On June 15, we were officially allowed to enter the laboratory and the members who had attended the training managed to start the experiment, always under the supervision of the professors. We wore masks throughout our stay in the laboratory while at the same time keeping the distances of 2 people per workbench. The authorized members were being temperature-checked and had also performed a self-test before entering the laboratory, until their vaccination was complete, thus limiting the possibility of disease and transmission of the coronavirus.

Involvement of our Supervisors

The laboratory part of all teams participating in the competition in 2020 and 2021 has been greatly affected due to the pandemic. In Greece, the entry of post-graduate, Ph.D., and senior students was allowed in mid-July and due to the limited time we had, the contribution of our supervisors was decisive for the conduct of our experiments. They helped us to theoretically measure the outcome of our experimental procedure, so our limited time inside the lab would be used wisely to validate our initial hypothesis and/or fix any unpredictable results. This included making us more awake to relevant regulations regarding working with genetically modified organisms and the way we must work to make sure that they will never be released into the environment. Additionally, while we were still unable to enter the laboratory, our Advisors contributed to the early stages of the experimental procedure and thanks to them we managed to gather vital results around our synthetic protein transmembrane production. In any event, we did our best to keep going considering the difficulties due to COVID-19 and we are very proud of all our accomplishments during this iGEM year!
https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-safety-practices.html

Ethics

After choosing this particular project one of our biggest fears was that we would face rejection and negativity from the local community as the project would probably be seen as a GMO product. In these troubling times, people are very concerned with the current pandemic, human rights, GDPR, and of course the environment. People now more than ever are trying to be more environmentally friendly, to recycle, and avoid everything that is chemically processed and not organic. Therefore we knew from the beginning that our project would cause some reactions even though in reality it is not considered a GMO. There is a very thin line between our project and GMOs and we knew it would be hard to try to explain it. This was a potential obstacle that we needed to overcome to gain the public's trust. Only then people would truly see the benefits that edible vaccines can have over conventional vaccines.

What is a genetically modified organism (GMO)?

GMOs are organisms made from specific genetic engineering techniques. These techniques do not include natural recombination or natural mating. Scientists are trying to alter specific genes in these organisms with advanced technology and expensive labs to give or change characteristics that these organisms are expressing. This philosophy of changing characteristics of the organisms for our benefit has been around forever and was done before genetic engineering by selective breeding. Selective breeding is when organisms with specific traits are forced to breed with each other so the next generation can evolve and produce more of the specific traits needed. There are hundreds of examples of animals and plants created with this technique. GMOs are a very controversial subject. This comes up in a lot of studies that are comparing scientists' opinions and other people's opinions. Approximately 80% of scientists believe GMOs are a great technology that can be used in a variety of ways. On the other hand, about 20% of the not scientific population agree with this statement. So the question that comes up from these studies is why there is such a big gap between these two groups. Many people tried to explain this and as it seems the reasons behind this are more complicated than we thought. Social, economic and political is the main reasons contributing to this negative attitude towards GMOs. There are of course people that believe that GMOs are not safe as a technology and as products for humans and the environment but that's only a small percentage. There is a negative trend of this opinion because of the thousands of scientific researches showing no signs of negative effects on humans or the environment from products that do exist in the market, mostly in America. As you go deeper into this rabbit hole you realize that this trend was huge a few years ago because of the bad representation of GMOs throughout the media.

How did we manage to overcome this obstacle?

We live on an island of Greece called Crete, hence the name of our team iGEM CRETE 2021. The people of Crete have a reputation among Greece for their strong spirit, values, and stoicism. Living here we had the chance to experience that ourselves. Although the last two years SARS-CoV-2 made its appearance in Crete too, we had the lowest percentages of vaccinations against SARS-CoV-2 in Greece. This is sort of consistent with the behavior we mentioned above. This behavior is also consistent regarding GMOs and maybe some other modern biological or medical technologies. So, we had to make people realize that GMOs are a great tool we have in our arsenal. Even though our project was not a GMO we found this opportunity to combine those two. Our human practice team had the brilliant idea of hosting a live conversation about GMOs. This idea gave us the chance to explain what GMOs are and why our project is not one of them. We thought that it was best for us to target the local community instead of trying to make it a big convention to attract a bigger audience. It was more important to us to convince the local community first. Therefore we chose to make it in Greek (local language) and present it live on youtube. Here the actual content of the Debate is not mentioned because it is written as a part of the education category in our wiki page, except the part about our project not being a GMO in the next paragraph. This was mostly to establish the reasoning behind the idea of the debate and some technicalities we came across.

Why is our project not a GMO?

To express the chimeric protein in lettuce leaves we use a method called “Agroinfiltration”. By using that method we don't actually make a transgenic plant but we transiently express the chimeric protein onto lettuce leaves. This means that the protein will be expressed for a limited amount of time and also the ability to express the chimeric protein will not be passed to the next generation. For those two main reasons, our edible vaccine is not considered a GMO.

General Data Protection Regulation -GDPR

Do we have a GMO-related project or not?

General Data Protection Regulation is one of the strongest and reliable laws in the world. The regulation was created and passed by the European Union on May 25, 2018. The European Union will impose extreme penalties and fines on those who violate this law. IGEM competition helps teams understand what GDPR is by handing them instructions in the form of a pdf file called “Five tips to ensure your project is GDPR compliant”. This is very helpful especially if you are planning to conduct individual interviews, focus groups, or even questionnaires. This is a very important part of Human Practices throughout the competition because these methods are great for giving every team amazing insights from a variety of people about their project. Projects can then be evaluated by outsiders and give a different but absolutely important perspective to improve them. These “tips” given by iGEM are the very basis of the EU GDPR law and instructions on how to protect the personal data of European citizens. According to the instructions firstly it is crucial to ask for consent. You can not document any personal data without taking the consent of every individual that participates in any social study, a questionnaire for example. This consent must inform all individuals to conduct this study, details about the team, the sponsors of the team, any information regarding third parties, conflicts of interests, earnings, and so on. After taking consent and conducting the social study you have to inform the participants that at any point in time they have the right to ask for their data to be erased. This implies giving them information for contacting you directly and the ethics committee for any complaints about the way you treated their personal data. Until this point, everything mentioned above can be given altogether in the form of written consent to the participants. Then every team has the responsibility of keeping the personal data collected safely. The way you decide to protect those data also has to be mentioned in the written consent. Getting permission to gather personal data is not an easy task anymore and this is justified because everyone has the right for their data to be as protected as possible.

How did we manage this obstacle?

After choosing this particular project one of our biggest fears was that we would face rejection and negativity from the local community as the project would probably be seen as a GMO product. In these troubling times, people are very concerned with the current pandemic, human rights, GDPR, and of course the environment. People now more than ever are trying to be more environmentally friendly, to recycle, and avoid everything that is chemically processed and not organic. Therefore we knew from the beginning that our project would cause some reactions even though in reality it is not considered a GMO. There is a very thin line between our project and GMOs and we knew it would be hard to try to explain it. This was a potential obstacle that we needed to overcome to gain the public's trust. Only then people would truly see the benefits that edible vaccines can have over conventional vaccines.

References

  • World Health Organization. (2004). Laboratory biosafety manual (3 ed.). Geneva: World Health Organization. Retrieved from https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1
  • Otto, M. et al. Team Bielefeld-CeBiTec: Education & Public Engagement. International Genetically Engineered Machine (iGEM) Foundation. at https://2018.igem.org/Team:Bielefeld-CeBiTec/Public_Engagement
  • https://www.oecd.org/env/ehs/environmenthealthandsafetypublications.htm
  • University of Crete- Safety Manual https://www.biology.uoc.gr/sites/default/files/field/files/GENERAL%20RULES%20FOR%20SAFE%20LAB%20PRACTICE.pdf