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Safety

Back in the 2018 iGEM competition, the TU Delft team established the phrase “safety always” in their project instead of the well-known “safety first.” And they were right! A year later, at the 2019 iGEM competition, the Athens team provided us with the amazing motto of “Safety isn’t expensive, it’s priceless.” This adage is one of the many that indicates the necessity of safety in scientific projects.

The aforementioned former teams helped us understand the importance of safety in the iGEM competition. But, in which “safety” are they referring to? Although laboratory safety aspects are mainly included in this term, ethical issues also arise. All these vary from biosafety rules about the under study organism and eco-friendly instructions to bioethical limits as far as the responsible use is concerned.

Our project’s main goal is to incorporate a software, which will translate the genotyping results easily. The software will be approachable even to a non-experienced physician. Our team conducted experiments both in dry and wet lab to perform the necessary tests to certify our diagnostic tool’s validity. Our laboratory is divided into different biosafety levels as it is equipped with a variety of benches used for certain procedures. Thus, the Post-PCR is classified in lower cleanness level compared to the Pre-PCR, where all supplies are sterilized to avoid DNA contamination.

- Laboratory Safety

In our Pharmacogenomics application, no genetically modified organisms were used, so we did not have to deal with possible risks regarding living organisms like viruses and cell lines. As far as the chemicals used during our experiments is concerned, none of them was hazardous.

A big unit of iGEM competition is the Parts Registry. Our team was not meant to add any part to the already existing iGEM database. However, thinking that our contribution to future teams would be significant, we decided to add four (4) parts at iGEM’s Parts Registry that we designed and ordered to accomplish our experiments. Since we are working on genotyping DNA samples referring to the SLCO1B1 gene, our parts are used as primers to perform Allele-Specific-PCR (AS-PCR).

For our team, safety plays an essential role in protecting ourselves and our lab colleagues, being aware of the possible risks, and being able to handle them. As part of that, before starting the experiments, the wet lab team was trained by our Instructor, Stavroula Siamoglou, according to the biosafety rules while working on a Laboratory of Molecular Biology to handle risky situations adequately.

One of the procedures that need more careful handling is the blood samples used for DNA extraction. During the extraction, the performer should wear double gloves. All the lab supplies used are discarded in a particular waste container with bleach to avoid the blood spread in the common laboratory wastes as it might contain, from a minor infectious microorganism to viruses that cause severe contagious diseases.

A big deal for every team which performs experiments in a laboratory space is the minimum ecological footprint to the extent possible. Dr. Patrinos, our Primary Principal Investigator, highlighted the fact that there is a slightly increased risk of non-predictable and undesired interactions of our products with the environment, such as wasted plastic dips or wasted pigments. To minimize this danger, he suggested us to be careful with our lab waste. Recycling all the used plastic dips and tubes and dismissing the wasted organic and inorganic solutions, in the predefined containers for this job to be safely released to the environment by the experts, would be the right steps towards this direction.

None of our techniques and parts are included in the iGEM Whitelist.

In our Dry-Lab space, no possible risk was identified and needed to be managed.

For more information and details, you can visit our Safety Form!

- Bioethics

We believe that Ethics is an integral part of the fields of Science and Technology. There are many different factors to be considered when trying to approach the ethical aspects of them, especially when we attempt to do that for the newly emerged field of Synthetic Biology. While searching the scientific literature, we realized various definitions of Synthetic Biology, but not entirely adequate. One that could partially be satisfactory is that Synthetic Biology is more than just another field in Biology or Engineering. It’s a fusion of these two, in ways that can help you design and build entirely new systems or copy the already existing ones artificially.

Our priority was to ensure patients’ consent for blood sampling. This was important to be assured as we needed the blood not only to conduct our experiments but also to train the algorithm. This procedure is done through a written document, and it requires specific information such as in which place the samples will be stored, who will have access to our data, and how they could be used. This consent should be legal and follow a specific procedure.

Bellow you can find the Consent Form legally accepted in Greece.

Consent Form

Finding a specialist lawyer to guide us through our future steps wasn’t as easy as it sounds! Vasileios Karkatzounis, a legal engineer specialized in the proper use of Artificial Intelligence, highlighted all the legal obstacles we may face while trying to turn our project into a sustainable business plan. Initially, he informed us about the regulatory system and guidelines published in 2018 by the European Council whilst he urged us to read them through, especially those referred to as personal data, used for the AI system. He underlined the necessity to create a confirmation form in order to be within the law while using the health data to develop the BentoLab-AI system. The reason and aim of using these data, the duration, the results, the owner, and the legal base system should be included in this form. In addition to these, all volunteers should be elaborately informed about the procedure that will be followed and how their personal data and the results will be used. Of course, it should be clarified from the beginning to all the participants that our project’s supervisor is the University of Patras. Last but not least, his most purposive advice was to clarify that the AI system will be used for physicians’ assistance, and it won’t replace their decision.

The general public’s scaremongering is also a crucial issue that should be mentioned. There is a widespread view that AI is an ambiguous subject because of the retention of personal data. So, we tried to solve this problem through the document we provided to each volunteer. The people should realize that Synthetic Biology, Pharmacogenomics, and AI can help solve societal issues using logical arguments. We should not be afraid of contrasting opinions since they can result in fruitful discussions.

Team:Patras/Safety

Safety

- Laboratory Safety

- Bioethics

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