To design research projects that are responsible and good for the world, it is necessary to identify all possible risks and establish proper precautions. On the following page, we listed all biosafety risks, biosecurity risks and ethical considerations related to our project. It is also mentioned how we changed our project to prevent these risks.
Safety training was according to different German regulations, namely (I) General lab safety, (II) Special regulation concerning hazardous substances, (III) Special regulations concerning biological substances, and (IV) Regulations concerning genetic engineering. The requirements include an initial on site training that has to be confirmed by a personal signature. The training has to be refreshed annually. All regulations are accessible on the intranet.
Local Rules and Regulations
Our team advisors are responsible for all issues related to Biological safety in the labs we worked in. Therefore, they are intimately involved in the biosafety considerations of our project. The iGEM student project was generally discussed with our primary PI, Prof. Jörn Kalinowski. For more information, please refer to the Instruction manual GenTSV (S1), the Instruction manual GefStoffV GefStoffV, and the Legal regulations.
Personal protective clothing and equipment, including lab coats, goggles, gloves, UV shields, are owned by each team member, or were provided in the lab. Due to the current Covid-19 pandemic, it was a must to wear a face mask in the laboratory. Our instructors and supervisors regularly checked that the safety regulations were followed. In case of an emergency there are many safety installations in the laboratory, which aim to reduce the effects and consequences of an accident. Our laboratory is equipped with a fire extinguisher, first aid kit, eye showers, emergency shower and an electrical emergency stop. Volatile substances are handled only inside appropriate hoods.
Genes and Chassis
Lab safety training includes safe handling regulations, mandatory lab coats and eye protection equipment during the work with bacteria. The definition of biosafety level 1 says that there is no risk according to the current scientific knowledge if everything is done properly. In our project we are exclusively working with biosafety level 1 Escherichia coli strains DH5alpha and ER2738. Also, the used helper phage M13K07 is classified as biosafety level 1. The nanobodies as well as the scfvs do not pose a threat to the public or to us working with them in the lab. Release of any genes or chassis into the environment as well as contact with the general public was prevented anyways. DNA molecules from our strains could be transferred into other bacteria if genetically modified organisms escape the lab. The biggest problems would arise from the antibiotic resistances, because they might be taken up by pathogenic bacteria. To prevent the unwanted release of our genetically modified organisms everything that might be contaminated with S1 organisms is autoclaved before leaving the lab. During the work with phages we use special filter tips. Everything that might be contaminated with phages is sterilized using UV radiation.
The entrance to the CeBiTec laboratory building, where our laboratory is located, as well as the laboratory entrance itself is physically secured. It is only possible to enter the laboratory area using a personalized access token. This security system restricts access to the laboratory building to authorized persons. In addition, access to individual laboratory areas within the building is controlled by a similar system, which is also based on personalized access tokens. Dual use describes the potential of scientific work to produce knowledge, tools, or technologies that can be directly misused to cause extensive harm to humans, plants, animals, or the environment. There are no safety risks caused by our device, since it will be a cell free biosensor. We also considered information security, as we generated an app for the user. One problem would be the unauthorized access to the data generated by the biosensor. This is prevented by local data storage and the disability of the app to connect to the internet. Each user should decide for themselves whether their own data should be passed on to, for example, doctors or health insurance companies, but a risk recommendation should also be included into the app that highlights potential disadvantages for sharing the data.Unfortunately, we do not have a security certificate for our app, but we are aware of the fact that medical software has to be validated extensively.
Since our project is designed to support women to better understand their hormone cycle, we are convinced that our project does not have any ethical implications. In the human practice part of our project, we addressed a survey to users for whom such a biosensor would be interesting. Since our survey is about research on humans, we had it approved by the ethics council of our university
Based on the above mentioned sections, we assess the risk of serious biosafety or biosecurity issues related to our project to be very low. We have considered biosecurity, information security, dual use, ethical aspects and we are sure that no issues will arise in the future from our project as it is planned.