Safety is a key aspect of Hormonic’s project. Taking into consideration that our aim is to develop a new treatment for hormonal disbalances, it has to be safe not only for patients, but for all the people involved in their development or application such as doctors, technicians or scientists.
To do so, we have taken into consideration different requirements that we accomplish to make Hormonic a safe device. These goes from safety considerations in our workspace, how It is designed to the bioethics behind its implementation.
We have been able to develop all of our experimental tasks thanks to the University Pompeu Fabra, which has provided us a laboratory at the PRBB (Parc de Recerca Biomèdica de Barcelona), near to our PI’s lab Translational Synthetic Biology Lab. Our lab is a biosafety Level 1 lab, with an open bench and a Bunsen, which have allowed us to work under sterility conditions. We were instructed in general lab safety and how to handle dangerous situations related with the lab practices, chemicals, electrical and fire safety. Also another important point is the correct management of the waste and the different containers available.
As we did not have access to all the necessary machinery for our experiments in our laboratory, we were also intrigued about the correct transport of samples between the different laboratories and common spaces.
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Chemicals and strains safety
Since DH5-Alpha strain comes from the K-12 strain of E.Coli, DH5-Alpha is not pathogenic. This is also the case for the Top10 and Rosetta strains of e-coli, which are also non pathogenic. Risks related with the use of these organisms in the laboratory will be focused on the contact with skin and eyes. To combat these events gloves, lab coat and laboratory glasses will be mandatory when using these organisms in the lab.
As for the environmental risks, K-12, the strain from which DH5-Alpha is derived has no habitat outside of the human body so possible damage to the environment is minimal. For the Rosetta strain, it is known to contain 0 % of components with unknown hazards to the aquatic environment, but there is no information on persistence or bioaccumulation of the strain. Finally, for the Top10 strain, no environmental hazards have been found. Although the 3 strains have little to none environmental risks we have always worked with sterility conditions and all cells that need to be disposed have been treated with bleach so that the cells remain isolated from the environment.
We also used SYBR Safe instead of Ethidium bromide, which allows us to use them in an identical way but avoiding carcinogenic risks.
In order to be able to work in a safe space under the pandemic circumstances under which our community is, we have followed strict rules about how to work avoiding COVID-19 infections.
The capacity of the work in our laboratory was reduced to 4 people only. To deal with this we divided into working groups where we maintained the same contacts between colleagues, so in case of a possible infection within the team the rest could continue working and it would only be necessary to confine a part of it.
To do so we split mainly into two wetlab groups and one for drylab: one for the T3-biosensor and another one for the implementation of the proof of concept that have been working in parallel, and another one for the electronics and software associated to the project. To respect this we prioritize online meetings to avoid social contact.
Finally there are the restrictions applied to our work space:
- Always wearing the mask (you can take it off under some exceptions as to eat or drink, but then you have to respect a safety distance with the people and if it is possible do it in an exterior space such as terraces).
- Respect the safety distance 1,5 m between your teammates.
- Notify any symptom related to COVID-19 and follow the protocol stablished by the PRBB.
- Promote the cleanliness of hands and common spaces.
- In the common spaces, circulate on the right.
- The use of the stairs has been recommended and the capacity of the elevators has been reduced to a maximum of 2 people.
Biosafety and biosecurity
One of the main concerns about our iGEM project is to make sure that it is completely safe, as for the members of the team and society. The main safety consideration that has to be taken into account when working with synthetic biology is to make sure that the modified organism in the laboratory implies no risk, either to humans or to the environment. That is why, the bacteria used in the experiments come from non-pathogenic strains, meaning that the risk of infection to the team while the development of the project is minimal. Moreover, there is no evidence that these used bacteria can be dangerous to the environment, making Hormonic safe for everyone.
Moreover, when designing the device to be as safe as possible for potential users, we decided to change our living biosensor to a cell free system, lowering the risks to people and to the environment to zero.
We also had to ensure the safety of the medical data from the potential user. The data of the levels of T3 are transmitted wireless to remotely control the injection of Levothyroxine to the patient. A crucial step was adding an encryption to these data in order to avoid health hacking.
All in all, the safety and security of Hormonic has been reinforced in all scenarios, we thought where potential dangers were, and therefore the risk of a non desired effect or use of the device has been minimized as much as possible. However, there is surely future work to do so that these risks are reduced to zero.
Bioethics are an important consideration not only in synthetic biology but also in the whole scientific field. Some of the nowadays topics that can involve a conflict with bioethics have been discussed and studied.
Confidentiality of medical information has to be ensured in order to avoid discrimination of an individual due to a compromised medical status. It is a crucial consideration that has been studied when developing Hormonic. This problem was solved by encrypting the data that the device remotely sends to a controller. Therefore, confidentiality is garanterized and we can avoid leaks of private information, being this medical information only visible to the clinician in charge.
Before even starting to think of clinical trials with humans, Hormonic should see an ethical committee approved, and make sure that the device can not endanger any human being. This committee must make sure that the rights of the patients are covered and no one is neglected, and must also make sure to promote fair policies and procedures.
Another important point is the informed consent of the study. Information must be given to participants in a comprehensible manner, and the voluntary nature of the trial must be clear at every moment. Therefore, the trial must be completely voluntary and universal, meaning that the selection of participants must be equitable.
The given information about the treatment must be clear and transparent, so the user knows at the detail what to expect and what the device is doing to their body. This also means that the user must also be aware of the possible complications and negative effects of Hormonic and that they must have the autonomy to decide either to accept or reject.