Ethics Work Plan
Ethical considerations are an important part of every iGEM project. Seeing as the skin microbiome is a relatively new area of research, there is not much published about the ethical considerations in the area of our research. For this reason, we decided to include this piece on some of our ethical highlights. This ethics work plan has thus been inspired by the great workshop hosted by Fredrik Blik and Ulf Osterstad and constructive feedback received from Blanka Novak and Erik Hartman from Synthethics, established back in 2019 through a collaboration between iGEM Lund and iGEM Stockholm.
The aim of the project is to develop a biosensor detecting different microorganisms. We planned the final end product to be safe and easy to use, thus the final biosensor does not include any engineered microorganisms. For the development of our biosensor, different experiments need to be done, which were designed to have as few risks as possible. The chosen microorganisms for selecting aptamers were S. aureus and C. acnes, the following strains:
- 417/52 [VPI 0391], Cutibacterium acnes Scholz and Kilian
- NCTC 737 [VPI 0389], Cutibacterium acnes Scholz and Kilian
- PTA-5669 Escherichia coli (TOP10 Competent cells), Clone 2
S. aureus is known to cause skin infections Additionally, it can cause more dangerous diseases including pneumonia, heart valve infections and bone infections. Thus, all work concerning S. aureus was planned to be carried out in BSL2 labs to prevent the possible spread of the bacterium. However, due to time shortage, these experiments were never conducted. The C. acnes strains used are both commonly found in the human skin flora and is considered a BSL1 bacteria.
In general, all of the potentially hazardous chemicals were carefully handled in the flow hood and general laboratory safety requirements were followed at all times.
Our project was carried out during the COVID-19 pandemic, which obviously had an impact on how we chose to organise lab work, as well as the types of events, and number of events, which we were able to attend or hold.
Some safety precautions that we took to ensure the safety of our team members and others around us was to have masks available within the lab, have all meetings possible to attend either in-person or online. Many of our events were held online, such as the Gathertown events. The team followed the national guidelines within Sweden throughout the project.
During the start of our project, all of our work was done digitally. Some meetings were organized in smaller groups once that was allowed according to the restrictions in the province of Stockholm. Additionally, lab work was done in smaller groups, with less changes between who would be in the lab. This to keep the social circles small, aiming to halt the spread of the pandemic. Of course, feeling unwell always led to staying at home and testing before coming back to work on campus.
It appears no one in our team has had Covid during our project, which we are grateful for. Throughout the whole of our project, we have tried to keep an eye on it by keeping to the most current rules and guidelines.
Important aspects in our project include the development, obtaining and disposal of the test. The test consists of taking a swab of the skin, after which the swab is tested for the presence of certain bacterial groups. These groups include bacteria commonly associated with skin disorders, as well as bacteria not commonly seen in high numbers on healthy skin. To research which bacterial groups are best to target, skin swabs from a variety of individuals would be needed. Here it is important to take into account informed consent, as well as the possibility to retract data from the study at any point in time.
Obtaining the rapid test depends on multiple factors, including the price. In (northern) European countries, inhabitants and research institutes are rich enough to acquire single-use self tests, even if they are relatively expensive (>30 euros per test). This is mainly based on GDP per capita (1, 2). However, outside of these spheres, not everyone might have access to a test like MIKROSKIN. This has to be taken into account when devising a pricing strategy. One suggestion could be to slightly increase the price in areas with a higher GDP per capita, thereby being able to lower the price in less financially strong countries.
Lastly, the disposal of the swab and test are important. The test result contains information about the individual, while the swab itself contains a sample of the patient's skin microbiome. In addition to this, single use self-tests are bad for both the local and global environment and promote the use of plastic, which is a cheap and 'safe' material, but a big pollutant and generally not easily recyclable (3-5).
All of these have to be taken into account during the design process of MIKROSKIN: our ideas include the use of biodegradable material, reusing whatever material is reusable (e.g. by using glass instead of plastic, which is easily sterilizable) and designing our plates ourselves in a more efficient manner(e.g. wasting less plastic by designing smaller plates). Furthermore, kits developed for individual use ,as mentioned in our future plans, would contain clear instructions on recycling. We do understand the increase in cost this would bring; throughout the design process, we will find out how doable our plans are (taking into account the cost of the material as well).
Once a collaboration with other companies would be started, ethics would become even more important, both within our own team and outside of it. Within the collaboration, we would have to ensure similar norms and values are followed. Additionally, the bigger the collaboration, the more chance of an ethical mistake being made.
Our future aims include collaboration with skin care companies with apps that can give personalized recommendations on skin care, as well as the creation of the MIKROSKIN database. This requires data collection.
Collection of personal data within Europe will of course have to follow GDPR, meaning, amongst others, only collecting personal data with a provable purpose, informing individuals of the purpose for which personal data is collected and processed (informed consent), storing the personal data within Europe and allowing individuals to retract their personal data at any point in time
For any business or research project it is important to consider whether you will be handling personal data or not. For specific input on this, we contacted Fredrik Blix, associate professor in cyber security, with 25 years of experience in data protection (GDPR). From our conversations with Fredrik we have arrived at the following conclusions: As the information we are planning to collect is abundances of bacteria in skin samples, and not sequencing results, our test results as such are not classified as personal data. This is because personal data by definition is information relating to an identified or identifiable person.
For this reason, we plan to ask our customers to anonymize test results before entering them into the MIKROSKIN database. This is done by the creation of a DERMID, a number that serves as an identifier of a test result, but not a person. To fulfil the aim of the MIKROSKIN database; bridging the knowledge gap between our skin and its inhabitants, we might need to collect additional information such as age and gender. We asked Fredrik about this: If we put the information of age, gender and test results together, is it considered personal data? The answer is no. While our customers may process personal data, with this plan we will not. GDPR is therefore not applicable to our project in its current state: any additions to the data we collect (e.g. data on location, name, state of health) will have to lead to a reconsideration in our plan. We will continue following the guidelines and ensure we anonymize, gather and protect the data to the best of our abilities.
The environmental impact of the test, which depends on the design and production of the test, has to be monitored. Does the test add to global health, or subtract by its addition to pollution? Is there a way to recycle material used for the test? Or to use biodegradable material in the development of the test? These are some of the questions that will have to be taken into account throughout the development and continued use of MIKROSKIN, to ensure an overall positive impact on our surroundings.
Worldbank. GDP per capita (current US$). The World Bank. Available from: GDP per capita (current US$) | Data (worldbank.org) [Accessed 15 October 2021].
IMF. World Economic Outlook Database, April 2021. IMF. Available from: World Economic Outlook Database, April 2021 (imf.org) [Accessed 15 October 2021].
Flyntm J. September 2, 2020. The plastic waste problem and the challenges of plastic recycling. 3D Insider: Manufacturing. Available from: The Plastic Waste Problem and The Challenges of Plastic Recycling - 3D Insider [Accessed 15 October 2021].
Shen L, Worrell E. Plastic recycling. In Handbook of recycling 2014 Jan 1 (pp. 179-190). Elsevier.
Hahladakis JN, Iacovidou E. An overview of the challenges and trade-offs in closing the loop of post-consumer plastic waste (PCPW): Focus on recycling. Journal of hazardous materials. 2019 Dec 15;380:120887.