Team:ZJUT China B/Ethics


At the beginning of our project, we had designed and received answers to our initial questionnaire. When we presented this to our mentor, Asal, she asked us about whether we had received approval from Ethics Committee or Institutional Review Board (IRB). We didn't have any idea, so we decided to explore ethical issues. The following is what we have learned and reflected on.

Attention should be paid to ethical issues at the beginning of the project.

Asal put us in touch with iGEM Ambassador, Dorothy, who is also on the Human Practices Committee. First of all, we had a telephone conversation with Dorothy to discuss what an Institutional Review Board (IRB) is and how to consider ethical issues, thus learning the importance of ethical issues.
Then, we read some literature and found that the ethical review system of social science research in China is still imperfect. As a result, many students will easily ignore this problem.
After preliminary exploration, we found that the ethical review in our school is limited to projects on animal experimentation.
At the CCiC meeting, we listened to lectures on ethics by Joy. Joy told us the things that should be considered when doing research.
1. Essential information about the project
2. Research methods
3. Ethical concerns (including indications of potential risks and confidentialissues)
4. Inform consent

Then,we got feedback from the public survey. The public acceptance for our portable virus detection device is relatively high. 32.6% of people said that they are willing to try the instrument if it is accurate. Meanwhile, 11.5% of people said that they would be tested by the people with professional medical or health knowledge instead of home testing. 7.9% of people said they would try the device if it is harmless to the body and our device exactly meets the requirement. Only 3.3% of people refuse to use home testing kit, as they think the results will not be so accurate. Thus, our portable virus detection device is acceptable to the public.But we thought the SARS-COV-2 outbroke has made people pay more attention to prevention.

Through the engineering ethics courses offered by our school, we know that in China, the ethical review of a certain industry is conducted by the association of that industry, and that iGEM teams are not within the scope of the newly established China Bioethics Committee. However, we believe that a comprehensive competition like iGEM requires a moral review of the whole project in human practices.

In order to solve our concerns about social research, we wrote an email to the iGEM Human Practices Committee through our mentor, and obtained the committee’s advice on conducting an investigation into ethical approval for social science projects in China.The HP committee recommended two professors for us. While we didn't have time to ask them questions, we read their work. From the work done by Prof Ruipeng Lei, we learned that our device needs to fully respect the human rights of consumers and pay special attention to informed consent and privacy protection. After several conversations with Asal, we also noticed that we needed to be concerned about the impact of false positives/false negatives on users.

How to consider ethical issues in the course of a project

By learning ethical issues, we felt a moral duty to protect people who took part in our human practices activities and tried our best to apply what we have learned in practice:
1. For the online survey questionnaire, we set the interface very succinct. In order to protect the anonymity of volunteers. Volunteers can directly fill in the questionnaire without user authentication, and users can choose to quit the questionnaire while filling it in.Every question in the questionnaire has been carefully considered and we have set up a number of options so that the volunteers can choose the answer more suitable to their mind
2. Before the research of the BIOER company, we had written and planned all the activities in advance. After a half month negotiation with the marketing manager of the company,we got the recognition of field research.During the research of the BIOER biotechnology company, our mobile phones were labeled with anti-shooting labels, our feet were covered with shoe covers, and we wore masks. In addition, we visited the company under the guidance of the person in charge.
3. During the medical institution research, in order to save their time, we prepared the questionnaire in advance and contacted them by phone.We followed the respondents' wishes and did not take any photos.
4. When interviewing experts, we wrote questions in advance and send them to synthetic biologists in a standard email format.With their permission, we went to their offices for interviews.
5. After the interview, we sorted out the research results and put them on our Wiki with the approvement of the interviewees.
6. We respected the individual wishes of the participants and all feedback was provided voluntarily.
7. When our activities involved minors, we sought their parents' consent in advance and promised not to disclose any minors' personal information. It was for this reason that we have not included a frontal image of a minor in the education setting.

How to ensure ethical issues after the end of the project

User Ethics Protection
The ethical risks related to users that need to be considered can be divided into three parts: safe operation of products, privacy protection and respect for human rights.
Privacy Protection
Users have ways to protect their privacy, and the product is equipped with "result elimination solution." Consumers can destroy test samples with this liquid or by treatment at high temperature, thus ensuring that the test samples will not be used for secondary research.
Respect for human rights
1. An informed consent form is prepared for each supplier / potential consumer on our "virusee" interface, which clearly states the purpose why the data is collected.The data collected will be protected by suppliers and governments and will be used mainly for scientific research.
2. In order to fully respect consumers' choices and reduce disputes caused by inspection errors, we will mark the positive rate of the product on the outer package of the product.
3. In order to protect the health of users, we will indicate in the instructions that if the test result is positive, it is recommended that consumers go to the hospital for further examination as soon as possible.
4. In order to protect the mental health of users, if the test result is positive or false positive, we have equipped the "virusee" for users to inquire about the basic information of the virus and provide the best solution. We hope to reduce the psychological burden of users through this method.

Environmental Ethics and Safety Analysis
The environmental concerns about the product mainly depends on whether the product will cause environmental pollution and harm to the garbage collector after use.
1. Our device is divided into a reaction section and detection section. The reaction section contains biochemical reagents, in a strictly sealed form and is disposable. Considering the saving of resources, our detection part can be used many times. After each detection is completed, users only need to recycle and replace the reaction part to continue using it.
2. As the kit contains biochemical reagents, we are prepared to note on the package: "It is recommended to treat it as medical waste."
3. The reaction part of the designated recovery unit and the sample plate will be recovered, which will be professionally treated to minimize the environmental and human impacts. We will contact professional clinical waste treatment companies and the EPA to specify the recycling plan.
4. We contacted the local Bureau of Ecological Protection and they advised us to contact a professional company to dispose of medical waste.

[1]Shasha Du, Fuqiang Yu.The practice and reflection of foreign social science research ethics review system[J].Science and Society, 2019, 9(04):73-92.
[2]Hou Junxia, Zhao Chunqing.Analysis of ethical issues in the application of empirical research methods in social sciences[J].Ethics Research, 2018(02):111-116.