At the very beginning of the project, the PaDetector we planned to do is a laboratory test kit, and the user could send a blood sample to us for testing. During the communication with Mr. Wood, a biologist at Zhejiang University, he pointed out the possible problems of sending and testing blood samples.

Mr. Wood: Is it legal to send a blood sample? Will blood samples be maliciously misused? How to convince consumers that we will not use blood samples for other research?

Mr. Wood pointed out the problems that may arise in the sending of inspection services and suggested that we make more investigations and reflections on bioethics.

After discussion, we believe that the security of sending samples was very poor, and the privacy protection for consumers was insufficient. Therefore, we changed our mind and turned into a self-service detection device for household testing. But is self-testing still present in other risks?

We have too many questions about bioethics to explore, and we decided to start from ethical security and make PaDetector accountable to users and society.

2. Dig deep into bioethics

Before discussing the ethical issues of the project, we must first know what is bioethics. We had communications with several bioethics experts and got in touch with the Chinese Bioethics Committee.

Prof. Lei: As a product for women, PaDetector needs to fully respect the human rights of consumers and pay special attention to informed consent and privacy protection.

In August, China will officially begin preparations for the establishment of the China Bioethics Committee. Professor Lei is one of the organizers. And in May, Prof. Lei published a review and commentary about science and technology ethics and governance policy in "Nature".

Professor Lei mentioned in her lecture of CCIC that synthetic biology has the function of promoting basic knowledge and manufacturing new products, but if it is misused, it may cause greater harm or risk to society and human beings. She mentioned that synthetic ethics issues mainly need to consider biosafety, biosecurity, non-physical injury or risk. The conversation with prof. Lei gave us a lot of inspiration for ethical thinking.

Dr. Wan: PaDetector can be explored in "three A": accessible, accountable, affordable.

Dr. Wang's main research area is the direction of bioethics, and also proposed for PaDetector on social credit and public health.

Chris Wood: From another perspective, bioethics can be considered in terms of people, animals (experimental objects) and the environment.

Mr. Wood opened a course on bioethics in Zhejiang University. During the exchange with Mr. Wood, he introduced us to another perspective on bioethical issues.

After communicating with a number of experts, we can simply categorize the ethical safety considerations that need to be made in synthetic biology research.

Fig1. The framework of bioethics

3. PaDetector X bioethics

(1) During iGEM

When we started our project design, we began to try to consider the possible ethical issues in our project and solve them. PaDetector hopes to help users better realize HPV early screening work at home and assist the hospital in pre-screening.

In the process of launching our project, we also control the ethical risks from three perspectives.

Ⅰ BIOSAFETY

iGEM attaches great importance to project safety. We also pay great attention to the possible risks of PaDetector to the health of experimental personnel, and whether it is possible to interact with other organisms during the experiment, or leak into the environment to cause unpredictable risks.

We have also carefully complied with relevant regulations and have carefully completed the filling of safety forms and safety review work.

Click following figures to see more details.

Working with living modified organisms is always a risk. All standard precautions must be taken. Before starting to work in the lab, every member of our team was asked to attend the laboratory safety lesson and take a biosafety examination.

Wearing safety：Everyone wears protective lab coats, enclosed leather shoes, gloves and safety glasses before laboratory activities.

Fig.2 Working with the Clean Bench.

Storage safety: The chemical and biological reagents are stored in the proper place and suitable temperature. Hazardous or corrosive chemicals are stored separately.

Fig.3 Storage for chemical and biological reagents.

Waste disposal safety

Fig.4 Flow chart of waste disposal.

Safety Apparatus: Our iGEM lab is equipped with safety apparatus such as fire extinguishers, emergency showers, eyewash stations, and first aid kits in case of dire situations.

Fig.5 Flow chart of waste disposal.

Fig.6 The fire blanket.

Fig.7 The emergency shower.

Fig.8 The eyewash equipment.

Fig.9 The first-aid case.

Our main experimental plan is to detect the HPV genome in women's menstrual blood, not only to consider the safety of laboratory researchers, but also to consider the need for safe and convenient use of products.

Therefore, based on the no-release principle, our final product is based on a cell-free system that does not apply true bacteria to our final product.

HPV is a dangerous and highly contagious virus and is not on the white list. To ensure safety, we used the L1 region of the HPV genome instead of the complete genome of HPV for detection and L1 region. We use L1 sequence for sorting different types of HPV traditionally and we want to use it to prove that our design can truly help us to recognize different heterogeneous groups of HPV.
(L1 sequence encodes a capsid protein which has no virulence, so that it won’t be dangerous. Further more, as we are using a cell-free system, the L1 sequence won’t have any chance to express a protein at all.)

Our test sample is women's menstrual blood. Considering the uncertain risk of menstrual blood samples, we decided to use artificial plasma instead of menstrual blood and mix artificial blood plasma with the L1 genome of HPV. To simulate the menstrual blood of patients after HPV infection.

Ⅱ BIOSECURITY

In our experiments, we replaced the whole genome with the L1 sequence of the HPV genome, and did not perform protein expression, which ensured that we did not synthesize toxic pathogens during the experiment or were misused. Our laboratory has a rigorous experimental level and access control, which also avoids malicious entry or use.

Some of the techniques in our experimental design, such as RPA, HCR, etc., are supported by literature, and a large number of experimental techniques are studied. The technology itself is not dangerous.

Ⅲ Non-physical risks

Patent and Intellectual Property Protection: We consulted a law firm and prepared to submit a patent application for PaDetector.

Commodity issues: We hope to bring PaDetector into the market as a self-checking product in the future. You can see more commercial discussions here at Link

Public engagement: We believe that a scientific research, our sponsors – taxpayers have the right to know and participate, you can see how the public participated in our projects on the human practices, education & public engagement, and how our projects are responsible for the public.

(2) After iGEM

We are ready to use PaDetector as a product to prepare for future commercialization and to carry out more pre-judgment and planning. The ethical issue lies not only in the safety of the laboratory, but also how to achieve respect for the rights of consumers after entering the market in the future, how to protect the privacy of consumers, and how to ensure that our products will not be misused is also a key need to consider.

Regarding PaDetector's pre-judgment and planning for future ethical risks, we set the background after iGEM. In the later stage of commercialization, we will prejudge ethical risks from the perspectives of products, consumers and environment. Please see the file below for details.
(The background of this report is: we have successfully developed a detection device based on Plan B)

4. Dare to conceive, dare to ask, dare to do

iGEM is a grand event in synthetic biology. Participants can not only think boldly here, but also need to ask boldly before do it boldly.

For China, the iGEM team is not within the scope of the newly established China Bioethics Committee. China is different from foreign countries. Every student does not have systematic bioethics learning before entering the biology. This also makes China The participating teams are not perfect in ethical considerations.

iGEM has made a lot of efforts in supervising the team's project ethics, for example, the safety form is a must for every team. However, the internationalization of iGEM makes the ethical guidance of the team and PI difficult and the self-monitoring of the team members especially important in the global teams. But in the process of our communication with other teams, although almost all teams have received safety training, Not all PIs pay attention to ethics. Most of the considerations of ethical issues are limited to experimental animals. Many teams have not conducted a more comprehensive ethical discussion, and they have not done a good job in social responsibility.

For iGEMers, we need to pay more attention to self-monitoring, raise awareness of ethical counseling, and boldly ask before we dare to do it.

We encourage more teams in the future to be more responsible for society from the perspective of bioethics. We have proposed the ethical review of the entire project in human practices.

You can click here to know more about what you can do with your project in a bioethics level.

Team:ZJU-China/Bioethics safety

1. Proposition of Bioethics