Team:ZJU-China/Human Practices
Introduction
PaDetector is an HPV detector using menstrual blood samples. PaDetector’s development were carried out based on our proposed Up & Downstream Guide Framework. In this section, we will give answers to the following questions:
1. How did all walks of life help us to drive our projects to the next stage?
2. How did we ensure that our project would be responsible for the society?
3. What new ideas of human practices can we provide to the future iGEM teams?
Human practices with wet-lab
In the course of experimental design, human practices provided us with a benchmark for verifying the project ideas, which clarified the objectives of our project.
(1) Lectures
Dr. Feng: “The five-year survival rate of cervical cancer caused by high-risk HPV infection is only 30%-50%. However, Cervical cancer is preventable because it has a clear cause, HPV. What my surprise you is that 80-90% of men and women were infected with HPV during their lifetime......”
At the beginning of our project, we have just set a primary goal of detecting HPV. We felt very fortunate to participate in Dr. Feng’s lecture about HPV and cervical cancer at that time. In the lecture, she introduced a lot of basic knowledges about HPV such as the reason for vaccine shortage in China, the incidence of cervical cancer as well as HPV infection rate among Chinese women. It really strengthened our resolve.
(2) Women’s hospital school of medicine Zhejiang university
After we decided to use Cas12a biosensing system for HPV detection (Plan A), our team went to Women’s Hospital School of Medicine Zhejiang University for a clinical visit as one of our team members who majored in medicine was involved in the clinical diagnosis and treatment of gynecology at that time.
After communicating with both patients and doctors, we learned that though traditional way for HPV detection requires invasive sampling, it can detect all kinds of high-risk subtypes with one test. However, Cas12a biosensing system is not ready for multiplexed detection until today. Thus, in order to enable PaDetector to provide women a more efficient detection, we developed a multiplexed way of detection, the HCR biosensing system. But it does not mean we give up the older one, Cas12a biosensing system is highly portable, for the intention to expand the application scope of PaDetector, we tried to develop quantified detection in addition to qualified detection based on it.
Dr. Lyu: “Cervical cancer control includes primary prevention (vaccination against HPV), secondary prevention (screening and treatment of pre-cancerous lesions), tertiary prevention (diagnosis and treatment of invasive cervical cancer). You guys should focus on HPV screening where the sensitivity of detection does matters.”
The Dean of Women’s hospital school of medicine Zhejiang university, Dr. Lyu's suggestion dissipated our long-standing confusion. The key point for a screening method is sensitivity rather than specificity, so we decided to put it at the top of the list. We tried our best to make sure that no positive result will be mis-detected to negative, because users with positive results are more likely to go to the hospital for further examination, and that is the way we protect our users.
(3) Preliminary discussion on ethics
At the beginning of our project, the goal we hoped to achieve are very similar to the genetic tests that can be purchased now. Menstrual blood samples would be sent to us and tested in the lab. Users can get the results inline. However, after communicating with Chris, we realized that there is a huge ethical problem of blood sample delivering. (click here to know more about our bioethics considerations) Thus, in order to avoid those potential problems, we decided to make a self-service household kit with portability and privacy.
(4) Proposing to establish a menstrual blood database
In the process of searching for related data, we found that although menstrual blood, which is produced every month in each sexual maturity women, is closely related to diseases that may occur in the reproductive tract, it is really hard for us to find the information about menstrual blood we want such as how many cervical cell there would be in 1mL menstrual blood.
Menstrual blood is a very convenient self-test sample, but there are so little researches have been done on it at present. For this reason, we communicated with hospitals and blood center, proposed to establish a menstrual blood database to provide more data and research background for menstrual blood-based detection.
Human practices with dry-lab
PaDetector is a self-service kit for rapid detection of HPV, so that the hardware design is indispensable. During human practices, we actively contacted pad manufacturers, potential users, and professional laboratories for seeking more help and feedbacks. We hope to protect women's health in the most convenient and comfortable way. The humanistic care for women and entrepreneurship is the core value of our hardware. We updated our hardware from version to version, hope to give the best experience to users as well as reduce the cost of production.
Integrated human practices
Medical tests or products are closely related to human beings, what makes human practice is an indispensable part of our project. But how to carry out human practice anyway? Considering all aspects that may have an impact on our project, it is not an easy job for us to clear our thoughts. Luckily, we found an effective way to find appropriate starting points for HP in the process of struggling, and proposed a new framework for human practices as well as ethical considerations. We would like to share it with other teams
(1) Up & Downstream guide framework
In order to have a multi-dimensional consideration of the project, we launched a new framework for human practices – Up & Downstream Guide Framework.
In modern society, every industry is not independently existed. From different perspectives, it has different social orientations and functions, and also has different upstream and downstream relationships.
From an upstream perspective, we found companies, departments, and other stakeholders who may have an impact on the project. Collecting feedback from them can help us know more about the current situation of an industry, thus we can adjust our plan accordingly. For example, the hospital’s feedback urged us to come up with a multiplexed detection method, and the feedback from the pad manufacturers helped promote our hardware design.
From a downstream perspective, we can see clearly which group/people/events the product is related to. We communicate a lot with our potential users, their suggestions give us a direction for improvement. Moreover, as we are at the upstream of them, we actually know more information, sometimes, we have to use this advantage to analyze users’ needs rather than ask them for their needs. For example, according to our investigation, we put forward an education plan for the people who know little about HPV.(education & public engagement)
This year, we carry out our HP work based on such a framework, you can see the plan of our human practices and the implementation of the plan in the overview link: overview. Starting from the three keywords of the product, we tried to explore the human practices potential of PaDetector from the three dimensions.
(2) Bioethical considerations
Ethical issues are important but also easily overlooked by teams. This year our project is related to women’s health and virus detection. Therefore, our team pays extra attention to the possible ethical risks of PaDetector. You can see what we have done within bioethical issues at bioethics and safety.
We also introduce a simple ethical guiding framework that can be applied to all projects.
Ethics is not just an individual research object. In the process of carrying out human practice plan, ethics is a powerful tool. Using ethical thinking, we can think more comprehensively about how to take responsibility for society.
From the start of our project, ethics may include three points, the people who come into contact with the project, the creatures related to the project, and the environment related to the project. In the process of doing our project we realized that it is not enough and expand our scope in a time scale. We systematically thought that for a project’s products, who will be related to the product now and in the future? What impact might it have on people’s health or future life? What are the organisms related to the product now and in the future? Is there any risks or benefits to creatures? What environment problems can our products make when we really launch it to the market? Are these damages controllable?
Searching for related projects or cases in the past provided us with some reference and inspirations.
That how Up & Downstream guide framework works to help us do our HP work. We hope that this framework can help future teams do their brainstorm freely and carry out their human practices plan boldly.
Supplementary documents
