Team:INSA-Lyon/HP/Gold
The Ethical Matrix: A lot of questions about the project
Summary
Simplicity of use, rapidity of realization, early diagnosis detection, low cost and autonomous use. Do these specifications raise new ethical issues?
In this section, we present our embedded ethics approach to work on the project and find some answers to our numerous questions about the project: the ethical matrix. This method addresses ideas and values (columns) to various interest groups (lines). Used as a tool to make ethical decisions, the matrix improved our project according to 4 directions: Innovation, Perception, Risk management, Responsibility.
Choosing a methodology: the ethical matrix
In parallel of our scientific development to achieve the technical aspect of the project, it was necessary to consider an embedded ethics approach.
As we had no previous experience in designing a medical device, we realized early on that this task was very different from building a super proficient bacterium. How should a diagnosis be delivered? How to consider the user’s expectations about a diagnosis tool? What does the user know and think about STI diagnostics? How to manage the interaction between the device and protect the free will and the dignity of the user?
We needed a methodology to analyze the ethical impacts of our technological device. Our ethical advisors suggested that we work on an ethical matrix according to the work of Ben Mepham, "The Ethical Matrix: a Framework for Teaching Ethics to Bioscience Students". This choice seemed truly relevant because it allowed us to have a global overview of the project. In the synthesis of the matrix, we used the survey and interviews we conducted to complete the reflection.
Preparing the Ethical Matrix: confronting values to interest groups
To prepare this matrix we needed to establish a list of agents that can have interests in our technology including stakeholders and relevant values and principles which were implicated in our project.
Considering the values, we chose to adapt Ben Mepham’s work to our project, we wanted to have a vast panel of values to have the largest approach and to apply them to the interest of the different groups. The reflection was reasoned by the meetings with healthcare professionals and nurses. During this exercise, we measured the differences between our point of view as students and the point of view of healthcare professionals. Consequently, it confirmed the relevance of our decision to go outside the lab and meet professionals.
Synthesizing the Matrix
During the analysis of the matrix we highlighted 4 groups of words:
1 - INNOVATION: early detection, short time for results, low cost
2 - PERCEPTION: human relationships, intimacy
3 - RISKS: banalization, biosafety, reliability , use decay
4 - RESPONSIBILITY : support, cycle of life,easy to use, accessibility
The analysis consisted in confronting these four statements to the following principles:
Respect of the human dignity, rights and fundamental freedoms
The well-being of the person
Civil responsibility of the engineer and individual responsibility
Respect of privacy
Access to medical care
Respect of the human vulnerability and integrity
Protection of future generations
1 - Innovation
Early detection of HIV
The early stage of the infection is a high risk transmission stage. What are the consequences of the early detection on the user? Early treatments to treat the symptoms, behaviour changes to reduce risk of transmission...
Learn More...The primo infection diagnosis is a major issue on individual and collective view. Indeed, the primo infection is a high viral charge and high transmission risk period. The early diagnosis of HIV allows to start immediately an antiretroviral therapy. This treatment is more efficient on important viral charge stock i.e. during early infection than during the chronic infection phase. It is primary to prevent the accumulation of viral charge in immune cells. Early therapy allows to improve symptoms of early infection. So the altruist dimension takes all of its meaning because the test give the opportunity of an early diagnosis which contributes to relieve the suffering of the patient, to greatly increase the life expectancy and guarantee decent life conditions. Individual responsibility: knowing one's serological status drives people to change their sexual behaviour: using condoms or using new antiretroviral treatments like PrEP which greatly reduces the apparent viral charge. So the transmission rate is greatly decreased. Protection of the future generation: Early diagnosis on pregnant women can reduce the transmission risk to the new born child. The consequence of some STI like Chlamydia or a Gonorrhea can be also infertility. 38% of the sterility in the world is due to STI that are not properly diagnosed and treated. In the long run, the future of the humanity is threatened.
Short time for results delivery
The short time for the results delivery offers numerous advantages for the all-day hospital diagnosis, for the campaign of diagnosis and for emergency-case diagnosis.
Learn More...The results are delivered 15 min after collecting the sample. Is it acceptable for the user to prepare himself to receive the results and read the user instructions with attention? In hospital, it allows to obtain the results without getting another appointment (decrease the flow in hospital, increase the number of tested people and save some time for the user). Moreover this 15 minutes waiting time allows a supplementary dialogue between medical staff and the patient. This model is also compatible with great diagnosis campaign outside the hospital lead by associations in order to target people who don't use diagnosis test or not often enough. The results can be quite immediately delivered. Consequently, short time for results delivery appears to be another argument which guarantee the accessibility to healthcare without distinction of culture or localization. In case of emergency like during the delivery of pregnant women with unknown serologic profiles, the rapidity of the test allows to protect the child of any contamination. According to a technical point of view, the rapidity preserves the test from any other external contamination which may interfere with the binding reaction or from inadequate environmental conditions. Rapidity is a guarantee of liability.
Low cost test
The low price is a necessary condition to increase the efficiency of a diagnosis test as a prevention tool. Indeed free test is the number one reason for women to go to an diagnosis center in France.
Learn More...In France the economic argument is really strong: if the ratio cost/efficiency is more favorable than any other tests or health care policies, the refund is total. Moreover the public engagement of STD-associations defends the right to people to use free diagnostic tests. So, most of the device or molecules that have been recognized for their efficiency are integrally reimbursed by the French medical coverage. In the USA, the price does not have the same importance than in France. The requirements to allow the american auto test OraQuick® didn't pay attention to the price in the final equation. Nevertheless the price is a barrier to access. The low cost may democratize the test worldwide by making it accessible for every buying power.
Finally, The price and the norm are the two greatest barriers to the massive use of a technology all around the world. For instance, OraQuick® is recognize by FDA but didn't receive the CE agreement.
2 - Perception
Human Relationship
This test presents a paradox between two aspects: on the one hand the isolation of the user and on the other hand the user confronted to someone of the medical staff or from an association who can provide support to the user in his diagnosis process. We suggest to analyze the respect of the dignity, confidentiality and privacy of the user.
Learn More...In the case of an self-test, the user has the choice to be alone with the diagnosis device and will face the results alone. The reaction of the user with his test is unknown. It is up to the user to break out of this loneliness bubble and to continue his diagnosis process by confirming the results by doing traditional tests for instance. The test has to be persuasive enough to condition the user's reaction and the decision after the results. The survey we conducted shows a good dynamic for the reaction (even if it is just a survey). Only 2% of the people wouldn't trust the test. A great majority chose to exchange with other people and to speak with family members or a trusted person. A lot of the interogated people were also looking for medical support by going to a diagnosis center or to their primary care physician. In case of a false negative test or non persuaded positive person, the risk of transmission for the HIV will be increased and the person will be extremely contagious.
Another interesting question about privacy and the respect of dignity studies the non-acceptance of the diagnosis by refusing to announce the situation to its private circle. What should be the position of the medical staff? Which values prevail? What about the medical confidentiality, which is the root of the trust of the patient to his doctor or the principle of helping person confronted to a danger (in the case of a doctor who knows that a patient risks to transmit the HIV to his partner who ignore the seropositivity)?
Privacy
How to protect the privacy of the user? Developing an non-invasive diagnosis test. Is anonymity essential or optional during the diagnosis process?
Learn More...To study privacy concerns, it's necessary to distinguish the body from the mind.
The test has to preserve the integrity of the user's body. Using blood as sample is an appropriate way to protect the integrity of the user it is considered as a non-invasive test. Intimacy of the body was also an argument against the hygienic pad (see introduction), which could be considered more intrusive for the user.
The intimacy of the mind is considered as anonymity. Can anonymity be guaranteed during the whole diagnosis process? Until where anonymity protects the user and should be necessary? Anonymity should not to be an obstacle to health care quality and has to be revoked until the health prognosis of the patient is threatened. Two articles in the French public healthcare policies describe the revocation of anonymity. It is possible only with the agreement of the patient in case of therapeutic emergency and it is supposed to improve the diagnosis process and the beginning of the therapy. The diagnosis test is not incompatible with those principle. Moreover anonymity is now considered as an option at diagnosis centers. The consultant is free to take the decision.
3 - Risk
Banalization
Using diagnosis tests too frequently? The doctors are not worried!
Learn More...The interviewed doctors do not sense banalization (the risk of a too frequent use after a risk taking) like a detrimental consequence of high accessibility. A high acceptability test will be rather used to support the diagnosis in population that do not use classical diagnosis method. Moreover, the risk of a too intensive use is sensed as a positive fact on the condition that the test has to be precise enough, well used, and associated with prevention measure (traditional diagnosis methods and protection).
Nowadays, the banalization risk is clearly not a problem. The priority is to give an access to a fast, easy and reliable test to everyone, in order to know its serologic profile.
Biosafety
Using non pathogen biological materials for the test is obvious: a diagnostic test should not be hazardous for the user.
Learn More...Biosafety characterizes the hazard relative to infectious microorganisms. In our project, biosafety dealt with the biologic materials used in the lab, especially the HIV reverse transcriptase because HIV is rank 3. Biosafety implies the respect of human dignity and vulnerability and the engineer civil responsibilities.
About the engineer civil responsibilities: the device does not present any biosafety risks. No protein was indexed as toxic or pathogen. Streptavidin and its cellulose binding domains do not present any toxic hazard.
Furthermore, the matrix has been consulted to take a decision concerning the migration witness. At first, we wanted to use reverse transcriptase on the detection pad. The presence of such a protein in the test was rejected due to technical issues (what about the risks of false positive due to background noise?), economic issues (the price of production and purification) and ethical issues: even if it is produced by bacteria, is it correct to use some viral protein on the test? How will it impact the user? During a test can we risk to get contaminated by HIV protein whereas the test has vocation to prevention and detection?
About the respect of others: precautions are essential about the management and the treatments of the blood-contaminated wastes. It is necessary to deliver with the diagnosis test a special waste bag and a single-use self pricker and to collect it at drugstores. In case of a medical use the central waste-collect remove this problem. The case of the plastic device will be explained in section 4.
Reliability
A diagnostic test is characterized by two risks: the false positive and the false negative which has to be strictly negative!
Learn More...Rapid diagnostic tests are additional and complementary tools for traditional diagnostic tests. No matter how the rapid diagnostic test can be reliable, results have to be confirmed. There are two risks for a diagnostic test: the false positive and the false negative. According to the virologist Prof. Chidiac, the risk of false negative has to be strictly null. In case of false negative, the infected people will not be aware of its positivity and can’t take the good measure to protect itself and its other partners. For HIV, the early stage of infection corresponds to a high transmission rate period. The engineer holds responsibility, so the false negative has to be eradicated at all cost. The risk of false positive has less ethical requirements because after confirmation by a traditional tests it is a happy-ending.
However, the use of such a test presents some hard ethical requirements in regards of the engineer's civil responsibilities and protection of the human integrity. It implies precautions taking by the healthcare authority in numerous domains: informations, medical or para medical support, juridical protection, free access, evaluation, accessibility limited to drugstore?
Use decays
Use on animals, use as a contraceptive tools,... Is it the responsibility of developers and/or retailers to assume the use decays of its device?
Learn More...The test can be easily misused: for instance use on animals (before unconventional practice?) or be used as a contraceptive tools (the early detection can be sensed as security) or as an incomplete prevention tool before an unprotected practice. Nevertheless, misuses under bad conditions (alcoholed-altered behaviour) or without the respect of the correct practices described in the usernote lead to erroneous diagnosis. Is it the responsibility of the developers and/or the retailers to assume the usernote respect? So retail of the diagnosis tests has to be correlated to a good support and with some quality informations for the good use. The redaction of a user note is fully part of that approach.
4 - Responsability
Accompaniment (support)
STDs are severe consequences diseases which engage the health pronostic and cause secondary effects in the long run. The diagnosis announcement is delivered by the doctor which accompany the patient. Support is divided in three parts: during the purchase, before and after taking the test. How our test calls questions the relationship between the medical staff and the user? Is a medical support needed?
Learn More...The accompaniment question contains three aspects. The accompaniment during the retail, it contains all the informations accessible to the potential user (usernote, advice of the para-medical staff, advertisement, comments on forum networks). The accompaniment ante/post test delivered by the medical staff or associative members.
STDs are severe consequences diseases which engage the health pronostic in the long run and carry very serious secondary effects like sterility, opportunistic infections and indirectly death. Informations about the meaning of the diseases, the treatments and the consequences has to be given objectively and with the respect of everyone's sensitivity. For instance the AIDS diagnosis implies the prognostic medical of the patient and its future on familial, professional and social points of view. The accompaniment delivered by doctor has to place the patient in a situation of informed consent. The patient has to exercise his free individual choices in order to plan his future. The role of the accompaniment is also to aware the patient about hygiene rules and protection measure about the others.
According to the diversity of patient sensitivity and thoughts path to the acceptation of the diseases, a psycholog can be required and also a social assistant to ensure the administrative procedure. The familial accompaniment has also consequences on the user. The opinions are subjective according two directions : the risk minoration ou the hyperbolization. The judgement of the close relatives is influenced by the affection for the patient and their will to answer at all cost to every sollicitations. Sometimes the relatives don’t have the knowledge and the pedagogy quality of a health professional. Accompany someone his not to be behind nor before nor to be at his place, it is to stand asides and to give support. It requires some scientifics knowledge and practical and being manners. It cannot be improvised. A useful accompaniment consist in rassure the user and encourage him to consult a healthcare professional or a diagnosis center.
The diagnosis test reconfigure the relationships between the medical staff and the users. How can we manage to reduce the loneliness of the user concerning the test and the results self interpretation ? The design of the user note has to bring some answers. It has to be ergonomic as much as possible, to reassure the user and to help in in the post results decision taking. (lien vers la user note). A call center also can be available to deliver advices to the users.
The question of the medical support has been asked in the survey.(lien vers) The answers show that an accompaniment is needed mainly during the test execution and during the results interpretation. This question reveals the limits of the matrix which is “only” a help tool for decision taking. How interacts the accessibility with medical support? Is prescription a sufficient accompaniment ? Is medical support a barrier to accessibility are a needed lock to ensure a correct use of the diagnosis test?
In such cases, it can be interesting to compare the issues with other diagnosis test like pregnancy tests or the genetics test. In France, pregnancy tests are available both with or without medical prescription. Hosting a child has certainly not the same consequences as hosting a STDs, in the first case it is to give birth to new human, it will surely impacts on the future of the future parents. In the other case it’s affecting the life of the person on a negative way. However in both cases, it impacts the future of the both partners. In the long run, the model of the retail of diagnosis tests will probably converge to a pregnancy tests like model.
The cycle of life
Integrated sustainable development to synthetic biology. Paper and biosourced materials : our technical choices to reduce the impact of our device on the planet.
Learn More...The diagnosis test as to be integrated on a sustainable perspective. The ethics matrices has guided our environmental conscience and gave us a rigorous anatomic thought path to environmentally optimize each part of the device. At the early stage of the cycle of life the biosourced materials has been privileged to reduce the rarefaction petrol and rare ore. For instance, we used latex beads which are potentially biosourced with rubber tree (Hevea brasiliensis) than nanoparticles of gold which is a common support to work with aptamer. Here is some other choices to reduce the impact of the diagnosis test on the environment. The support of the paper consists in recycled cellulose. The plastic device is made of bio-sourced plastic or recyclable resin. As often as possible, we used cell-produced biological materials instead of chemically produced ones. To conclude the project conciliate technical aspects and environmental specifications.
After the use the management of the biological trashed has to be investigated. Indeed STDs can survive during a long run in a liquid solution or six hours at the air. The goal is to protect the other person to get infected by contaminated materials. The paper is a pertinent solution has it can be easily burn or autoclaved to be recycled. It is the same specifications for the plastic device which has to be collected and recycled. Models of trashs collect can be practicable : the test can be returned to the drugstore and be centralized before being treated. The tests aim to modify the behaviour of the users, they have to be aware about the risk of contamination after use.
Furthermore, the matrix has been consulted to take a decision concerning the migration witness. At first, we wanted to use reverse transcriptase on the detection pad. The presence of a such protein in the test has been rejected due to technical issue (what about the risks of false positive due to background noise?) economic issue (the price of production and purification) and ethical issues : even if it is produced by bacteria, is it correct to use some viral protein on the test ? How it will impact the user? During a test can we risk to get contaminated by HIV protein whereas the test has vocation to prevention and detection?
Simplicity of use
Easy test = reliable results
Learn More...On the one hand the diagnosis test has to be usable to every people without any medical skills or knowledges. This condition is necessary to the test democratization: the right of the people to have an access to a diagnosis test. On the other hand, the simplicity of use contribute to reduce the mistake due to the manipulations during the test. The principal levers are the usernote and the easy handled design.
However, the use of such a test present some hard ethical requirements in matter of engineer civil responsibilities and protection of the human integrity. It implies precautions taking by the healthcare authority in numerous domains : informations, medical or para medical support, juridical protection, free access, evaluation, accessibility limited to drugstore ?
Easy access
Reinforcing the accessibility of the diagnosis test is encouraging the voluntary approach to get diagnosticate. Drugstore, self-service how do these place impacts on the users ?
Learn More...Outside the hospital, the prescription of a diagnosis test has be realized with the verbal agreements of the consultant.
Reinforcing the accessibility of the diagnosis test is encouraging the voluntary approach to get diagnosticate. This approach illustrate the expression of the free will. The easy access is the number one reason according to the men which go to free diagnosis center. The personal initiative to get diagnosticate is the motor of prevention by diagnosis. For some people, going at the hospital or a the free diagnosis center is mentally difficult. This problem can be deleted by the release in drugstore or in self service. The self service is questioning about the intimity and privacy. In super market, the abundance of the people can increase the feeling of being anonymous : I’m someone in the middle of the mass or at the opposite as meetings have a higher probability : How to stand the regard of someone when grabbing an autotest ? How should I react or how can a relative react if he or she see me buying an autotest ? Besides, the tellers do not have any medical skills and are not under medical secret. Furthermore, an accompaniment has to be provided (like condoms) because of the incompatibility of the self service and the informational procedure delivered by the medical staff. In case of internet self-service, the privacy seems to be well protected, for instance thanks to the use of avatars, intermediate bank account platform and privacy policies even if the datas own can escape very easily to the users.
Finally it will be pertinent to design a neutral and difficulty recognizable packing to protect the privacy of the users when buying an auto test.
Easy access is the key to ensure the largest use of the diagnosis test so it has to offer good condition : privacy and informations when buying it.
Using the ethical-matrix
Once the matrix was established, on the one hand, it was used as an instrument to have a human overview of the project. To take a needed step back as everyone was focused on its parts. A ethic matrix was a useful framework to assist us in our deliberation about technical choices by making. On the other hand, we confronted it with the results of the survey.
Examples of a decision taken thanks to the matrix :
Sample choices: non invasive test
Materials choices: paper, biosourced plastic…
Early-detection: RT instead of the p24
Reliability: a system that minimize the false negative risk by using to epitopes instead of one
Usability: redaction of a usernote
Biosafety: latex beads instead of RT proteins or HbSAg as migration controls
