Team:Oxford/HP/Silver

Silver Human Practices

Introduction

In order to develop a thorough understanding of the factors that would influence the design and application of our diagnostic in the field, we approached experts and a range of stakeholders to help us develop a sense of the social, ethical and environmental issues related to our project. We also evaluated the safety regulations associated with the use of our diagnostic device to ensure optimal sustainability and responsible design

Decision to Choose Diagnostics Track & Royal Society Conference

Attending a Royal Society conference ('Synthetic Biology: Does industry get it?'; 8th February 2017) at the start of our project highlighted the diversity of synthetic biology applications. However, we were particularly excited by the medical applications. We reviewed the conference for our general university newspaper to explain synthetic biology, through examples, to a non-science specialist readership. You can read the article by following the link below:

Surveys to the Public

Understanding of the current medical applications of synthetic biology guided our initial diagnostics track choice, which was corroborated by the results of our initial survey of the UK public, where more than half of the 200 surveyed wanted a synthetic biology solution for disease diagnosis. After deciding to pursue Chagas disease diagnosis for our project, we decided to create a survey for immediate stakeholders in Latin America with the aim of finding out the most acceptable mode of delivery for our diagnostic. The AQA Unesp (Brazil), Amazonas (Brazil) and TEC CEM (Mexico) teams translated and disseminated our survey. Some of the results (documented below) highlight that most teams were most comfortable with a pinprick or small syringe, all preferred a test delivered at a drop in clinic, and all wanted a test carried out by a trained professional. As a consequence we designed our kit to use as minimum volume of blood as possible and envisioned its use by a trained professional.

Figure 1: Results from a survey to the public in Brazil and Mexico

HeLEX - Centre for Health, Law and Emerging Technologies

Introduction:

HeLEX specialises in investigating the relationships between law, ethics and practice in the area of emerging technologies in health. We initially spoke with Dr Michael Morrison who is the Principal Investigator in biomodifying technologies at HeLEX. He is interested in the application of insights and perspectives from Science and Technology Studies (STS) and medical sociology to the study of novel and emerging biotechnologies. We had an email conversation with him throughout the summer and met with him in person twice to have more detailed discussions. He also introduced us to Dr Louise Bezuidenhout from InSIS.

Cell Free:

In our meeting with Dr Michael Morrison we outlined our project in order to gain his insight on important things to think about regarding law, ethics and safety. As we had been considered a cell-free device we decided to ask for Michael’s thoughts on this. He said that a cell-free device solves a lot of the current problems in emerging synthetic biology technologies. One of these issues is that there are different regulations and laws in this area in bordering countries and so containment can be a real problem especially with living organisms, however cell-free would solve this.

When talking about our diagnostic, Michael mentioned whether there was any regulations surrounding the use of cell-free systems in the field. After this meeting we went away and researched this area and were not very fruitful in our results. We then went back to him a few weeks later for more discussions and he said how regulations can often support innovation as they give a clear cut way of for scientists to know what they have to do in order for their research to get to market. Both of these meetings with Michael and further research led us to decide to create some kind of report on the regulations surrounding cell-free technology. This can be seen by following the link below.

Applied Design:

The target area being in Latin America could introduce problems around delivery and different lab resources. Michael advised us on how our device should ideally not require specialist equipment as that would limit its use in more rural areas (which may in fact be more in need of this technology). And also the elimination of the cold chain is a good advantage of cell free technology, in decreasing the price and allowing for more realistic conditions.

This led us to thinking about the medical infrastructure in these countries and how we would have to think about this for our final design. This comes into the portability of our device and how it does not require any specialist equipment that would only be present in well-equipped hospitals.

Safety and Ethics:

When talking about ethical issues surrounding the diagnostic the main worry that Michael had was issues with abortion as we were working with congenital diagnosis. However, we ascertained that this would not be an issue as the test is done postnatally and there is no danger of abortion being encouraged or even coming up in any discussions. He thought that this was an important thing to be clear on as we would be dealing with maybe more religious and less westernised cultures.

Michael suggested it might be a good idea to have a public health campaign to go along with this diagnostic. To see a draft of this click the link below:

A public health campaign would be good because it is important for people to know that Chagas disease is something that their child could have and needs to be tested for; as often it can be seen as a disease of the older generations. This kind of insight from Michael into thinking about different cultures and societal factors and how it would affect our product design was invaluable in our final vision.

Before we had a outline for how our product would work, we were thinking of possible using the placenta as the blood source. However, after advice from Michael we realised that this might not be the best idea for a number of reasons. There could be cultural issues surrounding use of the placenta as well as the practical and legal issues in storing human tissue. He told us that there are not many specific legal issues surrounding diagnostics, as long as standard safety measures are kept.

InSIS - Institute for Science, Innovation and Society

Introduction:

InSIS researches and informs key contemporary and emerging issues and processes of social, scientific, and technological change. After learning more about our project, Dr Michael Morrison from HeLEX put us in touch with Dr Louise Bezuidenhout, who is a research fellow at the Institute for Science, Innovation and Society. She is currently working on the Changing Ecologies of Knowledge and Action (CEKA) project. We arranged a meeting with Dr Louise and her colleague Dr Chris Goldsworthy, who is a postdoctoral research fellow at InSIS, working on the InSIS How Institutions Think (HIT) research project.

Cell Free:

Dr Chris Goldsworthy talked about how in some ways it is important to think about whether cell-free systems are seen as ‘legally living’ even if they are not considered living biologically. This is discussed in the cell free report linked below.

Safety and Ethics:

As with all synthetic biology research we had to consider any potential dual-usage research concerns. This links to the ‘FINK report’ which Dr Louise Bezuidenhout informed us about that mentions the 7 experiments of concern. This allowed us to clarify that our project did not include any of the experiments of concern as defined in the report.

With our device there are not many dual usage concerns. This is primarily because it is a cell-free technology and a diagnostic device. However its application could prove to have dangers for example in the data collection that would result from diagnosing many patients. Louise highlighted a very important consideration in thinking about what data will be collected and how it could be managed and used. Additional infrastructure and servers may be needed and this is an additional cost and management that the government or medical authorities would have to be consulted on. This is important because we would not want our technology to become problematic rather than useful due to bugs in the data management.

Conversely, there can also be ‘good dual use’, in that there is currently a lack of understanding on the transmission of chagas disease, and more data in this area could improve this and lead to more effective vector control efforts etc.

The diagnostic is not in itself dangerous but there may be issues in creating it in terms of containment. There are also concerns about disposal and so having our device cell free and with no needles involved allows the standard clinical waste procedures to be followed.

Political, Societal and Cultural Considerations:

In our meeting with InSIS we were advised on the practicalities and nuances of dealing with areas that are not so exposed to new scientific developments, as follows. In an ideal situation, we would want to educate and engage with all publics around the world; however, as a part of our policy and product marketing it is not necessarily a good idea to try to engage with local communities on synthetic biology as it could be more damaging than helpful. This is because there is a tendency to lump synthetic biology with GMOs which often have an associated fear factor. This would not be helpful for encouraging parents to get their child checked for Chagas; and while it is not information that should be hidden from people it is not something that needs to be actively pushed on them.

It would however be necessary to engage with other stakeholders, like governments, regulators and the entrepreneurial public on this. Towards this aim, we developed a policy proposal on the integration of our device into society, talking about the current political, social and economic landscape in Bolivia. To view this click the button below:

It was evident from our research and conversations with experts in the field that we would need the backing from the relevant governments, as in Bolivia for example, the treatment for Chagas after diagnosis is funded by the government health department.

We were reminded of the fact that there may be language barriers in this project and it would be important to try to ensure as best as possible that this does not affect our results. When we sent out a survey we asked for it to be translated into Spanish so that we would not be inadvertently selecting for participants. Louise also mentioned that biosafety, biosecurity and dual usage are the same word in Spanish so when writing policy proposals we would have to be careful.

It was clear from discussion with both Michael and Louise that we must ensure that for ethical reasons if we are diagnosing Chagas disease in babies then there must be access to treatment. Currently in Bolivia if the child is 15yrs old then they can receive the treatment for free. We were presented with the problem that if you diagnose the baby then this indirectly gives you information on her serology status. However she will not necessarily have access to treatment. After some research we realised that the mother would most likely be in the chronic stage of the disease and so the best option would be to have a campaign for helping mothers to come to terms with this information and help in living with the effects of the disease. Because of this we wanted to consider the potential stigmatisation of the people involved which would primarily be women and the effects this could have on their livelihoods. From speaking to various experts in the area we were told that Chagas disease is a quite accepted disease and there is little stigmatisation around it as it is so commonplace.

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