"What I cannot create I do not understand."
- Richard Feynmann

Ethics

Working with genetically-modified organisms (GMOs) in health-related fields has a tendency to lead to ethical issues. When working with living beings it always has to be considered whether the benefit to humanity or the detriment to these living things, to the environment and to nature weighs more. Genetically modifying bacteria is an intervention to nature that could possibly constitute a risk to the environment and must therefore be rethought well. It is also crucial to always think about the consequences of a possible misuse of an invention. To address these issues and to help us find potential resolutions, we consulted Dr. Raffael Iturrizaga, the general manager of the Science Coordination Staff in the Ethics Commission of the ETH Zurich.

Summary

This meeting made us consider the following questions:

Awareness about synthetic biology in Switzerland is low. People either think that it is terrible or something useful.
Health related devices are usually positively perceived by the population.
Research limits are artificial. Potential harm should be the most important limit.
Doctors will be the ones who will untimately decide how useful a device is going o be to a patient.
To benefit a large number of people, the device should be free of patents.

Talk with Dr. Raffael Iturrizaga from the Ethics Commission of ETH Zurich

How does perception of synthetic biology in Switzerland look like?

Synthetic biology is not addressed often in Swiss news. One of the basic indicators of this is that general population does not seem to be aware of the difference between synthetic biology and other related sciences, such as genetic engineering, despite attempts by scientists in the field to be very proactive in presenting and discussing the issues in their respective fields.

The general public’s views on synthetic biology can be divided into two classes: those who think that synthetic biology is about creating evil monsters and those who see it as something that can help solve health-related problems. Many of these issues stem from an uncertainty about the long-term effects of organisms that did not evolve naturally while interacting with nature.

In Dr. Iturrizaga’s view, however, this alleged public fear of synthetic biology is not significant and it is something that is concerning scientists much more. Numerous scientific conferences have been held over the years to discuss issues related to biosafety and ethics, but their frequency has been dropping, most likely after it emerged that many of the main concerns were not realistic.

Nonetheless, it is true that the general public perception of GMOs is negative, especially if they are involved in food. Dr. Iturrizaga believes that this is due to the fact that the health effects of these organisms or their interaction with nature has not been determined in the long term. To exacerbate this situation even further, movies that address the topic of GMOs tend to exaggerate or misrepresent their effects as catastrophic for dramatic purposes.

It is clear that the public perception of GMOs differs depending on whether they are being used for food or healthcare applications, with emotion serving as an important determinant of these perceptions due to a general lack of knowledge and understanding of the field. The public is very wary of consuming food whose origins it does not understand, such as GMO foods. At least in Western cultures, GMO foods are not considered to be a necessity, while “traditional” foods are perceived to be safer to eat because their history of consumption is “proof” of their long-term safety, despite evidence showing that GMOs will become increasingly important assuming predicted population growth patterns.

A different situation arises when GMOs are used in medical applications. Due to the maturity of the field, the general public, for the most part, is accustomed to being injected with chemicals of origin unknown to them for treatment, so the incorporation of another unknown produced through a new method is not perceived any differently as long as it works to improve their condition. Even for medical doctors, the efficacy of a drug is much more important than its mechanism or production method. This highlights the fundamental fact that medical doctors are more pragmatic and more concerned with helping their patients, while scientists are interested in studying and understanding a particular system.

Dr. Iturrizaga considers all guidelines for restricting research for ethical reasons to be artificial. In his opinion, research should only be restricted if there is a serious proven potential for harm to arise. Nonetheless, research on humans, in particular, is a point of great debate, as modifications to the brain or the genome can have huge societal impacts. Even the incorporation of human genes into organisms such as E. coli is perceived to be problematic.

What ethical issues could MicroBeacon have?

The main issue we wanted to address with MicroBeacon coli is whether it is preferable for our test to produce a false positive or a false negative result, as this will be a determining factor in our chip’s final design. Dr. Iturrizaga noted that in the case of patients that previously had cancer, a false negative could increase the chance of an unfavourable outcome and should be avoided. However, in a healthy patient, an assessment should be made based on the potential benefits and harms of a particular treatment. At the end of the day, however, the final decision is made by doctors as they are able to make better judgements based on their knowledge of their patients.

When considering the economics of our device it is clear that filing a patent would benefit us the most if investors are sufficiently interested in it. However, a device free from patent restrictions can more easily lead to the spread of knowledge and its further development. More freedom in research will always benefit society, as new applications can be found at a faster pace. In addition, patents can also affect the cost of a new treatment. An overly expensive device would only benefit those who can afford it, leading to a social justice issue in which research conducted using publicly-funded grant money is only accessible to a small subset of taxpayers.

These are the main ethical issues that concern MicroBeacon E. coli. As this device is not exploring a novel field of research its development should not provoke any new ethical concerns. Misuse of our device would, of course, be possible with enough creativity, but not more than any other existing devices.

Would the ethical committee be involved in our project?

The final step of our project would be to test the device with blood samples. This is considered to be human testing, and therefore, approval from the ethics committee is required to conduct these experiments. The main concern is data protection since a lot of personal information about the test subject (sex, age, medical history...) is required. If we chose to use our own blood instead, Dr. Iturrizaga commented that it would be legally possible, but still not recommended by the institution, as it can lead to risks for us and insurance issues. Regardless, permission from the ethics committee is required if we later decide to publish our results in a peer-reviewed journal. To get permission, a form has to be filled out and submitted to the ETH Ethics Commission or to one of the cantonal Ethics Committees. Usually, it is possible to get an answer in 2-4 months, depending on their workload at the time.