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Ethics of the DiaCHIP

If somebody is working in the field of synthetic biology it is inevitable for the researcher to deal with some ethical questions. Especially due to the rather negative connotation coming along with a word like "synthetic biology“, a project should be based on moral considerations. This includes the reflection on experiments that are conducted in scientific labs, methods that are used and possible applications that might result out of this work for the future.
The following paragraphs will present some of the most common ethical concerns in synthetic biology and relate them to our research on the DiaCHIP as well as to its application. We also presented our initial thoughts to PD Dr. Joachim Boldt - who is assistant director of the Institute for Ethics and History of Medicine of the University of Freiburg - and discussed further issues with him. He also further promoted the theater project we eventually took part in.

Biosafety
The two, probably most common concerns in synthetic biology are the aspects of biosafety and biosecurity. Biosafety mainly deals with questions of safety for the researchers themselves as well as for the environment. Regarding this point, we think that our project does not pose any critical questions. In the beginning of our iGEM project we received a safety training comprising information on juristic regulations as well as on regulations on how to behave and work in the lab to protect others and ourselves. We also checked for the different proteins we worked with and chemicals we used if they could do any special harm to us. In the late phase of our project some experiments included handling human serum samples. We consulted the respective guidelines before we started working with serum samples and always took special safety precautions. Therefore, concerning biosafety all requirements were fulfilled during our project.
The organisms we worked with were never transported out of the lab but only handled inside of it and disposed appropriately. In fact, concerning the issue of organisms in the environment the aim of the DiaCHIP is shipping a DNA template containing small nucleotide sequences coding for antigens. Therefore, the final user would not receive any living organism and shipping genetically modified organisms would be avoided. The researchers in the lab or medical staff receiving the DNA template would of course have to follow the safety guidelines regulating the work in a scientific lab. These rules being payed the appropriate attention to, no concerns in terms of biosafety are remaining.

Biosecurity
Biosecurity on the other hand deals with the possible abuse of biological material for acts of terrorism and with the arising danger of non-experts starting experimenting in home-labs. This mainly applies to hazardous biological materials such as toxins or virulence factors. Nowadays, individuals can order DNA sequences to be synthesized by specialized companies. These DNA sequences can be used to express potentially dangerous proteins in a relatively simple way. This way, it would be rather easy for terrorists to get access to substances that might be used to harm people. As there are guidelines for companies synthesizing nucleotide sequences, this risk is partially excluded but still remains in terms of people having free access to those dangerous sequences.
At this point, one faces a difficult question concerning biosecurity matters as it is really important for the progress in research to share know-how on the one hand, not only about basic biology but also about potentially dangerous proteins. But on the other hand extended knowledge available on complex biological mechanisms of course increases the possibility of improper use. Therefore, it is very important to find a reasonable compromise to maintain necessary progress in science while at the same time minimizing the risk of danger at the best.
In relation to our project the possibility of terrorist abuse is not given. We are working with sequences that encode for immunogenic peptides of viruses and bacteria that pose no threat for the environment. The way we are using them, they do not maintain any harmful function as they often represent only a small part of a functional protein. Moreover, the nucleotide sequences on the DiaCHIP do not encode anything that could reproduce and thereby multiply itself if released from the lab.

Synthetic Biology - Creation of Life?
Another aspect of synthetic biology heavily discussed is the question whether life is created artificially. Many people criticize synthetic biologists and accuse them of wanting to play God. This assumption is based on the idea of synthetic biology building new cellular networks and combining different natural components to create something new.
In this debate, it is important to distinguish between different tracks researchers in synthetic biology are working on. Some scientists really focus on finding a way of creating a whole new organism simply out of single bricks that are themselves not considered as living. Of course, this could be termed “creating life” and could lead to conflicts. However, there are also fields of research that are trying to recombine already existing parts to generate something beneficial. This is mainly achieved by editing the genome of a living organism, for example by adding new coding sequences derived from other species that are optimized for the new host.
The latter field of research is the one applying to our work. Critics also object to this kind of work since one is modifying the genome of an organism and some pose the question, if the researcher is “playing God”. This question, for example, was addressed at the theater project which we took part in. Without wanting to play down this issue, one has to admit that it is not only a question in synthetic biology but corresponds to biological research as a whole as well. Modification of the genome also is something mankind has been performing since decades by breeding different species and subspecies, even though current research expands this toolbox by introducing foreign DNA sequences.

Protection of Privacy
Besides these ethical concerns referring to synthetic biology as such, our project comprises another important issue examining the protection of privacy. The DiaCHIP combines many diseases on only one surface and could therefore reveal a lot of information on a patient by testing his blood. A patient, however, might refuse taking a test that could reveal incidental findings like an HIV infection or syphilis if, according to the symptoms, there is no reasonable hint that one of these could be the trigger of the complaint. Severe diseases like those can have a great impact on a patient’s lifestyle, and a medical professional is not allowed to perform a test like this without approval.
We thought about possible solutions for this problem to preserve the advantage of screening for many diseases at once while at the same time meeting the patient’s right to ignorance. Our idea is to provide special software allowing the restriction of evaluated disease spots on the DiaCHIP. We would group the immobilized antigens as expedient as possible and let the patient decide by written informed consent if the whole spectrum should be evaluated. The medical professional would then simply have to choose the according evaluation pattern and certain spots would not be evaluated.
Still, if the DiaCHIP would fall into the wrong hands it could be misused and reveal intimate information about the health status of an individual. Therefore, the access to the DiaCHIP should be restricted only to medical professionals or trained medical staff members bound to discretion concerning information about patients.
For further applications like the review of a patient’s vaccination status we could provide a cut-down version of the DiaCHIP that simply displays vaccine antigens in order to avoid incidental findings of diseases. As our own detection device is small, easy to handle and affordable, the vaccination test could also be performed by pharmacists to provide fast information for people.

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