Team:Freiburg/Practices/Ethics

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Ethics of the DiaCHIP

When 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 things that are done in scientific labs, methods that are used and 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.

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 are of the opinion 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 serum samples of humans. We consulted the respective guidelines before we started working with serum samples and we 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 were only handled in the lab and disposed appropriately. In fact it is the aim of the DiaCHIP to ship a DNA template containing small DNA fragments coding for antigens. The end user would therefore not receive any living organism, and shipping of genetically modified organisms would be avoided. The researchers in the lab receiving the DNA template would of course have to follow the safety guidelines regulating the work in a scientific lab. If this is payed the appropriate attention to, then 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 if laymen start 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 a specialized company. 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 banned but still remains in terms of people having free access to such dangerous sequences.
Here one faces a difficult question concerning Biosecurity matters as it is on the one hand really important for the progress in research to share know-how, not only about basic biology but also about potentially dangerous proteins. But on the other hand extended knowledge on complex biological mechanisms does of course increase the possibility of misuse. It is therefore very important to find a reasonable compromise to maintain needed 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. In the form we are using them they do not maintain any harmful function, as they are often 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. Many people criticize synthetic biologist and accuse them of wanting to play god. This assumption is based on the idea of synthetic biology to create new cellular networks and combine different natural components to create something new.
In this argument it is important to distinguish between different tracks researchers in synthetic biology are working on. Some scientists really focused 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 mainly with believing people. 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 are also objecting to this kind of work as one is modifying the genome of an organism and some are posing the question, if the researcher is “playing god”. This was for example also a question addressed at the theater project in which we took part. Without wanting to downplay this issue one has to admit that it is not only a question in synthetic biology but corresponds to research on the whole as well. The modification of the genome is also something mankind has been performing since decades by breeding different species and subspecies.

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 might however decline a test that could reveal incidental findings such as an HIV infection or syphilis if due to the symptoms there is no reasonable hint to these being the trigger of the complaint. Such severe diseases 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 meet 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 after 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 such as 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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