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Ethical considerations in synthetic biology on a micro level

Choices in design

In the previous chapter general ethical considerations regarding synthetic biology were described. It was demonstrated that when practicing synthetic biology science, several implicit assumptions are made. Ideas on naturalness or artificialness in relation to appreciating genetic engineering, specifically transgenetics, are easily adopted. Also topics related to intellectual property rights, biosafety and biosecurity were considered. In this chapter, the ideas of the TU Delft iGEM team members and supervisors are further investigated. Choices that are made in the design of the process are analyzed along with personal ideas of the individual team members. It will be investigated what the opinion of the participants is with respect to implicit ethics-related assumptions that are made in participating in the iGEM project, and what this further implies for the design process of the entire group, both students and instructors. It will further be demonstrated in which design steps, major ethical decisions are made.

Note: the tables are missing in this section. They can be found in the full report, which can be found by clicking on this link

4.5 Summary

In this chapter the ethical considerations in the iGEM project were investigated and the opinions of the team members regarding the involved ethical issues were captured. Furthermore, the design process was monitored. For developing the project’s design, the participants had several brainstorming sessions. First the project requirements were mentioned, of which the key one was that it was Delft University of Technology related, meaning an applied scientific application. Hereafter, a session on value sensitive design was held, which resulted in the idea that the project should take into account safety (for production, users and the environment), security (controllable applications and no intentional harm), transparency (for designers and of the project) and usefulness (of the application). Additional values included scientific simplicity, contributions to the good of society and transparency for end users.

In the following brainstorming sessions, wild ideas were generated, out of which a selection of potentially scientifically interesting and viable ideas were distilled. Further scientific probability assessment and ethical decision making, resulted in elimination of other projects, resulting in one project to be continued: the biothermometer.

The attitudes of the participants towards ethical issues and decisions within the project, and the attitudes towards the values that were previously adopted as important to consider, were further investigated with a questionnaire. The road map of Figure 4.3 was used to develop the questionnaire, which was conducted in a semi-structured way: the general line of the conversation is the same, but small deviations in question methods and order of questions are possible. In the survey, the focus was first on science to get the participants familiar with the used technologies and terminologies. Later the focus was on the ethics in synthetic biology, specifically in iGEM.

It appears that on most topics, no general group opinion is observed: individual participants give different reasons for participating, have different approaches towards risks and ethics in science, think differently about their responsibilities, etc. In the next chapter, the different attitudes the participants have are related to general ethics in synthetic biology as presented in Chapter 3.

4.1 The design process

Two of the four eventual supervisors of the group picked up the idea of participating to iGEM. Six students had applied to iGEM by May 2008, with different backgrounds, as described in the Methods section. During one of the first meetings (see TU Delft iGEM wiki webpage) the requirements for choosing a project were made in a brainstorming session. Figure 4.1 below depicts a part of this brainstorming session.

[figure not present] Figure 4.1: Requirements as assessed in the first brainstorming session of the iGEM team. Being from the applied science faculties of the TU Delft, the team members figured that in designing an application, the end product should be kept in mind. Also, ethical issues should be assessed and it should be able to be modeled. Some team members had additional specific wishes, like building a switch-like application or not having to with medical applications.

As can be seen in the figure above, some requirements of the Delft team were made. Being TU Delft related, the application that was to be developed should be an application that can actually be used on its own (a real application) and can be modelled. Also, ethical considerations should play a role in design of the application. Specific team member requirements were also made, e.g. that it should contain a biological switching element and that it should not relate to medical research or applications.

During following brainstorming session, the possibilities were further investigated. In this brainstorming, several applications were mentioned. During this session, also several interested researchers of the Kluyver Laboratory were present.

[figure not present] Figure 4.2: Brainstorming session in which the possible applications are first mentioned. The applications involve several fields of application. Several remarks for additional requirements were also suggested, having to do with general appeal of the application to be chosen.

The figure above shows the outcome of the application brainstorming session. Of these options, six main topics to be investigated further were chosen. These choices were purely on technical feasibility, not on further social/ethical considerations. The list is given below:

• Light emitting lactic acid bacteria for use in dog food to easily detect dog poo
• Magnetic bacteria or moving bacteria based on magnetism
• Sticky bacteria or bacterial glue
• Colorant production
• Temperature sensing
• Flavourings or smelly bacteria

These topics were investigated on technical feasibility by the team members and discussed in a following brainstorming session of the group. It turns out to be technically difficult to make magnetic or sticky bacteria. The light emitting lactic acid bacteria are also hard to produce, but besides, some team members expressed ethical concerns in producing genetically modified dog food afterwards, even though it had already been ruled out as an application, based on technical possibilities.

The colorant production, flavour components and temperature sensing applications were not ruled out on technical feasibility, and soon the collaborative idea originated to combine the input and output in a thermometer with a visible output, being visible colour. This idea was further investigated and resulted, via practical decisions on technical feasibility of the team members with a background in biotechnology. The technical methods and results of the used design strategy can be found on the TU Delft 2008 wiki web page.

4.2 Value sensitive design

After the brainstorming session where the team identifies the topics of interest for the first time, a meeting was organized by Ibo van de Poel of the TU Delft department of Philosophy. The central theme of this meeting was ‘value sensitive design’. In this session, the team members came up with moral values which they think are important to consider in a bio based product design. See the table below.

Table 4.1: minimal and additional moral values to play a role in the TU Delft 2008 iGEM project

Minimal moral values

• Safety (for production, users, environment)
• Security (controllable, intentional harm)
• Transparency for designers (process & product)
• Useful (early and later stage distinction)

Additional values

• Transparency for users
• Simplicity
• Contribution to society (short and long term)

The table shows a list of minimal moral values and some additional values that might be taken into account. The minimal values include safety, security, transparency and usefulness. Different things are concerned with safety: safe production and development methods, safe use for end users, but also no negative effects on the environment. Security means that the application can be controlled in technical functionality (perhaps partly overlapping with security for users) and that the possibilities for intentional harm with the application are minimized. Transparency implies that all research data is made public, so designers (but later perhaps also users) are able to learn exactly what the application is, how it is built, what the expectations are, etc. Usefulness of the application can be divided into early and late stages of development. The early stages of development do usually not concern the usefulness of the application, since the functionality first has to be demonstrated properly. After this phase, the usefulness of the eventual application can receive more attention. Additional values include transparency also for users, simplicity in design and in use, and also, if possible, a contribution to society. What this contribution is or may be, is up for deliberation.

But how these values come back or should come back in the eventual product design? In the questionnaire that was carried out, the opinions of the participants on this matter are investigated. The results are given in Chapter 4.4.5. One can imagine that at some point, these values may conflict. For example, security as controllability may make design more difficult, so simplicity cannot be guaranteed anymore. In an extreme case, usefulness and safety for the environment may conflict: unforeseen effects on e.g. natural diversity may appear when the application has to be used in an unprotected atmosphere (outside the laboratory, e.g. in nature). The challenge for the designers is to find the right balance of these values, within their responsibility. Where this responsibility lies, is also a subject investigated in the questionnaire, see Chapter 4.4.9.

4.3 Ethical decisions in design

From the previous paragraph it can be deduced that for coming to a practical design of a certain application, mainly decisions are made mainly based on technical feasibility. But in the eventual design of the thermometer, also ethical choices are made. Some major choices are indicated below.

The RNA secondary structure based temperature sensitive sequence : the developed sequences are based on known RNA structures from different organisms, some of which pathogenic; others were based on theoretical models without any affinity to sequences that can be found in nature . The group eventually decided that all sequences could be tested, hence all structures were ordered from a DNA sequence manufacturing company. Questions that could be raised here:

• Why not use only known sequences?
• Why not use sequences only from non-pathogenic organisms?
• Why use synthesized DNA rather than natural DNA for the non-pathogenic organisms?
• How ‘normal’ is it to simply order DNA from a company that manufactures any sequence you like?

The colour pathway output : the developed BioBricks were put together from genes from different micro-organisms and different existing BioBricks. The existing BioBricks also contain genes from different bacterial species, but the pathway is based on colour pathways that can be observed in plants, e.g. in the flowers. All used organisms in this pathway are known to be non-pathogenic. Also, in this case, no DNA was ordered, only genes were taken from the source organisms using PCR techniques . Still some questions could be raised:

• Why use a colour pathway based on plant pathways and not on e.g. bacterial colourants?
• Can or may one so easily construct a pathway using genes from several different organisms?

Some would say it is not the idea of iGEM participation to consider these ethical issues. However, certain ethical decisions are made, explicitly or implicitly, in participating in iGEM. Some of these implicit assumptions were already indicated in the previous chapter. But to what extent do the participants realize this and how are they using their own moral standards within this competition? To answer this question, a questionnaire was held with the participants of the group. To do this, first an ethical framework had to be built, based on the literature survey on ethical issues as shown in the previous chapter. The framework is depicted in Figure 4.3.

The framework shows that upon participating in iGEM, several different ethical considerations play a role. The consequences of participation imply using certain technologies. Consequential ethics play a role here and ideas of the participants towards open source technology and novel technology are to be investigated. The ideas on values of life and naturalness play a role more in the background, but are still present, as was illustrated in the previous chapter: implicit assumptions are made in synthetic biology. These values of life are used here as the more deontological ethical side of synthetic biology. The science and values come together in iGEM, a novel, open source approach of synthetic biology.

The questions asked in the survey investigating a team member’s opinions can be found in Appendix B. The ethical road map as presented in Figure 4.3 forms the basis of this questionnaire, of which the setup is given in Figure 4.4. First, general questions on participating in iGEM are asked to the team members. Secondly, the project goals as determined in the iGEM project proposal (Appendix A) are reviewed. The third question should illustrate what the participants think synthetic biology means, after which the science in synthetic biology is further discussed. The fourth question regards open source technology, specifically in the iGEM setting. The fifth item to be discussed is the value sensitive design, as discussed in Chapter 4.2. The risks and ethical issues in synthetic biology are further investigated and summarized in the sixth question. The seventh question regards naturalness or artificialness in synthetic biology and to what extent the participants think genetic engineering is allowed within the project. The eighth subject to be investigated is about misuse in synthetic biology, either deliberate or unintentional, and more specifically on misuse of the application developed by this university. The ninth question should illustrate what the participant think his/her responsibilities are towards science and society and which role they can play in science communication. The tenth and last question reviews the survey and further investigates the participant’s role in the design process.

Ethics road map

Figure 4.3: this image shows that participating in iGEM has several stages. One has to decide to participate, then the project is designed and an application is developed. In the design process, deontological ethics and consequential ethics play a role, converging in iGEM as a novel, open source technology. In all phases, decisions are made, implicitly and explicitly. Participants have ideas on all these topics, the challenge is to get these out of them, and subsequently finding out how much value they attribute to the different issues.

[figure not present] Figure 4.4: the overview shows the questionnaire set-up. 1: general questions about participation are asked. 2: questions related to the project goals as defined in the project proposal (see introduction). 3: questions relating to what synthetic biology means to the participants. 4: investigation of ideas around open source science approaches. 5: the project value sensitive design related issues. 6: risks and ethics in science. 7: issues regarding naturalness of genetic engineering in synthetic biology. 8: questions around misuse of the project. 9: questions about the participant’s responsibilities. 10: concluding remarks and the participant’s role in design.

4.4 Survey outcome

The results of a typical questionnaire, for which the setup was explained in the previous paragraph, can be found for one person in Appendix C. For reasons of anonymity, not all interviews will be included completely in this report. Because the subject group is relatively small (9 persons), no statistical data can be derived from the group. However, interesting topics can be recognized from these interviews. A short review per question will follow in this paragraph. General remarks on the team members’ recognized ethical considerations will be illustrated with quotes where suitable.

4.4.1 Question 1 – Participation

The students and supervisors give similar reasons to participate. All team members find synthetic biology an interesting research field with lots of opportunities. Especially the conceptualization and standardization are mentioned as being the most interesting parts in synthetic biology. The participants like the idea of building up biological machinery from scratch. However, the supervisors’ reasons for participation are fully interest based (interest in the research itself and in the iGEM approach), while the students give an additional more personal reason for participation: getting credits. This may of course be expected, yet still: it is a different reason than the supervisors give as a decision to participate, and this may have some implications. The obligatory part of participation for students may for example result in less motivation for the project or less optimism or expectations on the result, because one gets credit anyway. On the other hand, for the supervisors there is also nothing at stake.

4.4.2 Question 2 – Project goals contribution

The supervisors and students have several different backgrounds. The project goals, as defined in the introduction of this report, concern laboratory achievements, modelling achievements and ethical considerations. The participants with a background in biotechnology expect to contribute mainly in the lab, the people with a different background expect to contribute mainly to the modelling part. All participants did not see at first what their contribution to the ethics part in iGEM could be, besides participating in the questionnaire. The goal of the questionnaire was to make the participants aware of the ethical issues that play in synthetic biology and to investigate their opinion. After the questionnaire, all team members indicated to have heard at least some issues they hadn’t considered or even heard of before. In that sense, the goals of the questionnaire related to creating awareness are achieved.

The biotechnologists did not mention any other, more personal things they wanted to achieve, while the participants with a different background hoped to learn about the biological backgrounds in synthetic biology. One might expect that the biotechnologists would want to learn more about the modelling, like the modelling members would like to learn about biotechnology, but this was not mentioned as an achievement that the biotechnologists wish for.

4.4.3 Question 3 – Synthetic biology terminology

The third question of the questionnaire focuses on the terminology of the synthetic biology concept. When asked what synthetic biology, purely in a scientific way, means to the participants, they all answer that it relates to building with biology, synthetic biology in a constructing sense. In a sense, that is what is to be expected, since they are all participating in the iGEM competition, which is about building cells with BioBricks. All participants seem to have far less attention for the deconstructing part of synthetic biology, relating to building e.g. minimal cells or understanding cellular fundamental processes. Some participants brought up the idea that the deconstructing part automatically follows the constructing part, in a sense that when building, one also learns about the biological systems that are involved.

4.4.4 Question 4 – Open source in iGEM

With the goals and terminology in synthetic biology made clear in the previous question, the fourth question of the survey asks the participants their opinion on the use of an open source setting in synthetic biology. The following relations were brought up:

• Open source and technological novelty
• Open source and usefulness of developed applications
• Open source and commercialization
• Open source and patents in iGEM
• Turning lead into gold and participating in iGEM

The first thing to notice after the questionnaires is that the participant’s opinions really differ on these topics. When asked what the relation is between the open source approach of biology in iGEM and the technological novelty, or innovation, of the discoveries that are made in research, the participants all agree that open source stimulates innovation. When sharing information, people all around the world can look at your data and look at it from a different perspective and come up with something additional or new.

Yet when asked what the relation then is between open source and the usefulness of the newly developed applications, the opinions start to differ. Some state that in the open source setting, the different perspectives of the people that look at a certain BioBrick can result in a large number of creative applications, and in that sense technological novelty in open source stimulates usefulness and development of new applications. However, other participants do not agree and state that when something really useful is developed, the inventors will not publish their data in an open source database and will patent their application. Hence, no really innovative or useful applications will result from iGEM.

Again some others think that innovation and usefulness in an open source environment will not stand in each other’s way. Inventions can be patented and the biological background can be published in an open source database. This way, the knowledge is available, while the application is protected.

The answer the participants give on the question relating to usefulness of inventions greatly influences their opinion on the relation between open source and commercialization. The team members stating that no useful applications will follow from iGEM generally think that open source and commercialization of products are hard to combine, because of e.g. patent regulations and protection of property. The participants stating that usefulness is increased by open source generally state that commercialization is possible and perhaps even stimulated in an open source setting.

The relation between patents and open source within the iGEM competition is also a topic on which the team members have very different opinions. A device made with different BioBricks can be patented (from a legal point of view), with the data on the biological background also being published in the open source database. As an example, there are patents in the area of application the TU Delft team is working on . See Table 4.2 below for an example of different answers of participants.

Table 4.2: answers of two different participants to the question whether patents should be considered in the iGEM project. Participant A had never even considered patents, Participant B would look for a compromise between open source and patents, Participant C has given it some thought, but feels it’s not the team’s responsibility. [table not present]

Table 4.2 shows the different approaches the different participants of the TU Delft team have. Some think that in an open source setting, no patents can be granted. Others don’t think patents are related to open source, because no really useful or commercializable products are developed anyway. Others state that “in the spirit of iGEM”, patents are not to be considered, because the goal of iGEM is to participate in a scientific project, not in a project resulting in something that is to be commercialized. Others had not considered patents at all or do not know what they really mean. The question then is, whether patents and, highly related, the commercialization of products are to be considered within the project. Some state that patents are important to consider in research, others state it is too early to start thinking about patents. Some state that commercialization in an early phase of development is to be considered in design; others state it is too early for that. Within the iGEM project, taking into account commercialization and patents is not a prerequisite. Still, when thinking about commercialization and patents, it may be interesting to see what the relation between open source and the (practical) usefulness of the developed applications is. The opinions of the TU Delft team members can be very different, as is indicated in Table 4.3 below.

Table 4.3: Answers of two different participants to the question whether open source synthetic biology would result in more useful applications or more fundamental scientific knowledge. Two different approaches yield two different outcomes: participant A thinks more fundamental knowledge will be generated, participant B thinks more useful products will be developed. [table not present]

The table above shows that participants have very different opinions. Two general lines of thought are observed. The first (as indicated by Participant A) gives research pressure a central role, stating less pressure in open source generates less pressure for useful applications. The second gives the transparency of research in open source the central role, stating that one person is never as smart as all the rest, and that different viewpoints can result in many useful applications.

But what if the developed application could be so successful (from a commercial point of view), that enormous amount of money could be made. Chapter 3.9 also reviewed the role of real “cash cows” in open source science. On this topic, the participants also have very different opinions. Would the team still be able to participate in iGEM? See Table 4.4 below.

Table 4.4: Answer of three different participants to the question whether or not the TU Delft team should still participate if an application was discovered that could metaphorically turn lead into gold. Participant A states that the science is most important not making money, participant B isn’t sure, participant C thinks that the team should not submit it to iGEM and go for personal gain. [table not present]

The table shows that participants have different opinions on participating if a product is developed that could generate large amounts of money, with different moral approaches. One team member thinks the science is most important, and would still participate. Another states that the team should not participate anymore and go for personal gain. The third participant isn’t sure.

4.4.5 Question 5 – Value sensitive design

In the fifth question of the questionnaire, the value sensitive design session (see Chapter 4.2) played a central role. In this session, the values of transparency, usefulness, security and safety came forward was minimal moral values to consider in design. But to what extent do these values really come back in the project? Which values do the team members think are important? Regarding transparency, all participants think this is important to consider. Of course, participating in iGEM implies that the teams are 100% transparent on what they do, by publications on a website. But regarding the other values that were considered important, different participants have different opinions. For example, relating to usefulness of the application: see Table 4.5.

Table 4.5: Answer to the question how important the participants think the value “usefulness” really is. Participant A feels generating knowledge is more important than making a useful application. Participants B and C think that more focus on usefulness should have played a more important role. [table not present]

The table above shows that some participants think it is important to consider the application and the usefulness on the application, even in early stages of design. Others think that the group should focus on the knowledge (science) related to the application, and consider usefulness of the application later. Yet still, applications are not something that is considered into much detail or with very much attention in early stages of design, i.e. before testing functionality of the application.

Table 4.6: Questions and answers related to sustainability and safety. Both values are expected to play a more important role, while this is currently not the case. [table not present]

Than the value of sustainability: almost instantly the participants state that they think sustainability is a very important value to consider. However, when asked what exactly is sustainable about the developed application, the participants have to conclude that sustainability is not very relevant. The biothermometer is not considered to be a highly sustainable development, while sustainability was a key value to consider in design. Also see Table 4.6 (participant A) for a reason why sustainability should not be included in the project at this moment. Still, none of the participants commented that the application may contribute to sustainable applications in the future. In that sense, the innovative value of the biothermometer is a sustainable component.

Safety and security were also components to consider in design. These values come back in Question 6 (next section) on the scientific risks and further ethical considerations within iGEM. Most participants feel that safety and security are important to consider, but how this is currently happening, the participants also don’t know, like was the case for sustainability. When asked how the application could be made safer for the environment or more secure in use or for misuse, the participants don’t really have an answer ready. They do think it is something to consider in e.g. a dedicated meeting. The participants also feel that it may be too early to consider these issues now, because no functional apparatus has been developed yet. Also see Table 4.6 (participant B) for a line of thought that indicates the importance of taking these values into account, but that this should be done in a later stage.

Summarizing: the value sensitive design session did not really result in a value sensitive design in the sense that the indicated values come back in the eventual application. The participants do think these values are important to consider, but not in this early a stage in development. When applications can become more realistic to achieve, it is the right moment to consider the values of sustainability, safety and security. Apparently there is a difference between the phase of conceptual design and the implementation phase. The team members recognize that the values are placed in the back in this project. It seems very easy to just forget about them and start doing more fundamental science. Also, in developing the application, perhaps new values to consider may arise. This is an issue that has not been considered in this questionnaire.

4.4.6 Question 6 – Ethical risk evaluation

In a way, ethical concerns can be considered as risks, and taking risks into account can be an ethical consideration. In the sixth question of the survey it was investigated where the participants see risks or have (ethical) concerns in synthetic biology in general or in participating in the iGEM project specifically. Ethical considerations in synthetic biology were given in Chapter 3.4. They relate to biosafety and biosecurity, naturalness and artificial life, and intellectual property issues. So which thoughts do participants of the TU Delft iGEM team have in terms of risks and in terms of ethical considerations? In Table 4.7 some the thoughts on risks are indicated.

Table 4.7: Answers to the question which scientific risks the participants see in the iGEM project. Particpant A, who doesn’t have a background in biotechnology, looks at risks in the scientific outcome of the project. Participant B, who does have a background in biotechnology, also involves societal effects and recognizes the danger in genetic engineering in general. [table not present]

The table above indicates the difference in approach of synthetic biology that biotechnologists and non-biotechnologists have. The team members without a background in biotechnology relate the risks purely to scientific outcome of the project: that the product doesn’t behave in the way it was predicted to do. Participants schooled in biotechnology perceive risks related to societal issues: biosafety and biosecurity are indicated as major risks. One may wonder whether the same may be observed for ethical considerations in iGEM. Table 4.8 indicates the approaches of different participants.

Table 4.8: Answers to the question which ethical considerations play a prominent role in synthetic biology. Participant A, who doesn’t have a background in biotechnology, seems to be unsure of what the ethical considerations are, but does seem to recognize some problems. Participants B, C and D do have a background in biotechnology, but see different ethical considerations that need consideration. Participant B wonders whether genetic engineering should be the solution to every problem. Participant C feels public opinion is important to consider. Participant D doesn’t have any particular concerns. [table not present]

The table above shows that different participants have different opinions. As was the case for risk perception, the participants not schooled in biotechnology approach the question in a more shallow way, and more questions are needed to learn the participant’s opinion. Still, without knowing the details, the issue of naturalness is recognized. The participants with a background in biotechnology answer the question more directly, but have different ideas on what the most important in synthetic biology. Some seem to have no concerns whatsoever (other than technological risks, as indicated in Table 4.7), others have concerns relating to naturalness or intellectual property rights, sometimes also taking into account also public attitude towards genetic engineering.

The question now is how ethical considerations should play a role in design. Question 5 (Chapter 4.4.5) already indicated the importance of some ethical considerations and how these play their part in the project. But what about the role of ethicists in science? Table 4.9 shows the answer to the question how the participants see ethicists play a role in biological product design.

Table 4.9: Answers to the question on how the participants see ethicists and scientists come together. Participant A feels that scientists have to think about ethical issues by themselves, while Participant B feels they should be stimulated to do so. [table not present]

The participants all conclude that ethicists and scientists should work together in some way. Yet the table above shows two opposite opinions two participants seem to have. One states that scientists should be stimulated to take ethics into account by direct stimulus of ethicists. The other states that this “knocking on the door” of ethicists is not the right approach, but feels that scientists should take ethical considerations into account all by themselves. This particular participant did nonetheless recognize that it is hard for scientists to let ethical considerations form direct constraints on their research setup or product design.

One may argue that taking into account ethical considerations or risk assessment in product design, also makes sure that when a real product is developed, it can be commercialized safely. The question that arises then, is whether commercialization should be a goal in itself, or that taking into account these ethical issues or risks is a goal in product design, without it being related to commercialization. The question whether or not commercialization should have a focus in design, was already asked in Question 4 (Chapter 4.4.4) in a different context, but is asked again in Question 6. The answers are indicated in Table 4.10.

Table 4.10: Answers to the question whether commercialization should be taken into account in design in iGEM. Participant A states that commercialization should be considered in design, but also states that within the iGEM project, commercializing an end product is not a goal. Participant B states that commercialization doesn’t always have to be considered, but issues of safety and security should. Participant C states that commercialization should be considered, but also indicates that he/she isn’t interested in this goal and also thinks there is a difference between developing an application and commercializing it. [table not present]

The table above indicates different approaches towards commercialization. The answers indicate that the participants are somewhat unsure about whether or not commercialization should be a goal in itself. Implicitly they recognize the difference between general synthetic biology product design and participation in the iGEM project. Within the project, commercialization is not an obligatory goal, and hence it should not have a great focus in design. Still, participants have different approaches. One thinks that in early phases of design you already decide whether or not your product is going to be deliberately released into the environment, and hence when you commercialize this product, this release is to be taken into account. Another participant states that commercialization should perhaps have a focus, but this is not his/her particular interest: the science is. Also it is indicated that making an application is different from commercializing. “Usefulness” and “application” are highly entwined, while “usefulness” and “commercialization” or “application” and “commercialization” are not necessarily related. Another participant indicated that commercialization is not always a goal, but this is no excuse to think about other values like safety and security. Hence: application by value sensitive design and commercialization are not necessarily related.

4.4.7 Question 7 – Naturalness and genetic engineering

The seventh question of the interviews relates to what the participants think is to be allowed or not allowed in genetic engineering. Where do they draw the line? Table 4.11 shows the different approaches the participants have towards host and source organisms in genetic engineering. Within the project, the host organism is a bacterium. The restrictions the participants feel on the organism that the genes come from, are indicated in the left column, the restrictions the team members have for the host organism (where the genes can go into) are indicated on the right.

Table 4.11: impression of what is allowed or not allowed according to various participants, distilled from interviews. Differentiated between originally biotechnology schooled vs. not originally biotechnology schooled. [table not present]

The table above indicates that for the source organism, the participants do not really have any constraints. Some indicated specifically that they do not want to use genes that have known harmful effects, like would be the case for e.g. pathogenic gene combinations. Only one participant indicated that he/she has a problem with using human genes in research.

The restrictions the team members have for the host organism are actually quite various. No obvious differences in opinion could be observed between people with or without a background in biotechnology or between supervisors and students. Apparently the restrictions are very personal within the group. The participants without a background in biotechnology do, however, needed slightly more time to come up with an answer and sounded a little uncertain, while the participants with a background in biotechnology had their answers ready and were quite certain.

Also, the team members recognize that members of the general public may have constraints on what they think is technologically possible. Religion or environmental concerns are given as reasons for people to reject genetic engineering. On the other hand, all participants indicate that the people in their direct environment (family and friends) do not have particular concerns about genetic modification after the participants inform them of the possibilities and benefits.

4.4.8 Question 8 – Misuse in iGEM

The eighth question of the survey focused on misuse of the developed application. A distinction is made between unintentional misuse (error) and intentional misuse (terror) and the responsibility of the researchers in safety and security issues. The participants were asked where they see chances for errors or terrors in use and development. See Table 4.12.

Table 4.12: Answers of participants to questions relating to safety and security. Participants A and B were asked which errors may be expected, and answer in relation to different topics. Participant A (biotechnology schooled) relates errors to the open source character of iGEM, participant B (not schooled in biotechnology) is very application focussed. Participants C and D were asked what can be done to prevent misuse. Participant C thinks the team can actively try to prevent misuse, while participant C feels that this is not the case. [table not present]

The table above shows that participants have very different attitudes towards safety and security within the project. Typically, non-biotechnology schooled participants relate their answers to the question on where errors and terrors may be encountered, directly to the science of the application, e.g. that the application doesn’t work properly. The participants schooled in biotechnology relate their answers not directly to the application: they see errors in the open source setup, mistakes in the work by using e.g. unknown pathogenic combinations of genes.

When asked which terrorist actions could be done with the application the team develops, the terrorist application the participants think of, rely on the temperature sensitive switching ability of the used RNA structure. A temperature sensitive switch could be used to activate any kind of application, all sorts of applications could be imagined by the participants . The colour output is not expected to have any potentially harmless effects. But do the participants think these (un)intentional misuses can be prevented? The table above also shows two opposing answers. Some participants state that the team could actively try to prevent misuse (it is not further specified how this would be possible), other participants state that this is not possible. But is the team also responsible for the safety and security of the application? This question was also asked in the survey, see Table 4.13.

Table 4.13: Answer of participants to the question who should be responsible for the safety/security of the potential application the team is going to develop. Participant A thinks that the team is. Participant B states that the developers should limit misuse possibilities. Participant C said that besides the team, the biological safety officer of the involved laboratory is. Participant D feels that responsibility ends when someone else starts to use the application. [table not present]

The table above shows that participants have different opinions on who is to be responsible for the safety of the developed application. Some participants state that the team is always responsible, some say that it is the team’s responsibility to develop a safe application in a safe way, but that the user of the developed application is afterwards. Others state that the responsibility lies with the involved laboratory’s biological safety officer, and also another stated that the organizers of iGEM should be. But the question of who is responsible for safety of the application is somewhat different than the question who should decide if the developed application is safe. Responsibility for this decision lies with different people, according to the participants. See Table 4.14.

Table 4.14: Answer of participants to the question who should decide whether or not the application is safe. Participant A states the team is responsible, participant B states the iGEM organizers are, participant C states the user is responsible. [table not present]

The table shows that participants have different opinions on who should decide the application is safe. Some say that the team itself should be, but others recognize that one would be biased to judge one’s own application on safety. Others state that the iGEM organization should be responsible, others don’t know. Apparently this is a topic the participants did not really consider before asking the question, since all participants did need some time to think about their answers and seemed somewhat unsure in their response.

4.4.9 Question 9 – The scientist’s responsibilities

The ninth question of the questionnaire focuses on the scientist’s responsibility as a researcher. The participants were asked what they think their responsibilities are towards science and the scientific community, their supervisors, society and the general public specifically. All participants answer differently to the questions. Very different approaches are observed, but generally, when asked what their ideas are on science communication and their responsibilities in this communication, they answer that for them, science communication is towards the public. This quite open question can be interpreted in multiple ways, to it is interesting to see that the participants all focus on the public specifically. See Table 4.15 below for different ideas on what these responsibilities may be.

Table 4.15: Answer to the question what the participant’s ideas are on science communication and where they have responsibilities in that. Participants below both focus on their responsibility towards the public. Participant A focuses on why you are doing the research, explaining your long term goals. Participant B focuses on gaining trust by explaining what your are doing and making sure that what you do would not harm the public. [table not present]

Table 4.15 shows that two different participants have a different idea on science communication towards the public. One would say that explaining your goals is most important, while the other states that explaining exactly what you are doing will earn most trust. Implicitly also the first participant recognizes that science communication towards the public is a trust issue. Of course, one may question whether communication to the public is even a responsibility for scientists, so debate on how to communicate may even be redundant. It may even be debated whether or not communication towards the public is purely a scientific responsibility: see Table 4.16 below.

Table 4.16: Answer to the question what the participant’s ideas are on their responsibilities towards the public. Participant A states that communication towards the public should focus on safety. Participant B indicates that responsibility towards the public is not purely a scientist’s responsibility, but a responsibility you have as a human being. [table not present]

Table 4.16 shows two different approaches in responsibility towards the public. Most participants answer that their responsibility as a scientist towards the public relates to explaining what they are doing and why they are doing that, and to make sure that what they do is safe. One participant answered that this is not purely a scientist’s responsibility, but that everyone has a certain responsibility towards the public. It is always your responsibility to validate what you are doing, in whatever profession you are active.

4.4.10 Question 10 – Evaluation

The tenth question reviews the questionnaire. It appears that all participants could think of at least one issue they had not considered in this questionnaire. This indicates that one of the goals of the questionnaire, to make people aware of the ethical issues in synthetic biology, was achieved. Especially issues relating to intellectual property and commercialization in an open source environment were things to reflect upon that were new for the participants.

Also, most participants indicated that there was at least one issue mentioned in the questionnaire of which they think it should have had more attention in project design. Especially the usefulness and application were things that need more consideration. Still, participants realize that at the moment that this report is written, the group is still in the early phases of design. According to most participants, focus should be on developing a working application. Afterwards, other issues relating to intellectual property, safety, security and perhaps commercialization should be considered.

Another question in this evaluation regarded the participant’s preference for either the thermometer’s input or output system: the input system that is used relies on RNA structures, of which the functionality is unknown, also in literature. The output system relies on well documented research, with known functionality. The question was asked which of the two had the participant’s preference. All but one participant indicated that the more fundamental research on the RNA structure input had their preference.

4.4.11 Survey summary

It appears that all participants have different reasons for participating, but the most heard argument was to participate in a “fun” project. The participants without a background in biotechnology had the additional goal to learn about biological principles. Biotechnology schooled participants did not state they wanted to learn about other related fields of research, like computer modelling of biological systems.

Participants have different ideas towards the relation between open source in iGEM and concepts of usefulness and commercialization. Some feel that open source enhances usefulness of the things that are published in the open source database, other feel that usefulness is not enhanced in open source. Some feel that more commercializable products are developed, others think less. Different opinions are observed to base their opinions on.

Participants have different opinions on whether or not commercialization related issues (economic issues, issues related to market introduction, relating to safety and security, etc.) are to be considered in this project. Some state that it is always necessary to think about commercialization of the product, others feel that it is not a goal in the project. However, these issues are not necessarily concerning commercialization, but other values can be considered, like usefulness, safety, security, transparency.

These values were also mentioned in the value sensitive design session that was held in the very early stages of design. They were considered important to take into account, but in general conclusion, most participants feel that it is currently too early in design to consider issues like safety, security, sustainability and commercializability. First the focus should be on making a functional application. Later, other values can be considered.

The participants recognize different risks and ethical considerations in synthetic biology. Biosafety and biosecurity were mentioned as prominent risks. Ethical considerations were more various, but generally related to naturalness and in which instances genetic engineering should be applied. All participants indicate that a certain cooperation between ethicists and scientists is needed to incorporate value sensitive design or ethical decision making in scientific projects.

The idea on what is or is not allowed in scientific processes in terms of genetic engineering is a subject on which all participants have different opinions. As long as the team is working safely and responsibly, with bacterial cells, generally no moral restrictions are mentioned. All participants do realize that there are groups of people in the general public that may oppose the use of genetic engineering, based on various reasons like religious reasons or environmental concerns.

In terms of misuse, a differentiation can be made between errors and terrors. The team members realize that there is a certain chance of error, but the risk can be minimized by working by the rules of the laboratory. Regarding erroneous applications, the participants feel that it is only to a certain extent the team’s own responsibility to make a safe application in an open source environment. The eventual user of the produced BioBricks is responsible for proper use, as long as a safe product is delivered by the team. What this implies in technological terms is somewhat unsure: to what extent bioterror can be prevented in a BioBrick is probably unknown.

The participants all feel responsible in some way in science communication. Most participants relate science communication to interaction with the public. Demonstrating to the public what they are doing and why they are doing it is mentioned as being important.

Also, in the survey, all participants mentioned that there was at least one issue they had not considered before. In that sense, the interview has stimulated them to think about the ethical issues in synthetic biology, which was a goal of the survey as mentioned in the introduction of this report.

• [http://www.dsm.com   ]
• [http://www.kluyvercentre.nl   ]
• [http://www.bn.tudelft.nl   ]
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