Team:TUDelft/Ethics conclusions

=Conclusions & Executive summary=

Executive summary: see below

Full report: Click this [[Media:TUDelft_iGEM_Ethics_StevenF.pdf|link]]

In this chapter the results of the study will be summarized, conclusions will be drawn from the findings and the goals of the project will be further discussed. In addition, future research and the value of the information of this report to the iGEM organizers will be suggested.

6.1	Research summary
Since the reintroduction of the term “synthetic biology” a simultaneous effort has been made by social scientists and natural scientists to make synthetic biology a success. There is still a long road ahead, but at the least, the ethical issues that play a role in synthetic biology research and product development have been recognized and are currently being thought over. The key ethical issues in synthetic biology regard biosafety, biosecurity, naturalness concepts and intellectual property rights.

Over the past decades, biology has stated to become an engineering study and with the introduction of synthetic biology in 2005, this process accelerated. Students from different disciplines can currently contribute to scientific research in an open source setting, in the synthetic biology student competition called “iGEM”. In this report, the ethical considerations that play a role in this project were investigated and the ideas the students and supervisors of the 2008 TU Delft team on the related ethical concepts have been investigated. For this investigation, a semi structured questionnaire was developed by which the participants were inquired. It appears that ethical considerations play a role at different levels in this project. It starts with implicit assumptions on what is possible with the technology from a moral point of view, even before the project has started: first, the participants have to decide to participate. At the start of the project, a value sensitive design session was held in collaboration with the TU Delft’s Philosophy department. Values that appeared to be found important (biosecurity, transparency, safety, usefulness) show similarities with what is found important in synthetic biology ethics literature. This indicates that the team is already quite aware of the issues that may play in biotechnology research.

During the project, several ethical considerations the participants have came forward. Decisions on the biological parts used, designed and tested; ideas on the application areas, the use of recombinant DNA techniques, all are related to ethical points of view of the participants. But still, not a single general opinion could be distilled from the participants. There are clashes in scientific approach, being either fundamental or more applied. The values that were to play a role are judged on importance differently by all participants. Team members have different ideas on responsibilities towards the public, the scientific community, etc. in terms of safety, security and transparency.

It also appears that during the project, it turns out to be difficult to take all the values or ethical considerations into account. It appears that the participants feel that different issues play a role in different stages of design. Once an application is produced, the issues as proposed for synthetic biology can play a role, according to most participants, but also in design phases, thinking about applications is already necessary. A related risk/benefit analysis is currently perceived as necessary, but still lacking.

The standardization concept through the BioBrick idea in synthetic biology also experiences some resistance. Some say that biology is to complex to be standardized. Other state that the open source BioBrick approach will never generate successful products, because in the capitalist system we live in, personal gain will always be involved and hence the good products will not be added to the registry of standard biological parts.

It was also argued that currently science is already highly conceptualized: in design, concepts for proving principles are stated, which are said to be very easy. But as it appears later, testing methods have to be customized to the application that is being developed, which also means that the concepts are not as easy as is sometimes perceived. Also, in development, scientists must be aware that during the research project, practical or efficiency based decisions will not overrule ethical principles as previously assessed in value sensitive design.

6.2	Project goals
The goals of this study were twofold. The first was to investigate the ethical issues in the iGEM project, and the second to investigate the TU Delft participants’ opinions on these ethical issues and to increase awareness about these issues. This report summarized the ethical considerations in participating in iGEM and discusses several issues relating to open source novel biotechnology research. The participant’s opinions were monitored by means of a questionnaire. All participants answered that issues had been brought up that they had not considered earlier, so in that sense increasing awareness on the relevant ethical issues has also succeeded.

6.3	Further research
The research for this report was finished by September 2008. However, the iGEM project still continues until November 2008. During the final months, topics relating to some ethical principle in the project will be discussed in weekly meetings, to keep letting the participants think about the relevant societal implications of the work that is being done. These group reflections can contribute to generating further awareness of the societal issues that play, of the role of ethics in science in different phases of development, and also to the way the scientists can “sell” their research. Especially this last contribution of thinking about ethics is sometimes forgotten: by thinking about the issues in relation to the public, it becomes easier for the scientists to talk about the science of their research, to articulate their motives and to describe what their research means to society.

But there are also other things that can be done with the data in this report. It can be the basis of a modern case study in ethics education in the field of biotechnology: the moral dilemmas the participants experience, relate to real life, modern biotechnology research, something perhaps currently missing in science education.

The synthetic biology case may also be discussed in other research groups, or perhaps in a “science café” setting, to make researchers aware of the ethical issues that play in modern biotechnology research, with “biology” becoming more and more “synthetic”. This case can be interesting and challenging for researchers, with the different opinions of scientists so clearly stated.

In addition, this report can be the basis for improving the relation between considering ethics and considering science in the iGEM project. See the next paragraph for a summary on the possibilities for the iGEM competition organizers.

6.4 iGEM recommendations
This final paragraph of the report suggests how the information of this report might contribute to the iGEM competition. These suggestions relate to value sensitive design incorporation, competition goals, liability cases, etc. See the list below for a number of suggestions:
 * Generally scientists start to realize that ethics should be a part of science research. When the research can have great impact on society or poses several moral challenges, as is the case in synthetic biology research, especially in an open source setting, this should be the case. Perhaps these ethical considerations should not be a gold medal requirement, but a minimal requirement, as is the case for modern research. This report could perhaps be a basis for an ethical checklist, before the project has started, once the project is starting, during the project and afterwards.
 * Value sensitive design sessions were appreciated by all team members. These sessions ensure (when someone in the team makes sure of it) that these values are considered during the project. This report can be the basis of a value sensitive design brainstorming session or checklist for future iGEM teams. Perhaps value sensitive design sessions should even be a medal requirement.
 * Also, all iGEM teams may benefit from experiencing value sensitive design sessions and thinking about moral issues. Thinking about ethics in the project ensures thinking about the potential impact on society, helps scientists articulate their motives and generally helps scientists understand ethical concerns, which contributes to more fruitful public engagement strategies, also on small scale (i.e. family and friends).
 * Within the project, it is currently unclear whether the focus should be on application or on fundamental science. It is understandable that the iGEM organization doesn’t want to focus on either of these (to let teams decide by themselves), but one has to consider how “real” science (and not an undergraduate student project) is conducted and how grants are obtained. Being clear about your goals, and explaining the contribution the research has to society (or company interest) is becoming more and more important. The focus of iGEM is for a large part on experiencing the real scientific culture: teams have to arrange their own labs, get their own permits, etc. But from the iGEM competition organizers, a little more steering could be given in terms of clearly setting goals. There are “best area” prizes for the best application in a certain research area, but this is not the same as setting clear goals in a project summary. Perhaps protocols can be developed with the help of this report to let teams think about their goals and make sure that all noses within the team are in the same direction. For example, that certain team members perceive the project as fundamental, while other see it as applied, as was the case in the TU Delft team.
 * This also means that the way in which iGEM is currently perceived (“building with biology” in a student competition) may be unjustifiable from a moral point of view: it is not fully an “applied science” project, but in many instances a fundamental science project. Teams start off with ambitious ideas, but along the way most of them realise that fundamental knowledge is needed.
 * Moreover, the iGEM website main page should perhaps indicate what iGEM is, and which goals there are for the competition. Currently, the iGEM goals are only defined on the iGEM wikipedia site . The goals are to find out whether biological systems can be standardized, to enable systematic engineering of biology, to promote open source engineering of biology and to help construct a society that can productively apply biological technology. But especially for this last goal it is unclear as to how the organization tries to achieve this. In fact, no active effort can probably be demonstrated. But still, if this is a goal of the iGEM competition, thinking about societal issues should be a requirement for all teams.
 * Some participants of the TU Delft team state that the iGEM organizers are (at least partially) responsible for misuse and safety. Yet the organizers of iGEM send DNA around, and some people feel that the senders are responsible for the safety and security of parts. Others again state that the laboratory where the research is conducted should be held responsible, others state the team itself is responsible. Nevertheless, clarity on liability issues (relating to safety and intellectual property, see below) from the iGEM organization, e.g. on the iGEM website, would be appreciated.
 * Uncertainties are also observed in intellectual property issues. Currently, the only link to e.g. intellectual property rights on DNA can be found on the Help:Standardization website, stating that “We recommend getting your gene synthesized, but be forewarned, this can be a costly process with issues about intellectual property (more on this later...)”. One might think that the iGEM organization deliberately doesn’t mention its opinions (or the rules) on intellectual property rights. Nonetheless, apparently it is working out for the organization, since no legal cases regarding iGEM have been observed.

=Executive summary=

This report discusses ethical considerations within the iGEM open source synthetic biology student competition. The goal of this study is to investigate the ethical issues that play in this student competition, and to make the participants aware of these issues and investigating their opinions on these issues. A literature survey was carried out to investigate the ethical issues that play in open source synthetic biology. Subsequently a questionnaire was developed by which participants of the TU Delft 2008 iGEM team were inquired, to learn their opinions.

It appears that currently, what is meant by “synthetic biology” is still somewhat unclear: different stakeholders have different definitions. At the least it can be stated that it takes recombinant DNA techniques to the extreme: completely new systems may be built. But currently most research carried out in the area of synthetic biology is not as synthetic as it may be in the future.

The four major ethical issues in open source synthetic biology that are proposed in literature comprise biosafety (for users, producers, the environment, etc.), biosecurity (no intentional or unintentional misuse), naturalness (the artificialness of “life” or living systems), and intellectual property rights (relating to open source knowledge and patents).

Before the opinions of the TU Delft 2008 iGEM team are described, one should first realize which implicit assumptions (on what synthetic biology may mean) are also made in participating in a science project where students from several disciplines are working on. Participants working in areas other than biotechnology are initially unaware of any ethical issues that already play in biotechnology: issues relating to public resistance, trust between stakeholders, naturalness or artificialness, religion and biotechnology, gut-feelings in this area, globalization, etc.

When starting the iGEM project, the students and supervisors brainstormed on possible ideas and project requirements. Meetings with experts from the TU Delft’s Biotechnology department were held, to further select topics of interest. In addition, a value sensitive design session was held, in which the values to take into account during the project were assessed. These values were safety, security, usefulness and transparency of data; these values overlap with ethical issues defined in literature to some extent. In the end, the biothermometer project was selected from a number of alternatives.

In the semi structured questionnaire, questions were asked regarding reasons for participation, open source technology, values and value sensitive design, risks and ethical considerations, and regarding naturalness, misuse and responsibility specifically. Differences in opinions on these and more topics were observed: between all participants, between supervisors and students, between those schooled in biotechnology and those not schooled in biotechnology.

It appears that participants have very dissimilar opinions on the way they think open source relates to usefulness and commercialization. Some say it stimulates, some say it inhibits. In literature, experts also warn that probably very few valuable (in terms of money) applications will be developed, and that the relation between patenting and open source is difficult. When asked whether or not the participants would quit the project when an application was developed that could metaphorically turn gold into lead, also very different approaches were observed: some would quit for various reasons, others would continue. It appears that moral values are very dissimilar or even contradictory among the participants, probably much reflecting “public opinion” itself.

Also the participants feel that they have very different responsibilities in safety, security and transparency towards the users of the developed application and towards society in general. Some feel the team should actively try to prevent misuse and guarantee safety (but do not specify how this should be done), others state that this cannot be the team’s responsibility.

Relating to both responsibilities and the attitude towards open source, some state that the iGEM competition is currently for the TU Delft team not about developing an application (as assessed in the project requirements initially), but about doing fundamental science. It appears that participants have different expectations towards the outcome of the project. Yet in the fundamental scientific approach, less moral values seem to play a part: science becomes science “because we can”, and does not take into account the moral values that would play if the team would be developing an application for society. Apparently, different stages in development are to be distinguished. Some state it is currently too early to consider usefulness or commercialization or risks in production, because first a working system has to be developed. Others state that in designing a working system, already crucial decisions on end use are made, so in design the relevant values need to be considered. In that sense, the persons with a more fundamental approach generally attribute less value to value sensitive designing than the more application oriented participants. This is also reflected in their attitude towards personal responsibility towards society: “fundamentalists” feel less responsible.

The outcome of the survey may be used to identify some topics on which the iGEM competition may be improved. For example, value sensitive design sessions were appreciated by all team members. Perhaps these value sensitive design sessions are to be obligatory for iGEM participation, and not just as a “gold medal requirement”: making students aware of the implications of their research also means that they can understand public concerns, and take these concerns into account when talking about their work, resulting in a more clear description of what they are doing, and moreover, why that is necessary.

Also, regarding the responsibilities of the teams towards safety and security, the responsibilities of the iGEM competition organizers (who send around DNA) remain somewhat unclear. Some state the organizers should be clear on their responsibilities. It can be understandable, nonetheless, that iGEM doesn’t want to consider this, since it is a student project and students are not responsible, but their supervisors. Still, it should be clear beforehand where the responsibilities lie.

The same may hold for the position of iGEM on intellectual property rights. Teams can send in any DNA sequence they like, and are expected to check for patent infringement, but at the moment it is unclear who is ultimately responsible for checking any infringement of patents on these sequences: the infringement isn’t centrally (re)investigated by iGEM.

As stated above, the goals of this study were to identify ethics in iGEM and to investigate the TU Delft 2008 participants’ opinions on the relevant ethical issues and making them more aware of the issues that play. These goals were achieved, but more can be done with the data. As also stated above, some suggestions for the iGEM competition organizers are made. Also, the data may be used as a case study in ethics and technology education, in discussion within biotechnology research groups, etc. Also, it might be used as a study to help improve integration of ethics in science.

In short, it appears that synthetic biology holds many applications with many benefits for society in the future, but we must not forget the ethical considerations regarding the factual risks as can be scientifically assessed and the perceived risk in public concerns. We can be optimistic, but the open source approach also holds some drawbacks and relies on moral values that may not be present in every person’s moral palette. This study, “Life to Lego, SynthEthics in the iGEM project” reflects upon the relevant ethical considerations with interesting results.