Final Report Summary - SYNTH-ETHICS (Ethical and regulatory challenges raised by synthetic biology)
Executive summary
The SYNTH-ETHICS project aimed to address the ethical, legal and social implications of the emerging field of synthetic biology (SB). It focused on biosafety, biosecurity and notions of life. The project set out with an assessment of relevant ethical issues, a task that was conducted in close collaboration with the SB community. Next, the emergent public debates over these issues were analysed. An analysis was conducted of current ethical and regulative frameworks that are applicable on SB by making comparisons to closely related fields like nanobiotechnology and genetic engineering. The extent to which existing regulations can deal adequately with existing and newly emerging ethical issues in SB was assessed and on that basis, challenges for current regulatory and ethical frameworks were identified and recommendations for dealing with these challenges were defined. These were specifically targeted at three relevant groups: the SB community, European Union (EU) policymaker and non-governmental organisations (NGOs)/the public.
An important experience that was drawn from the project is that a mapping of the ethical, legal and social issues connected SB is different from assessing such issues in for example neurology, since most research conducted in SB finds itself in a pre-application phase. This demands a different approach, since the vocabulary in which SB is discussed is ever-changing and therefore identification of the connected ethical, social and legal issues is difficult. Currently, patents play an important role in how scientific research and technology innovation are thought to be motivated. This also goes for SB. However, rewarding intellectual achievement through patents is showing an increasing number of flaws. In theory, financial compensation and profit seem to be self-evident motivators for innovation, but in practice it seems that certain innovations are not in the interest of large patent holders. Ethical technology assessments often miss out on this design-flaw of the patent system.
The project positioned itself at the intersection of ethics, technology assessment. Foresight, law, new technologies and expertise from all relevant fields were included in the project team. The project built on insights and discussions from other fields such as biotechnology and nanotechnology. It also assessed which aspects of SB might give rise to ethical problems of a different nature, specific to the field. It contributed to a more adequate and broadly applicable approach to ethical aspects of new technology. Traditionally, much of the ethical debate on emerging science and technology focuses on risk assessment, which leads to restrictive governance. The ethical assessment of science and technology therefore misses out in contributing to a positive shaping of science and technology. The project contributed to a common understanding of SB and the ethical, legal and social issues involved in EU Member States and to the shaping of a distinct European approach without ignoring discussions and developments elsewhere. Stakeholders' views have been solicited during and taken into account. The project helped to prepare for a rational and informed public dialogue on SB. It provided a sound basis for EU policymaking in the coming years, partly by cooperation with other EU-funded and international projects.
Project context and objectives
The project was targeted at analysing the ethical, social and regulatory contexts of SB as basis for advice for policy. It aimed to contribute to a common understanding of SB and the ethical, legal and social issues involved in EU Member States and to the shaping of a distinct European approach without ignoring discussions and developments elsewhere. Stakeholders' views have been solicited and taken into account. The project helped to prepare for a rational and informed public dialogue on SB. The project provided a sound basis for EU policymaking in the coming years by cooperation with other EU-funded and international projects.
The overall aim of the project was to contribute substantially to the development of a European approach to SB. For comparative reasons, the agenda-setting in the United States (US) was taken into account and analysed, although it was acknowledged that the diversity of cultures and ethics in Europe and the political specifics rule out a copy of United States approaches. To analyse the European context and define advice and recommendations we defined a proactive approach in which the specific European strengths and needs, relevant public values and strategy through which societal concerns could be identified and taken into account in the development of SB in such a way that its benefits could be better safeguarded for society while minimising social costs.
Significant contributions were made with regard to:
- a responsible development of SB in Europe with regard to ethical and societal values and with regard to the question of the importance of biosecurity; it will take into account the overall goal to profit from the benefits of SB that are most promising in the European context;
- the shaping of a European community in which expertise from all relevant fields of research is systematically integrated in a normative analysis of the developments of SB;
- the broadening of ethically relevant research and activities, in particular with regard to SB's 'dual use' and comprehensive philosophical and societal aspects;
- the facilitation of societal discourses, academic research and related networking activities, reflecting the situation in Europe while taking into account international debates.
Objectives of the project included:
- to identify actual and emerging ethical issues raised by developments in SB and the embedding of the developed technologies in society;
- to trace and analyse the public discourse on these issues;
- to analyse whether these ethical issues and the concerns raised in the public discourse can be adequately dealt with the current normative frameworks existing in SB and in closely related fields such as nano- and biotechnology genetic engineering and identify shortcomings;
- to analyse topics in SB on which EU policy and regulation might be required and to make recommendations.
The second phase of the project aimed at the translation of the findings of work packages (WPs) to different stakeholder groups and the public at large. The project objectives for the first reporting period were the following:
WP1
- Identification of ethical issues raised by SB.
- Assessment of how the European SB community is currently dealing with issues.
- Inventory of expert opinions on these issues.
- In-depth analysis of ethical issues.
- Analysis and proposals with respect to public discourse on recent, emerging and potential developments in SB.
- Identification of potential tensions between public discourse, expert opinions and the way the European SB community is dealing with ethical issues.
- In-depth analysis of public discourse on a number of specific ethical issues in relation to notions of life, conceptions of nature, problems of dual use and societal setting of application, etc.
WP2
The identification and detailed description of current normative frameworks applied to ethical issues and public discourse in SB. This includes the normative frameworks developed in SB and in neighbouring areas like nanotechnology and genetic engineering. Attention will be paid to both formal and informal rules and regulations.
WP3
WP3 contains analysis of potential gaps or shortcomings of the current normative frameworks. If gaps or shortcomings are identified, proposals on how to deal with them will be developed. WP3 also contains prospective ethical analysis of emerging or possible future issues in SB.
WP4
To identify ethical and regulatory challenges raised by SB and to formulate recommendations for relevant communities for dealing with these challenges. Public dialogue events will be designed and organised to discuss challenges in a broad public setting and validate results before we finalise the recommendations.
WP5
WP5 consists of management and coordination of the project and meeting of all deadlines and production of all deliverables for the project. Next to that the dissemination of project results to relevant target groups.
The consortium emphasises that the nature and urgency of SB governance measures depend on the epistemological status that is attributed to the field. Relevant policymaker must keep themselves informed by observing developments with the support of advisory bodies, research councils and technology assessment institutions. The scientific community should take a more active role in public discourse and stakeholder dialogue on SB and should pursue cooperation with CSOs, social scientists and ethicists. Transparency of research and a dialogue between authorities, researchers, stakeholders and the general public must be ensured in order to find out what kind of research society would prefer to see publicly funded. The consortium emphasises that it is difficult and perhaps impossible, to predict which approaches or systems in SB will result in breakthrough knowledge and technologies that are beneficial for and demanded by society. Consideration should be given to public funding of SB basic research, with originality and scientific excellence of the projects and of the scientists involved being used as decisive funding criteria. The consortium accordingly warns against tying public funding of the field to the label-SB and recommends considering that a politically fuelled hype around the label may lead to bandwagon effects and to a tactical re-labelling of less innovative, non-excellent research activities.
Project results
SB has emerged as a vibrant field of scientific inquiry with considerable potential for practical application and public benefit. Combining engineering with biology, it promises to fulfil many of the anticipated goals of nanotechnology in an easier fashion. While nanotechnology involves the development of materials and machines at the nano scale, SB builds on the insight that nature holds parts and methods for constructing machines and materials at small scales. Synthetic biologists hope to develop a set of tools, using off-the-shelf parts and methods used in biology and by developing new tools and methods to hasten the advent of various promises of nanotechnology. The project yielded important insights for other parties as well. These end-user groups are to be approached through different means and at different occasions. To be able to increase the success of dissemination, we aim to extend the cooperation of partners in the project beyond its duration. Such mutual collaborations already exist in several projects, but there are initiatives to take it beyond its current scope.
A large portion of the literature on SB and the ethics thereof is devoted to defining the boundaries of the term and field. On the overlapping field of systems biology and genomics, Powell et al. (2007) note: 'understanding how scientific activities use naming stories to achieve disciplinary status is important not only for insight into the past, but for evaluating current claims that new disciplines are emerging. The birth of a new discipline is not merely a spontaneous happening. It includes paradigmatic achievements, technological innovation and social formations. Powell suggests: further attention to disciplinary histories could, we suggest, give us richer insight into scientific development.' 'SB is an increasingly high-profile area of research that can be understood as encompassing three broad approaches towards the synthesis of living systems: DNA-based device construction, genome-driven cell engineering and protocell creation. SB is described as a meeting-point of two cultures. The first, represented by those interested in deconstructing life, dissects biological systems in search for simplified and minimal forms that will help us understand adaptation and evolution of natural processes. The second, complementary and symmetrical culture is the construction of life approach. The goal is to build systems that are inspired by biological principles and use biological or chemical components to reproduce the behaviours of live systems. The area of SB has not emerged fully out of the semantic battle over its definition proper'.
The definitions of SB sketch the field as something radically new. Does this mean we need new ethics? There are a number of recurring ethical issues in various different fields of applied ethics. These issues seem to resurface in any debate in any field of biotechnology. They include how to deal with risk, with security issues, with safety issues, how to avoid the formation of monopolies, how to safeguard local and global just distribution, how to deal with possible dual use, etc. The problem is that it reduces the analysis of potential ethical issues to a standard checklist. Although it is wise to look at issues separately, it stands in the way of a deeper ethical reflection on the social and societal consequences of a novel technology. This is pressing because different disciplines will have different societal relevance, a different place in society and different consequences and therefore need different modes of analysis. This does not mean there is no similarity between these areas. As Parens, Johnston and Moses claim: 'Particular ethical questions are more pressing in some arenas than in others'.
The questions themselves are virtually identical to the ethical questions that have arisen in the past. Failing to recognise that fact can lead to reinventing the wheel for each new technology and squandering of scarce resources. Although creating such a subfield might be in the short-term self-interest of bioethicists, in the long run further balkanization of bioethics would be a mistake. Instead of listing the ethical questions that arise over and over, we need to dig deeper. We need to test intuitions, arguments and responses developed in previous contexts against new fact patterns. There is a critical need to examine ethical implications of the new field of SB, but Hastings Centre scholars discourage the creation of a subfield of 'synthetic bioethics'. One should not merely look at what new issues are brought up by SB. One also needs to investigate in what way old issues may be altered, amplified, or diminished.
There is much debate on the unifying characteristics of SB but the diversity of its applications renders the necessity of a specific ´synth-bioethics´ unlikely and maybe even undesirable. Still, it may be desirable to look into differences with other subfields in bioethics. The trick seems to be to make use of past experiences without neglecting issues that are properly those of the field in question. A problematic issue is that its definitions do not merely describe the birth of a novel discipline. The definition process is governed by its own internal politics. Cynical voices claim that SB is not much more than selling old lamps as new ones, while more enthusiastic voices claim SB takes the vital step from being able to read the code to being able to write it and that this means SB will prove to be the genie from the old lamp. In either case, in distinguishing the field from other fields at least a specific interdisciplinary specialism is claimed and associated with SB. With regard to its areas of application this will have different consequences for every field. As was the case with nanotechnology, SB largely emanated from the US, with the EU being aware of it and contributing to the efforts, but somewhat lagging behind. The leading role of the US in SB is partly due to the fact that the concept was largely developed in the US. Some European researchers who are active in this field do not identify their work with the new label. SB builds on exiting fields and disciplinary approaches. It emerged from biotechnological research and the life sciences. It is at the intersection of biology, chemistry and physics, overlapping and cross-fertilising with a range of other fields of research and technology development. An important characteristic of SB is the wedding of biology with engineering approaches. We are currently at an early stage of SB. The applications of engineering principles to basic biological systems heralds a new era of progress. It remains difficult to synthesise anything but the smallest of organisms, most of which will be viruses. Much of the work relates to identifying the minimum set of elements within 'artificial' bacteria. This could result in a living system capable of replication. But, such a system might not be desirable.
That which is most likely to become possible is the identification of elements of organisms that have specific functions and to provide for these functions. Synthesis of DNA constitutes a crucial part of any efforts to design biological systems to perform a given function. Design in a biological context implies tinkering with DNA to achieve intended results, whether that result is a new protein or a modified process. Such artificially modified DNA then needs to be synthesised and it can then be inserted into the appropriate vector to carry out its intended function. One of the characteristics that set SB apart from other engineering disciplines is the potential to create replicable materials. Additional safeguards need to be adopted before the results of SB can be released from containment. It has proven difficult to come up with one consistent definition of SB, complicating the definition of both the ethical and the legal frameworks. In spite of this lack of a consistent definition of SB, it is increasingly perceived of as a distinct field of research and development (R&D).
An important experience that can be drawn from this project is that a mapping of the ethical, legal and social issues connected SB is different from assessing such issues in for example neurology, since most research conducted in SB is still very basic and therefore pre-application research. This demands a different approach since the vocabulary in which SB is discussed is ever-changing and therefore the connected issues find themselves on shaky ground. As brief conclusion from all WPs it can be said that traditionally, much of the ethical debate on emerging science and technology focuses on risk assessment. This automatically leads to restrictive governance of innovation in such areas. The ethical assessment of science and technology misses out in contributing to a positive shaping of science and technology.
Patents play an important role in how scientific research and technology innovation are thought to be motivated. This also goes for SB. Rewarding intellectual achievement through patents is showing an increasing number of flaws. In theory, financial compensation and profit seem to be self-evident motivators for innovation, but in practice it seems that certain innovations are not in the interest of large patent holders. Ethical technology assessments often miss out on this 'design-flaw' of the patent system. Specifically for SB, a patent system would slow down innovation. The end products of innovation are often directed at benefiting the West, while humanitarian problems in the south are more pressing. An open access system may therefore further innovation in a more productive fashion than a patent system and it may yield more beneficial products on global level. Such a shift of mentality calls for an in-depth approach of the ethical analysis of SB, one that focuses on the organic and complex nature of technology innovation.
SB has emerged recently as a vibrant field of scientific inquiry with considerable potential for practical application and public benefit. Combining engineering with biology, it promises to fulfil anticipated goals of nanotechnology in an easier fashion: while nanotechnology involves the development of materials and machines at nanoscale, SB builds on the insight that nature already holds parts and methods for constructing machines and materials at small scales. Synthetic biologists hope to develop a set of tools, using off-the-shelf parts and methods used in biology and by developing new methods, to hasten the advent of the various promises of nanotechnology. SB has received media attention and significant funding, in part due to high-profile researchers. Anticipating public and governmental anxieties about potential risks and ethical concerns, projects geared toward addressing any new or emerging ethical issues raised by SB were launched. These initiatives and inquiries focus largely on ethical issues related to biosecurity and environmental or public risks.
Much has been written concerning ethical problems raised by this new science and yet there remain gaps in the conversation. Numerous projects, colloquia and public and private inquiries into ethics and SB have focused on potential risks, both to security and safety posed as the technology advances. These concerns are among those most often referred to in popular media and about which workshops, statements and efforts to formalise safety and security procedures in the practice of SB have been directed. But another widely-discussed concern, that regarding angst about man-made life, has received less serious discussion in academic literature and policymaking. This is perhaps because scientists and scholars recognise that a certain line has already been crossed with the advent of genetic engineering and that ethical concerns that are posited to arise from SB have already been raised with genetic engineering. The public discourse on SB and its ethical implications is still in its infancy. The various segments of the discourse often appear to be unconnected. Some governance reports try to bridge the gap between the public image of SB as it is portrayed in media and the concerns in the science system and among stakeholders.
The various discourses represent societys attempt to deal with an emerging field of R&D which at the present stage still has highly visionary features and is difficult to govern. Recently, synthetic biologist Martin Fussenegger said: 'The field has had its hype phase. Now it needs to deliver'. If SB does deliver in the near future, it might be that real progress will be overshadowed by media reporting on the wilder dreams of visionary scientists and stakeholders and that in the view of the public will be dwarfed by the promises of revolutionary impacts of the field. Some of the visions appear to be highly contentious, because there is the danger that the academic discussion of the ethical aspects of SB will focus on them, leading to dominance of speculative ethics whose negative impacts on the discourse on nanotechnology and other fields have already been noticed and criticised. Systematic discourse analyses may help to prevent such a narrowing of academic discussion and to broaden the knowledge base for public dialogue activities.
Different interests and worldviews associated with technology and innovation need to be addressed and not to be dismissed as unscientific. This would need to include the worldviews of scientists and science promoters in the field. One of the next tasks of the project will be to contribute to the awareness of stakeholders with respect to SB and its ethical and societal implications. The project will be able to use and extend existing contacts with stakeholders who are already active in this area. As a preparatory step, the results of their work on SB will be analysed in detail. Moreover, the media analysis should be updated at a later stage, since recent developments suggest that the increase in articles will continue. An extension to countries other than those included in the first phase is also desirable. We expect public knowledge about SB to increase, which will allow further analyses of the publics views on the subject.
Given the experiences with related fields of R&D and application, it is important to integrate the whole range of ethical, legal and societal aspects and concerns from the start. Besides those aspects that are often termed environmental, health and safety (EHS) implications and are already focused in ongoing EU-funded research, broad ethical and philosophical aspects have to be tackled. One should take into account that SB has not only already been discussed within the context of technological convergence and with respect to other fields but is likely to raise similar fears. These aspects relate to questions that are highly relevant with regard to European value systems and the sensibilities of several stakeholders. There might be additional concerns that are specific to SB. A high quality of research in the field of ethics of new technologies, an early identification of ethical issues and foresight with respect to potential public concerns are needed. In Europe there is a wide range of ethical, philosophical and social-scientific expertise on these and related issues, but it is often dispersed and unconnected. If this expertise is not bundled, there is a danger that developments in SB might result in the repetition of shortcomings and mistakes that we have witnessed in public and political debates on other fields. Several European debates and ethical research were triggered by an agenda-setting in US R&D policy, and as a result tended to import and reproduce ethical lines of debate which emanate from the US and are often not appropriate in the European context. The same holds true for the issue of biosecurity. Europe has experienced terrorist attacks and is aware of the related threats, but political approaches differ in several ways from the US.
The promises of SB have to be assessed in view of Europes specific needs and political priorities. It will be appropriate to include scientists and philosophers from the New Member States. The reconstruction of relevant regulatory frameworks has been made by focusing on some the domains of environmental risks, biomedical applications, cosmetics regulation, intellectual property, bio-informatics, occupational health and human rights law. In shaping the legal frameworks that can be relevant for SB in each of these domains, both hard and soft law have been considered. This is regarded as a suitable method in order to enlighten the way the two types of legal norms work and interplay and how they could be improved. On the basis of the analysis that has been worked out, it can be maintained that GMOs normative frameworks is applicable to SB products and processes but a degree of specification in SB definition is required to select which parts of GMO regulation are applicable to SB and which not. For biofuels, it has been seen that EU strategy is intended to increase the use of biofuels in order to reduce the use of fossil fuel, on the assumption that this will produce economic and environmental advantages. In this sense the application of SB may be coherent with this aim, but sustainability of SB processes need to be shown.
Medical application legislation has turned out to be fragmented and partly overlapping. Fragmentation is, to a certain extent, necessary in order to adequately consider different stages of R&D and specific characteristics of different kinds of products. Effort should be made to coordinate procedures and requirements in terms of product-based and process/technology based regulation. Some critical aspects relate to international harmonisation. The role of the EU could be pivotal, both to elevate international standards of quality, safety and efficacy of biomedical products and to prevent the delocalisation of R&D of biomedical products in countries with less restrictive regulations. It is important to develop harmonised standardisation and new methods of safety evaluation for risk assessment and to collect more data about safety. The impact of intellectual property (IP) regulatory frameworks on the field of SB is the subject most addressed in literature. The overview in this report has shown how the debate is currently developing along two paths, the ethical issues limiting the access to patentability and the new model to promote innovation, using a co-existence of proprietary rights and the commons model. These paths have to be analysed separately since their basis is completely different. On one side there is the risk of ethical implication in a new field, using genes and DNA sequences. On the other side there is the insufficiency of the model of IP developed to protect mechanical inventions and the necessity to find a new complex model providing the sharing of information. Some relevant legal implications of SB in the bio-informatics domain have been discovered.
For what concerns the occupational health area it can be said that at the moment it is necessary to stick to the legislation in force on the subject of protection of health and safety in workplaces. There is a need for pursuing the highest possible protection according to the sector or to the nature of the sources of risk. R&D EU law has established the obligation to keep technologically up-to-date aimed at the criterion of the highest technologically protection possible, tempered by reasonable practicability. It is necessary to study the possibility of adopting standards and practices for single branches of application based on the single 'category' of the material handled or the product obtained the process to be carried out and in relation to the subjects involved to fix eventual thresholds of maximum exposure that will only be possible with full knowledge of the potential risk, just as the monitoring of the conditions of health of the workers or the systems of risk management should be updated in relation to scientific and technical advances. It seems that the instruments of soft law can be considered a complement of hard law in guaranteeing the uniformity of protocols and standards. Regarding the potential impact of human rights law on SB, an analysis of the international normative framework, focused on the EU level and the European Court of Justice (ECJ) jurisprudence and main instruments of the Council of Europe and the European Court of Human Rights (ECtHR) jurisprudence, has been developed. This choice is based on the premise that, due to the broadness and vagueness that tends to characterise the norms of human rights, the inquiry into the relationships between human rights law and SB needs to tackle the judicial application of the norms. The report argues that the framework of the rights enforced by ECJ is not ready to cover future trends of R&D in the SB field yet, whereas the rights guaranteed in European Convention on Human Rights (ECHR) by ECtHR are perfectly operative in this sense.
This conclusion is relevant in the light of the EU negotiating mandate to accede to ECHR, which will give to the Court of Strasbourg a role within EU legal system. This is due to the fact that in the EU law human rights may be balanced with some different values. The case law of the ECJ is clear in this regard and it is not likely to change soon. Health is not handled by ECJ jurisprudence as an individual right. The ECJ applied human rights before as principles of the EU law and as constitutional traditions common to the Member States, but it never treated health as an individual right, especially in the field of consumer safety and biotechnologies. The regulatory frameworks that can apply to SB rise in conceptual and practical issues dealing with; the meaning and concrete working of the precautionary principle, problems and challenges posed by applying norms already in force for different purposes to SB, the role of soft law and the convergence of ethical and legal principles into regulatory tools.
The way to give substance to the precautionary principle with reference to the potential developments and applications of SB turns out to be the crucial point in order to assess the suitability of the regulatory frameworks already in force for different purposes and to propose changes to frameworks or to propose the introduction of ad hoc norms. During the past decade, the problem of dual-use research, science and technology has been one of the most debated issues in discourse surrounding biological weapons and the bioterrorist threat and an especially controversial topic regarding science policy and SB in particular. The expression dual-use technology was originally used to refer to technology that could be used for both civilian and military purposes. This was a non-normative use of the expression dual use. Dual-use technology was not necessarily considered to be problematic. From the perspective of policymakers, this kind of dual-use technology could sometimes be considered a good thing. There are economic advantages to developing technologies that will simultaneously meet both a countrys civilian and its military needs. Although dual-use technologies could in some contexts be considered desirable, they could give cause for concern. A country might be reluctant to export dual-use technologies to adversary countries to which it would not ordinarily want to export weapons.
In recent years, the expression 'dual use' has most commonly been used in an explicitly normative fashion. The expression is now usually meant to refer to research, knowledge, technology or materials that can be used for both beneficial and harmful purposes. Current debates about dual use science and technology refer to science and technology that has legitimate uses but might be used by malevolent actors for nefarious purposes. The expression dual use could be applied broadly and almost everything could count as dual use. Contemporary debates about dual-use science and technology have been more narrowly circumscribed. Most of the current debate has focused on research with implications for weapons, where the consequences of malevolent use would be especially severe. There are at least three plausible definitions of dual-use science and technology: that which has both civilian and military applications, that which can be used for both beneficial and harmful purposes and that which has both beneficial and harmful purposes where the harmful purposes involve weapons. The third definition of dual use is the way dual use is most commonly used in contemporary debates about the 'dual use dilemma'. The dual-use dilemma arises when one and the same discrete piece of scientific research intentionally undertaken for good ends has the potential to be intentionally used for great evil. Accordingly, there is a primary user who creates new knowledge or designs new technology for good but there is also a secondary user who uses the knowledge or technology for some evil purpose. Many so-called dual-use dilemmas are not dilemmas in the narrow sense of being situations involving two options which are equally ethically problematic.
First, the dilemmas in question could be tri-lemmas; there could be four or five or more options all of which are equally ethically problematic. Second, the options are not equally ethically problematic. There are ethical considerations for and against each of the options, however it may well be that one of the options is morally preferable to the others and that this is relatively obvious to any rational, morally sensitive person. The point is that there are some significant moral costs associated with each of the available options. Many scientific discoveries and new technologies have dual-use potential in the trivial sense that they could be used by someone for some malevolent purpose. Any newly designed object has dual-use potential in this sense. However, it is implicit in the use of the term dual use in the academic literature that the potential harm in question is of great magnitude. Accidents involving science and technology are not dual use in our sense since there is no secondary evil user, although they may involve unethical behaviour. The dual-use dilemma is not new. When atomic physicists made key discoveries regarding atomic fission and the chain reaction they realised that these discoveries might have beneficial applications in medicine and the generation of energy, but they also realised that they might lead to the development of new, monstrously devastating weapons. If dangerous scientific information were kept secret the development and use of such weapons might be avoided.
Since the dawn of the 21st century, the dual-use potential of life sciences has become salient. In many ways, the situation of life sciences at present is similar to that of physics when atomic weapons first became possible. The biological sciences are progressing rapidly, and recent developments in biotechnology may have tremendous medical benefits. In many cases the same discoveries that may promote advancement of medicine could also facilitate production of biological weapons of mass destruction. This is partly revealed by a recent unclassified CIA document titled 'Our darker bioweapons future' which claims that recent advances in biotechnology enable the production of biological agents worse than any disease known to man. As noted by Samuel et al., concerns about dual-use life science research are especially salient in the context of synthetic life sciences. The dual-use phenomenon raises important questions about responsibilities of scientists, research institutions, the scientific community and policy makers. Responsible actors at each of these levels should aim to promote the progress of science insofar, as progress will benefit humanity. However, they should aim to avoid outcomes where developments ultimately result in more harm than good. One idea in recent debates is that we should aim for policy that strikes a balance between the goal to promote scientific progress and the goal to protect security.
There remain some obstacles to the establishment of adequate measures to deal with the dual-use problem in science and technology. A number of these stem from various perverse incentive structures that derive from collective action problems. First, in the past and the present there have been a variety of arms races in which scientists play a central role. The problem is that national self-interest is pitted against humanitys collective interest in a context in which there is no enforceable international law. Evidently nation-states cannot effectively collectively self-regulate. Second, non-military institutional incentive structures are potentially in conflict with the application of the no means to harm principle. Third, there is the possibility of the untoward consequences of scientific freeriding. Let us assume that Polanyis scientific freedom model is the best model to acquire new knowledge; those operating entirely outside the model cannot compete. Accordingly, the 'good guys' stay ahead of the 'bad guys'; the bad guys are always playing play catch-up. Contrary to this, it might be claimed that a well-qualified national cohort of bad guys can always free ride and then get ahead of good guys.
Given the potentially disastrous consequences of bioterrorist activities and the significant extent of public concern regarding this issue, the consortium recommends opting for an internationally coordinated approach in the lines of 'the more, the better'. This would include governmental responsibility on all levels and would be supplemented by a wide range of obligatory activities to be undertaken by relevant research communities. It would involve fostering an ethos-based security culture supported by specific educational and training measures. Combining a strong role of governmental institutions with wide-ranging activities within research communities should include setting new incentives to encourage individual scientists to refrain from and report dangerous and malicious activities. While the consortium agrees that advanced SB research is not attractive to bioterrorists yet, it views the emerging governance discourse as an opportunity to deal with shortcomings and gaps in existing regulations, governance frameworks and professional security cultures. In line with this stance, the consortium agrees with the view that governmental bodies should act as clearinghouses that check databases for DNA sequence requests and not as clearinghouses established solely on the basis of scientific self-regulation. Policy makers should set up external surveillance institutions to monitor dual-use research and should create specific guidelines and regulations.
Another measure could be to develop a system of security checks for personnel working in licensed laboratories. When it comes to restrictions on scientific freedom, the dangers of governmental over-regulation must be taken into account. Considerations should be made with the aid of an ethical analysis if obligations and restrictions in this area should be established. This could include obliging laboratories and researchers wishing to investigate dual-use possibilities to seek state permission to do so, bans on the publication of certain research results and granting governmental licensing authority powers that would in effect override human rights to freedom of intellectual inquiry and freedom of dissemination by only licensing government research centres.
The consortium emphasises the specific challenges facing the private sector. Because private sector research is less subject to institutional control, one might be justified in fearing that private companies may be comparatively less reluctant to pursue research with the potential for malevolent use. Another cause for concern is that private research is not generally subject to the same institutional oversight as research undertaken in universities. Consideration should be given to the merits of strengthening institutional control over private sector research. Although many recommended measures would be feasible in the Western world, a great deal of relevant work is now carried out in countries where regulations would be far more difficult to impose. It appears important to find incentives to prevent excellent scientists from defecting to research programmes whose aim is to cause harm. The consortium emphasises the role that publishers need to play when it comes to dangerous publications. Specific review processes could be established for dual-use publications.
The consortium recognises that such reviews will often be difficult in conducting with the right balance between protecting scientific freedom, promoting scientific progress and addressing biosecurity problems. Relevant institutional actors have institutional responsibilities which are also moral responsibilities. Research institutions and the relevant institutional actors in positions of authority must decide how best to monitor dual-use research taking place within their confines. Research institutions should provide guidance and consultation to researchers involved in dual-use research and those who make unexpected dual use discoveries. Students should be trained and educated about bio risks. Funding agencies should consider investing in research to explore the use of bar code technology to detect and trace the origins of genetically modified organisms. It will be difficult to effectively control future SB-weapon activities of nation states. Relevant international agreements lack compliance measures. Even if such measures existed, international control agencies would depend on collaboration with and information from national governmental agencies.
Standardised methods to evaluate safety issues need to be found and methods need to be periodically adapted to new scientific and technical developments. A framework for SB risk governance should be based on regulations that govern genetic engineering and its various areas of potential application. It should include mechanisms to control trade with specific SB items and should be in place before SB applications are released. Some amendments will have to be made to Directive 2009/41/EC in order to make it applicable to the SB field. Although providing a separate classification for activities related to SB is justified, minor adjustment may be appropriate.
The legal approach should be based on a broad definition of SB and include both soft and hard law. Soft law should be regarded as a complementary tool and should be coherent with legal principles. The instruments of soft law can be considered as a complement to hard law, increasing compliance with established principles, fostering uniformity of protocols and standards and encouraging the adoption of mechanisms that are able to accommodate the diffused nature of responsibility regarding technology development. Governments bear the ultimate institutional and moral responsibility for safety and security of citizens. Many SB regulations could for example be applied by biosafety committees operating as university-based biosafety committees. Such committees would in turn need to be accountable to the government, perhaps via an independent authority. As regards the contribution to the regulation of SB stemming from the law of human rights, it can be maintained that the framework of rights enforced by the ECJ is not ready to cover future research and development trends in the SB field, whereas the rights guaranteed in the ECHR and enforced by the ECtHR appear to be fully operative in this sense. Policy makers and scientists should be prepared and attempt to anticipate developments in SB which could constitute a challenge to the use of parent organisms as points of reference in biosafety regulations.
A combination of process-oriented and product-oriented legal approaches appears desirable. It should be considered whether existing general legislation on 'good manufacturing practice' needs to be adapted to new biotechnology manufacturing procedures. SB as a field of converging sciences and technologies in which non-biologists may increasingly be found, needs to place emphasis on biosafety training and on biosafety standards in labs. Scientific competencies as general biosafety research, ecological and biodiversity research and sustainability research should be taken into account more strongly in discourse on SB safety. Employers should not only comply with existing regulations, but should also see it as their duty to help identify and to react to new challenges that occur as a result of scientific and technical progress in SB. If SB does become an economically important and distinct new field of research and development, then major economic players such as large corporations in relevant industries should be involved possible in discourse on the fields socioeconomic and innovative prospects. At present, such players are almost entirely absent from discourse on SB. Any prospective and proactive governance of SB needs to constantly deal with and analyse the hype that often characterises emerging techno scientific fields. If SB promises to bring a new industrial revolution and solutions to major global problems, the views of sceptics should be systematically invited in the political and socioeconomic assessments. Socioeconomic scenarios and visions of applications should not only be based on views of future developed by promoters and drivers of the field, but should also be created by a broad range of stakeholders with a view to the needs of society at large. Policy makers, CSOs and relevant research communities should analyse if and how hype is created with regard to SB and who might profit from it, possibly impeding the field from advancing sustainably and preventing its socioeconomic benefits from being reaped. Experience gained in other discourses can help us better understand the dynamics of hype, disillusionment and the establishment of realistic expectations and innovation policies.
The consortium supports the proposal to create institutions and mechanisms that may help make public communication on SB more rational and evidence-based. Policy makers and other actor groups should take into account the fact that even firms that have specialised in SB can have significantly different views of the needs for regulation of SB research, products and public funding policies. All orders and commercial processes involving SB materials and products should be notified to a central clearinghouse which should have an international character. When it comes to public funding of SB, the consortium supports the idea of testing whether extended peer review processes might improve the social usefulness of R&D projects. As regards the mainstream of accompanying research, the SB research community should not only be open to cooperation with research institutions and public dialogue facilitators, but should also develop in-house capabilities. The consortium sees one of the major tasks of SB governance in ensuring that the benefits and burdens that might go hand in hand with the field's further development are distributed fairly within societies and between the global north and the global south.
The consortium recommends finding a compromise between proprietary rights and the commons model, though this is a difficult task. The consortium draws attention to the fact that some ethically relevant issues might make it necessary to establish limits on patentability. The consortium agrees with civil society and other participants in the discourse, who stress how important it is for SB governance to give consideration to general problems in the area of biofuels, such as land use conflicts regarding the utilisation of agricultural areas for food production. The consortium emphasises the need to apply principles of sustainability in this context. It also recommends that policy makers, CSOs and the SB research community intensify their efforts to help representatives of those groups and populations which might be negatively affected by biofuels production get involved in SB discourse and governance.
It is difficult to make accurate predictions about the point in time when scientific knowledge will be gained, the scientific sources of key developments and the socioeconomic consequences that applications of scientific advances will have. Low predictability appears to be an even more severe problem when it comes to the governance of research fields such as SB that are markedly shaped by far-reaching techno scientific future visions. The analysed reports make a large number of recommendations for the prospective governance of SBs scientific development with a view to fostering research and promoting research directions and to assessing or preventing potential risks. Most recommendations are addressed to policy makers and concern the requirements for governance, basic principles of governance, incentives for innovation and public funding of research. Recommendations addressed to the SB research community are fairly numerous and mainly consist of measures aimed at improving scientific infrastructure, knowledge generation and researcher training. Recommendations for CSOs are rare. Those that do exist tend to encourage CSOs to react to SB in a coordinated way and to participate in activities intended to mainstream ethics education.
High prevalence of recommendations for public funding of SB found in analysed reports suggests that this is widely perceived as a proper means of promoting the fields development. Recommendations for public funding come from different groups of actors and their broad thematic spectrum reflects different views and preferences for the future of SB. Due to significant differences between the points of view expressed in the analysed reports it comes as no surprise that consensual recommendations concerning the fields further development are rare.
Potential impact
To ensure successful dissemination of the project results and involvement of stakeholders and the public, resources like a website and leaflets to disseminate the results to target groups are required. In the 2000s, the concern was often expressed that ethical reflections, risk assessments, analyses of social implications, and public discourse take place too late. Currently, there is broad political consensus that research on ethical, legal and societal aspects or implications of science and technology and into the EHS issues of emerging technologies should begin at as early as possible. Field like SB are in some way the products of re-labelling of established fields of research and development. Preparatory activities appear to have become more significant. Ethical implications of future developments in science and technology are discussed by ethicists, while the potentially socioeconomic impacts are discussed in reports published by institutions.
Public engagement with emerging techno scientific fields is promoted and funded before the fields have even materialised. Longer-term public deliberation activities offer good opportunities for opinion-forming. The emergence of SB is still new and only few public deliberation activities have taken place so far. Most are short-term and involve the public only in the form of anonymous and large audiences. While public discourse of SB is in its infancy, some of its main features have already become visible, partly because it is similar to recent discourses on other new techno scientific fields and partly because it represents a continuation of public discourse on biotechnology and the life sciences. Among its main features are an ambiguity of the use of the term synthetic biology and the framing of discourse on SB by a 'new regime' of techno science or a new mode of governing emerging techno scientific fields in which there is greater awareness of the complexity of the social shaping of science and technology.
A discrepancy exists between the claims of novelty made with regard to SB and the view that this is genetic engineering by another name. This makes it difficult for the general public and experts to discuss the specific implications, not only of ethical and broader societal issues, but also of socioeconomic, legal, regulatory and research policy issues. SB discourse developed during a period of time which was characterised by the rise of a new regime of techno science. This included a keenness to initiate activities aimed at assessing emerging techno scientific fields and fostering their social embedding and public acceptance, a participative and deliberative turn in the governance of emerging techno scientific fields, the rise of stakeholderism, broad funding of accompanying research studies into the ELSA of science and technology and into EHS issues of emerging techno scientific fields, an ethicisation of governance of science and technology, a growing awareness of the complexity of the social shaping of science and technology including a self-reflexive turn among protagonists of this new regime and a new emphasis on the relevance of science-art interrelations, a strong interest in phenomena of convergence of different fields of science and technology and at establishment of concepts of responsible research and innovation and responsible development aimed at addressing the complexity of the new regime.
It is still possible to gain the impression that public dialogue and communication activities initiated or funded by political institutions are designed foremost as elements of political strategies aimed at avoiding public distrust. There often appears to be an unhealthy suspicion of the public, which is problematic in a democratic society and reveals the persistence of overly simplified views of the public and society. Such an understanding is not suited to fostering responsible research and innovation in a comprehensive way. The public is not an external factor influencing research and innovation processes, but their medium when it comes to publicly funded science and technology in democratic societies. It is known that it does not make sense to ask citizens about their opinions on emerging techno scientific fields at a time when even experts struggle to understand it. The project decided to focus its research on the way SB is portrayed in the mass media.
The project ensures that products are disseminated in a practical fashion. In the project, end users are first and foremost European policy makers, in the second place scientists and engineers and the general public. We aim to present its findings in a way that they can be picked up easily by targeted end-users so that they are better able to use the findings. We designed a three-step process to do this: writing, production and distribution of leaflets with main results targeted at three target groups, an evaluation of the publications submitted to appropriate journals to ensure that the results of the project are widely disseminated in scientific and ethics literature and dissemination to relevant parties, maintaining the network established during the project. One of the problems of innovation in industrial biotechnology is that its products do not affect individual users in the same way as gm food in relation to consumer's choice or medical genomics in relation to patients. Public engagement does not emerge spontaneously. This means that that narrow segment of the public that does involve has clear cut opinions that tend more towards the negative, while the main part of the population remains indifferent, until the media reports on the more controversial sides. It is crucial to disseminate results to the wider public in an early stage.
The findings of SYNTHETHICS were in part disseminated during the project. The results of WP1 were disseminated during the Delft workshop. Other forms of dissemination were formed by interviews conducted in the context of WP2, which gave the opportunity to increase the project's public recognition by disseminating its activities and results to a large group of younger life sciences students and academics. The three main target groups are SB community, EU policy makers and societal stakeholders. To optimise knowledge utilisation, we have subdivided the targeted end-users in five different groups of end users: policy makers working on the definition of regulations for SB and related fields, industrial partners in society working to develop new applications of SB, academic researchers working in the life sciences, academic researchers working in the area of ethical, legal and social issues connected to SB and the wider public. Experts from the academic and the industrial SB community were invited to the workshops and public meetings. Members of the project consortium have participated in scientific meetings of this community. Lectures on ethical issues were given and will be given in the future at conferences. The main goal was to embed ethical, social and legal issues in SB research. Several scientific papers were prepared for publication in scientific journals to assure dissemination. Policy makers have been invited for stakeholder meetings and public dialogues. Briefing documents will be distributed to EU policy makers. Several societal stakeholders have been invited to the stakeholder workshops and public dialogues. Researchers on the ethical, legal and social implications (ELSI) of science and technology will be reached by the papers that have been prepared and those that are to be published. The results will be posted on the website, depending of the journal's house rules.
Collaboration with the Seventh Framework Programme (FP7) SYBHEL project and the FP7 Value Isobars project has been established, leading to further publications. The project website posts all reports. Contact has been established with a number of SB programmes and projects. The Karlsruhe group has actively contacted the media and will disseminate our results to journalists directly and the wider public indirectly. WP1 has identified several main areas of ethical concern in SB raised by experts and in the public discourse. WP2 has analysed normative frameworks that underpin these discussions. WP3 has identified the gaps in these frameworks. The results were presented in a public dialogue meeting organised in Karlsruhe. The results have been incorporated in the final recommendations. Scientific and ethics publications on the results from WP1, 2 and 3 will be disseminated to the community of SB researchers and the community of ELSI researchers. In part this has already been achieved by the workshops and the public event organised in Karlsruhe, but the aim is to extend this beyond the end of the project. For academic dissemination of the project output, we aim to rewrite the most important findings of our project and publish these in relevant peer reviewed journals. The SYNTHETHICS consortium is aiming for a publication of its results in a special issue of a journal. Several ideas on the outline for such a book were developed. Since not all papers produced can be published in the book it will be necessary to make a selection.
Project website: http://www.synethethics.eu(odnośnik otworzy się w nowym oknie)
Contacts:
Patricia Osseweijer - p.osseweijer@tudelft.nl
Laurens Landeweerd - l.landeweed@tudelft.nl
TUDelft, TNW, Department of Biotechnology; Julianalaan 67; 2628BC Delft, the Netherlands.
The SYNTH-ETHICS project aimed to address the ethical, legal and social implications of the emerging field of synthetic biology (SB). It focused on biosafety, biosecurity and notions of life. The project set out with an assessment of relevant ethical issues, a task that was conducted in close collaboration with the SB community. Next, the emergent public debates over these issues were analysed. An analysis was conducted of current ethical and regulative frameworks that are applicable on SB by making comparisons to closely related fields like nanobiotechnology and genetic engineering. The extent to which existing regulations can deal adequately with existing and newly emerging ethical issues in SB was assessed and on that basis, challenges for current regulatory and ethical frameworks were identified and recommendations for dealing with these challenges were defined. These were specifically targeted at three relevant groups: the SB community, European Union (EU) policymaker and non-governmental organisations (NGOs)/the public.
An important experience that was drawn from the project is that a mapping of the ethical, legal and social issues connected SB is different from assessing such issues in for example neurology, since most research conducted in SB finds itself in a pre-application phase. This demands a different approach, since the vocabulary in which SB is discussed is ever-changing and therefore identification of the connected ethical, social and legal issues is difficult. Currently, patents play an important role in how scientific research and technology innovation are thought to be motivated. This also goes for SB. However, rewarding intellectual achievement through patents is showing an increasing number of flaws. In theory, financial compensation and profit seem to be self-evident motivators for innovation, but in practice it seems that certain innovations are not in the interest of large patent holders. Ethical technology assessments often miss out on this design-flaw of the patent system.
The project positioned itself at the intersection of ethics, technology assessment. Foresight, law, new technologies and expertise from all relevant fields were included in the project team. The project built on insights and discussions from other fields such as biotechnology and nanotechnology. It also assessed which aspects of SB might give rise to ethical problems of a different nature, specific to the field. It contributed to a more adequate and broadly applicable approach to ethical aspects of new technology. Traditionally, much of the ethical debate on emerging science and technology focuses on risk assessment, which leads to restrictive governance. The ethical assessment of science and technology therefore misses out in contributing to a positive shaping of science and technology. The project contributed to a common understanding of SB and the ethical, legal and social issues involved in EU Member States and to the shaping of a distinct European approach without ignoring discussions and developments elsewhere. Stakeholders' views have been solicited during and taken into account. The project helped to prepare for a rational and informed public dialogue on SB. It provided a sound basis for EU policymaking in the coming years, partly by cooperation with other EU-funded and international projects.
Project context and objectives
The project was targeted at analysing the ethical, social and regulatory contexts of SB as basis for advice for policy. It aimed to contribute to a common understanding of SB and the ethical, legal and social issues involved in EU Member States and to the shaping of a distinct European approach without ignoring discussions and developments elsewhere. Stakeholders' views have been solicited and taken into account. The project helped to prepare for a rational and informed public dialogue on SB. The project provided a sound basis for EU policymaking in the coming years by cooperation with other EU-funded and international projects.
The overall aim of the project was to contribute substantially to the development of a European approach to SB. For comparative reasons, the agenda-setting in the United States (US) was taken into account and analysed, although it was acknowledged that the diversity of cultures and ethics in Europe and the political specifics rule out a copy of United States approaches. To analyse the European context and define advice and recommendations we defined a proactive approach in which the specific European strengths and needs, relevant public values and strategy through which societal concerns could be identified and taken into account in the development of SB in such a way that its benefits could be better safeguarded for society while minimising social costs.
Significant contributions were made with regard to:
- a responsible development of SB in Europe with regard to ethical and societal values and with regard to the question of the importance of biosecurity; it will take into account the overall goal to profit from the benefits of SB that are most promising in the European context;
- the shaping of a European community in which expertise from all relevant fields of research is systematically integrated in a normative analysis of the developments of SB;
- the broadening of ethically relevant research and activities, in particular with regard to SB's 'dual use' and comprehensive philosophical and societal aspects;
- the facilitation of societal discourses, academic research and related networking activities, reflecting the situation in Europe while taking into account international debates.
Objectives of the project included:
- to identify actual and emerging ethical issues raised by developments in SB and the embedding of the developed technologies in society;
- to trace and analyse the public discourse on these issues;
- to analyse whether these ethical issues and the concerns raised in the public discourse can be adequately dealt with the current normative frameworks existing in SB and in closely related fields such as nano- and biotechnology genetic engineering and identify shortcomings;
- to analyse topics in SB on which EU policy and regulation might be required and to make recommendations.
The second phase of the project aimed at the translation of the findings of work packages (WPs) to different stakeholder groups and the public at large. The project objectives for the first reporting period were the following:
WP1
- Identification of ethical issues raised by SB.
- Assessment of how the European SB community is currently dealing with issues.
- Inventory of expert opinions on these issues.
- In-depth analysis of ethical issues.
- Analysis and proposals with respect to public discourse on recent, emerging and potential developments in SB.
- Identification of potential tensions between public discourse, expert opinions and the way the European SB community is dealing with ethical issues.
- In-depth analysis of public discourse on a number of specific ethical issues in relation to notions of life, conceptions of nature, problems of dual use and societal setting of application, etc.
WP2
The identification and detailed description of current normative frameworks applied to ethical issues and public discourse in SB. This includes the normative frameworks developed in SB and in neighbouring areas like nanotechnology and genetic engineering. Attention will be paid to both formal and informal rules and regulations.
WP3
WP3 contains analysis of potential gaps or shortcomings of the current normative frameworks. If gaps or shortcomings are identified, proposals on how to deal with them will be developed. WP3 also contains prospective ethical analysis of emerging or possible future issues in SB.
WP4
To identify ethical and regulatory challenges raised by SB and to formulate recommendations for relevant communities for dealing with these challenges. Public dialogue events will be designed and organised to discuss challenges in a broad public setting and validate results before we finalise the recommendations.
WP5
WP5 consists of management and coordination of the project and meeting of all deadlines and production of all deliverables for the project. Next to that the dissemination of project results to relevant target groups.
The consortium emphasises that the nature and urgency of SB governance measures depend on the epistemological status that is attributed to the field. Relevant policymaker must keep themselves informed by observing developments with the support of advisory bodies, research councils and technology assessment institutions. The scientific community should take a more active role in public discourse and stakeholder dialogue on SB and should pursue cooperation with CSOs, social scientists and ethicists. Transparency of research and a dialogue between authorities, researchers, stakeholders and the general public must be ensured in order to find out what kind of research society would prefer to see publicly funded. The consortium emphasises that it is difficult and perhaps impossible, to predict which approaches or systems in SB will result in breakthrough knowledge and technologies that are beneficial for and demanded by society. Consideration should be given to public funding of SB basic research, with originality and scientific excellence of the projects and of the scientists involved being used as decisive funding criteria. The consortium accordingly warns against tying public funding of the field to the label-SB and recommends considering that a politically fuelled hype around the label may lead to bandwagon effects and to a tactical re-labelling of less innovative, non-excellent research activities.
Project results
SB has emerged as a vibrant field of scientific inquiry with considerable potential for practical application and public benefit. Combining engineering with biology, it promises to fulfil many of the anticipated goals of nanotechnology in an easier fashion. While nanotechnology involves the development of materials and machines at the nano scale, SB builds on the insight that nature holds parts and methods for constructing machines and materials at small scales. Synthetic biologists hope to develop a set of tools, using off-the-shelf parts and methods used in biology and by developing new tools and methods to hasten the advent of various promises of nanotechnology. The project yielded important insights for other parties as well. These end-user groups are to be approached through different means and at different occasions. To be able to increase the success of dissemination, we aim to extend the cooperation of partners in the project beyond its duration. Such mutual collaborations already exist in several projects, but there are initiatives to take it beyond its current scope.
A large portion of the literature on SB and the ethics thereof is devoted to defining the boundaries of the term and field. On the overlapping field of systems biology and genomics, Powell et al. (2007) note: 'understanding how scientific activities use naming stories to achieve disciplinary status is important not only for insight into the past, but for evaluating current claims that new disciplines are emerging. The birth of a new discipline is not merely a spontaneous happening. It includes paradigmatic achievements, technological innovation and social formations. Powell suggests: further attention to disciplinary histories could, we suggest, give us richer insight into scientific development.' 'SB is an increasingly high-profile area of research that can be understood as encompassing three broad approaches towards the synthesis of living systems: DNA-based device construction, genome-driven cell engineering and protocell creation. SB is described as a meeting-point of two cultures. The first, represented by those interested in deconstructing life, dissects biological systems in search for simplified and minimal forms that will help us understand adaptation and evolution of natural processes. The second, complementary and symmetrical culture is the construction of life approach. The goal is to build systems that are inspired by biological principles and use biological or chemical components to reproduce the behaviours of live systems. The area of SB has not emerged fully out of the semantic battle over its definition proper'.
The definitions of SB sketch the field as something radically new. Does this mean we need new ethics? There are a number of recurring ethical issues in various different fields of applied ethics. These issues seem to resurface in any debate in any field of biotechnology. They include how to deal with risk, with security issues, with safety issues, how to avoid the formation of monopolies, how to safeguard local and global just distribution, how to deal with possible dual use, etc. The problem is that it reduces the analysis of potential ethical issues to a standard checklist. Although it is wise to look at issues separately, it stands in the way of a deeper ethical reflection on the social and societal consequences of a novel technology. This is pressing because different disciplines will have different societal relevance, a different place in society and different consequences and therefore need different modes of analysis. This does not mean there is no similarity between these areas. As Parens, Johnston and Moses claim: 'Particular ethical questions are more pressing in some arenas than in others'.
The questions themselves are virtually identical to the ethical questions that have arisen in the past. Failing to recognise that fact can lead to reinventing the wheel for each new technology and squandering of scarce resources. Although creating such a subfield might be in the short-term self-interest of bioethicists, in the long run further balkanization of bioethics would be a mistake. Instead of listing the ethical questions that arise over and over, we need to dig deeper. We need to test intuitions, arguments and responses developed in previous contexts against new fact patterns. There is a critical need to examine ethical implications of the new field of SB, but Hastings Centre scholars discourage the creation of a subfield of 'synthetic bioethics'. One should not merely look at what new issues are brought up by SB. One also needs to investigate in what way old issues may be altered, amplified, or diminished.
There is much debate on the unifying characteristics of SB but the diversity of its applications renders the necessity of a specific ´synth-bioethics´ unlikely and maybe even undesirable. Still, it may be desirable to look into differences with other subfields in bioethics. The trick seems to be to make use of past experiences without neglecting issues that are properly those of the field in question. A problematic issue is that its definitions do not merely describe the birth of a novel discipline. The definition process is governed by its own internal politics. Cynical voices claim that SB is not much more than selling old lamps as new ones, while more enthusiastic voices claim SB takes the vital step from being able to read the code to being able to write it and that this means SB will prove to be the genie from the old lamp. In either case, in distinguishing the field from other fields at least a specific interdisciplinary specialism is claimed and associated with SB. With regard to its areas of application this will have different consequences for every field. As was the case with nanotechnology, SB largely emanated from the US, with the EU being aware of it and contributing to the efforts, but somewhat lagging behind. The leading role of the US in SB is partly due to the fact that the concept was largely developed in the US. Some European researchers who are active in this field do not identify their work with the new label. SB builds on exiting fields and disciplinary approaches. It emerged from biotechnological research and the life sciences. It is at the intersection of biology, chemistry and physics, overlapping and cross-fertilising with a range of other fields of research and technology development. An important characteristic of SB is the wedding of biology with engineering approaches. We are currently at an early stage of SB. The applications of engineering principles to basic biological systems heralds a new era of progress. It remains difficult to synthesise anything but the smallest of organisms, most of which will be viruses. Much of the work relates to identifying the minimum set of elements within 'artificial' bacteria. This could result in a living system capable of replication. But, such a system might not be desirable.
That which is most likely to become possible is the identification of elements of organisms that have specific functions and to provide for these functions. Synthesis of DNA constitutes a crucial part of any efforts to design biological systems to perform a given function. Design in a biological context implies tinkering with DNA to achieve intended results, whether that result is a new protein or a modified process. Such artificially modified DNA then needs to be synthesised and it can then be inserted into the appropriate vector to carry out its intended function. One of the characteristics that set SB apart from other engineering disciplines is the potential to create replicable materials. Additional safeguards need to be adopted before the results of SB can be released from containment. It has proven difficult to come up with one consistent definition of SB, complicating the definition of both the ethical and the legal frameworks. In spite of this lack of a consistent definition of SB, it is increasingly perceived of as a distinct field of research and development (R&D).
An important experience that can be drawn from this project is that a mapping of the ethical, legal and social issues connected SB is different from assessing such issues in for example neurology, since most research conducted in SB is still very basic and therefore pre-application research. This demands a different approach since the vocabulary in which SB is discussed is ever-changing and therefore the connected issues find themselves on shaky ground. As brief conclusion from all WPs it can be said that traditionally, much of the ethical debate on emerging science and technology focuses on risk assessment. This automatically leads to restrictive governance of innovation in such areas. The ethical assessment of science and technology misses out in contributing to a positive shaping of science and technology.
Patents play an important role in how scientific research and technology innovation are thought to be motivated. This also goes for SB. Rewarding intellectual achievement through patents is showing an increasing number of flaws. In theory, financial compensation and profit seem to be self-evident motivators for innovation, but in practice it seems that certain innovations are not in the interest of large patent holders. Ethical technology assessments often miss out on this 'design-flaw' of the patent system. Specifically for SB, a patent system would slow down innovation. The end products of innovation are often directed at benefiting the West, while humanitarian problems in the south are more pressing. An open access system may therefore further innovation in a more productive fashion than a patent system and it may yield more beneficial products on global level. Such a shift of mentality calls for an in-depth approach of the ethical analysis of SB, one that focuses on the organic and complex nature of technology innovation.
SB has emerged recently as a vibrant field of scientific inquiry with considerable potential for practical application and public benefit. Combining engineering with biology, it promises to fulfil anticipated goals of nanotechnology in an easier fashion: while nanotechnology involves the development of materials and machines at nanoscale, SB builds on the insight that nature already holds parts and methods for constructing machines and materials at small scales. Synthetic biologists hope to develop a set of tools, using off-the-shelf parts and methods used in biology and by developing new methods, to hasten the advent of the various promises of nanotechnology. SB has received media attention and significant funding, in part due to high-profile researchers. Anticipating public and governmental anxieties about potential risks and ethical concerns, projects geared toward addressing any new or emerging ethical issues raised by SB were launched. These initiatives and inquiries focus largely on ethical issues related to biosecurity and environmental or public risks.
Much has been written concerning ethical problems raised by this new science and yet there remain gaps in the conversation. Numerous projects, colloquia and public and private inquiries into ethics and SB have focused on potential risks, both to security and safety posed as the technology advances. These concerns are among those most often referred to in popular media and about which workshops, statements and efforts to formalise safety and security procedures in the practice of SB have been directed. But another widely-discussed concern, that regarding angst about man-made life, has received less serious discussion in academic literature and policymaking. This is perhaps because scientists and scholars recognise that a certain line has already been crossed with the advent of genetic engineering and that ethical concerns that are posited to arise from SB have already been raised with genetic engineering. The public discourse on SB and its ethical implications is still in its infancy. The various segments of the discourse often appear to be unconnected. Some governance reports try to bridge the gap between the public image of SB as it is portrayed in media and the concerns in the science system and among stakeholders.
The various discourses represent societys attempt to deal with an emerging field of R&D which at the present stage still has highly visionary features and is difficult to govern. Recently, synthetic biologist Martin Fussenegger said: 'The field has had its hype phase. Now it needs to deliver'. If SB does deliver in the near future, it might be that real progress will be overshadowed by media reporting on the wilder dreams of visionary scientists and stakeholders and that in the view of the public will be dwarfed by the promises of revolutionary impacts of the field. Some of the visions appear to be highly contentious, because there is the danger that the academic discussion of the ethical aspects of SB will focus on them, leading to dominance of speculative ethics whose negative impacts on the discourse on nanotechnology and other fields have already been noticed and criticised. Systematic discourse analyses may help to prevent such a narrowing of academic discussion and to broaden the knowledge base for public dialogue activities.
Different interests and worldviews associated with technology and innovation need to be addressed and not to be dismissed as unscientific. This would need to include the worldviews of scientists and science promoters in the field. One of the next tasks of the project will be to contribute to the awareness of stakeholders with respect to SB and its ethical and societal implications. The project will be able to use and extend existing contacts with stakeholders who are already active in this area. As a preparatory step, the results of their work on SB will be analysed in detail. Moreover, the media analysis should be updated at a later stage, since recent developments suggest that the increase in articles will continue. An extension to countries other than those included in the first phase is also desirable. We expect public knowledge about SB to increase, which will allow further analyses of the publics views on the subject.
Given the experiences with related fields of R&D and application, it is important to integrate the whole range of ethical, legal and societal aspects and concerns from the start. Besides those aspects that are often termed environmental, health and safety (EHS) implications and are already focused in ongoing EU-funded research, broad ethical and philosophical aspects have to be tackled. One should take into account that SB has not only already been discussed within the context of technological convergence and with respect to other fields but is likely to raise similar fears. These aspects relate to questions that are highly relevant with regard to European value systems and the sensibilities of several stakeholders. There might be additional concerns that are specific to SB. A high quality of research in the field of ethics of new technologies, an early identification of ethical issues and foresight with respect to potential public concerns are needed. In Europe there is a wide range of ethical, philosophical and social-scientific expertise on these and related issues, but it is often dispersed and unconnected. If this expertise is not bundled, there is a danger that developments in SB might result in the repetition of shortcomings and mistakes that we have witnessed in public and political debates on other fields. Several European debates and ethical research were triggered by an agenda-setting in US R&D policy, and as a result tended to import and reproduce ethical lines of debate which emanate from the US and are often not appropriate in the European context. The same holds true for the issue of biosecurity. Europe has experienced terrorist attacks and is aware of the related threats, but political approaches differ in several ways from the US.
The promises of SB have to be assessed in view of Europes specific needs and political priorities. It will be appropriate to include scientists and philosophers from the New Member States. The reconstruction of relevant regulatory frameworks has been made by focusing on some the domains of environmental risks, biomedical applications, cosmetics regulation, intellectual property, bio-informatics, occupational health and human rights law. In shaping the legal frameworks that can be relevant for SB in each of these domains, both hard and soft law have been considered. This is regarded as a suitable method in order to enlighten the way the two types of legal norms work and interplay and how they could be improved. On the basis of the analysis that has been worked out, it can be maintained that GMOs normative frameworks is applicable to SB products and processes but a degree of specification in SB definition is required to select which parts of GMO regulation are applicable to SB and which not. For biofuels, it has been seen that EU strategy is intended to increase the use of biofuels in order to reduce the use of fossil fuel, on the assumption that this will produce economic and environmental advantages. In this sense the application of SB may be coherent with this aim, but sustainability of SB processes need to be shown.
Medical application legislation has turned out to be fragmented and partly overlapping. Fragmentation is, to a certain extent, necessary in order to adequately consider different stages of R&D and specific characteristics of different kinds of products. Effort should be made to coordinate procedures and requirements in terms of product-based and process/technology based regulation. Some critical aspects relate to international harmonisation. The role of the EU could be pivotal, both to elevate international standards of quality, safety and efficacy of biomedical products and to prevent the delocalisation of R&D of biomedical products in countries with less restrictive regulations. It is important to develop harmonised standardisation and new methods of safety evaluation for risk assessment and to collect more data about safety. The impact of intellectual property (IP) regulatory frameworks on the field of SB is the subject most addressed in literature. The overview in this report has shown how the debate is currently developing along two paths, the ethical issues limiting the access to patentability and the new model to promote innovation, using a co-existence of proprietary rights and the commons model. These paths have to be analysed separately since their basis is completely different. On one side there is the risk of ethical implication in a new field, using genes and DNA sequences. On the other side there is the insufficiency of the model of IP developed to protect mechanical inventions and the necessity to find a new complex model providing the sharing of information. Some relevant legal implications of SB in the bio-informatics domain have been discovered.
For what concerns the occupational health area it can be said that at the moment it is necessary to stick to the legislation in force on the subject of protection of health and safety in workplaces. There is a need for pursuing the highest possible protection according to the sector or to the nature of the sources of risk. R&D EU law has established the obligation to keep technologically up-to-date aimed at the criterion of the highest technologically protection possible, tempered by reasonable practicability. It is necessary to study the possibility of adopting standards and practices for single branches of application based on the single 'category' of the material handled or the product obtained the process to be carried out and in relation to the subjects involved to fix eventual thresholds of maximum exposure that will only be possible with full knowledge of the potential risk, just as the monitoring of the conditions of health of the workers or the systems of risk management should be updated in relation to scientific and technical advances. It seems that the instruments of soft law can be considered a complement of hard law in guaranteeing the uniformity of protocols and standards. Regarding the potential impact of human rights law on SB, an analysis of the international normative framework, focused on the EU level and the European Court of Justice (ECJ) jurisprudence and main instruments of the Council of Europe and the European Court of Human Rights (ECtHR) jurisprudence, has been developed. This choice is based on the premise that, due to the broadness and vagueness that tends to characterise the norms of human rights, the inquiry into the relationships between human rights law and SB needs to tackle the judicial application of the norms. The report argues that the framework of the rights enforced by ECJ is not ready to cover future trends of R&D in the SB field yet, whereas the rights guaranteed in European Convention on Human Rights (ECHR) by ECtHR are perfectly operative in this sense.
This conclusion is relevant in the light of the EU negotiating mandate to accede to ECHR, which will give to the Court of Strasbourg a role within EU legal system. This is due to the fact that in the EU law human rights may be balanced with some different values. The case law of the ECJ is clear in this regard and it is not likely to change soon. Health is not handled by ECJ jurisprudence as an individual right. The ECJ applied human rights before as principles of the EU law and as constitutional traditions common to the Member States, but it never treated health as an individual right, especially in the field of consumer safety and biotechnologies. The regulatory frameworks that can apply to SB rise in conceptual and practical issues dealing with; the meaning and concrete working of the precautionary principle, problems and challenges posed by applying norms already in force for different purposes to SB, the role of soft law and the convergence of ethical and legal principles into regulatory tools.
The way to give substance to the precautionary principle with reference to the potential developments and applications of SB turns out to be the crucial point in order to assess the suitability of the regulatory frameworks already in force for different purposes and to propose changes to frameworks or to propose the introduction of ad hoc norms. During the past decade, the problem of dual-use research, science and technology has been one of the most debated issues in discourse surrounding biological weapons and the bioterrorist threat and an especially controversial topic regarding science policy and SB in particular. The expression dual-use technology was originally used to refer to technology that could be used for both civilian and military purposes. This was a non-normative use of the expression dual use. Dual-use technology was not necessarily considered to be problematic. From the perspective of policymakers, this kind of dual-use technology could sometimes be considered a good thing. There are economic advantages to developing technologies that will simultaneously meet both a countrys civilian and its military needs. Although dual-use technologies could in some contexts be considered desirable, they could give cause for concern. A country might be reluctant to export dual-use technologies to adversary countries to which it would not ordinarily want to export weapons.
In recent years, the expression 'dual use' has most commonly been used in an explicitly normative fashion. The expression is now usually meant to refer to research, knowledge, technology or materials that can be used for both beneficial and harmful purposes. Current debates about dual use science and technology refer to science and technology that has legitimate uses but might be used by malevolent actors for nefarious purposes. The expression dual use could be applied broadly and almost everything could count as dual use. Contemporary debates about dual-use science and technology have been more narrowly circumscribed. Most of the current debate has focused on research with implications for weapons, where the consequences of malevolent use would be especially severe. There are at least three plausible definitions of dual-use science and technology: that which has both civilian and military applications, that which can be used for both beneficial and harmful purposes and that which has both beneficial and harmful purposes where the harmful purposes involve weapons. The third definition of dual use is the way dual use is most commonly used in contemporary debates about the 'dual use dilemma'. The dual-use dilemma arises when one and the same discrete piece of scientific research intentionally undertaken for good ends has the potential to be intentionally used for great evil. Accordingly, there is a primary user who creates new knowledge or designs new technology for good but there is also a secondary user who uses the knowledge or technology for some evil purpose. Many so-called dual-use dilemmas are not dilemmas in the narrow sense of being situations involving two options which are equally ethically problematic.
First, the dilemmas in question could be tri-lemmas; there could be four or five or more options all of which are equally ethically problematic. Second, the options are not equally ethically problematic. There are ethical considerations for and against each of the options, however it may well be that one of the options is morally preferable to the others and that this is relatively obvious to any rational, morally sensitive person. The point is that there are some significant moral costs associated with each of the available options. Many scientific discoveries and new technologies have dual-use potential in the trivial sense that they could be used by someone for some malevolent purpose. Any newly designed object has dual-use potential in this sense. However, it is implicit in the use of the term dual use in the academic literature that the potential harm in question is of great magnitude. Accidents involving science and technology are not dual use in our sense since there is no secondary evil user, although they may involve unethical behaviour. The dual-use dilemma is not new. When atomic physicists made key discoveries regarding atomic fission and the chain reaction they realised that these discoveries might have beneficial applications in medicine and the generation of energy, but they also realised that they might lead to the development of new, monstrously devastating weapons. If dangerous scientific information were kept secret the development and use of such weapons might be avoided.
Since the dawn of the 21st century, the dual-use potential of life sciences has become salient. In many ways, the situation of life sciences at present is similar to that of physics when atomic weapons first became possible. The biological sciences are progressing rapidly, and recent developments in biotechnology may have tremendous medical benefits. In many cases the same discoveries that may promote advancement of medicine could also facilitate production of biological weapons of mass destruction. This is partly revealed by a recent unclassified CIA document titled 'Our darker bioweapons future' which claims that recent advances in biotechnology enable the production of biological agents worse than any disease known to man. As noted by Samuel et al., concerns about dual-use life science research are especially salient in the context of synthetic life sciences. The dual-use phenomenon raises important questions about responsibilities of scientists, research institutions, the scientific community and policy makers. Responsible actors at each of these levels should aim to promote the progress of science insofar, as progress will benefit humanity. However, they should aim to avoid outcomes where developments ultimately result in more harm than good. One idea in recent debates is that we should aim for policy that strikes a balance between the goal to promote scientific progress and the goal to protect security.
There remain some obstacles to the establishment of adequate measures to deal with the dual-use problem in science and technology. A number of these stem from various perverse incentive structures that derive from collective action problems. First, in the past and the present there have been a variety of arms races in which scientists play a central role. The problem is that national self-interest is pitted against humanitys collective interest in a context in which there is no enforceable international law. Evidently nation-states cannot effectively collectively self-regulate. Second, non-military institutional incentive structures are potentially in conflict with the application of the no means to harm principle. Third, there is the possibility of the untoward consequences of scientific freeriding. Let us assume that Polanyis scientific freedom model is the best model to acquire new knowledge; those operating entirely outside the model cannot compete. Accordingly, the 'good guys' stay ahead of the 'bad guys'; the bad guys are always playing play catch-up. Contrary to this, it might be claimed that a well-qualified national cohort of bad guys can always free ride and then get ahead of good guys.
Given the potentially disastrous consequences of bioterrorist activities and the significant extent of public concern regarding this issue, the consortium recommends opting for an internationally coordinated approach in the lines of 'the more, the better'. This would include governmental responsibility on all levels and would be supplemented by a wide range of obligatory activities to be undertaken by relevant research communities. It would involve fostering an ethos-based security culture supported by specific educational and training measures. Combining a strong role of governmental institutions with wide-ranging activities within research communities should include setting new incentives to encourage individual scientists to refrain from and report dangerous and malicious activities. While the consortium agrees that advanced SB research is not attractive to bioterrorists yet, it views the emerging governance discourse as an opportunity to deal with shortcomings and gaps in existing regulations, governance frameworks and professional security cultures. In line with this stance, the consortium agrees with the view that governmental bodies should act as clearinghouses that check databases for DNA sequence requests and not as clearinghouses established solely on the basis of scientific self-regulation. Policy makers should set up external surveillance institutions to monitor dual-use research and should create specific guidelines and regulations.
Another measure could be to develop a system of security checks for personnel working in licensed laboratories. When it comes to restrictions on scientific freedom, the dangers of governmental over-regulation must be taken into account. Considerations should be made with the aid of an ethical analysis if obligations and restrictions in this area should be established. This could include obliging laboratories and researchers wishing to investigate dual-use possibilities to seek state permission to do so, bans on the publication of certain research results and granting governmental licensing authority powers that would in effect override human rights to freedom of intellectual inquiry and freedom of dissemination by only licensing government research centres.
The consortium emphasises the specific challenges facing the private sector. Because private sector research is less subject to institutional control, one might be justified in fearing that private companies may be comparatively less reluctant to pursue research with the potential for malevolent use. Another cause for concern is that private research is not generally subject to the same institutional oversight as research undertaken in universities. Consideration should be given to the merits of strengthening institutional control over private sector research. Although many recommended measures would be feasible in the Western world, a great deal of relevant work is now carried out in countries where regulations would be far more difficult to impose. It appears important to find incentives to prevent excellent scientists from defecting to research programmes whose aim is to cause harm. The consortium emphasises the role that publishers need to play when it comes to dangerous publications. Specific review processes could be established for dual-use publications.
The consortium recognises that such reviews will often be difficult in conducting with the right balance between protecting scientific freedom, promoting scientific progress and addressing biosecurity problems. Relevant institutional actors have institutional responsibilities which are also moral responsibilities. Research institutions and the relevant institutional actors in positions of authority must decide how best to monitor dual-use research taking place within their confines. Research institutions should provide guidance and consultation to researchers involved in dual-use research and those who make unexpected dual use discoveries. Students should be trained and educated about bio risks. Funding agencies should consider investing in research to explore the use of bar code technology to detect and trace the origins of genetically modified organisms. It will be difficult to effectively control future SB-weapon activities of nation states. Relevant international agreements lack compliance measures. Even if such measures existed, international control agencies would depend on collaboration with and information from national governmental agencies.
Standardised methods to evaluate safety issues need to be found and methods need to be periodically adapted to new scientific and technical developments. A framework for SB risk governance should be based on regulations that govern genetic engineering and its various areas of potential application. It should include mechanisms to control trade with specific SB items and should be in place before SB applications are released. Some amendments will have to be made to Directive 2009/41/EC in order to make it applicable to the SB field. Although providing a separate classification for activities related to SB is justified, minor adjustment may be appropriate.
The legal approach should be based on a broad definition of SB and include both soft and hard law. Soft law should be regarded as a complementary tool and should be coherent with legal principles. The instruments of soft law can be considered as a complement to hard law, increasing compliance with established principles, fostering uniformity of protocols and standards and encouraging the adoption of mechanisms that are able to accommodate the diffused nature of responsibility regarding technology development. Governments bear the ultimate institutional and moral responsibility for safety and security of citizens. Many SB regulations could for example be applied by biosafety committees operating as university-based biosafety committees. Such committees would in turn need to be accountable to the government, perhaps via an independent authority. As regards the contribution to the regulation of SB stemming from the law of human rights, it can be maintained that the framework of rights enforced by the ECJ is not ready to cover future research and development trends in the SB field, whereas the rights guaranteed in the ECHR and enforced by the ECtHR appear to be fully operative in this sense. Policy makers and scientists should be prepared and attempt to anticipate developments in SB which could constitute a challenge to the use of parent organisms as points of reference in biosafety regulations.
A combination of process-oriented and product-oriented legal approaches appears desirable. It should be considered whether existing general legislation on 'good manufacturing practice' needs to be adapted to new biotechnology manufacturing procedures. SB as a field of converging sciences and technologies in which non-biologists may increasingly be found, needs to place emphasis on biosafety training and on biosafety standards in labs. Scientific competencies as general biosafety research, ecological and biodiversity research and sustainability research should be taken into account more strongly in discourse on SB safety. Employers should not only comply with existing regulations, but should also see it as their duty to help identify and to react to new challenges that occur as a result of scientific and technical progress in SB. If SB does become an economically important and distinct new field of research and development, then major economic players such as large corporations in relevant industries should be involved possible in discourse on the fields socioeconomic and innovative prospects. At present, such players are almost entirely absent from discourse on SB. Any prospective and proactive governance of SB needs to constantly deal with and analyse the hype that often characterises emerging techno scientific fields. If SB promises to bring a new industrial revolution and solutions to major global problems, the views of sceptics should be systematically invited in the political and socioeconomic assessments. Socioeconomic scenarios and visions of applications should not only be based on views of future developed by promoters and drivers of the field, but should also be created by a broad range of stakeholders with a view to the needs of society at large. Policy makers, CSOs and relevant research communities should analyse if and how hype is created with regard to SB and who might profit from it, possibly impeding the field from advancing sustainably and preventing its socioeconomic benefits from being reaped. Experience gained in other discourses can help us better understand the dynamics of hype, disillusionment and the establishment of realistic expectations and innovation policies.
The consortium supports the proposal to create institutions and mechanisms that may help make public communication on SB more rational and evidence-based. Policy makers and other actor groups should take into account the fact that even firms that have specialised in SB can have significantly different views of the needs for regulation of SB research, products and public funding policies. All orders and commercial processes involving SB materials and products should be notified to a central clearinghouse which should have an international character. When it comes to public funding of SB, the consortium supports the idea of testing whether extended peer review processes might improve the social usefulness of R&D projects. As regards the mainstream of accompanying research, the SB research community should not only be open to cooperation with research institutions and public dialogue facilitators, but should also develop in-house capabilities. The consortium sees one of the major tasks of SB governance in ensuring that the benefits and burdens that might go hand in hand with the field's further development are distributed fairly within societies and between the global north and the global south.
The consortium recommends finding a compromise between proprietary rights and the commons model, though this is a difficult task. The consortium draws attention to the fact that some ethically relevant issues might make it necessary to establish limits on patentability. The consortium agrees with civil society and other participants in the discourse, who stress how important it is for SB governance to give consideration to general problems in the area of biofuels, such as land use conflicts regarding the utilisation of agricultural areas for food production. The consortium emphasises the need to apply principles of sustainability in this context. It also recommends that policy makers, CSOs and the SB research community intensify their efforts to help representatives of those groups and populations which might be negatively affected by biofuels production get involved in SB discourse and governance.
It is difficult to make accurate predictions about the point in time when scientific knowledge will be gained, the scientific sources of key developments and the socioeconomic consequences that applications of scientific advances will have. Low predictability appears to be an even more severe problem when it comes to the governance of research fields such as SB that are markedly shaped by far-reaching techno scientific future visions. The analysed reports make a large number of recommendations for the prospective governance of SBs scientific development with a view to fostering research and promoting research directions and to assessing or preventing potential risks. Most recommendations are addressed to policy makers and concern the requirements for governance, basic principles of governance, incentives for innovation and public funding of research. Recommendations addressed to the SB research community are fairly numerous and mainly consist of measures aimed at improving scientific infrastructure, knowledge generation and researcher training. Recommendations for CSOs are rare. Those that do exist tend to encourage CSOs to react to SB in a coordinated way and to participate in activities intended to mainstream ethics education.
High prevalence of recommendations for public funding of SB found in analysed reports suggests that this is widely perceived as a proper means of promoting the fields development. Recommendations for public funding come from different groups of actors and their broad thematic spectrum reflects different views and preferences for the future of SB. Due to significant differences between the points of view expressed in the analysed reports it comes as no surprise that consensual recommendations concerning the fields further development are rare.
Potential impact
To ensure successful dissemination of the project results and involvement of stakeholders and the public, resources like a website and leaflets to disseminate the results to target groups are required. In the 2000s, the concern was often expressed that ethical reflections, risk assessments, analyses of social implications, and public discourse take place too late. Currently, there is broad political consensus that research on ethical, legal and societal aspects or implications of science and technology and into the EHS issues of emerging technologies should begin at as early as possible. Field like SB are in some way the products of re-labelling of established fields of research and development. Preparatory activities appear to have become more significant. Ethical implications of future developments in science and technology are discussed by ethicists, while the potentially socioeconomic impacts are discussed in reports published by institutions.
Public engagement with emerging techno scientific fields is promoted and funded before the fields have even materialised. Longer-term public deliberation activities offer good opportunities for opinion-forming. The emergence of SB is still new and only few public deliberation activities have taken place so far. Most are short-term and involve the public only in the form of anonymous and large audiences. While public discourse of SB is in its infancy, some of its main features have already become visible, partly because it is similar to recent discourses on other new techno scientific fields and partly because it represents a continuation of public discourse on biotechnology and the life sciences. Among its main features are an ambiguity of the use of the term synthetic biology and the framing of discourse on SB by a 'new regime' of techno science or a new mode of governing emerging techno scientific fields in which there is greater awareness of the complexity of the social shaping of science and technology.
A discrepancy exists between the claims of novelty made with regard to SB and the view that this is genetic engineering by another name. This makes it difficult for the general public and experts to discuss the specific implications, not only of ethical and broader societal issues, but also of socioeconomic, legal, regulatory and research policy issues. SB discourse developed during a period of time which was characterised by the rise of a new regime of techno science. This included a keenness to initiate activities aimed at assessing emerging techno scientific fields and fostering their social embedding and public acceptance, a participative and deliberative turn in the governance of emerging techno scientific fields, the rise of stakeholderism, broad funding of accompanying research studies into the ELSA of science and technology and into EHS issues of emerging techno scientific fields, an ethicisation of governance of science and technology, a growing awareness of the complexity of the social shaping of science and technology including a self-reflexive turn among protagonists of this new regime and a new emphasis on the relevance of science-art interrelations, a strong interest in phenomena of convergence of different fields of science and technology and at establishment of concepts of responsible research and innovation and responsible development aimed at addressing the complexity of the new regime.
It is still possible to gain the impression that public dialogue and communication activities initiated or funded by political institutions are designed foremost as elements of political strategies aimed at avoiding public distrust. There often appears to be an unhealthy suspicion of the public, which is problematic in a democratic society and reveals the persistence of overly simplified views of the public and society. Such an understanding is not suited to fostering responsible research and innovation in a comprehensive way. The public is not an external factor influencing research and innovation processes, but their medium when it comes to publicly funded science and technology in democratic societies. It is known that it does not make sense to ask citizens about their opinions on emerging techno scientific fields at a time when even experts struggle to understand it. The project decided to focus its research on the way SB is portrayed in the mass media.
The project ensures that products are disseminated in a practical fashion. In the project, end users are first and foremost European policy makers, in the second place scientists and engineers and the general public. We aim to present its findings in a way that they can be picked up easily by targeted end-users so that they are better able to use the findings. We designed a three-step process to do this: writing, production and distribution of leaflets with main results targeted at three target groups, an evaluation of the publications submitted to appropriate journals to ensure that the results of the project are widely disseminated in scientific and ethics literature and dissemination to relevant parties, maintaining the network established during the project. One of the problems of innovation in industrial biotechnology is that its products do not affect individual users in the same way as gm food in relation to consumer's choice or medical genomics in relation to patients. Public engagement does not emerge spontaneously. This means that that narrow segment of the public that does involve has clear cut opinions that tend more towards the negative, while the main part of the population remains indifferent, until the media reports on the more controversial sides. It is crucial to disseminate results to the wider public in an early stage.
The findings of SYNTHETHICS were in part disseminated during the project. The results of WP1 were disseminated during the Delft workshop. Other forms of dissemination were formed by interviews conducted in the context of WP2, which gave the opportunity to increase the project's public recognition by disseminating its activities and results to a large group of younger life sciences students and academics. The three main target groups are SB community, EU policy makers and societal stakeholders. To optimise knowledge utilisation, we have subdivided the targeted end-users in five different groups of end users: policy makers working on the definition of regulations for SB and related fields, industrial partners in society working to develop new applications of SB, academic researchers working in the life sciences, academic researchers working in the area of ethical, legal and social issues connected to SB and the wider public. Experts from the academic and the industrial SB community were invited to the workshops and public meetings. Members of the project consortium have participated in scientific meetings of this community. Lectures on ethical issues were given and will be given in the future at conferences. The main goal was to embed ethical, social and legal issues in SB research. Several scientific papers were prepared for publication in scientific journals to assure dissemination. Policy makers have been invited for stakeholder meetings and public dialogues. Briefing documents will be distributed to EU policy makers. Several societal stakeholders have been invited to the stakeholder workshops and public dialogues. Researchers on the ethical, legal and social implications (ELSI) of science and technology will be reached by the papers that have been prepared and those that are to be published. The results will be posted on the website, depending of the journal's house rules.
Collaboration with the Seventh Framework Programme (FP7) SYBHEL project and the FP7 Value Isobars project has been established, leading to further publications. The project website posts all reports. Contact has been established with a number of SB programmes and projects. The Karlsruhe group has actively contacted the media and will disseminate our results to journalists directly and the wider public indirectly. WP1 has identified several main areas of ethical concern in SB raised by experts and in the public discourse. WP2 has analysed normative frameworks that underpin these discussions. WP3 has identified the gaps in these frameworks. The results were presented in a public dialogue meeting organised in Karlsruhe. The results have been incorporated in the final recommendations. Scientific and ethics publications on the results from WP1, 2 and 3 will be disseminated to the community of SB researchers and the community of ELSI researchers. In part this has already been achieved by the workshops and the public event organised in Karlsruhe, but the aim is to extend this beyond the end of the project. For academic dissemination of the project output, we aim to rewrite the most important findings of our project and publish these in relevant peer reviewed journals. The SYNTHETHICS consortium is aiming for a publication of its results in a special issue of a journal. Several ideas on the outline for such a book were developed. Since not all papers produced can be published in the book it will be necessary to make a selection.
Project website: http://www.synethethics.eu(odnośnik otworzy się w nowym oknie)
Contacts:
Patricia Osseweijer - p.osseweijer@tudelft.nl
Laurens Landeweerd - l.landeweed@tudelft.nl
TUDelft, TNW, Department of Biotechnology; Julianalaan 67; 2628BC Delft, the Netherlands.