The book considers the relationship between governance and participation, and the ways participation has been understood, framed and applied in the context of synthetic biology (SB) governance approaches. Based on fundamental questions about the scope, purpose, and responsibilities assigned to public participation activities, the authors conducted an literature review of policy reports and articles on SB governance. The authors identify key characteristics of synthetic biology, such as the complex interplay of research, engineering and (...) IT expertise in the field, as well as the challenges these characteristics pose in designing governance frameworks. Drawing on insights from a literature review, the authors contest calls for “earlier” and “more” participation on the basis that such calls fail to consider the necessary structural adjustments and resources needed for such endeavors. The brief addresses ethical questions arising in synthetic biology that could be used for developing frameworks of governance in the ongoing COVID-19 crisis and the consequent innovations in vaccine research. (shrink)

Synthetic biology is an emerging technology that aims to design and engineer DNA and molecular structures of single cell organisms. Existing organisms can be altered, novel organisms can be created. In doing so, synthetic biology makes use of specific technoscientific understandings of living beings. This volume sets out to explore and assess synthetic biology and its notions of life from philosophical, ethical, social, and legal perspectives. Contents Concepts, Metaphors, Worldviews.- Public Good and Private Ownership.Social (...) and Legal Ramifications.- Opportunities, Risks, Governance. Target Groups Scholars of sociology, philosophy, theory of science, history of science, biology, engineering Politicians and policymakers The Editor Dr. Joachim Boldt is Deputy Director at the Institut für Ethik und Geschichte der Medizin in Freiburg, Germany. (shrink)

The emergence of synthetic biology holds the potential of a major breakthrough in the life sciences by transforming biology into a predictive science. The dual-use characteristics of similar breakthroughs during the twentieth century have led to the application of benignly intended research in e.g. virology, bacteriology and aerobiology in offensive biological weapons programmes. Against this background the article raises the question whether the precautionary governance of synthetic biology can aid in preventing this techno-science witnessing (...) the same fate? In order to address this question, this paper proceeds in four steps: it firstly introduces the emerging techno-science of synthetic biology and presents some of its potential beneficial applications. It secondly analyses contributions to the bioethical discourse on synthetic biology as well as precautionary reasoning and its application to life science research in general and synthetic biology more specifically. The paper then identifies manifestations of a moderate precautionary principle in the emerging synthetic biology dual-use governance discourse. Using a dual-use governance matrix as heuristic device to analyse some of the proposed measures, it concludes that the identified measures can best be described as “patchwork precaution” and that a more systematic approach to construct a web of dual-use precaution for synthetic biology is needed in order to guard more effectively against the field’s future misuse for harmful applications. (shrink)

Synthetic biology may be an important source of progress as well as societal and political conflict. Against this backdrop, several technology assessment organizations have been seeking to contribute to timely societal and political opinion-making on synthetic biology. The Rathenau Instituut, based in the Netherlands, is one of these organizations. In 2011, the institute organized a ‘Meeting of Young Minds’: a young people’s debate between ‘future synthetic biologists’ and ‘future politicians’. The former were represented by participants (...) in the international Genetically Engineered Machines competition, the latter by political youth organizations linked to Dutch political parties. The Rathenau Instituut found seven PYOs—including right wing, left wing, Green and Christian groups—willing to commit to an intensive process aimed at formulating a tentative partisan view on synthetic biology and discussing it with fellow PYOs and iGEM participants. Given the minimal amount of available data on how political parties understand synthetic biology, mapping the debate may provide valuable insights. In this article, I aim to provide such a mapping exercise and also to reflect on how and why the Rathenau Instituut organized the event. (shrink)

For many innovations, oversight fits nicely within existing governance mechanisms; nevertheless, others pose unique public health, environmental, and ethical challenges. Synthetic artemisinin, for example, has many precursors in laboratory‐developed drugs that emulate natural forms of the same drug. The policy challenges posed by synthetic artemisinin do not differ significantly in kind from other laboratory‐formulated drugs. Synthetic biofuels and gene drives, however, fit less clearly into existing governance structures. How many of the new categories of products (...) require new forms of regulatory oversight, or at least extensive forms of testing, remains unclear.Any effort to improve the governance of synthetic biology should start with a rich understanding of the different possible science‐policy interfaces that could help to inform governance. CBA falls into a subset of the overall range of possibilities, and which interface is appropriate may turn out to depend on context, on the demands of the decision at hand. In what follows, we lay out a typology of interfaces. After that, we turn to the question of how to draw upon the range of possible interfaces and effectively address the factual and moral complexities of emerging technologies. We propose a governance model built around structures that we call “governance coordinating committees.” GCCs are intended to be mechanisms for accommodating the complexities of innovations that have far‐ranging societal impacts. The production of biofuels, for example, could contaminate water supplies and have a destructive environmental impact if not managed correctly. The introduction of a gene drive could have economic and environmental impacts that are not restricted to one nation. Forging appropriate means for determining and evaluating those societal impacts, to the best of a corporation's, industry's, or government's ability, is central to responsible research and innovation. Public policy must be shaped in a manner that accommodates as many concerns as possible and minimizes risks. (shrink)

To illustrate dramatically the progress and potential in the field of synthetic biology, one can begin the story with the 2011 winner of the Lasker Clinical Medical Research Award (Youyou 2011). She was an 81-year-old Chinese scientist, Dr. Tu Youyou, who was given an assignment in 1969 by the Chinese government to find a treatment for malaria from among Chinese herbal medicines. She investigated more than 2,000 Chinese herbal preparations, winnowed them down to some 640 possibilities, obtained 380 (...) extracts from about 200 Chinese herbs, and tested them against a mouse model of malaria. She found one extract, of the Artemisia plant, effective in mice, but she could not reproduce the results consistently. So she .. (shrink)

Synthetic biology, as an engineering approach to biological systems, has the potential to disruptively innovate the development of vaccines, therapeutics, and diagnostics. Data accessibility and differences in data-usage capabilities are important factors in shaping this innovation landscape. In this paper, the data that underpin synthetic biology responses to the COVID-19 pandemic are analyzed as positional information goods—goods whose value depends on exclusivity. The positionality of biological data impacts the ability to guide innovations toward societally preferred goals. (...) From both an ethical and economic point of view, positionality can lead to suboptimal as well as beneficial situations. When aiming for responsible innovation (i.e. embedding societal deliberation in the innovation process), it is important to consider hurdles and facilitators in data access and use. Central governance and knowledge commons provide routes to mitigate the negative effects of data positionality. (shrink)

Synthetic biology" is the label of a new technoscientific field with many different facets and agendas. One common aim is to "create life", primarily by using engineering principles to design and modify biological systems for human use. In a wider context, the topic has become one of the big cases in the legitimization processes associated with the political agenda to solve global problems with the aid of (bio-)technological innovation. Conceptual-level and meta-level analyses are needed: we should sort out (...) conceptual ambiguities to agree on what we talk about, and we need to spell out agendas to see the disagreements clearly. The book is based on the interdisciplinary summer school "Analyzing the societal dimensions of synthetic biology", which took place in Berlin in September 2014. The contributions address controversial discussions around the philosophical examination, public perception, moral evaluation and governance of synthetic biology. (shrink)

In science policy, public controversy around synthetic biology has often been presented as a major risk because it could deter innovation. The following inter-related strategies for avoiding contestation have been observed: There have been attempts to close down debates by alluding to the importance and legitimacy of reliance on scientific evidence as input to regulatory processes. Scientific policy advice has stressed sufficiency of existing regulation, economic risks of additional regulation and/or suggestions for monitoring that are limited in scope. (...) Initiatives for self-governance have narrowed the scope of topics for consideration. Engagement with humanities, social sciences and arts has been co-opted for legitimisation and science communication. Although such agendas are of course not ubiquitous, in this paper, I criticise that instrumentally motivated engagement has been supported not only by the scientific community but also by policy institutions and funding bodies. I argue that it is good that this now seems to fuel controversy in the academic and policy realms. As synthetic biology is not the only technoscientific field to see such dynamics, this is also part of the broader context of debate about the governance of science, especially the concept of “responsible research and innovation” currently promoted in the EU. (shrink)

As synthetic biology develops into a promising science and engineering field, we need to have clear ideas and priorities regarding its safety, security, ethical and public dialogue implications. Based on an extensive literature search, interviews with scientists, social scientists, a 4 week long public e-forum, and consultation with several stakeholders from science, industry and civil society organisations, we compiled a list of priority topics regarding societal issues of synthetic biology for the years ahead. The points presented (...) here are intended to encourage all stakeholders to engage in the prioritisation of these issues and to participate in a continuous dialogue, with the ultimate goal of providing a basis for a multi-stakeholder governance in synthetic biology. Here we show possible ways to solve the challenges to synthetic biology in the field of safety, security, ethics and the science-public interface. (shrink)

In this paper, we reflect on our experience as science and technology studies researchers who were members of the working group that produced A Synthetic Biology Roadmap for the UK in 2012. We explore how this initiative sought to govern an uncertain future and describe how it was successfully used to mobilize public funds for synthetic biology from the UK government. We discuss our attempts to incorporate the insights and sensibilities of STS into the policy process (...) and why we chose to use the concept of responsible research and innovation to do so. We analyze how the roadmapping process, and the final report, narrowed and transformed our contributions to the roadmap. We show how difficult it is for STS researchers to influence policy when our ideas challenge deeply entrenched pervasive assumptions, framings, and narratives about how technological innovation necessarily leads to economic progress, about public reticence as a roadblock to that progress, and about the supposed separation between science and society. We end by reflecting on the constraints under which we were operating from the outset and on the challenges for STS in policy. (shrink)

Emergence of novel genome engineering technologies such as clustered regularly interspaced short palindromic repeat has refocused attention on unresolved ethical complications of synthetic biology. Biosecurity concerns, deontological issues and human right aspects of genome editing have been the subject of in-depth debate; however, a lack of transparent regulatory guidelines, outdated governance codes, inefficient time-consuming clinical trial pathways and frequent misunderstanding of the scientific potential of cutting-edge technologies have created substantial obstacles to translational research in this area. While (...) a precautionary principle should be applied at all stages of genome engineering research, the stigma of germline editing, synthesis of new life forms and unrealistic presentation of current technologies should not arrest the transition of new therapeutic, diagnostic or preventive tools from research to clinic. We provide a brief review on the present regulation of CRISPR and discuss the translational aspect of genome engineering research and patient autonomy with respect to the “right to try” potential novel non-germline gene therapies. (shrink)

Synthetic biology has generated extensive discussion about a wide range of risks and potential benefits, the intrinsic value of the technology, and the soci­etal distribution of its risks and benefits. However, be­fore these questions can be resolved, it is important to first ask a critical question: Is synthetic biology different enough from the technologies that came before it that it raises new questions or concerns? By putting synthetic biology into context, we gain a better (...) understanding of the issues, both old and new, that it raises. We can then consider practical governance questions, including ways to improve current practices. (shrink)

Synthetic biology represents a recent and explicit attempt to make biology easier to engineer, and through this to open up the design space of genetic engineering to a wider range of practitioners. Proponents of this approach emphasize the standardization of practices as key to successful biological engineering; yet, meaningful transatlantic differences are emerging with respect to the constitution of key concerns and the governance of synthetic biology in the United States and the United Kingdom. (...) In this article, I tease out how national approaches to governing synthetic biology are being framed against different salient past experiences with recombinant DNA technology. In the US, the governance of synthetic biology is consistently articulated in relation to the early days of recombinant DNA technology and the self-governance mechanisms pioneered in response to Asilomar. In the UK, more recent experiences with genetically modified crops provide the overarching imaginary against which governance initiatives are being proposed. I suggest that these differing sociotechnical imaginaries have implications for how new “groups of concern” are being defined in relation to synthetic biology and how measures to contain perceived risks are being pursued in the US and Britain. (shrink)

Synthetic biology aims at designing biological systems, at building ‘living machines’. The emergence of synthetic biology has reignited the cycle of public debate. The old biotechnology debate is being reiterated and the controversies are deepened. The societal debate follows the technological hype cycle. A new technology with a high visibility and high expectations also raises high controversies. For synthetic biology, this hype is currently near its peak and the first signs of disillusionment are getting (...) visible. In policy development, on the other hand, synthetic biology is in the early stages. Governments examine the need for adaptations to existing regulatory frameworks. There is a gap between the visibility of the technological developments and policy formulation. This gap is crucial for technology assessment: while the hype in public attention is over, essential policy steps are taken. In order to close this gap, technology assessment needs to facilitate the societal–ethical debate when media attention, and thus the visibility of the technological developments, declines. (shrink)

As part of the SYNBIOSAFE project, we carried out an open electronic conference (e-conference), with the aim to stimulate an open debate on the societal issues of synthetic biology in a proactive way. The e-conference attracted 124 registered participants from 23 different countries and different professional backgrounds, who wrote 182 contributions in six different categories: (I) Ethics; (II) Safety; (III) Security; (IV) IPR; (V) Governance and regulation; (VI) and Public perception. In this paper we discuss the main (...) arguments brought up during the e-conference and provide our conclusions about how the community thinks, and thinks differently on the societal impact of synthetic biology. Finally we conclude that there is a chance for an open discourse on the societal issues of synthetic biology happening, and that the rules to govern such a discourse might be set up much easier and be respected more readily than many would suggest. (shrink)

In this article, we raise ethical concerns about the potential misuse of open-source biology : biological research and development that progresses through an organisational model of radical openness, deskilling, and innovation. We compare this organisational structure to that of the open-source software model, and detail salient ethical implications of this model. We demonstrate that OSB, in virtue of its commitment to openness, may be resistant to governance attempts.

Kaebnick, Gusmano, and Murray tackle some important issues raised by the emerging field of synthetic biology. Many of these issues arise pre­cisely because synthetic biology is still emerging, making it hard, if not impossible, to predict how the technology will pan out. In the context of this uncertainty, Kaebnick, Gusmano, and Murray imply, we may have to change our familiar patterns of thinking and governing. It is this point that I elaborate on here. I argue that (...) if we embrace the distinctive characteris­tics of emerging biotechnologies, we can shift away from attempts to analyze the risks and benefits of technologi­cal developments and toward discussions of the moti­vations and purposes that drive them in the first place. This perspective gives us a solid rationale for public and stakeholder engagement (or “democratic deliberation,” as Kaebnick et al. call it) and helps us address some of the concerns Kaebnick and colleagues raise about how this engagement should be organized. (shrink)

The rise of precision medicine has led to an unprecedented focus on human biological material in biomedical research. In addition, rapid advances in stem cell technology, regenerative medicine and synthetic biology are leading to more complex human tissue structures and new applications with tremendous potential for medicine. While promising, these developments also raise several ethical and practical challenges which have been the subject of extensive academic debate. These debates have led to increasing calls for longitudinal governance arrangements (...) between tissue providers and biobanks that go beyond the initial moment of obtaining consent, such as closer involvement of tissue providers in what happens to their tissue, and more active participatory approaches to the governance of biobanks. However, in spite of these calls, such measures are being adopted slowly in practice, and there remains a strong tendency to focus on the consent procedure as the tool for addressing the ethical challenges of contemporary biobanking. In this paper, we argue that one of the barriers to this transition is the dominant language pervading the field of human tissue research, in which the provision of tissue is phrased as a ‘donation’ or ‘gift’, and tissue providers are referred to as ‘donors’. Because of the performative qualities of language, the effect of using ‘donation’ and ‘donor’ shapes a professional culture in which biobank participants are perceived as passive providers of tissue free from further considerations or entitlements. This hampers the kind of participatory approaches to governance that are deemed necessary to adequately address the ethical challenges currently faced in human tissue research. Rather than reinforcing this idea through language, we need to pave the way for the kind of participatory approaches to governance that are being extensively argued for by starting with the appropriate terminology. (shrink)

This paper reviews the location of Responsible Research and Innovation approaches within the access and benefit sharing policy spaces of the Convention on Biological Diversity and Nagoya Protocol. We describe how a range of dialogues on ethical research practices found a home, almost inadvertently, within the ABS policy process. However, more recent RRI dialogues around emerging technologies have not been similarly absorbed into ABS policy, due in part to the original framing of ABS and associated definitional and scope issues. Consideration (...) is given to the challenges posed to these policy processes by the transformative and rapid nature of scientific and technological change today, including the emerging field of synthetic biology. Drawing on experiences from regulating ABS, we emphasize that the integration of RRI into policies for new, emerging, or poorly understood activities such as synthetic biology faces deficiencies such as limits to government capacity, jurisdictional confusion, shortages in funds, and an absence of strategic approaches. We conclude that a coordinated combination of diverse policy processes within the CBD might provide an invaluable space for RRI dialogues on social justice, sustainability, biosafety, and other issues raised by emerging technologies. (shrink)

The dual-use dilemma arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of scientific research sometimes has the potential to be used for bad as well as good purposes. It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e.g., the promotion of health in the context of providing the wherewithal for the killing of (...) innocents. It is an ethical dilemma for the researcher because of the potential actions of others, e.g., malevolent non-researchers who might steal dangerous biological agents, or make use of the original researcher’s work. And it is a dilemma for governments concerned with the security of their citizens, as well as their health. In this article we construct a taxonomy of types of “experiments of concern” in the biological sciences, and thereby map the terrain of ethical risk. We then provide a series of analyses of the ethical problems and considerations at issue in the dual-use dilemma, including the impermissibility of certain kinds of research and possible restrictions on dissemination of research results given the risks to health and security. Finally, we explore the main available institutional responses to some of the specific ethical problems posed by the dual-use dilemma in the biological sciences. (shrink)

Many scientific models in biology are how-possibly models. These models depict things as they could be, but do not necessarily capture actual states of affairs in the biological world. In contemporary philosophy of science, it is customary to treat how-possibly models as second-rate theoretical tools. Although possibly important in the early stages of theorizing, they do not constitute the main aim of modelling, namely, to discover the actual mechanism responsible for the phenomenon under study. In the paper it is (...) argued that this prevailing picture does not do justice to the synthetic strategy that is commonly used in biological engineering. In synthetic biology, how-possibly models are not simply speculations or eliminable scaffolds towards a single how-actually model, but indispensable design hypotheses for a field whose ultimate goal is to build novel biological systems. The paper explicates this by providing an example from the study of alternative genetic systems by synthetic biologist Steven Benner and his group. The case will also highlight how the method of synthesis, even when it fails, provides an effective way to limit the space of possible models for biological systems. (shrink)

Mammalian synthetic biology holds the promise of providing novel therapeutic strategies, and the first success stories are beginning to be reported. Here we focus on the latest generation of mammalian transgene control devices, highlight state‐of‐the‐art synthetic gene network design, and cover prototype therapeutic circuits. These will have an impact on future gene‐ and cell‐based therapies and help bring drug discovery into a new era. The inventory of biological parts that are essential for life on this planet is (...) becoming increasingly complete. The postgenomic era has provided encyclopedic information on gene‐function correlations and systems biology is now delivering comprehensive details on the dynamics of biochemical reaction networks in living organisms. The time has come to reassemble these catalogued items and design new biological devices and systems with novel and useful functionality in a rational and systematic manner. This is the premise of synthetic biology, a constructive systems biology discipline likely to become the life science revolution of the 21st century. (shrink)

Synthetic biology presents a challenge to traditional accounts of biology: Whereas traditional biology emphasizes the evolvability, variability, and heterogeneity of living organisms, synthetic biology envisions a future of homogeneous, humanly engineered biological systems that may be combined in modular fashion. The present paper approaches this challenge from the perspective of the epistemology of technoscience. In particular, it is argued that synthetic-biological artifacts lend themselves to an analysis in terms of what has been called (...) ‘thing knowledge’. As such, they should neither be regarded as the simple outcome of applying theoretical knowledge and engineering principles to specific technological problems, nor should they be treated as mere sources of new evidence in the general pursuit of scientific understanding. Instead, synthetic-biological artifacts should be viewed as partly autonomous research objects which, qua their material-biological constitution, embody knowledge about the natural world—knowledge that, in turn, can be accessed via continuous experimental interrogation. (shrink)

Synthetic biologists aim to generate biological organisms according to rational design principles. Their work may have many beneficial applications, but it also raises potentially serious ethical concerns. In this article, we consider what attention the discipline demands from bioethicists. We argue that the most important issue for ethicists to examine is the risk that knowledge from synthetic biology will be misused, for example, in biological terrorism or warfare. To adequately address this concern, bioethics will need to broaden (...) its scope, contemplating not just the means by which scientific knowledge is produced, but also what kinds of knowledge should be sought and disseminated. (shrink)

Maintaining the coherence of the distinction between nature and artefact has long been central to environmental thinking. By building genomes from scratch out of 'bio-bricks', synthetic biology promises to create biotic artefacts markedly different from anything created thus far in biotechnology. These new biotic artefacts depart from a core principle of Darwinian natural selection – descent through modification – leaving them with no causal connection to historical evolutionary processes. This departure from the core principle of Darwinism presents a (...) challenge to the normative foundation of a number of leading positions in environmental ethics. As a result, environmental ethicists with a commitment to the normative significance of the historical evolutionary process may see synthetic biology as a moral 'line in the sand'. (shrink)

Probably the most distinctive feature of synthetic biology is its being “synthetic” in some sense or another. For some, synthesis plays a unique role in the production of knowledge that is most distinct from that played by analysis: it is claimed to deliver knowledge that would otherwise not be attained. In this contribution, my aim is to explore how synthetic biology delivers knowledge via synthesis, and to assess the extent to which this knowledge is distinctly (...) synthetic. On the basis of distinctions between knowledge-how and knowledge-why, and between syntheses that succeed and syntheses that fail, I argue that the contribution of synthesis to knowledge is best understood when syntheses are construed as experimental interventions that aim at probing causal relationships between properties of the entities that are combined through these syntheses and properties of their target products. The distinctiveness of synthetic biology in its quest for knowledge through synthesis stems from its ability to sample at will a space of empirical possibilities that is not only huge but also that has been so scarcely sampled by nature. (shrink)

A range of views on the morality of synthetic biology and its place in public policy and political discourse.

We attempt to justify the use of synthetic biology in response to the climate crisis, based on the premise that it is impossible to avert runaway climate change without sequestering sufficient greenhouse gases (GHG), which could only become possible through Negative Emissions Technologies (NETs). Then, moving from a consequentialist standpoint, we acquiesce to how the consequences of using NETs through synthetic biology are preferable to the catastrophic consequences of runaway climate change. In conclusion, we show how (...) our analysis of synthetic biology resonates with a zoecentric view of climate science and ethics. (shrink)

In this article I discuss the ethics of synthetic biology from a broadly deontological perspective, evaluating its morality in terms of the integrity of nature, the dignity of life and the relationship between God and his creation. Most ethical analyses to date have been largely consequentialist in nature; they reveal a dual use dilemma, showing that synbio has potential for great good and great evil, possibly more so than any step humanity has taken before. A deontological analysis may (...) help to resolve this dilemma, by evaluating whether synbio is right or wrong in itself. I also assess whether deontology alone is a sufficient methodological paradigm for the proper evaluation of synbio ethics. (shrink)

Through the relatively new science and technology known as synthetic biology, scientists are attempting to create useful new life forms. Any attempt to “create life” inevitably prompts some to ask whether man is trespassing into areas properly reserved for a divine creator. The potential creative power of synthetic biology raises this concern to a level that has not been known before. Thus a new chapter in the history of the relationship between science and religion is being (...) written. This article presents some of the scholarly perspectives on that chapter. (shrink)

Synthetic biology aims at making life easier to an engineer by applying biotechnology engineering principles such as standardization and modularity. I argue that living organisms are inherently non-machine, non-standardized entities and that the current state-of-the-art in SynBio combines pre- and post-standardization efforts, in a scenario without evidence that full standardization in biology is even possible. I finally propose a new view on SynBio based on purpose rather than on technicalities.

Emerging technologies present a challenging but fascinating set of ethical, legal and regulatory issues. The articles selected for this volume provide a broad overview of the most influential historical and current thinking in this area and show that existing frameworks are often inadequate to address new technologies - such as biotechnology, nanotechnology, synthetic biology and robotics - and innovative new models are needed. This collection brings together invaluable, innovative and often complementary approaches for overcoming the unique challenges of (...) emerging technology ethics and governance. (shrink)

In debates about criteria for human death, several camps have emerged, the main two focusing on either loss of the "organism as a whole" (the mainstream view) or loss of consciousness or "personhood." Controversies also rage over the proper definition of "irreversible" in criteria for death. The situation is reminiscent of the proverbial blind men palpating an elephant; each describes the creature according to the part he can touch. Similarly, each camp grasps some aspect of the complex reality of death. (...) The personhood camp, in contrast to the mainstream "organism" camp, recognizes that a human organism can still be a biological living whole even without brain function. The mainstream camp, in contrast to the personhood camp, recognizes that a person can be permanently, even irreversibly unconscious, and still be a living person so long as his/her body is alive. The author proposes that hylomorphic dualism incorporates both these key insights. But to complete the picture of the entire "death elephant," a fundamental paradigm shift is needed to make sense of other seemingly conflicting insights. The author proposes a "semantic bisection" of the concept of death, analogous to the traditional distinction at the beginning of life between "conception" and "birth." To avoid the semantic baggage associated with the term "death," the two new death-related concepts are referred to as "passing away" (or "deceased") and "deanimation," corresponding, respectively, to sociolegal ceasing-to-be (mirror image of birth) and ontological/theological ceasing-to-be of the bodily organism (mirror image of conception). Regarding criteria, the distinguishing feature is whether the cessation of function is permanent (passing away) or irreversible (deanimation). If the "dead donor rule" were renamed the "deceased donor rule" (both acronyms felicitously being "DDR"), the ethics of organ transplantation from non–heart-beating donors could, in principle, be validly governed by the DDR, even though the donors are not yet ontologically "deanimated." Thus, the paradigm shift satisfies both those who insist on maintaining the DDR and those who claim that it has all along been receiving only lip service and should be explicitly loosened to include those who are "as good as dead." Even so, a number of practical caveats remain to be worked out for non–heart-beating protocols. (shrink)

I discuss the moral significance of artificial life within synthetic biology via a discussion of Douglas, Powell and Savulescu's paper 'Is the creation of artificial life morally significant’. I argue that the definitions of 'artificial life’ and of 'moral significance’ are too narrow. Douglas, Powell and Savulescu's definition of artificial life does not capture all core projects of synthetic biology or the ethical concerns that have been voiced, and their definition of moral significance fails to take (...) into account the possibility that creating artificial life is conditionally acceptable. Finally, I show how several important objections to synthetic biology are plausibly understood as arguing that creating artificial life in a wide sense is only conditionally acceptable. (shrink)

The scientific study of living organisms is permeated by machine and design metaphors. Genes are thought of as the ‘‘blueprint’’ of an organism, organisms are ‘‘reverse engineered’’ to discover their func- tionality, and living cells are compared to biochemical factories, complete with assembly lines, transport systems, messenger circuits, etc. Although the notion of design is indispensable to think about adapta- tions, and engineering analogies have considerable heuristic value (e.g., optimality assumptions), we argue they are limited in several important respects. In (...) particular, the analogy with human-made machines falters when we move down to the level of molecular biology and genetics. Living organisms are far more messy and less transparent than human-made machines. Notoriously, evolution is an oppor- tunistic tinkerer, blindly stumbling on ‘‘designs’’ that no sensible engineer would come up with. Despite impressive technological innovation, the prospect of artificially designing new life forms from scratch has proven more difficult than the superficial analogy with ‘‘programming’’ the right ‘‘software’’ would sug- gest. The idea of applying straightforward engineering approaches to living systems and their genomes— isolating functional components, designing new parts from scratch, recombining and assembling them into novel life forms—pushes the analogy with human artifacts beyond its limits. In the absence of a one-to-one correspondence between genotype and phenotype, there is no straightforward way to imple- ment novel biological functions and design new life forms. Both the developmental complexity of gene expression and the multifarious interactions of genes and environments are serious obstacles for ‘‘engi- neering’’ a particular phenotype. The problem of reverse-engineering a desired phenotype to its genetic ‘‘instructions’’ is probably intractable for any but the most simple phenotypes. Recent developments in the field of bio-engineering and synthetic biology reflect these limitations. Instead of genetically engi- neering a desired trait from scratch, as the machine/engineering metaphor promises, researchers are making greater strides by co-opting natural selection to ‘‘search’’ for a suitable genotype, or by borrowing and recombining genetic material from extant life forms. (shrink)

The interests of synthetic biologists may appear to differ greatly from those of evolutionary biologists. The engineering of organisms must be distinguished from the tinkering action of evolution; the ambition of synthetic biologists is to overcome the limits of natural evolution. But the relations between synthetic biology and evolutionary biology are more complex than this abrupt opposition: Synthetic biology may play an important role in the increasing interactions between functional and evolutionary biology. (...) In practice, synthetic biologists have learnt to submit the proteins and modules they construct to a Darwinian process of selection that optimizes their functioning. More importantly, synthetic biology can provide evolutionary biologists with decisive tools to test the scenarios they have elaborated by resurrecting some of the postulated intermediates in the evolutionary process, characterizing their properties, and experimentally testing the genetic changes supposed to be the source of new morphologies and functions. This synthetic, experimental evolution will renew and clarify many debates in evolutionary biology: It will lead to the explosion of some vague concepts as constraints, parallel evolution, and convergence, and replace them with precise mechanistic descriptions. In this way, synthetic biology resurrects the old philosophical debate about the relations between the real and the possible. (shrink)

Recent developments in synthetic biology are described and characterized as moving the era of biotechnology into platform technologies. Platform technologies enable rapid and diffuse innovations and simultaneous product development in diffuse markets, often targeting sectors of the economy that have traditionally been thought to have little relationship to one another. In the case of synthetic biology, pharmaceutical and biofuel product development are occurring interactively. But the regulatory and ethical issues associated with these two applications share very (...) little overlap. As such, there is some risk that focus on traditional medical applications, for which the ethical expertise is highly developed, will overshadow the ethical issues that arise in connection with land use and its attendant socioeconomic consequences, especially in the developing world. The 2010 report of the Presidential Commission for the Study of Bioethics exhibits this tendency. (shrink)

Synthetic biology is an emerging engineering discipline that attempts to design and rewire biological components, so as to achieve new functions in a robust and predictable manner. The new tools and strategies provided by synthetic biology have the potential to improve therapeutics for neurodegenerative diseases. In particular, synthetic biology will help design small molecules, proteins, gene networks, and vectors to target disease‐related genes. Ultimately, new intelligent delivery systems will provide targeted and sustained therapeutic benefits. (...) New treatments will arise from combining ‘protect and repair’ strategies: the use of drug treatments, the promotion of neurotrophic factor synthesis, and gene targeting. Going beyond RNAi and artificial transcription factors, site‐specific genome modification is likely to play an increasing role, especially with newly available gene editing tools such as CRISPR/Cas9 systems. Taken together, these advances will help develop safe and long‐term therapies for many brain diseases in human patients. (shrink)

It is a most commonly accepted hypothesis that life originated from inanimate matter, somehow being a synthetic product of organic aggregates, and as such, a result of some sort of prebiotic synthetic biology. In the past decades, the newly formed scientific discipline of synthetic biology has set ambitious goals by pursuing the complete design and production of genetic circuits, entire genomes or even whole organisms. In this paper, I argue that synthetic biology might (...) also shed some novel and interesting perspectives on the question of the origin of life, and that, in addition, it might challenge our most commonly accepted definitions of life, thereby changing the ways we might think about life and its origin. (shrink)

Synthetic biology research is often described in terms of programming cells through the introduction of synthetic genes. Genetic material is seemingly attributed with a high level of causal responsibility. We discuss genetic causation in synthetic biology and distinguish three gene concepts differing in their assumptions of genetic control. We argue that synthetic biology generally employs a difference-making approach to establishing genetic causes, and that this approach does not commit to a specific notion of (...) genetic program or genetic control. Still, we suggest that a strong program concept of genetic material can be used as a successful heuristic in certain areas of synthetic biology. Its application requires control of causal context, and may stand in need of a modular decomposition of the target system. We relate different modularity concepts to the discussion of genetic causation and point to possible advantages of and important limitations to seeking modularity in synthetic biology systems. (shrink)

Synthetic biology 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. Each approach is characterized by different aims, methods and constructs, in addition to a range of positions on intellectual property and regulatory regimes. We identify subtle but important differences between the schools in relation to their treatments of genetic determinism, cellular context and complexity. These distinctions (...) tie into two broader issues that define synthetic biology: the relationships between biology and engineering, and between synthesis and analysis. These themes also illuminate synthetic biology's connections to genetic and other forms of biological engineering, as well as to systems biology. We suggest that all these knowledge-making distinctions in synthetic biology raise fundamental questions about the nature of biological investigation and its relationship to the construction of biological components and systems. (shrink)

The scientific study of living organisms is permeated by machine and design metaphors. Genes are thought of as the ‘‘blueprint’’ of an organism, organisms are ‘‘reverse engineered’’ to discover their functionality, and living cells are compared to biochemical factories, complete with assembly lines, transport systems, messenger circuits, etc. Although the notion of design is indispensable to think about adaptations, and engineering analogies have considerable heuristic value (e.g., optimality assumptions), we argue they are limited in several important respects. In particular, the (...) analogy with human-made machines falters when we move down to the level of molecular biology and genetics. Living organisms are far more messy and less transparent than human-made machines. Notoriously, evolution is an opportunistic tinkerer, blindly stumbling on ‘‘designs’’ that no sensible engineer would come up with. Despite impressive technological innovation, the prospect of artificially designing new life forms from scratch has proven more difficult than the superficial analogy with ‘‘programming’’ the right ‘‘software’’ would suggest. The idea of applying straightforward engineering approaches to living systems and their genomes— isolating functional components, designing new parts from scratch, recombining and assembling them into novel life forms—pushes the analogy with human artifacts beyond its limits. In the absence of a one-to-one correspondence between genotype and phenotype, there is no straightforward way to implement novel biological functions and design new life forms. Both the developmental complexity of gene expression and the multifarious interactions of genes and environments are serious obstacles for ‘‘engineering’’ a particular phenotype. The problem of reverse-engineering a desired phenotype to its genetic ‘‘instructions’’ is probably intractable for any but the most simple phenotypes. Recent developments in the field of bio-engineering and synthetic biology reflect these limitations. Instead of genetically engineering a desired trait from scratch, as the machine/engineering metaphor promises, researchers are making greater strides by co-opting natural selection to ‘‘search’’ for a suitable genotype, or by borrowing and recombining genetic material from extant life forms. (shrink)

This article examines how minimal genome research mobilizes philosophical concepts such as minimality and essentiality. Following a historical approach the article aims to uncover what function this terminology plays and which problems are raised by them. Specifically, four historical moments are examined, linked to the work of Harold J. Morowitz, Mitsuhiro Itaya, Eugene Koonin and Arcady Mushegian, and J. Craig Venter. What this survey shows is a historical shift away from historical questions about life or descriptive questions about specific organisms (...) towards questions that explore biological possibilities: what are possible forms of minimal genomes, regardless of whether they exist in nature? Moreover, it highlights a fundamental ambiguity at work in minimal genome research between a universality claim and a standardization claim: does a minimal genome refer to the minimal gene set for any organism whatsoever? Or does it refer rather to a gene set that will provide stable, robust and predictable behaviour, suited for biotechnological applications? Two diagnoses are proposed for this ambiguity: a philosophical diagnosis of how minimal genome research either misunderstands the ontology of biological entities or philosophically misarticulates scientific practice. Secondly, a historical diagnosis that suggests that this ambiguity is part of a broader shift towards technoscience. (shrink)

Paul Thompson argues that current synthetic biology amounts to synthetic genomics, comprising a ‘platform’ technology, and that Christopher Preston's deontological objections based on its supposed rejection of the historical process of evolution miscarry. This makes it surprising that Thompson's normative ethic consists in a deontological appeal to Kantian duties of imperfect obligation. Construed as obligations subject to choice, such constraints risk being excessively malleable where the ethical objections to deployment of this technology concern land rights and/or exploitation. (...) Thompson's advocacy of processes ‘more beneficial’ well illustrates another vulnerability; processes more beneficial than ones that undermine livelihoods could be best avoided themselves, although ones more beneficial than the status quo may not. He well argues that non-deontological arguments should not be confined to human survival, but neglects stances that are either biocentric, consequentialist, or both. Yet a truly synthetic bioethics would be likely to embody these characteristics. (shrink)

The question is discussed how noise gained a functional meaning in the context of biology. According to the common view, noise is considered a disturbance or perturbation. I analyze how this understanding changed and what kind of developments during the last 10 years contributed to the emergence of a new understanding of noise. Results gained during a field study in a synthetic biology laboratory show that the emergence of this new research discipline—its highly interdisciplinary character, its new (...) technologies and novel modeling strategies—provided essential impulses, which led to the observed change in the concept of noise. The laboratory study is combined with a historical analysis, which explores the general question as to how concepts travel between disciplines and, specifically, how noise was transferred from engineering and physics into biology. In the past, scientists, such as Lotka and Goodwin, tried to introduce a statistical mechanics into biology and discussed the problem of “unfitting” concepts. The change in the meaning of the concept can be interpreted as a way of making it fit to the novel context in which it is applied. (shrink)

Synthetic biology is a field of research that concentrates on the design, construction, and modification of new biomolecular parts and metabolic pathways using engineering techniques and computational models. By employing knowledge of operational pathways from engineering and mathematics such as circuits, oscillators, and digital logic gates, it uses these to understand, model, rewire, and reprogram biological networks and modules. Standard biological parts with known functions are catalogued in a number of registries (e.g. Massachusetts Institute of Technology Registry of (...) Standard Biological Parts). Biological parts can then be selected from the catalogue and assembled in a variety of combinations to construct a system or pathway in a microbe. Through the innovative re-engineering of biological circuits and the optimization of certain metabolic pathways, biological modules can be designed to reprogram organisms to produce products or behaviors. Synthetic biology is what is known as a “platform technology”. That is, it generates highly transferrable theoretical models, engineering principles, and know-how that can be applied to create potential products in a wide variety of industries. Proponents suggest that applications of synthetic biology may be able to provide scientific and engineered solutions to a multitude of worldwide problems from health to energy. Synthetic biology research has already been successful in constructing microbial products which promise to offer cheaper pharmaceuticals such as the antimalarial synthetic drug artemisinin, engineered microbes capable of cleaning up oil spills, and the engineering of biosensors that can detect the presence of high concentrations of arsenic in drinking water. One of the potential benefits of synthetic biology research is in its application to biofuel production. It is this application which is the focus of this entry. The term “biofuel” has referred generally to all liquid fuels that are sourced from plant or plant byproducts and are used for energy necessary for transportation vehicles (Thompson 2012). Biofuels that are produced using synthetic biological techniques re-engineer microbes into biofuel factories are a subset of these. (shrink)

A widespread and influential characterization of synthetic biology emphasizes that synthetic biology is the application of engineering principles to living systems. Furthermore, there is a strong tendency to express the engineering approach to organisms in terms of what seems to be an ontological claim: organisms are machines. In the paper I investigate the ontological and heuristic significance of the machine analogy in synthetic biology. I argue that the use of the machine analogy and the (...) aim of producing rationally designed organisms does not necessarily imply a commitment to mechanical biology. The ideal of applying engineering principles to biology is best understood as expressing recognition of the machine-unlikeness of natural organisms and the limits of human cognition. The paper suggests an interpretation of the identification of organisms with machines in synthetic biology according to which it expresses a strategy for representing, understanding, and constructing living systems that are more machine-like than natural organisms. (shrink)