Synthetic biology (SynBio) covers two main areas: application engineering, exemplified by metabolic engi- neering, and the design of life from artificial building blocks. As the general public is often reluctant to embrace synthetic approaches, preferring nature to artifice, its immediate future will depend very much on the public’s reaction to the unmet needs created by the pervasive demands of sustainability. On the other hand, this reluctance should not have a negative impact on research that will now take into account (...) the existence of the multiple transitions that cells face over time. The ages of life—birth, development, maturation, senescence and death—reflect specific key transitions and have, until now, rarely been taken into account in SynBio designs. This results in a mismatch between novelty and the very long evolutionary time that led to the existing chassis [remember that this is the common term used to describe the cellular framework as seen by synthetic biologists (de Lorenzo & Danchin, 2008)]. It also implies that, in general, transitions between growth stages will be taken into account with the appro- priate embodiment of highly specific processes. This is particularly important when adapting new models to their host, whether natural or artificial. Adaptation fol- lows two stages, short-term accommodation of new entities and long-term assimilation into the cell as a whole. This requires discrimination between classes of entities. We suggest that proteins playing the essential role of Maxwell’ demons, here named Maxwell’s dis- criminators (MxDs) to refer to their original function, will permit the assimilation and accommodation of artificial constructs. As a consequence, we can foresee that class discrimination, beyond mere recognition, will be implemented in SynBio 2.0, leading to an authentic par- adigm shift (Kuhn, 1996), based on conceptions that embody information as a genuine currency of reality. (shrink)

I examine the positive and negative features of synthetic biology (‘SynBio’) from a utilitarian ethical perspective. The potential beneficial outcomes from SynBio in the context of medicine are substantial; however it is not presently possible to predict precise outcomes due to the nascent state of the field. Potential negative outcomes from SynBio also exist, including iatrogenesis and bioterrorism; however it is not yet possible to quantify these risks. I argue that the application of a ‘precautionary’ approach to (...) SynBio is ethically fraught, as is the notion that SynBio-associated knowledge ought to be restricted. I conclude that utilitarians ought to support a broadly laissez-faire stance in respect of SynBio. (shrink)

:This article analyzes the ethics of synthetic biology from a consequentialist perspective, examining potential effects on food and agriculture, and on medicine, fuel, and the advancement of science. The issues of biosafety and biosecurity are also examined. A consequentialist analysis offers an essential road map to policymakers and regulators as to how to deal with synbio. Additionally, the article discusses the limitations of consequentialism as a tool for analysing synbioethics. Is it possible to predict, with any degree of plausibility, (...) what the consequences of synthetic biology will be in 50 years, or in 100, or in 500? Synbio may take humanity to a place of radical departure from what is known or knowable. (shrink)

Synthetic biology (synbio) involves designing and creating new living systems to serve human ends, using techniques including molecular biology, genomics, and engineering. Existing bioethical analyses of synbio focus largely on balancing benefits against harms, the dual-use dilemma, and metaphysical questions about creating and commercializing synthetic organisms. We argue that these approaches fail to consider key feminist concerns. We ground our normative claims in two case studies, focusing on the public good, who holds and wields power, and synbio (...) research projects’ particularity and context. Attention to feminist concerns is essential for synbio to realize its potential in ethically justifiable ways. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due (...) to the novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (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.

Assembly of minimal genomes revealed many genes encoding unknown functions. Three overlooked functional categories account for some of them. Cells are prone to make errors and age. As a first key function, discrimination between proper and changed entities is indispensable. Discrimination requires management of information, an authentic, yet abstract, cur- rency of reality. For example proteins age, sometimes very fast. The cell must identify, then get rid of old proteins without destroying young ones. Implementing discrimination in cells leads to the (...) second set of functions, usually ignored. Being abstract, information must nevertheless be embodied into material entities, with unavoidable idiosyncratic properties. This brings about novel unmet needs. Hence, the buildup of cells elicits specific but awkward material implementations, ‘kludges’ that become essential under particular settings, while difficult to identify. Finally, a third functional category char- acterizes the need for growth, with metabolic implementations allowing the cell to put together the growth of its cytoplasm, membranes, and genome, spanning different spatial dimensions. Solving this metabolic quandary, critical for engineering novel synthetic biology chassis, uncovered an unexpected role for CTP synthetase as the coordinator of nonhomothetic growth. Because a significant number of SynBio constructs aim at creating cell factories we expect that they will be attacked by viruses (it is not by chance that the function of the CRISPR system was identified in industrial settings). Substantiating the role of CTP, natural selection has dealt with this hurdle via synthesis of the antimetabolite 30-deoxy-30,40-didehydro- CTP, recruited for antiviral immunity in all domains of life. (shrink)

Synthetic biology is a broad term covering multiple scientific methodologies, technologies, and practices. Pairing biology with engineering, synbio seeks to design and build biological systems, either through improving living cells by adding in new functions, or creating new structures by combining natural and synthetic components. As with all new technologies, synthetic biology raises a number of ethical considerations. In order to understand what these issues might be, and how they relate to those covered in ethics literature on synbio, (...) we conducted an interview study with practicing synthetic biologists affiliated with a synthetic biology centre in Australia. Scientists identified a range of ethical challenges germane to the field, including precarious employment, pressures from industry, gender inequity, and the negative effects of the hyping of synbio. These challenges differed markedly from those identified in the ethics literature, whose treatment of the harms and benefits of synbio remains largely speculative and abstract. In our discussion of the pragmatic, every day ethical issues synthetic biologists face, we illustrate how issues of waste or research integrity play pivotal roles in everything from lived experiences in the laboratory, to long-term research trajectories guiding the field. In a confirmation of the ethical relevance of our participant’s views on the field, we argue that the subjects they raise must be included in any ethical analysis of synbio as a field. (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)

Coping with the existential risk of synthetic biology Synthetic biology (synbio) is a domain in full development, with a potentially big impact on humanity, both in a positive and a negative way. In that sense, synbio is not unique. After a short introduction into synbio, we survey the natural phenomena and technologies that can lead to a premature extinction of Earth-originating life or that can lead to the permanent and drastic reduction of its potential. Within that framework, (...) synbio can be classified as an anthropogenic existential risk in the short term. This leads to the question of how to deal with such risky technologies taking into account existential risks. For emerging technologies, Europe has chosen to be guided by the precautionary principle, focussing heavily on the prevention of possible harm. Implementing the principle has however not been able to offset the increase in anthropogenic existential risks. In addition the principle prevents synbio to play an important role in mitigating intermediate existential risks. Hence, there are reasons to abandon the precautionary principle in favour of a European version of the proactionary principle. (shrink)

Current ethical analysis tends to evaluate synthetic biology at an overview level. Synthetic biology, however, is an umbrella term that covers a variety of areas of research. These areas contain, in turn, a hierarchy of different research fields. This abstraction hierarchy—the term is borrowed from engineering—permits synthetic biologists to specialise to a very high degree. Though synthetic biology per se may create profound ethical challenges, much of the day-to-day research does not. Yet seemingly innocuous research could lead to ethically problematic (...) results. For example, Dolly the sheep resulted from a long series of research steps, none of which presented any ethical problems. The atomic bomb was developed as a result of Einstein’s uncontentions theoretical research that proved the equivalence of matter and energy. Therefore it would seem wise for ethicists to evaluate synbio research across its subfields and through its abstraction hierarchies, comparing and inter-relating the various areas of research. In addition, it would be useful if journals that publish synbio papers require an ethical statement from authors, as standard practice, so as to encourage scientists to constantly engage with ethical issues in their work. Also, this would allow an ethical snapshot of the state of the research at any given time to exist, allowing for accurate evaluation by scientists and ethicists, regulators and policymakers. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:In the Belly of the Whale:Some Thoughts on Preserving the Integrity of the New Bioethics CommissionF. Daniel Davis (bio)10 July 2010. Washington, D.C. President Obama's Presidential Commission for the Study of Bioethical Issues has just concluded its inaugural meeting, designed as a primer—the first of three that it plans to hold—on synthetic biology. As a topic for deliberation by a national bioethics commission, "synbio" is ideal. A cloud (...) of equipoise hangs over the practical implications of recent developments in this, the latest phase in the evolution of biotechnology—a seemingly genuine uncertainty about the need for additional mechanisms of oversight to mitigate potential risks to biosafety or biosecurity. Despite these concerns, its advocates and practitioners enthusiastically champion the prospect of eventual, perhaps significant benefits to be gained with progress in "synbio," including, for example, enhanced processes for the mass production of vaccines and biofuels. And yet like the advent of recombinant DNA technologies in the mid-1970s, synthetic biology has generated not only hope for benefits and concern for risks, but also questions variously described as "deep," "profound," "fundamental," and "philosophical": Is the capacity to synthesize novel, living entities yet another technological invitation to hubris on the part of humankind? Will that capacity alter the relationship between humankind and nature? How should we think about the moral status of living entities created de novo in the laboratory? Should we even care? How will wide-scale applications of synthetic biology tip the scales of social justice? And finally, the democratization of synthetic biology, the growth of DIY-BIO (do-it-yourself-biology) communities beyond the usual scientific arenas of academia and industry, has infused old questions about scientific freedom and responsibility with new complexities—all in the midst of an American public that is reportedly unaware and uneducated about this new chapter in the often triumphant, unsettling history of biotechnology.Thus, the topic of synthetic biology presents the new commission with several possibilities. It could very well make a substantial contribution to public policies responsive to both the current capabilities and the possible trajectories of [End Page 291] these emergent biotechnologies. The very fact that the President explicitly asked the Commission to take up the topic and report back to him (in six months) means that that potential is especially promising. It could, as well, delve into the "deeper" philosophical questions that "synbio" raises with the aim of bringing both depth and breadth to the tasks of critically analyzing and reflecting upon what currently is known and what, with regard to the future, can only be glimpsed of this amalgam of the life sciences, engineering, and other disciplines. The Commission could also set its sights on diminishing the apparent deficit in public understanding of these biotechnologies. And finally, with this topic as well as any others it takes up, the Commission, along with the administration that established it, could make an effort to reinvigorate public bioethics in the United States. At the very least, in the sobering light of experience with the President's Council on Bioethics, certain actions or behaviors could be avoided in the interests of preserving the integrity—the moral and political legitimacy—of the new commission. Although each of these possibilities warrants further explanation, my focus here is the final one.The Belly of the WhaleIn several decades, some future historian of public bioethics in the U.S. will be able to look back on the bioethics commissions established to date and offer an insightful, comprehensive—maybe even magisterial—account of their beginnings and endings, their deliberations and the political forces that shaped them, and perhaps most important, their ultimate value as public bodies. Lacking the strategic perch of historical distance, and fresh from the trenches, I can only offer a few somewhat informed but partial observations and arguments about public bioethics in the context of contemporary American politics, acknowledging at the outset that my thoughts are open to, and needful of, critical amendment or supplement by others.In the U.S., bioethics commissions are political creatures, established through the authority of the Congress or the President for the purpose of providing counsel to the legislative and/or executive... (shrink)

Some religious believers may see synthetic biology as usurping God's creative role. The Catholic Church has yet to issue a formal teaching on the field (though it has issued some informal statements in response to Craig Venter's development of a ‘synthetic’ cell). In this paper I examine the likely reaction of the Catholic Magisterium to synthetic biology in its entirety. I begin by examining the Church's teaching role, from its own viewpoint, to set the necessary backround and context for the (...) discussion that follows. I then describe the Church's attitude to science, and particularly to biotechnology. From this I derive a likely Catholic theology of synthetic biology.The Church's teachings on scientific and biotech research show that it is likely to have a generally positive disposition to synbio, if it and its products can be acceptably safe. Proper evaluation of, and protection against, risk will be a significant factor in determining the morality of the research. If the risks can be minimized through regulation or other means, then the Church is likely to be supportive. The Church will also critique the social and legal environment in which the research is done, evaluating issues such as the patenting of scientific discoveries and of life. (shrink)

Currently, under the law of intellectual property, IP owners may exclude from use or production substances and processes that we would ordinarily consider to be products of nature. This has helped companies monopolize disease genes, and thus diagnostic testing for those diseases, and “biosimilar” products, pharmaceutical materials that mimic biological materials. Extending the current paradigm to the world of synthetic biology and nanotechnology will create further injustices in the delivery of health care to billions of people around the world. As (...) such, I advocate heading this trend off at the pass. Scientists ought to conduct basic research into the building blocks of biology and matter in the open, publishing their results, releasing knowledge into the public domain upstream so that beneficial innovation can be produced without fear of downstream litigation, and so that what ought to remain in the public domain as a matter of right (products of nature) does not become unjustly monopolized. (shrink)