A majority opinion seems to have emerged in scholarly analysis of the assortment of technologies that have been given the label “synthetic biology.” According to this view, society should allow the technology to proceed and even provide it some financial support, while monitor­ing its progress and attempting to ensure that the development leads to good outcomes. The near‐consensus is captured by the U.S. Presidential Commission for the Study of Bioethical Issues in its report New Directions: The Ethics of Synthetic Biology (...) and Emerging Technologies, which arguably marked the end of a preliminary round of analysis about the ethical and policy questions raised by synthetic bi­ology. Like a number of other, earlier documents issued by various groups around the world, the re­port called attention to questions about how the technology will be used; whether it might be mis­used; what sorts of accidents might happen along the way; the economic, environmental, and social impacts of the eventual applications; whether the very idea of “synthetic biology” should be trou­bling; and how the debate over all of these ques­tions will be conducted. Also like most similar documents, however, while it called for careful monitoring and oversight of technology, it did not recommend any significant new constraints on its development and use. The commission's stance was that it would be “imprudent either to declare a moratorium on synthetic biology until all risks can be determined and mitigated, or to simply ‘let science rip,’ regardless of the likely risks.”In this report, we will take stock of the current consensus, comment on some of the major points of disagreement, and identify the next steps for the debate. In part I, we offer a brief overview of the research and applications commonly grouped together under the heading of synthetic biology, partly in order to set the stage for the rest of the discussion and partly because we want to highlight some conceptual problems that attend the very la­bel given this field. In parts II, III, and IV, we take up, respectively, three broad classes of concerns that arise in the context of synthetic biology: con­cerns about the intrinsic or inherent value of do­ing synthetic biology, concerns about the concrete harms and benefits of doing synthetic biology, and concerns about justice. Addressing these concerns requires a method for bringing the public's values to bear on policy‐making concerning emerging biotechnologies; in part V, we discuss the chal­lenges in developing such a method. (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)

The growing interest in bioethics has given rise to a new group of experts: experts in bioethics. They come from different walks of life and their motives, claims, and qualifications for expertise are manifold. Various academic disciplines can be said to contribute to one's status as an expert in bioethics. Studies and research in, say, philosophy, law, anthropology, history, theology, and sociology with an emphasis on bioethical matters are often thought of as suitably qualifying a person as a bioethicist. In (...) addition to these academic qualifications there are two routes to becoming a bioethicist. I will call these the self-nomination and the through-work-experience routes. Self-nominated expertise is most common with medics who have strong religious or other ideological views about ethical matters. Another path to self-nominated expertise starts with strongly held ideological views with interest in bioethical matters. For this category of bioethical experts there does not have to be any institutional acknowledgment of their status; they are experts because they think they are. The other nonacademic type of expert in bioethics emerges through administrative channels. When the various ethics committees and regulatory bodies that now abound were first founded, there were no experts in bioethics to sit on these committees. People became experts by serving in these institutions for sufficiently long periods of time. This still happens with ethics committees in which just a few of the members are experts in ethics. People join the committees as experts of other fields, but are thought to have become experts through the fact that they have served on such committees. (shrink)

As bioethics gains more prominence in public policy debates, it is time to more fully reflect on the following: what is its role in the public square, and what limitations relate to and barriers impede its fulfilment of this role? I contend we should consider the how of bioethics (as a policy influencer) rather than simply focus on the who or what of bioethical enquiry. This is not to suggest considerations of latter categories are not important, only that too little (...) attention has been paid to parallel or resulting policy involvement—involvement that will require specialised skills and knowledge that we can develop with a proactive (vs reactive) stance. Moreover, and equally critically, this how of public policy involvement will require more transparency regarding influences (eg, philosophical, ideological, cultural, socio-political) on what bioethicists bring to the table and what constituency base each represents—a humility as to the scope of one's role. In this vision, bioethics is not one single person or belief system for a policymaker to call to guide or give support to a position; rather, it offers tools—formed and utilised by a diverse disciplinary range of individuals—to help guide ethical analysis of biomedical endeavours, with the goal of infusion and diffusion of ethical enquiry and prioritisation in health policymaking, and greater humility among bioethicists who inform this discussion. (shrink)