Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how non-utilitarian principles are prominent (...) in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)

The U.S. oversight system for genetically engineered organisms was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader (...) conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products. (shrink)

U.S. approaches to oversight of research and technological products have developed over time in an effort to ensure safety to humans, animals, and the environment and to control use in a social context. In modern times, regulatory and oversight tools have evolved to include diverse approaches such as performance standards, tradable allowances, consultations between government and industry, and pre-market safety and efficacy reviews. The decision whether to impose an oversight system, the oversight elements, the level of oversight, the choice of (...) approach, and its execution can profoundly affect technological development, individual and collective interests, and public confidence in technological products. Oversight is conducted by a range of institutions with various capabilities, cultures, and motives. Avenues for disputing oversight decisions are also important, and some argue that the U.S. operates in an adversarial regulatory culture in which Congress, the media, and stakeholders regularly contest the decisions of federal agencies. (shrink)

Parallel to the public discussion on the benefits and risks of nanotechnology, a debate on the ethics of nanotechnology has begun. It has been postulated that a new “nano-ethics” is necessary. In this debate, the — positive as well as negative — visionary and speculative innovations which are brought into connection with nanotechnology stand in the foreground. In this contribution, an attempt is made to discover new ethical aspects of nanotechnology in a more systematic manner than has been the case. (...) It turns out that there are hardly any completely new ethical aspects raised by nanotechnology. It is much rather primarily a case of gradual shifts of emphasis and of relevance in questions which, in principle, are already known and which give reason for ethical discussions on nanotechnology. In a certain manner, structurally novel ethical aspects arise through the important role played by visions in the public discourse. New questions are also posed by the fact that previously separate lines of ethical reflection converge in the field of nanotechnology. The proposal of an independent “nano-ethics”, however, seems exaggerated. (shrink)

Nanotechnology is a swiftly developing field of technology that is believed to have the potential of great upsides and excessive downsides. In the ethical debate there has been a strong tendency to strongly focus on either the first or the latter. As a consequence ethical assessments of nanotechnology tend to radically diverge. Optimistic visionaries predict truly utopian states of affairs. Pessimistic thinkers present all manner of apocalyptic visions. Whereas the utopian views follow from one-sidedly focusing on the potential benefits of (...) nanotechnology, the apocalyptic perspectives result from giving exclusive attention to possible worst-case scenarios. These radically opposing evaluations hold the risk of conflicts and unwanted backlashes. Furthermore, many of these drastic views are based on simplified and outdated visions of a nanotechnology dominated by self-replicating assemblers and nanomachines. Hence, the present state of the ethical debate on nanotechnology calls for the development of more balanced and better-informed assessments. As a first step in this direction this contribution presents a new method of framing the ethical debate on nanotechnology. Thus, the focus of this paper is on methodology, not on normative analysis. (shrink)

In August 2001,just after President Bush announced his stem cell funding policy and the creation of a new Presidents Council on Bioethics PCB), the new chair of the PCB, Leon Kass, set out his philosophy for constructing public bioethics bodies: There are several ways of running commissions, he said. One is to stack it with your people, make them homogenous, and force a consensus. Another is to make them heterogeneous, so that you can only come to the lowest common denominator. (...) We re not going to adopt either. We are going to allow the debate to be developed and heard. Now, three years, sixteen meetings, and five reports later, there are nagging questions about whether this council indeed has allowed the debate to be developed and heard. And the charge of politicizing public bioethics to a degree heretofore unknown and stifling the voices of dissenting members comes not from the political left but from President Bushs own appointees, including one scientist who was dismissed from further service. (shrink)

In August 2001,just after President Bush announced his stem cell funding policy and the creation of a new Presidents Council on Bioethics PCB), the new chair of the PCB, Leon Kass, set out his philosophy for constructing public bioethics bodies: There are several ways of running commissions, he said. One is to stack it with your people, make them homogenous, and force a consensus. Another is to make them heterogeneous, so that you can only come to the lowest common denominator. (...) We re not going to adopt either. We are going to allow the debate to be developed and heard. Now, three years, sixteen meetings, and five reports later, there are nagging questions about whether this council indeed has allowed the debate to be developed and heard. And the charge of politicizing public bioethics to a degree heretofore unknown and stifling the voices of dissenting members comes not from the political left but from President Bushs own appointees, including one scientist who was dismissed from further service. (shrink)