In order to explore public views on nanobiotechnology (NBT), convergence seminars were held in four places in Europe; namely in Visby (Sweden), Sheffield (UK), Lublin (Poland), and Porto (Portugal). A convergence seminar is a new form of public participatory activity that can be used to deal systematically with the uncertainty associated for instance with the development of an emerging technology like nanobiotechnology. In its first phase, the participants are divided into three “scenario groups” that discuss different future scenarios. (...) In the second phase, the participants are regrouped into three “convergence groups”, each of which contains representatives from each of the three groups from the first phase. In the final third phase, all participants meet for a summary discussion. This pilot project had two aims: (1) to develop and assess the new methodology and (2) to gather advice and recommendations from the public that may be useful for future decisions on nanobiotechnology (NBT). Participants emphasized that they wanted the technology to focus on solutions to environmental and medical problems and to meet the needs of developing countries. The need for further public participation and deliberation on NBT issues seemed to be acknowledged by all participants. Many of them also raised equality concerns. Views on the means by which NBT should be steered into socially useful directions were more divided. In particular, different views were expressed on how much regulation of company activities is needed to curb unwanted developments. The participants’ responses in a questionnaire indicate that the methodology of the convergence seminars was successful for decision-making under uncertainty. In particular, the participants stated that their advice was influenced both by access to different possible future developments and by the points of view of their co-participants, which is what the method is specifically intended to achieve. (shrink)

Regulatory oversight and public communication are intimately intertwined. Oversight failures quickly galvanize media and public attention. In addition, regulations sometimes require that risks and uncertainties be included in communication efforts aimed at non-experts outside of the regulatory and policy communities — whether in obtaining informed consent for novel medical treatments; by including risk information on drug labels, in drug advertisements, or on chemicals used in the workplace; in providing nutritional information on food packages; or by opening environmental impact assessments to (...) public comment. In recent decades, broad public input with respect to new technologies has also been sought “upstream” of hard policy decisions in the hope of ultimately gaining legitimacy for those decisions — and perhaps increasing their quality. When communication fails, oversight may also be seen as failing — rightly or wrongly. As part of a larger project organized by the University of Minnesota, this paper presents six models of public risk communication and uses those models to analyze the communication challenges facing nanotechnology and nanobiotechnology. Reviewing the communication dynamics associated with the historical cases of technology regulation with which this symposium issue is concerned helps shed light on the communications challenges facing nanobiotechnology. (shrink)

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene (...) transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (shrink)

Regulatory oversight and public communication are intimately intertwined. Oversight failures, both actual and perceived, quickly galvanize attention from both the media and the public, as has occasionally happened in all of the historical cases with which this symposium is concerned — gene therapy, workplace chemicals, drugs and devices, and genetically modified organisms, especially those used as foods. Some developments, such as GMOs, seem to have more cultural significance or “cultural resonance” than others and are especially likely to garner public attention. (...) Developments in nanotechnology, on the other hand, do not seem to have captured as much popular attention. However, the accelerating convergence between nanotechnology as material science and biotechnology, health, and medicine could easily change this situation. (shrink)

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past oversight efforts aimed (...) at emerging technologies. This article reports on work funded by the National Science Foundation aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I (...) describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to (...) guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)

This study explores the history of nanotechnology from the perspective of protein engineering, which differs from the history of nanotechnology that has arisen from mechanical and materials engineering; it also demonstrates points of convergence between the two. Focusing on directed evolution—an experimental system of molecular biomimetics that mimics nature as an inspiration for material design—this study follows the emergence of an evolutionary experimental system from the 1960s to the present, by detailing the material culture, practices, and techniques involved. Directed evolution, (...) as an aspect of nanobiotechnology, is also distinct from the dominant biotechnologies of the 20th century. The experimental systems of directed evolution produce new ways of thinking about molecular diversity that could affect concepts concerning both biology and life. (shrink)

Far-reaching promises made by nanotechnology have raised the question of whether we are on the way to understanding human beings more and more as belonging to the realm of technology. In this paper, an increasing need to understand the technological re-conceptualization of human beings is diagnosed whenever increasingly “technical” interpretations of humans as mechanical entities are disseminated. And this can be observed at present in the framework of nanobiotechnology, a foremost “technical” self-description where a technical language is adopted. The (...) arena in which the decision is made on increasing the use of technological understanding to define mankind will not be found in the surgery room in which one works with implants, nor the NBIC-laboratory, in which “nerve plugs” are supposed to be developed. The thesis of this paper is that such arena is rather related to the manner in which concepts of humanity are associated with it, how we think and talk about ourselves, and which consequences we draw out of it. (shrink)

At present there is an enormous discrepancy between our nanotechnological capabilities (particularly our nanobiotechnologies), our social wisdom, and consensus on how to apply them. To date, cost considerations have greatly constrained our application of nanotechnologies. However, novel advances in microsystem platform technologies are about to greatly diminish that economic constraint while developing new industries. Properly used in a solid legal and ethical framework, within an educated population, these advances will vastly enrich our quality of life without being intrusive. Improperly used, (...) these technologies could lead to a modern-day Luddism, social turmoil, or possibly even to emulating those societies described in the darkest of novels. These technologies must be developed in tandem with the social and legal frameworks needed to ensure that they improve both individuals and our society. To ensure that this occurs, we need to have the ethical, legal, scientific, and engineering experts working together and with the public. (shrink)

This commentary asks what we can learn from our oversight of controversial science and how can we do better in the future? After briefly examining the history of gene transfer research oversight, some observations are offered for the oversight of nanobiotechnology and other emerging areas of science.

With the rapid progress and considerable promise of nanobiotechnology/neurosciences there is the potential of transforming the very nature of human beings and of how humans can conceive of themselves as rational animals through technological innovations. The interface between humans and machines (neuro-digital interface), can potentially alter what it means to be human, i.e., the very idea of human nature and of normal functioning will be changed. In this paper, I argue that we are potentially on the verge of a (...) paradigm shift in terms of the ends and goals of techno-science and its applications in the biomedical sciences. In particular, the development of brain-computer interfaces could reconceptualize the very notion of what it means to be human. Hence, we should not limit our reflections of applications in terms of therapy and enhancement but also include an examination of applications aiming at the alteration of human nature. To this end I will first delineate the potential paradigm shift and then map out four distinct clusters of concerns in relation to the brain-computer interface. Finally, I argue that our moral and philosophical reflections should follow a procedural model based on managed consensus due to our pluralistic context. (shrink)

Instead of postulated fixed structures and abstract principles of usual positivistic science, the unreduced diversity of living world reality is consistently derived as dynamically emerging results of unreduced interaction process development, starting from its simplest configuration of two coupled homogeneous protofields. The dynamically multivalued, or complex and intrinsically chaotic, nature of these real interaction results extends dramatically the artificially reduced, dynamically single-valued projection of standard theory and solves its stagnating old and accumulating new problems, “mysteries” and “paradoxes” within the unified (...) and causally complete picture of intrinsically evolving, dynamically complex reality. The permanently unfolding complexity progress thus revealed is fundamentally unlimited and does not need to stop at the directly observed diversity of usual matter complexity. The exciting, but rigorously substantiated and objectively inevitable prospects of further civilisation complexity development towards its superior levels of genuine sustainability and global Noosphere are outlined, with practically important conclusions for today’s critical problem solution. (shrink)