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)

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)

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)

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms , challenges current practices of governance and science. Employing environmental risk assessment for governance and oversight assumes we have a reasonable ability to understand consequences and predict adverse effects. However, traditional ERA has come under considerable criticism for its many shortcomings and current governance institutions have demonstrated limitations in transparency, public input, and capacity. Problem Formulation and Options Assessment is a methodology founded on three key concepts in risk assessment (...) and three in governance . Developed through a series of international workshops, the PFOA process emphasizes engagement with stakeholders in iterative stages, from identification of the problem through comparison of multiple technology solutions that could be used in the future with their relative benefits, harms, and risk. It provides “upstream public engagement” in a deliberation informed by science that identifies values for improved decision making. (shrink)

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms, challenges current practices of governance and science. When a governing body is confronted by a technology whose use has potential environmental risks, some form of risk analysis is typically conducted to help decision makers consider the range of possible benefits and harms posed by the technology. Environmental risk assessment is a critical component in the governance of nanotechnology and genetically engineered organisms because the uncertainties and complexities surrounding these technologies (...) pose such risk potential. However, GEOs are unique technologies, and there is widespread, international recognition that many traditional forms of ERA are not well-suited for evaluating them. Nanotechnology products are also likely to need different models of risk assessment, as there is very little information on their fate, transport, and impacts in the environment. (shrink)

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation (...) arena. (shrink)

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of (...) protection around the latter.As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence. (shrink)

This review addresses the current and future potential of nanomedicine, and its ethical considerations within the comprehensive framework of the four dimensions of medical ethics: Beneficence, Non-Maleficence, Respect, and Justice. From this perspective, the ethical considerations for nanomedicine are not novel, but have been addressed by precedents throughout the history of medicine. While these ethical challenges are not unique to nanomedicine, some require additional consideration, given the envisioned pervasive impact of nanomedicine on society.

While the definitions employed by different governmental agencies and scientific societies differ somewhat, the term “nanotechnology” is generally understood to refer to the manufacturing, characterization, and use of man-made devices with dimensions on the order of 1-100 nanometers. Devices that comprise a fundamental functional element that is nanotechnological are also frequently comprised within nanotechnology, as are manufactured objects with dimensions less than one micrometer. The differences in definition lead to occasional paradoxes, such as the fact that the most widely used (...) nanodrug is labeled a “nanopharmaceutical” by governments of European countries, Canada, and Australia, but it is not a nanotechnology for the U.S. Food and Drug Administration. It is also common in scientific domains to restrict the term “nanotechnology” to objects that possess special, “emerging” properties that only arise because of their nanoscale dimension. (shrink)

This paper describes issues associated with integrating the study of Ethical, Legal and Social Issues (ELSI) into ongoing scientific and technical research and describes an approach adopted by the authors for their own work with the center for nanophase materials sciences (CNMS) at the Oak Ridge national laboratory (ORNL). Four key questions are considered: (a) What is ELSI and how should it identify and address topics of interest for the CNMS? (b) What advantages accrue to incorporating ELSI into the CNMS? (...) (c) How should the integration of ELSI into the CNMS take place? (d) How should one judge the effectiveness of the activity? We conclude that ELSI research is not a monolithic body of knowledge, but should be adapted to the question at hand. Our approach focuses on junctures in the R&D continuum at which key decisions occur, avoids topics of a purely ethical nature or advocacy, and seeks to gather data in ways that permit testing the validity of generalization. Integrating ELSI into the CNMS allows dealing with topics firmly grounded in science, offers concrete examples of potential downstream applications and provides access to the scientists using the CNMS and their insights and observations. As well, integration provides the opportunity for R&D managers to benefit from ELSI insights and the potential to modify R&D agendas. Successful integration is dependent on the particular ELSI question set that drives the project. In this case questions sought to identify key choices, information of value to scientists, institutional attributes, key attributes of the CNMS culture, and alternatives for communicating results. The opportunity to consult with scientists on ELSI implications is offered, but not promoted. Finally, ELSI effectiveness is judged by observing the use to which research products are put within the CNMS, ORNL, and the community of external scholars. (shrink)