Like all technologies, nanotechnology will inevitably present risks, whether they result from unintentional effects of otherwise beneficial applications, or from the malevolent misuse of technology. Increasingly, risks from new and emerging technologies are being regulated at the international level, although governments and private experts are only beginning to consider the appropriate international responses to nanotechnology. In this paper, we explore both the potential risks posed by nanotechnology and potential regulatory frameworks that law may impose. In so doing, we also explore (...) the various rationales for international regulation including the potential for cross-boundary harms, sharing of regulatory expertise and resources, controlling protectionism and trade conflicts, avoiding a “race to the bottom” in which governments seek economic advantage through lax regulation, and limiting the “nano divide” between North and South. Finally, we examine some models for international regulation and offer tentative thoughts on the prospects for each. (shrink)

Risk management of nanotechnology is challenged by the enormous uncertainties about the risks, benefits, properties, and future direction of nanotechnology applications. Because of these uncertainties, traditional risk management principles such as acceptable risk, cost–benefit analysis, and feasibility are unworkable, as is the newest risk management principle, the precautionary principle. Yet, simply waiting for these uncertainties to be resolved before undertaking risk management efforts would not be prudent, in part because of the growing public concerns about nanotechnology driven by risk perception (...) heuristics such as affect and availability. A more reflexive, incremental, and cooperative risk management approach is required, which not only will help manage emerging risks from nanotechnology applications, but will also create a new risk management model for managing future emerging technologies. (shrink)

There is much we do not know about nanotechnology. Despite its tremendous promise, nanotechnology today is mostly forecast and fervent hope. Predictions that spending on nanotechnology will increase from current levels of $13 billion to more than $1 trillion by 2015 are no more than that – simply predictions. Hopes that nanotechnology will be an essential part of solving the globe's energy, food, and water problems should be tempered by recalling a century of revolutionary technologies that failed to live up (...) to their early promise such as nuclear energy, supersonic airplanes, or gene therapy. Many other questions continue to nip at nanotechnology's heels, not the least of which are debates about what is and is not technically feasible. Despite these uncertainties, we can have complete confidence in one aspect of nanotechnology's future – it will be subject to a host of regulations. (shrink)

Scientific research is subject to a number of regulations which impose incidental (time, place), rather than substantive (type of research), restrictions on scientific research and the knowledge created through such research. In recent years, however, the premise that scientific research and knowledge should be free from substantive regulation has increasingly been called into question. Some have suggested that the law should be used as a tool to substantively restrict research which is dual-use in nature or which raises moral objections. There (...) are, however, some problems with using law to restrict or prohibit certain types of scientific research, including (i) the inherent imprecision of law for regulating complex and rapidly evolving scientific research; (ii) the difficulties of enforcing legal restrictions on an activity that is international in scope; (iii) the limited predictability of the consequences of restricting specific branches of scientific research; (iv) inertia in the legislative process; and (v) the susceptibility of legislators and regulators to inappropriate factors and influence. Rather than using law to restrict scientific research, it may be more appropriate and effective to use a combination of non-traditional legal tools including norms, codes of conduct, restrictions on publication, and scientist-developed voluntary standards to regulate problematic scientific research. (shrink)

As policy makers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are the following: public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; regulation should avoid discriminating against particular technologies unless there is a scientifically based rationale for the disparate treatment; regulatory systems need to be flexible (...) and adaptive to rapidly changing technologies; ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and international harmonization of regulation may be beneficial in a rapidly globalizing world. (shrink)

Nanotechnology is the latest in a growing list of emerging technologies that includes nuclear technologies, genetics, reproductive biology, biotechnology, information technology, robotics, communication technologies, surveillance technologies, synthetic biology, and neuroscience. As was the case for many of the technologies that came before, a key question facing nanotechnology is what type of regulatory oversight is appropriate for this emerging technology. As two of us wrote several years ago, the question facing nanotechnology is not whether it will be regulated, but when and (...) how.Yet, appropriate regulation of nanotechnology will be challenging. The term “nanotechnology” incorporates a broad, diverse range of materials, technologies, and products, with an even greater spectrum of potential risks and benefits. This technology slashes across the jurisdiction of many existing regulatory statutes and regulatory agencies, and does so across the globe. Nanotechnology is developing at an enormously rapid rate, perhaps surpassing the capability of any potential regulatory framework to keep pace. Finally, the risks of nanotechnology remain largely unknown, both because of the multitude of variations in the technology and because of the limited applicability of traditional toxicological approaches such as structure-activity relationship to nanotechnology products. (shrink)

As the health care system transitions to a precision medicine approach that tailors clinical care to the genetic profile of the individual patient, there is a potential tension between the clinical uptake of new technologies by providers and the legal system's expectation of the standard of care in applying such technologies. We examine this tension by comparing the type of evidence that physicians and courts are likely to rely on in determining a duty to recommend pharmacogenetic testing of patients prescribed (...) the oral anti-coagulant drug warfarin. There is a large body of inconsistent evidence and factors for and against such testing, but physicians and courts are likely to weigh this evidence differently. The potential implications for medical malpractice risk are evaluated and discussed. (shrink)

Clinical trials of nanotechnology medical products present complex risk management challenges that involve many uncertainties and important risk-risk trade-offs. This paper inquires whether the precautionary principle can help to inform risk management approaches to nanomedicine clinical trials. It concludes that prudent precaution may be appropriate for ensuring the safety of such trials, but that the precautionary principle itself, especially in its more extreme forms, does not provide useful guidance for specific safety measures.

Medical technologies, including nanomedicine products, are intended to improve health but in many cases may also create their own health risks. Medical products that create their own health risks differ from most other risk-creating technologies in that the very purpose of the medical technology is to prevent or treat health risks. This paradox of technologies intended to reduce existing risks that may have the effect of creating new risks has two conflicting implications. On one hand, we may be more tolerant (...) of health risks from medical technologies because these products are intended to, and often do, reduce overall health risks and improve our health. The health benefits of a medical technology may outweigh the unavoidable adverse effects of that same technology in an individual patient or in the overall treated population. (shrink)

Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both (...) health care and legal actors to address and manage those liability risks. (shrink)

For many innovations, oversight fits nicely within existing governance mechanisms; nevertheless, others pose unique public health, environmental, and ethical challenges. Synthetic artemisinin, for example, has many precursors in laboratory‐developed drugs that emulate natural forms of the same drug. The policy challenges posed by synthetic artemisinin do not differ significantly in kind from other laboratory‐formulated drugs. Synthetic biofuels and gene drives, however, fit less clearly into existing governance structures. How many of the new categories of products require new forms of regulatory (...) oversight, or at least extensive forms of testing, remains unclear.Any effort to improve the governance of synthetic biology should start with a rich understanding of the different possible science‐policy interfaces that could help to inform governance. CBA falls into a subset of the overall range of possibilities, and which interface is appropriate may turn out to depend on context, on the demands of the decision at hand. In what follows, we lay out a typology of interfaces. After that, we turn to the question of how to draw upon the range of possible interfaces and effectively address the factual and moral complexities of emerging technologies. We propose a governance model built around structures that we call “governance coordinating committees.” GCCs are intended to be mechanisms for accommodating the complexities of innovations that have far‐ranging societal impacts. The production of biofuels, for example, could contaminate water supplies and have a destructive environmental impact if not managed correctly. The introduction of a gene drive could have economic and environmental impacts that are not restricted to one nation. Forging appropriate means for determining and evaluating those societal impacts, to the best of a corporation's, industry's, or government's ability, is central to responsible research and innovation. Public policy must be shaped in a manner that accommodates as many concerns as possible and minimizes risks. (shrink)

Emerging technologies present a challenging but fascinating set of ethical, legal and regulatory issues. The articles selected for this volume provide a broad overview of the most influential historical and current thinking in this area and show that existing frameworks are often inadequate to address new technologies - such as biotechnology, nanotechnology, synthetic biology and robotics - and innovative new models are needed. This collection brings together invaluable, innovative and often complementary approaches for overcoming the unique challenges of emerging technology (...) ethics and governance. (shrink)

The Test of Basic Auditory Capabilities is a battery of auditory-discrimination tasks and speech-identification tasks that has been normed on several hundred young normal-hearing adults. Previous research with the TBAC suggested that cognitive function may impact the performance of older adults. Here, we examined differences in performance on several TBAC tasks between a group of 34 young adults with a mean age of 22.5 years and a group of 115 older adults with a mean age of 69.2 years recruited from (...) the local community. Performance of the young adults was consistent with prior norms for this age group. Not surprisingly, the two groups differed significantly in hearing loss and working memory with the older adults having more hearing loss and poorer working memory than the young adults. The two age groups also differed significantly in performance on six of the nine measures extracted from the TBAC with the older adults consistently performing worse than the young adults. However, when these age-group comparisons were repeated with working memory and hearing loss as covariates, the groups differed in performance on only one of the nine auditory measures from the TBAC. For eight of the nine TBAC measures, working memory was a significant covariate and hearing loss never emerged as a significant factor. Thus, the age-group deficits observed initially on the TBAC most often appeared to be mediated by age-related differences in working memory rather than deficits in auditory processing. The results of these analyses of age-group differences were supported further by linear-regression analyses with each of the 9 TBAC scores serving as the dependent measure and age, hearing loss, and working memory as the predictors. Regression analyses were conducted for the full set of 149 adults and for just the 115 older adults. Working memory again emerged as the predominant factor impacting TBAC performance. It is concluded that working memory should be considered when comparing the performance of young and older adults on auditory tasks, including the TBAC. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

In _Bioethics in Context_, Gary Jones and Joseph DeMarco connect ethical theory, medicine, and the law, guiding readers toward a practical and legally grounded understanding of key issues in health-care ethics. This book is uniquely up-to-date in its discussion of health-care law and unpacks the complex web of American policies, including the Patient Protection and Affordable Care Act. Useful case studies and examples are embedded throughout, and a companion website offers a thorough, curated database of relevant legal precedents as (...) well as additional case studies and other resources. (shrink)

The proponents of the ‘vindication’ or ‘pragmatic justification’ of induction have attempted to show that induction will work if any method does. This in turn serves as grounds for their claim that we have everything to gain by using induction and nothing to lose. Hence, they conclude that it is rational to use induction. Their claim that induction will work if any mehtod does is based upon the following argument:If nature is uniform, induction will work. If nature is not uniform (...) and some other method works, the success of that method will then constitute a regularity to which induction can be successfully applied. In that case, induction will sanction the continued use of the successful method and hence will be successful as well. (shrink)

Edmund Husserl's historical importance is marked by a curious conjunction. He is easily among the most influential philosophers of the twentieth century and yet no one has taken up his view. The first of these has received a monumental amount of consideration, the second virtually none. But the second, in its own way, is at least equally remarkable. In this essay I will consider why his view of philosophy found no subscribers and what we might make of this legacy of (...) failure. (shrink)

In his recent essay on moral pluralism in environmental ethics, J. Baird Callicott exaggerates the advantages of monism, ignoring the environmentally unsound implications of Leopold’s holism. In addition, he fails to see that Leopold’s view requires the same kind of intellectual schitzophrenia for which he criticizes the version of moral pluralism advocated by Christopher D. Stone in Earth and Other Ethics. If itis plausible to say that holistic entities like ecosystems are directly morally considerable-and that is a very big if-it (...) must be for a very different reason than is usually given for saying that individual human beings are directly morally considerable. (shrink)

_The Quantum of Explanation_ advances a bold new theory of how explanation ought to be understood in philosophical and cosmological inquiries. Using a complete interpretation of Alfred North Whitehead’s philosophical and mathematical writings and an interpretive structure that is essentially new, Auxier and Herstein argue that Whitehead has never been properly understood, nor has the depth and breadth of his contribution to the human search for knowledge been assimilated by his successors. This important book effectively applies Whitehead’s philosophy to problems (...) in the interpretation of science, empirical knowledge, and nature. It develops a new account of philosophical naturalism that will contribute to the current naturalism debate in both Analytic and Continental philosophy. Auxier and Herstein also draw attention to some of the most important differences between the process theology tradition and Whitehead’s thought, arguing in favor of a Whiteheadian naturalism that is more or less independent of theological concerns. This book offers a clear and comprehensive introduction to Whitehead’s philosophy and is an essential resource for students and scholars interested in American philosophy, the philosophy of mathematics and physics, and issues associated with naturalism, explanation and radical empiricism. (shrink)

Darwin's theory of natural selection is as applicable to the analysis of the behavior of organisms as it is to their origins. Skinner's theoretical writings have guided operant psychologists in this area. The behavioral account of selection by Donahoe and Palmer (1994) is positively compared to the points on operant selection made by Hull et al. The “general account of selection” was found to be useful.

Letson’s text is a dense, richly worded exposition of three of perhaps the most engaging philosophers of contemporary philosophy: Rorty, Putnam, and Davidson.

Edited by James Sennett, this collection of articles by Alvin Plantinga is certainly deserving. The problem facing Sennett, however, is how to choose articles from an author whose writings span forty years of reflection. Fortunately, in Plantinga's after-word to this book, he approves of Sennett's choice. Plantinga states that the selection is a “snapshot” of his work thus far in the philosophy of religion, one that represents two major concerns: negative apologetics and the development of Christian philosophy.

This recent study on the ethics of human cloning is a lively exchange between two articulate and well informed opponents: Leon R. Kass and James Q. Wilson. Kass is the Addie Clark Harding Professor in the Committee on Social Thought and the College of the University of Chicago. Wilson is the James A. Collins Professor of Management and Public Policy Emeritus at the University of California, Los Angeles.

This research examines the association between attitudes on cheating and cognitive moral development. In this research, we use Rest's (1979a) Defining Issues Test, the Attitudes on Honesty Scale (Authors) and Academic Integrity Index (Authors); the last two are adaptations of the DIT. A total of 220 students from three universities participated in the study (66 psychology majors and 154 business majors). The data indicate that 66.4 percent of the students reported that they cheated in high school, college, or both high (...) school and college. Psychology majors scored higher than business majors on both the Defining Issues Test (Rest, 1979a) and the Attitudes on Honesty Scale (AHS, Authors). Using factor analysis, we found significant associations between students' ratings of the importance considerations present in the three cheating scenarios and their estimates of whether cheating would occur (i.e., the Academic Integrity Index). Finally, using logistic regression, we found that the scores on the Attitudes on Honesty Scale and Academic Integrity Index associate with the self-reported cheating behavior of college students. (shrink)