Risk Management Principles for Nanotechnology

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.     

Transnational Governance Arrangements: Legitimate Alternatives to Regulating Nanotechnologies?

In recent years, the development and the use of engineered nanomaterials have generated many debates on whether these materials should be part of the new or existing regulatory frameworks. The uncertainty, lack of scientific knowledge and rapid expansion of products containing nanomaterials have added even more to the regulatory dilemma with policy makers and public/private actors contenting periods of both under and over regulation. Responding to these regulatory challenges, as well as to the global reach of nanotechnology research and industrial needs, governance arrangements beyond the state have addressed the challenge head-on. This article focuses on the governance arrangements of the International Organization for Standardization (ISO), which has led to the development of numerous “horizontal anticipatory standards” with an important role in setting the foundation for science, technology and market development. During the course of its operation ISO has broadened its scope to address not only technical issues related to the concept and the size of nanomaterials but also broader aspects of the technology, including health, environment and safety issues. The increasing relevance of the ISO to regulate economic relations and achieve certain public policy goals has given rise to many concerns about its legitimacy. The important questions are whether these governance arrangements may be deemed as being legitimate and where this legitimacy is derived from? What are the main sources of legitimacy at the transnational level and how we can apply them to analyse nanotechnology standardization? This article provides concise answers to these questions. It focuses at the normative concepts of democratic and scientific legitimacy and explores the institutional structures and processes by which nanotechnology standards are established.     

Advances in stalking risk assessment

Over the past 15 years, forensic mental health has become more concerned with the concepts of violence prevention, management, and treatment. The development of specialist tools to aid in the assessment of a range of risks reflects this concern. This article explores contemporary thinking on violence risk assessment and how this knowledge can be applied to the relatively newer field of stalking risk assessment. The role of risk state and risk status are discussed, in addition to the way that standard structured professional judgment procedures need to be adapted to reflect the variety of risks present in stalking situations. The authors go on to describe the development and format of the Stalking Risk Profile, a set of structured professional judgment guidelines for assessing risk in stalkers. Suggestions are made for future research to enhance knowledge and improve practice in the field of stalking risk assessment.     

Would You Mind, If We Record This? Perceptions on Regulation and Responsibility among Indian Nanoscientists

Looking at our knowledge of the risks associated with nanotechnology, one wonders to what degree should its products and applications be regulated? Do we need any governing body to regulate nanotechnology research and development? Do individuals have a right to know to make informed decisions through labelling mechanism? The question of regulation and responsibility in the interaction between science, technology and society is one of the most pressing issues. Risks and regulations regarding nanoscience and nanotechnology are mostly debated amongst policy-makers and not amongst the nanoscientists, who actually produce the new science. Thus, the paper makes an attempt to contribute significantly to an increased body of knowledge regarding how scientists think and talk about science. Little has been documented about perceptions of nanotechnology regulation and responsibility in developing countries. Given the importance of perceptions in the genetically-modified foods debate, the way nanotechnology is perceived holds serious repercussions for the framing of its ethical, legal and social implications. Through a field-survey that records the opinions of leading Indian nanoscientists, the paper examines scientists' perceptions about nanotech-regulation. Such discussion is imperative to address technological risks and uncertainties. The paper further explores whether scientists have different views on what responsibility amounts to and under what conditions one is responsible. Though the study has considered Indian nanoscientists due to access issues, the research questions raised and addressed in this study are universal in nature.     

Nanotechnologies and Novel Foods in European Law

Food is a big business in the EU and nanofood products are beginning to be placed on the market. It is still unclear whether the absence of minimum regulation at a global level promotes or prevents the growth of a market in nanofood. However, the development of an adequate risk management policy in relation to food safety is a key concern for consumers. Importantly, the European Parliament in its 2009 Resolution on “Legal aspects on nanomaterials” called for more in-depth scientific research on the toxicity of compounds in nanomaterials, and for the adoption of an EU definition of nanomaterials for regulatory purposes. Unfortunately, in 2011, nanotechnology led to inconclusive debates in the context of the revision of Novel Food Regulation. General Food Law applies to nanofood in terms of safety requirements, and specific rules also apply to food contact materials containing nanoparticles as well as to to additives, vitamins and minerals. The EU legislator also introduced mandatory labelling in respect of products derived from nanotechnologies. The legal framework is evolving according to the so-called “incremental approach”, a governance model that creates the risk of fragmentation. But the main problem is the inconsistent definition of the terms “nanotechnology” and “nanomaterials” when looking at the enforcement of regulations and the provision of a wide range of specific tools for different nanofoods: for example the use of positive lists of authorised substances applying only to food contact materials, additives and supplements. This contribution aims to review the regulations in force in respect to nanofood and novel foods and to highlight the problems that are still unresolved.     

Beiträge der deutschsprachigen forensischen Verhaltenswissenschaft zur kriminalprognostischen Methodenentwicklung

Forensic risk assessment of an offender is a complex process of obtaining targeted information from diverse sources and creating an integrated conceptualization of the information. The goal must not be limited to an assessment of the risk of recidivism of an offender. In fact, it is important to understand why an offender committed such a crime in order to inform decision makers and enable them to provide appropriate interventions and tailored management of future risks in individual cases. Risk assessment and risk measures have considerably evolved over the last decades and distinct approaches to and generations of risk assessment can be differentiated. This article gives an overview and introduction to the different approaches to scientifically based risk assessment including the strengths, weaknesses and empirical foundation. The focus will be on approaches used in the German language due to specific judicial considerations of the German legal system. This places special requirements on the degree of individualization and consideration of any special characteristics of individual cases for the assessment of the risk of recidivism relevant to criminal law. On the other hand, many of the currently employed methods and instruments originate from other, mostly English-speaking countries. For this reason, an outline of the international research on risk assessment is initially given.     

Recruiting and Selecting Professionals: Context,Qualities and Methods

Evidence based on a survey of professional firms and in-depth interviews with decision-makers responsible for selection examines the most frequently used and valued methods for hiring qualified professional staff in a sample of Scottish accountancy, architecture, law, and surveying practices. The survey suggests an emphasis on personality, work experience and general attributes for senior posts, and that high value is placed on interviews and informal sources of information in assessing these qualities. Firm characteristics and context, particularly size of practice, the role of the partner in the selection process, labour supply, and perception of recruitment difficulties are shown to be related to the type of selection method used. Consistent with the view of selection as a social process, the case study evidence suggests that ‘informality’ may play an important role when partners responsible for selection have long tenure with their firm and when firms experience recruitment difficulties. More generally, informal networks and interview processes may act as effective information and communication vehicles for small and medium-sized professional practices.     

Operationalizing the Assessment and Management of Violence Risk in the Short-term

Assessing risk of violence in the short term is crucial for managing and preventing violence, especially in institutions such as psychiatric units and prisons. Despite a lack of consensus on the definition of "short term", a number of recent tools and guidelines have been developed to aid short-term clinical decision-making. Whereas the supporting evidence for the new tools is impressive, limitations remain in terms of the focus on prediction, limited consideration of strengths, and poor integration with formulation and risk management. The Short-Term Assessment of Risk and Treatability (START) is a brief clinical guide for the dynamic assessment of risks, strengths and treatability. It focuses on short-term risks and the characteristics of the individual that, if changed, might lead to an increase or decrease in risk. The START has the potential to operationalize the structured professional judgment (SPJ) approach in order to inform the evaluation of multiple risk domains relevant to everyday psychiatric clinical practice. However, explicit guidance on integrating risk assessment, formulation and management is limited in the START and this paper describes the SPJ approach, reviews recent developments in approaches to risk, and considers how the START can be used to inform SPJ approaches and link risk assessment, formulation, and management. Copyright ? 2012 John Wiley & Sons, Ltd.     

The Prospect of Genome-guided Preventive Medicine: A Need and Opportunity for Genetic Counselors

One of the major anticipated benefits of genomic medicine is the area of preventive medicine. Commercially available genomic profiling is now able to generate risk information for a number of common conditions several of which have recognized preventive guidelines. Similarly, family history assessment affords powerful health risk prediction based on the shared genetic, physical and lifestyle environments within families. Thus, with the ability to help predict disease risk and enable preemptive health plans, genome-guided preventive medicine has the potential to improve population health on an individualized level. To realize this potential, steps to broaden access to accurate genomic health information must be considered. With expertise in genetic science, risk assessment and communication, and a patient-centered practice approach, genetic counselors are poised to play a critical role in facilitating the incorporation of genomic health risks into the burgeoning field of genome-guided preventive medicine.     

Devices of Responsibility: Over a Decade of Responsible Research and Innovation Initiatives for Nanotechnologies

Responsible research and innovation (RRI) has come to represent a change in the relationship between science, technology and society. With origins in the democratisation of science, and the inclusion of ethical and societal aspects in research and development activities, RRI offers a means of integrating society and the research and innovation communities. In this article, we frame RRI activities through the lens of layers of science and technology governance as a means of characterising the context in which the RRI activity is positioned and the goal of those actors promoting the RRI activities in shaping overall governance patterns. RRI began to emerge during a time of considerable deliberation about the societal and governance challenges around nanotechnology, in which stakeholders were looking for new ways of integrating notions of responsibility in nanotechnology research and development. For this reason, this article focuses on nanotechnology as the site for exploring the evolution and growth of RRI.     

Communicating the Risk of Violent and Offending Behavior: Review and Introduction to this Special Issue

How to communicate risk of recidivism in correctional and forensic contexts has been a subject of scholarly discussion for two decades. This emerging literature, however, is sparse compared with studies on the assessment of risk for violent and offending behavior. In this special issue of Behavioral Sciences and the Law, we have gathered together empirical and review papers exemplifying promising directions and methodologies. We begin with a review of the state of the field, and lessons that can be drawn from research into medical risk assessment and risk communication, finding that many of the same principles apply to the forensic context. How risks are framed, and how numerate assessors are, affects how risk information is understood and applied. We discuss the existing research bearing on these issues, as well as the conceptual, practical, empirical, and legal implications of communicating risk using numerical or categorical risk terms. Along with the seven articles in this volume, we suggest directions for future research on measuring and communicating change, understanding and managing the statistical literacy of those who use and communicate risk assessments, and developing a theoretical framework for forensic risk communication research. We hope this volume will help integrate and invigorate research into forensic risk communication. Copyright © 2015 John Wiley & Sons, Ltd.     

Laboratory Safety and Nanotechnology Workers: an Analysis of Current Guidelines in the USA

Although some regulatory frameworks for the occupational health and safety of nanotechnology workers have been developed, worker safety and health issues in these laboratory environments have received less attention than many other areas of nanotechnology regulation. In addition, workers in nanotechnology labs are likely to face unknown risks and hazards because few of the guidelines and rules for worker safety are mandatory. In this article, we provide an overview of the current health and safety guidelines for nanotechnology laboratory workers by exploring guidelines from different organizations, including the Department of Energy Nanoscale Science Research Centers (DOE-NSRC), Massachusetts Institute of Technology (MIT), the National Institutes of Health (NIH), the National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA), Texas A&M University (TAMU), and University of Massachusetts-Lowell (UML). After discussing these current guidelines, we apply an ethical framework to each set of guidelines to explore any gaps that might exist in them. By conducting this gap analysis, we are able to highlight some of the weaknesses that might be important for future policy development in this area. We conclude by outlining how future guidelines might address some of these gaps, specifically the issue of workers’ participation in the process of establishing safety measures and the development and enforcement of more unified (and mandatory) guidelines.     

Framing the Discussion: Nanotechnology and the Social Construction of Technology--What STS Scholars Are Saying

The emergence of nanotechnology, with all its promises of economic, social, and medical benefits, along with dire predictions of environmental, health, and safety threats, has occasioned an active debate in the Science and Technology Studies field, in which we have seen five distinct conversations that frame the discussion. The topical threads include ethics, regulation, opportunities and threats including utopian/dystopian visions of the future, public perception, public participation. These conversational distinctions are not absolutes with firm borders as they clearly overlap at many points. Nonetheless, common to all is a strong sense that control and consequence are significant problems that have yet to be addressed adequately by the promoters of nanotechnology. A final section addresses articles on nanotechnology that exemplify the social construction theory of technology. We include herein a selective summary of this recent body of science, technology, and society (STS) journal literature focused on the social and ethical interactions of nanotechnology (SEIN) that has emerged in the last few years. The intent is not to be encyclopedic in coverage, but rather to seek to understand, in a general way, the key issues and concepts STS scholars are discussing. It is clear that STS-oriented scholars are well poised to grapple explicitly with the cultural, socio-political, and ethical dimensions of nanotechnology. Drawing on understandings of earlier socio-technical areas of interest and concern??nuclear power, genetically modified organisms, the human genome??such scholars have moved well beyond the questions of whether and where nanotechnology intersects society. More important is their effort to seek an understanding in depth of exactly how they are socio-politically, culturally, and ethically interconnected. In doing so, SEIN studies have at the same time become increasingly diverse and more sophisticated and mature over the course of the past decade. Scholars have quite rightly recognized the inadequacies of blanket ideas of moratoria versus non-regulatory environments, utopian versus dystopian futures, and whether or not the public has a role to play in nanotechnology decision making. Rather, a more sophisticated, often case specific, flexible understanding of the societal context of a given issue or concern is called for.     

Genomic Counseling: Next Generation Counseling

Personalized medicine continues to expand with the development and increasing use of genome-based testing. While these advances present new opportunities for diagnosis and risk assessment, they also present challenges to clinical delivery. Genetic counselors will play an important role in ushering in this new era of testing; however, it will warrant a shift from traditional genetic counseling to “genomic counseling.” This shift will be marked by a move from reactive genetic testing for diagnosis of primarily single-gene diseases to proactive genome-based testing for multiple complex diseases for the purpose of disease prevention. It will also require discussion of risk information for a number of diseases, some of which may have low relative risks or weak associations, and thus, may not substantially impact clinical care. Additionally, genomic counselors will expand their roles, particularly in the area of health promotion to reduce disease risk. This additional role will require a style of counseling that is more directive than traditional counseling and require greater knowledge about risk reducing behaviors and disease screening.     

Ethics and Technology ‘in the Making’: An Essay on the Challenge of Nanoethics

After reviewing portions of the 21st Century Nanotechnology Research and Development Act that call for examination of societal and ethical issues, this essay seeks to understand how nanoethics can play a role in nanotechnology development. What can and should nanoethics aim to achieve? The focus of the essay is on the challenges of examining ethical issues with regard to a technology that is still emerging, still ‘in the making.’ The literature of science and technology studies (STS) is used to understand the nanotechnology endeavor in a way that makes room for influence by nanoethics. The analysis emphasizes: the contingency of technology and the many actors involved in its development; a conception of technology as sociotechnical systems; and, the values infused (in a variety of ways) in technology. Nanoethicists can be among the many actors who shape the meaning and materiality of an emerging technology. Nevertheless, there are dangers that nanoethicists should try to avoid. The possibility of being co-opted from working along side nanotechnology engineers and scientists is one danger that is inseparable from trying to influence. Related but somewhat different is the danger of not asking about the worthiness of the nanotechnology enterprise as a social investment in the future.     

Negotiating Plausibility: Intervening in the Future of Nanotechnology

The national-level scenarios project NanoFutures focuses on the social, political, economic, and ethical implications of nanotechnology, and is initiated by the Center for Nanotechnology in Society at Arizona State University (CNS-ASU). The project involves novel methods for the development of plausible visions of nanotechnology-enabled futures, elucidates public preferences for various alternatives, and, using such preferences, helps refine future visions for research and outreach. In doing so, the NanoFutures project aims to address a central question: how to deliberate the social implications of an emergent technology whose outcomes are not known. The solution pursued by the NanoFutures project is twofold. First, NanoFutures limits speculation about the technology to plausible visions. This ambition introduces a host of concerns about the limits of prediction, the nature of plausibility, and how to establish plausibility. Second, it subjects these visions to democratic assessment by a range of stakeholders, thus raising methodological questions as to who are relevant stakeholders and how to activate different communities so as to engage the far future. This article makes the dilemmas posed by decisions about such methodological issues transparent and therefore articulates the role of plausibility in anticipatory governance.     

A review of cognitive biases in youth depression: attention,interpretation and memory

Depression is one of the most common mental health problems in childhood and adolescence. Although data consistently show it is associated with self-reported negative cognitive styles, less is known about the mechanisms underlying this relationship. Cognitive biases in attention, interpretation and memory represent plausible mechanisms and are known to characterise adult depression. We provide the first structured review of studies investigating the nature and causal role of cognitive biases in youth depression. Key questions are (i) do cognitive biases characterise youth depression? (ii) are cognitive biases a vulnerability factor for youth depression? and (iii) do cognitive biases play a causal role in youth depression? We find consistent evidence for positive associations between attention and interpretation biases and youth depression. Stronger biases in youth with an elevated risk of depression support cognitive-vulnerability models. Preliminary evidence from cognitive bias modification paradigms supports a causal role of attention and interpretation biases in youth depression but these paradigms require testing in clinical samples before they can be considered treatment tools. Studies of memory biases in youth samples have produced mixed findings and none have investigated the causal role of memory bias. We identify numerous areas for future research in this emerging field.     

Governing with Ignorance: Understanding the Australian Food Regulator’s Response to Nano Food

This paper examines regulatory responses to the presence of previously undetected and unlabelled nanoparticles in the Australian food system. Until 2015, the Australian regulatory body Food Standards Australia New Zealand (FSANZ) denied that nanoparticles were present in Australian food. However, and despite repeated claims from Australia’s food regulator, research commissioned by civil society group Friends of the Earth has demonstrated that nanoparticles are deliberately included as ingredients in an array of food available for sale in Australia. This paper critically examines how nanoparticles have come to be integrated into Australia’s food system under the radar of Australia’s food regulator. Our case study of FSANZ—including its responses to the civil society-led science that determined the existence of nanoparticles in Australian food—raises a number of important questions about the governance of risk in relation to emerging technologies such as nanotechnology. In this paper, we argue that FSANZ’ response to the presence of nanotechnology in Australia’s food system is an example of ‘governing with ignorance’. This is demonstrated via the denial and dismissal of science claims as a basis for limited regulatory intervention. FSANZ’ response intersects with the centrality of commercial interests in shaping science research and commercialisation, alongside the ‘hands off’ approach to regulation that is characteristic of neoliberal governance approaches. We conclude by arguing that in the current food governance framework, and alongside a paucity of impact science, civil society plays a vital role in attempts to democratise the Australian food system.     

Talking Health With a Machine: How Does Message Interactivity Affect Attitudes and Cognitions?

By affording interactive communication and natural, human‐like conversations, can media tools affect the way we engage with content in human–machine interactions and influence our attitudes toward that content? A between‐subjects experiment (N = 172) examined the effects of two communication variables: (a) message‐interactivity and (b) conversational tone, in an online health information (Q&A) tool. Findings suggest that informal conversational tone lowers perceptions of relative susceptibility to health risks. Perceived contingency positively mediates the influence of message interactivity on individuals' health attitudes and behavioral intentions whereas perceived interactivity negatively mediates the relationships between these variables. These contrasting mediation effects are further explored via a phantom model analysis that tests two theoretically distinct paths, with implications for both theory and practice.