Post-Normal Science as a theory links epistemology and governance. It not only focuses on problem situations where facts are uncertain, values in dispute, stakes high and decisions urgent, but also tries to develop epistemic approaches that allow for sound scientific answers. The following article addresses major epistemological challenges within a typical ‘‘wicked-problem situation’’, i.e., risk assessment of emerging technologies. Such challenges include epistemological problems intrinsic to the task of proving the absence of risk, problems related to the multi-sited (...) production of evidence and the multitude of epistemic cultures involved, the incompatibility of the various implicit objectives and the complex actor-constellations, that shape not only the way scientific knowledge is translated into action, but also which kind of knowledge is produced and which experts are listened to. To illustrate and discuss these characteristics, the article draws on an empirical study of risk research in the fields of agri-biotechnology and telecommunication technology in Germany. It concludes that although some aspects of PNS are already part of current epistemic practices in these fields, a state of ‘‘functional post-normality’’ depends upon a meaningful co-evolution between post-normal science and post-normal governance that has not yet been achieved. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to (...) the novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (shrink)

Comparative risk assessment is playing an ever-increasing role in environmental policy priority setting, as manifested in national and numerous subnational comparative risk projects. It is widely accepted that public values, interests, and concerns should play an important role in CRA. However, the philosophical basis for public involvement in CRA has not been adequately explored, nor have comparative risk projects always made explicit their rationales for public involvement. The author examines the political, normative, and epistemic rationales for public (...) involvement and explores the case for public involvement in the making of ethical, valuation, and evidentiary judgments. The author considers key issues each rationale raises, problems eachfaces, and some of the implications of each for specific aspects of CRA. (shrink)

This paper is devoted to showing that a safety priority should be accorded the highest priority in decision-making and that such a prioritisation is an ethical responsibility. The connection between a safety-first priority and ethics is that an ultimate concern for safety is an integral feature of respect for human life. This paper exposes the illogic behind the misleading phrase "risky technology" and the fallacies which underlie the seemingly morally neutral phrase "risk assessment". It is argued that human (...) beings ultimately possess the responsibility of the choice to employ one technological system as over another and hence the decision to employ unsafe technology is a case of "risky assessment" rather than "risky technology". The phrase "risky technology" implies that the risk factor is inherent to the technology when the risk factor is inherent to the choice of which technology to employ. Risk assessment has been portrayed as amoral numerical calculation without clarifying the basis of the assessment. It is argued here that risk assessment must include the basis of its figures and that, to be epistemologically sound, the basis should be past engineering performance and not "subjective engineering judgement". To be ethically sound, risk assessment must take into account not only probabilities of occurrence but consequences of occurrence, such as life or death risks to risk takers and all those on whom the risk taken will ultimately make an impact. It is argued that risk takers possess a right to know of the specific risks to which they are exposing themselves and that risk makers possess the corresponding duty to inform risk takers. The Challenger case is utilised as a lesson in unsound and unethical risk assessment. It is also utilised as a case in which the right of the astronauts and civilian passengers to know of the risk they were taking was not respected and the ethical duty to inform the astronauts and civilian passengers of the risk they were taking was not observed. Distinctions are drawn between general and unknown risks of space travel and the specifically foreknown risks of a design deficient O-ring which malfunctioned below specific temperature readings. The belief that progress requires risk taking is exposed as an oversimplification since progress can be made as in the case of the development of commercial air travel without taking reckless risks. Passenger aircraft must meet certain criteria of safety to be operable but this is not an obstacle to progress. The observance of the right to know and the duty to inform is an asset to business. In the case of Delta Airlines and Northwest Airlines, the decision to notify the public of bomb threats may have given business a boost since passengers have deduced in absence of such a threat that their flight was a safe one as they trusted these airlines. (shrink)

Economist Frank Knight drew a distinction between decisions under risk and decisions under uncertainty. Despite the significance of this distinction for decision theory, we argue that there has been inadequate attention to the difficulties involved in classifying decision situations into these categories. Using the risk assessment of carbon nanotubes as an example, we show that it is often unclear whether there is adequate information to classify a decision situation as being under risk as opposed to uncertainty. We (...) conclude by providing two suggestions for responding to these difficulties: treating decisions as real-world experiments; and promoting broadly based deliberation about quantitative information. (shrink)

For the purpose of this analysis, risk assessment becomes the primary term and risk management the secondary term. The concept of risk management as a primary term is based upon a false ontology. Risk management implies that risk is already there, not created by the decision, but lies already inherent in the situation that the decision sets into motion. The risk that already exists in the objective situation simply needs to be “managed”. By considering (...) risk assessment as the primary term, the ethics of responsibility for risking the lives of others, the environment and future generations in the first place comes into the forefront. The issue of risk heeding is especially important as it highlights the need to pay attention to warnings of danger and to take action to redress problems before disasters occur. In this paper, the decision making that led to the choice of technology utilized and the implementation of such technology in the case of the space shuttle Challenger disaster will be used as a model to illustrate the need to take ethical factors into account when making decisions regarding the safety of technological systems and the heeding of danger warnings. While twenty-five years separates the decision to launch the Challenger and the Fukushima Daiichi nuclear plant disaster, the lessons of the Challenger disaster are still to be learned. (shrink)

College student entrepreneurship is a complex and dynamic process, in which the potential risks faced by entrepreneurial enterprises are interactive and diverse. The changes in risk assessment for college student entrepreneurship are also dynamic and nonlinear and are affected by many factors, which make the risk assessment process for college student entrepreneurship quite complicated. Big data analysis technology is a new product formed under the background of cloud computing and Internet technology, which has the characteristics of (...) large data scale, multiple data types, and strong data value and provides more technical support for the researches on the risk assessment algorithm for college student entrepreneurship. On the basis of summarizing and analyzing previous research results, this article expounded the research status and significance of the risk assessment algorithm for college student entrepreneurship, elaborated the development background, current status, and future challenges of big data analysis technology, introduced the basic principles of support vector machine and hierarchical analytic process, constructed a risk assessment model for college student entrepreneurship based on big data analysis, analyzed the risk factors and assessment indicators of the entrepreneurial model, proposed a risk assessment algorithm for college student entrepreneurship based on big data analysis, performed the discrimination coefficient calculation and comprehensive correlation optimization, and finally conducted a case experiment and its result analysis. The study results show that the risk assessment algorithm for college student entrepreneurship based on big data analysis can effectively realize the comprehensive management of risk factors, make full use of the value of assessment parameter data, and significantly improve the accuracy and efficiency of the risk assessment for college student entrepreneurship, providing more technical support for the researches on the risk assessment algorithm for college student entrepreneurship. The study results of this article provide a reference for further researches on the risk assessment algorithm of college student entrepreneurship based on big data analysis. (shrink)

Focusing on the controversial birth control pills Yaz and Yasmin, this article explores how debates about the safety of these drugs have materialized in risk evaluations and the management of technological risk. Drawing on in-depth interviews with stakeholders and content analysis of legal, medical, and regulatory documents, I highlight how professional contraceptive risk assessment is characterized by systemic uncertainty and doubt, resulting in increased responsibility for users themselves to manage the drugs’ potentially increased risks of venous thromboembolism. (...) The analysis centers on three key areas in the assessment process that denote disagreement: risk measurement in postmarket surveillance data, the distinctiveness of the drugs’ benefits when compared to other contraceptive technologies, and the weighing of the risks and benefits against each other. While professionals negotiate uncertainty both in epidemiological research and in clinical practice, users are constructed as agents who should manage risk individually. Such processes are underlined by a diffusion of responsibility in the systemic management of contraceptive risk. This article suggests, more broadly, that medical technologies can be conceptualized as artifacts that are instrumental in the dispersion of risks. (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)

'A comprehensive and important collection that includes essays by some of the leading figures in the field....Essential reading for anyone interested in risk assessment.' Professor Kristin Shrader-Frechette, University of Notre Dame 'The editors are to be congratulated for bringing together a distinguished international group of theorists to reflect on the issues. This volume will be sure to raise the level of debate while at the same time showing the importance of philosophical reflection in approaches to the problems of the (...) age.' Professor Jonathan Wolff, University College London This volume brings together top authors from the fields of risk, philosophy, social sciences and psychology to address the issue of how we should decide how far technological risks are morally acceptable or not. The underlying principles are examined, along with methodological challenges, public involvement and instruments for democratization. A strong theoretical basis is complemented by a range of case studies from some of the most contentious areas, including medical ethics and GM crops. This book is a vital new resource for researchers, students and anyone concerned that traditional approaches to risk management don't adequately address ethical considerations. (shrink)

For the purpose of this analysis, risk assessment becomes the primary term and risk management the secondary term. The concept of risk management as a primary term is based upon a false ontology. Risk management implies that risk is already there, not created by the decision, but lies already inherent in the situation that the decision sets into motion. The risk that already exists in the objective situation simply needs to be “managed”. By considering (...) risk assessment as the primary term, the ethics of responsibility for risking the lives of others, the environment and future generations in the first place comes into the forefront. The issue of risk heeding is especially important as it highlights the need to pay attention to warnings of danger and to take action to redress problems before disasters occur. In this paper, the decision making that led to the choice of technology utilized and the implementation of such technology in the case of the space shuttle Challenger disaster will be used as a model to illustrate the need to take ethical factors into account when making decisions regarding the safety of technological systems and the heeding of danger warnings. While twenty-five years separates the decision to launch the Challenger and the Fukushima Daiichi nuclear plant disaster, the lessons of the Challenger disaster are still to be learned. (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 (...) class='Hi'>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)

The basic question for risk assessment is not "What are the risks?" but "How safe is safe enough?" Its ambitious goal is to make risk management a scientific enterprise. In order to succeed, not only must risks be quantified but also the many kinds of costs and benefits associated with technology and its control must be quantified and we must find a common metric for comparing these different factors. The risks of risk assessment include the possibility (...) of distorting values in the quest for general comparability and also the problem of responding rationally to different kinds of uncertainty. The problems discussed include comparing novel events to statistically frequent events, comparing different distributions of risk, and quantifying the value of saving human lives. (shrink)

Governments and citizens of nearly every nation have been compelled to respond to COVID-19. Many measures have been adopted, including contact tracing and risk assessment algorithms, whereby citizen whereabouts are monitored to trace contact with other infectious individuals in order to generate a risk status via algorithmic evaluation. Based on 38 in-depth interviews, we investigate how people make sense of Health Code, the Chinese contact tracing and risk assessment algorithmic sociotechnical assemblage. We probe how people accept or (...) resist Health Code by examining their ongoing, dynamic, and relational interactions with it. Participants display a rich variety of attitudes toward privacy and surveillance, ranging from fatalism to the possibility of privacy to trade-offs for surveillance in exchange for public health, which is mediated by the perceived effectiveness of Health Code and changing views on the intentions of institutions who deploy it. We show how perceived competency varies not just on how well the technology works, but on the social and cultural enforcement of various non-technical aspects like quarantine, citizen data inputs, and cell reception. Furthermore, we illustrate how perceptions of Health Code are nested in people’s broader interpretations of disease control at the national and global level, and unexpectedly strengthen the Chinese authority’s legitimacy. None of the Chinese public, Health Code, or people’s perceptions toward Health Code are predetermined, fixed, or categorically consistent, but are co-constitutive and dynamic over time. We conclude with a theorization of a relational perception and methodological reflections to study algorithmic sociotechnical assemblages beyond COVID-19. (shrink)

The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to issuing a final ruling on animal cloning is not part of its mission. In this article, the authors reject the FDA's claim that its mission to protect (...) and advance public health can be accomplished without considering ethical issues or without making value judgments. The authors offer two arguments in support of their position. First, the agency's mission statement presupposes significant normative commitments and judgments. Second, the FDA's risk assessment of food products from cloned animals and their offspring is itself clearly shaped by a variety of normative commitments. (shrink)

This article traces the different classifications of diesel emissions either as “safe” or as “hazardous” in the US and in West Germany between 1977 and 1995. It argues that the environmental regulation of diesel emissions was a political threshold. It contributes to our general understanding of how politicians, environmental lobbyists, scientists, and engineers constructed the standards and norms that defined the “safe” limit of environmental pollutants. After discussing how diesel emissions came under review as a potential carcinogen, I will show (...) that the coding as “safe” or as “hazardous” resulted from negotiations that were entirely dependent on the temporal, geographical, and intellectual contexts in which diesel technology, scientific research on their emissions, and political regulation were embedded. In particular, I trace the differences in German and US regulatory policy. While US regulation relied more on epidemiology that provided only weak data on the carcinogenicity of diesel particulates in the early 1980s, German government agencies tended to base their policy around the mid-1980s more on the results of animal tests and shortly afterwards also on epidemiology. Furthermore, the article reveals how US and German automakers tried to foster doubt on the carcinogenicity of diesel emissions and how their approaches differed and shifted. Thereby, it sheds light on the triangular relationship between technology, science, and politics in regulatory processes by analyzing the different roles of the state, automakers, scientists, and environmental agencies in Germany and in the United States. (shrink)

As states increasingly use algorithms to improve the legibility of society, particularly during the COVID-19 pandemic, it is common for concerns about the expanding power of the algorithm or the state to be raised in a deterministic manner. However, how are the algorithms for states’ legibility projects enacted, contested, and reconfigured? Drawing on interviews and media data, this study fills this gap by examining Health Code, the Chinese contact tracing and risk assessment algorithmic system that serves as the COVID-19 (...) health passport. I first explore the intensive and invisible work and infrastructures that enact and stabilize Health Code’s sociotechnical assemblage. I then show how this assemblage is frequently challenged and destabilized by errors, breakdowns, and exclusions. Facing unintended engagements from heterogeneous social actors, local interests, and power hierarchies, Health Code reassembles into multiple and contradictory assemblages at different periods and social localities. Finally, I examine how people game and bypass the algorithm’s surveillance with their agencies. Recognizing this messiness and heterogeneity contributes to a more nuanced and realistic understanding of states’ use of algorithms, including the risks. Doing so also urges us to rethink the politics of citizenship and inequality in the digital age beyond inclusion. (shrink)

The introduction of new technologies in society is sometimes met with public resistance. Supported by public policy calls for “upstream engagement” and “responsible innovation,” recent years have seen a notable rise in attempts to attune research and innovation processes to societal needs, so that stakeholders’ concerns are taken into account in the design phase of technology. Both within the social sciences and in the ethics of technology, we see many interdisciplinary collaborations being initiated that aim to address tensions (...) between various normative expectations about science and engineering and the actual outcomes. However, despite pleas to integrate social science research into the ethics of technology, effective normative models for assessing technologies are still scarce. Rawls’s wide reflective equilibrium is often mentioned as a promising approach to integrate insights from the social sciences in the normative analysis of concrete cases, but an in-depth discussion of how this would work in practice is still lacking. In this article, we explore to what extent the WRE method can be used in the context of technology development. Using cases in engineering and technology development, we discuss three issues that are currently neglected in the applied ethics literature on WRE. The first issue concerns the operationalization of abstract background theories to moral principles. The second issue concerns the inclusiveness of the method and the demand for openness. The third issue is how to establish whether or not an equilibrium has been reached. These issues should be taken into account when applying the methods to real-world cases involving technological risks. Applying the WRE method in the context of engaged interdisciplinary collaboration requires sensitivity for issues of power and representativeness to properly deal with the dynamics between the technical and normative researchers involved as well as society at large. (shrink)

Cover -- Title -- Copyright -- Dedication -- Contents -- Acknowledgments -- 1 Introduction: Risk and Emotions -- PART I Risk Debates, Stalemates, Values and Emotions -- 2 Emotions and Values in Current Approaches to Decision Making About Risk -- 3 Risk Perception, Intuitions and Values -- PART II Reasonable Risk Emotions -- 4 Risk Emotions: The 'Affect Heuristic', its Biases and Beyond -- 5 The Philosophy of Moral Risk Emotions: Toward a New (...) Paradigm of Risk Emotions -- PART III Emotional Deliberation About Risk -- 6 Reflection on and with Risk Emotions -- 7 Participation with Emotion -- 8 Emotional Deliberation on Technological Risks in Practice -- Epilogue -- References -- Index. (shrink)

Constructivist analyses of risk regulation are typically agnostic about what should count as robust or reliable knowledge. Indeed, constructivists usually portray competing accounts of risk as if they were always equally contingent or engaged with different and incommensurable issues and problem definitions. This article argues that assumptions about the equal reliability of competing accounts of risk deserve to be, and sometimes can be, examined empirically. A constructivist approach grounded in epistemological realism is outlined and applied empirically to (...) a particular comparative U.S./u.k. case study of pesticide regulation. The article argues that while the scope for interpretative flexibility when addressing risk issues is clearly extensive, it is not unconstrained. By scrutinizing the structure and coherence of particular risk assessments and policy decisions by reference to both empirical evidence and commonly held robust standards of interpretation, the article argues that the U.K. evaluation was not only less precautionary than its U.S. equivalent, but it was also less well constructed and therefore less reliable. Several social and institutional characteristics of U.S. and U.K. policy making are highlighted that appear variously to facilitate or inhibit the production of reliable knowledge and the making of prudent policy decisions. (shrink)

As technology advances, and the life and death consequences of its failure become more and more removed from proximate human action, technology management requires greater degrees of ethical awareness and the management of safety becomes a matter of corporate ethical imperative. The corporate ethical imperative includes ethical mandates to take no action which places the lives of others at risk and to inform persons of dangers to their physical safety of which they may otherwise be unaware when (...) one possesses information relevant to the safety of others such that, with the possession of that knowledge, the others can make decisions relevant to protecting their safety, or if others fail to take such action, to take upon oneself the responsibility of taking such action. The ethical duty of primum non nocere implies the corresponding right of the life risking participant to be informed of the kind and degree of risk to which they are to be exposed and the freedom to refuse to take such risk without prejudice. The corporate ethical imperative is to hold human life precious and to uphold that imperative through selectively non-acting, properly informing and acting. The case of the Challenger disaster is utilised as an illustration of decision making which violated these ethical precepts. (shrink)

Discussions about the appropriate way of assessing and managing new or emerging technologies—like nanomaterials—expose the problematic relationship between scientific knowledge production and regulatory decision-making. On one hand, there is a strong demand for scientific expertise to support decisions, especially by analyzing risks and hazards when uncertainties are prevalent and society’s stakes are high. On the other hand, science is criticized for its authoritative claim to objectivity and for keeping the inherent uncertainty, ambiguity, and selectivity of scientific observation latent. Requests for (...) more transparency in science can lead to revealing, to risk managers and the public, the indeterminacy in knowledge production processes. This has consequences for the prevalence of scientific knowledge in decision-making, because it increases uncertainty on both sides of the breach between science and decisions: scientists lose confidence regarding the scientifically tested knowledge which they pass on, and risk managers lose confidence regarding their decisions based on this knowledge. Nonetheless, the concept of “probabilistic risk assessment” remains an important heuristic for dealing with potential future events. This paper addresses questions of the function of scientific risk assessment in organized risk management. The main argument in this paper is that knowledge alone no longer functions as a mechanism for absorbing uncertainty. Accordingly, the interaction between science and decisions must enable a temporarily stable commitment to manage new threats like products and applications coming from the field of nanoscience and nanomaterials. (shrink)

While the demands for greater engagement in science in general and regulatory science in particular have been steadily increasing, we still face limited understanding of the empirical resonance of these demands. Against this context, this paper presents findings from a recent study of a potential participatory opening of the German Federal Institute for Risk Assessment, a prominent regulatory scientific organization in the field of risk governance. Drawing upon quantitative surveys of the public and selected professional experts as well (...) as in-depth qualitative expert interviews, we identify a general support for greater engagement in science-based risk assessment. However, we also find significant contestation concerning its potential enactment and its normative and strategic merit. Underlying these contestations, we identify the persistence of a normal view of science and decisionist understanding of risk assessment, which create conflicting legitimacy demands for BfR and other regulatory scientific organizations. Together with concerns about imbalances in the power to participate, especially in highly specialized engagement processes, these pose significant challenges for the institutionalization of more participatory practices. (shrink)

In this article, I show why it is necessary to abolish the use of predictive algorithms in the US criminal justice system at sentencing. After presenting the functioning of these algorithms in their context of emergence, I offer three arguments to demonstrate why their abolition is imperative. First, I show that sentencing based on predictive algorithms induces a process of rewriting the temporality of the judged individual, flattening their life into a present inescapably doomed by its past. Second, I demonstrate (...) that recursive processes, comprising predictive algorithms and the decisions based on their predictions, systematically suppress outliers and progressively transform reality to match predictions. In my third and final argument, I show that decisions made on the basis of predictive algorithms actively perform a biopolitical understanding of justice as management and modulation of risks. In such a framework, justice becomes a means to maintain a perverse social homeostasis that systematically exposes disenfranchised Black and Brown populations to risk. (shrink)

In this article, I show why it is necessary to abolish the use of predictive algorithms in the US criminal justice system at sentencing. After presenting the functioning of these algorithms in their context of emergence, I offer three arguments to demonstrate why their abolition is imperative. First, I show that sentencing based on predictive algorithms induces a process of rewriting the temporality of the judged individual, flattening their life into a present inescapably doomed by its past. Second, I demonstrate (...) that recursive processes, comprising predictive algorithms and the decisions based on their predictions, systematically suppress outliers and progressively transform reality to match predictions. In my third and final argument, I show that decisions made on the basis of predictive algorithms actively perform a biopolitical understanding of justice as management and modulation of risks. In such a framework, justice becomes a means to maintain a perverse social homeostasis that systematically exposes disenfranchised Black and Brown populations to risk. (shrink)

This chapter contains sections titled: Introduction Technological Risks Future Technology Dealing with Technological Uncertainty How Special Is Technology? References and Further Reading.

The purpose of this paper is to set out a structured meta‐methodology, named DIODE, for the ethical assessment of new and emerging technologies. DIODE has been designed by a mixture of academics, governmental people and commercial practitioners. It is designed to help diverse organisations and individuals conduct ethical assessments of new and emerging technologies. A framework discussion paper was developed for consultation to ensure that DIODE addresses fundamental ethical concerns, has appropriate and manageable scope and is comprehensive in its ethical (...) compass. The resulting DIODE meta‐methodology uses flowcharts and templates, encompassing the use of diverse tools and techniques. There are two different angles for the ethical assessment of new technologies; a strategic-abstract angle and a project-application specific angle. DIODE includes two channels to accommodate this distinction. Early stage testing yielded positive feedback and mostly favourable comment. Additional guidance materials are being developed in response to the feedback. Without training and guidance, it is difficult for technologists to take ethical concerns into account during the development and deployment of new technologies. DIODE can provide that training and guidance through a practical meta‐methodology which should help ICT professionals, policy makers and academics. There is very little structured methodology material available on the ethical assessment of new technologies. The depth and sophistication contained in DIODE is therefore believed to be unique. DIODE provides practical help while remaining rooted in the philosophical and theoretical concepts of ethics. (shrink)

As products of the "new biotechnology," genetically modified organisms have provoked a wide-ranging risk debate on potential harm, especially from herbicide-tolerant crops. In response to this legitimacy problem, the European Community adopted precautionary legislation, which left open the definition of environmental harm. When the U.K. proposed Europe-wide market approval of a herbicide-tolerant oilseed rape, the proposal encountered dissent from some countries and environmentalist groups. Further debate on normative judgments became necessary to implement the precaution ary legislation. In dispute were (...) several regulatory boundaries—of administrative re sponsibility, causality, acceptability, and evidence. The boundary disputes expressed divergentframings of biotechnological risk, each with its implicit model of the socionatu ral order. In this way, the disputes can illuminate the sorts of risk framings that have already become embedded and standardized in other regulatory sectors. (shrink)

Recently, two prescription drugs have become salient to breast cancer prevention. With the advent of these drugs, referred to as “chemoprevention,” a mandate has emerged to classify certain women as high risk for breast cancer to determine a group of legitimate users of the drugs. This article examines the development and standardization of the model used to create such a group of high-risk women. The author argues that while the model remains uncertain and controversial, it has become the (...) standard tool for the many jobs associated with legitimizing chemoprevention use in the United States. It has become the assumed standard—shaping practices, identities, and definitions—through its organizational embeddedness in the multiple practices and public images of chemoprevention despite its uncertainty and widespread critique. (shrink)

Technology assessment (TA) is – for several reasons – not detachable from ethical questions. The development of institutions and concepts for TA, especially in the USA and Western Europe, has been marked by an increasing tendency to focus evaluative and normative questions. In the following paper, we point out, in as far as the common notions of TA are implicitly normative, why reflection upon conceptual options of TA inevitably leads to ethical questions, and that the key question of participation (...) necessarily comes up in the context of societal decisions made under conditions of risk or uncertainty. Arrangements of participatory and discoursive TA are referred to as possible applications of discourse ethics, but there are consequences to consider, which result from discourses in TA not being ideal discourses. Concepts and performance of TA arrangements on biotechnology and gene technology in different European countries are compared, analysing what similarities and differences can be found with respect to ethical clarification. Crucial questions of how to conceptualise participatory TA (pTA) and current topics in ethics of technology are shown to coincide. A proposal is presented of how these – theoretical normative and empirical descriptive – considerations can be used in a comprehensive conception for participatory and discoursive TA. (shrink)

Technology assessment (TA) as aninstitution was introduced nearly thirty yearsago as an instrument to render possible themaking of responsible decisions concerning newtechnological options. Another recentdevelopment however has been the introductionof participatory technology assessment (pTA),mainly connected to the growing insight thatthe evaluation of technological options withrespect to their risks and benefits, is not –only – a scientific question. This paper willfocus on the questions, to what degree theideas of technology assessment and thePrecautionary Principle are connected and how.Without naming (...) it explicitly, the PrecautionaryPrinciple is put to debate in the``TA-arrangement on the cultivation oftransgenic herbicide resistant crops,''organized by the Science Centre, Berlin. Fromthe perspective of ethical clarification, someunique features concerning theconceptualization of the discoursive procedureand reconstruction of the argumentation processin order to come to results have to beanalyzed. Finally the performance and resultsof the pTA-arrangement are reflected in thelight of the Precautionary Principle andconclusions are drawn. (shrink)

Synthetic biology is regarded as one of the key technosciences of the future. The goal of this paper is to present some fundamental considerations to enable procedures of a technology assessment of synthetic biology. To accomplish such an early “upstream” assessment of a not yet fully developed technology, a special type of TA will be considered: Prospective TA. At the center of ProTA are the analysis and the framing of “synthetic biology,” including a characterization and assessment of the (...) technological core. The thesis is that if there is any differentia specifica giving substance to the umbrella term “synthetic biology,” it is the idea of harnessing self-organization for engineering purposes. To underline that we are likely experiencing an epochal break in the ontology of technoscientific systems, this new type of technology is called “late-modern technology.” —I start this paper by analyzing the three most common visions of synthetic biology. Then I argue that one particular vision deserves more attention because it underlies the others: the vision of self-organization. I discuss the inherent limits of this new type of late-modern technology in the attempt to control and monitor possible risk issues. I refer to Hans Jonas’ ethics and his early anticipation of the risks of a novel type of technology. I end by drawing conclusions for the approach of ProTA towards an early societal shaping of synthetic biology. (shrink)

Risk analysis as a regulatory driver has now become firmly entrenched in public health and environmental protection. Risk analysis at any level essentially has to accommodate two gut feelings of the constituency: whether society should be risk-prone or risk averse, and whether government and its institutions can be trusted to make the necessary decisions with a high or a low degree of discretion. The precautionary principle (or rejection thereof) arguably is the ultimate reflection of the promotion (...) of risk to a societal value. There is no doubt that especially amongst the representatives of the Member States (as opposed to the officials at the European Commission), public (pre)caution with respect to the long-term environmental and public health implications of gene technology influenced the reluctance to allow marketing of GM foods and feeds until a strict regulatory regime had been rolled out. Industry would argue that the delay in regulation, as well as the eventual regime was of such a nature as to stifle the technology. This contribution reviews a number of features of standard EU risk analysis decisions, so as to assess its current propensity towards smothering rather than smoothing the introduction of new technology. The current development of a regulatory framework for nanotechnology serves as a case study. (shrink)

The general idea developed in this paper from a sociological perspective is that some of the foundational categories on which the debate about privacy, security and technology rests are blurring. This process is a consequence of a blurring of physical and digital worlds. In order to define limits for legitimate use of intrusive digital technologies, one has to refer to binary distinctions such as private versus public, human versus technical, security versus insecurity to draw differences determining limits for the (...) use of surveillance technologies. These distinctions developed in the physical world and are rooted in a cultural understanding of pre-digital culture. Attempts to capture the problems emerging with the implementation of security technologies using legal reasoning encounter a number of problems since law is by definition oriented backwards, adapting new developments to existing traditions, whereas the intrusion of new technologies in the physical world produces changes and creates fundamentally new problems. (shrink)

A comprehensive assessment of a health technology requires that a wide variety of questions are addressed. These range from whether the use of a technology results in achievement of its intended effects at acceptable costs and without incurring undue risks to the patient, to whether its use may challenge existing social arrangements and values. Clearly, this is a major challenge, since it requires the use of quite different methods of inquiry. In the past decades, we have rarely witnessed (...) assessments where both types of questions were addressed in a balanced way. Rather, a wide gap exists between inquiries with a strong empirical focus and an almost complete neglect of underlying normative issues, and inquiries which are largely discursive, but with a serious disregard of relevant empirical data. The complex interplay between normative frameworks and empirical data in the assessment of health technologies is illustrated in two case studies: the assessment of surgical management of children with glue ears, and the assessment of Extra Corporeal Membrane Oxygenation in neonates. (shrink)

The genetically manipulated organism crisis demonstrated that technological development based solely on the law of the marketplace and State protection against serious risks to health and safety is no longer a warrant of ethical acceptability. In the first part of our paper, we critique the implicitly individualist social-acceptance model for State regulation of technology and recommend an interdisciplinary approach for comprehensive analysis of the impacts and ethical acceptability of technologies. In the second part, we present a framework for the (...) analysis of impacts and acceptability, devised—with the goal of supporting the development of specific nanotechnological applications—by a team of researchers from various disciplines. At the conceptual level, this analytic framework is intended to make explicit those various operations required in preparing a judgement about the acceptability of technologies that have been implicit in the classical analysis of toxicological risk. On a practical level, we present a reflective tool that makes it possible to take into account all the dimensions involved and understand the reasons invoked in determining impacts, assessing them, and arriving at a judgement about acceptability. (shrink)

Handling the impacts and consequences of technology has become a problem of political, social and scientific relevance since the Sixties. The earlier assumption that technological evolution would automatically lead to social and human progress in an emphatic sense can no longer be sustained. The ambivalence of technology has become a standing topic in the public, philosophical and scientific debate .In this situation new challenges to technology policy are emerging. Functions of an `early warning' with respect to the (...) risks or potentials of new technologies or to ways of avoiding or, at least, resolving technology conflicts by compromise have been postulated . Technology policy pursued by parliament or government, therefore, is in need of scientific consultation . Since the Seventies a number of institutions in this field have been founded , either primarily as parliamentary bureaus of knowledge-transfer to the decision-makers , as networks with a low degree of institutionalization or as independent scientific institutes .The scientific discussion on how to acquire and establish orientational knowledge for decision-makers facing the ambivalence of technology is sectoralized into two branches: the ethics of technology and technology assessment . These two branches are based on fundamentally different assumptions concerning how to give orientation to technology policy: the philosophical ethics, of course, emphasizes the normative implications of decisions on technology and the importance of moral conflicts , while technology assessment relies mainly on sociological or economic research .Both approaches have largely been developed and practised without regard to one another. In Germany, at the beginning of the Nineties the conceptual discussion around these questions was initiated. At first, a lot of misunderstandings appeared, both parties fundamentally criticizing each other, often one denying the competence of the other to deal appropriately with technology problems . In this paper the conflict is analyzed by looking at the situation in Germany, summarizing and weighing the main arguments which have been brought up by TA and the ethical approach to technology.As a result it will be shown that both are partly right, whereby the relative weight of both approaches in their capacity to give orientation is dependent on contextual circumstances. A non-reductionistic overall approach must take into account the normative aspects of the ethics of technology when handling moral conflicts as well as the need for operationalization, concreteness and established knowledge about the processes of “managing technology in society” postulated by TA. (shrink)

Research protocols must have a reasonable balance of risks and anticipated benefits to be ethically and legally acceptable. This article explores three characteristics of research on reproductive genetic technologies that complicate the assessment of the risk-benefit ratio for such research. First, a number of different people may be affected by a research protocol, raising the question of who should be considered to be the subject of reproductive genetic research. Second, such research could involve a wide range of possible harms (...) and benefits, making the evaluation and comparison of those harms and benefits a challenging task. Finally, the risk-benefit ratio for this type of research is difficult to estimate because such research can have unpredictable, long-term implications. The article aims to facilitate the assessment of risk-benefit ratios in research on reproductive genetic technologies by proposing and defending some guidelines for dealing with each of these complicating factors. (shrink)

PurposeThe purpose of this paper is to examine the risk arising from technological devices, such as closed circuit television and nuclear power plants and the consequent effect on the rights to privacy and security of individuals.Design/methodology/approachThe paper presents critical and conceptual analyses of CCTV, nuclear power plants and the rights of individuals. It also analyses how communitarianism and liberal individualism would respond to right‐infringements and risk‐imposition. It draws on W.D. Ross's prima facie and actual duties to explain the (...) pre‐eminence of duty when certain duties conflict in a bid to improve technology.FindingsThe paper discovers the importance of rights to individuals, particularly the rights to privacy and security. It shows that, in some situations, government's duty to respect the right to the privacy of individuals conflicts with the duty to provide public goods, such as CCTV. The paper, therefore, stresses that one duty has greater moral force than the other. In essence, the more incumbent duty can be employed by government in justifying right‐infringement and risk‐imposition, though this does not disvalue the rights of individuals.Originality/valueThe paper offers insight into ways of addressing questions such as: when is it morally acceptable or justifiable to expose others to risk? When is infringement on people's rights permissible? Also, the paper is relevant to those in the areas of ethics and technology because it offers an ethical analysis of risk‐imposition and right‐infringement by examining how ethical theories, such as communitarianism and liberal individualism, would assess risks resulting from CCTV and nuclear energy. It argues that consent is not enough to justify risk‐imposition and right‐infringement. It concludes by drawing on W.D. Ross's prima facie and actual duties as a means of justifying risk‐imposition and right‐infringement by government. (shrink)