Des mortalités anormales frappent les ruchers d’Europe et d’autres continents depuis un peu plus de vingt ans. Depuis le début des troubles, des suspicions pèsent sur des insecticides d’un genre nouveau, utilisés en traitement de semences. La législation prescrivant l’évaluation des risques environnementaux de toute substance insecticide dès avant sa mise sur le marché, des apiculteurs sont allés consulter les dossiers portant sur les molécules suspectées, ce qui les a amenés à s’impliquer dans la critique et l’élaboration des règles d’évaluation, (...) et à côtoyer le monde des experts en toxicologie de l’abeille.Beehives across Europe and other continents have been affected by abnormal mortality for the last twenty years. Since these problems first appeared, suspicion has fallen on a new type of insecticide, which is used to treat seeds. The legislation prescribes environmental risk assessments of any insecticide substance before it reaches the market, and beekeepers therefore decided to consult the files concerning the suspect molecules. As a result, they became involved in critically reviewing and developing assessment rules, and thus came to rub shoulders with experts in bee toxicology. (shrink)

This article examines the way in which public controversies affect regulatory science. It describes the controversy that unfolded in Europe around the use of the ninety-day rat-feeding tests for the risk assessment of genetically modified plants. This type of test had been criticized for almost two decades by toxicologists, nongovernmental organizations, and industry alike for its inability to capture the specific health effects of GM plants. But GM risk assessment experts showed great reluctance to move toward (...) a more systematic use of other tests, such as chronic two-year studies or toxicogenomic techniques, and made sure that official guidance continues to recommend the use of the ninety-day rat-feeding study. The article shows that these tactics of standardization are a defining feature of regulatory science, and a resource for toxicity experts to defend their authority and credibility against competing expertises that arise during controversies. (shrink)

In a recent paper in Science and Engineering Ethics (SEE) Elliott proposed an ethics of expertise, providing its theoretical foundation along with its application in a case study devoted to the topic of hormesis. The application is based on a commentary in the journal Nature, and it includes assertions of ethical breaches. Elliott concludes that the authors of the commentary failed to promote the informed consent of decision makers by not providing representative information about alternative frequency estimates of hormesis in (...) the literature, thereby hindering the capacity of the scientific community to promote informed consent relating to chemical regulation. This paper argues that Elliott should have incorporated due process into his system of evaluation. His argument is also seriously deficient technically, in that it misinterprets the toxicological issues, misrepresents the scientific literature with respect to the frequency of hormesis, and incorrectly assesses the extent to which the Nature paper revealed opposing/alternative views on hormesis. Given the seriousness of assertions of noncompliance to ethical norms, there must be procedures to protect those whose ethics were called into question, to fairly evaluate the technical justification for an assertion, and to enable corrections in the event of errors. If a journal is willing to publish assertions that individuals acted in an ethically questionable way, it should be guided by a documented code of ethics and meet a standard of responsibility far greater than normal peer-review processes for papers that do not entail such ethical judgments. (shrink)

Scientists are often asked to advise political institutions on pressing risk-related questions, like climate change or the authorization of medical drugs. Given that deliberation will often not eliminate all disagreements between scientists, how should their risk assessments be aggregated? I argue that this problem is distinct from two familiar and well-studied problems in the literature: judgment aggregation and probability aggregation. I introduce a novel decision-theoretic model where risk assessments are compared with acceptability thresholds. Majority voting is then (...) defended by means of robustness considerations. (shrink)

Risk assessment is an evidence-based analytical framework used to evaluate research findings related to environmental and public health decision-making. Different routines have been adopted for assessing the potential risks posed by substances and products to human health. In general, the traditional paradigm is a hazard-driven approach, based on a monocausal toxicological perspective. Questions have been raised about the applicability of the general chemical risk assessment approach in the specific case of nanomaterials. Most scientists and stakeholders assume (...) that the current standard methods are in principle suitable, but point out that experimental aspects and practical guidelines need specific adaptations. Beyond this laboratory level, risk assessment of nanomaterials also faces a number of substantive and procedural limitations, which are intrinsically attributed to the general orthodoxy of the risk assessment concept. Moreover, the developed formalism used to organize scientific knowledge is closely interlinked with the underlying governance design and the mode of interaction between the two spheres of ‘science’ and ‘decisions’. This contribution will provide a closer look at the evolution of different institutional settings for risk assessment in the context of decision-making. Improved risk governance frameworks with different narratives, process designs and procedural elements will be compared. The question of a general principle of enhanced organization of risk assessment will be discussed taking account of the barriers of substantive and procedural limitations in the special case of nanomaterials. (shrink)

Environmental risk assessment is often affected by severe uncertainty. The frequently invoked precautionary principle helps to guide risk assessment and decision-making in the face of scientific uncertainty. In many contexts, however, uncertainties play a role not only in the application of scientific models but also in their development. Building on recent literature in the philosophy of science, this paper argues that precaution should be exercised at the stage when tools for risk assessment are developed (...) as well as when they are used to inform decision-making. The relevance and consequences of this claim are discussed in the context of the threshold of the toxicological concern approach in food toxicology. I conclude that the approach does not meet the standards of an epistemic version of the precautionary principle. (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)

Brazil is the biggest market for pesticides in the world. In the registration process, a pesticide must be authorized by the Institute of the Environment, Health Surveillance Agency and Ministry of Agriculture. Evaluations follow a package of toxicological studies submitted by the companies and also based on the Brazilian law regarding pesticides. We confronted data produced by private laboratories, submitted to the Institute of the Environment for registration, with data obtained from scientific databases, corresponding to mutagenicity, carcinogenicity and teratogenicity of (...) pesticides. All studies submitted by the companies were carried out by private laboratories. From 247 pesticide formulations analyzed, none showed positive results for mutagenicity, carcinogenicity or teratogenicity. From 574 articles in the scientific literature, 84% published by public laboratories showed positive results, while 79% of those showing negative results came from private laboratories. There is an ethical concern about a conflict of interest between public/independent laboratories and private laboratories that produce data for registering pesticides. We demonstrated that there is a clear contradiction between public and private laboratories. Brazilian regulatory authorities have approved the registration of pesticides based almost exclusively on the monographs provided by the pesticide industry, because the use of scientific articles or information from the independent literature is strongly belittled by the industry. Pesticide companies argue that scientific articles cannot be trusted. Also, according to the industry, pesticide registration cannot be refused based on results from scientific articles. Thus, the registration of pesticides with mutagenic, carcinogenic and teratogenic risks has been approved in Brazil. (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)

How can we determine an acceptable level of risk? Should these decisions be made by experts, or by the people they affect? How should safety and security be balanced against other goods, such as liberty? This is the first collection to examine the philosophical dimensions of these pressing practical problems. Leading scholars exploring the full range of philosophical implications of risk, including: risk and ethics risk and rationality risk and scientific expertise risk and lay (...) knowledge the objectivity of risk assessment risk and the precautionary principle risk and terror. With contributions from Carl F. Cranor, Sven Ove Hansson, Martin Kusch, Tim Lewens, D.H. Mellor, Adam Morton, Stephen Perry, Martin Peterson, Alan Ryan, Per Sandin, Cass R. Sunstein and Jonathan Wolff; this collection is essential reading, not only for philosophers and researchers in legal, economic and environmental studies, but for those seeking to gain a better understanding of the decisions we must make as concerned citizens. (shrink)

Regulating technologies, innovations and risks is an activity that, as much as scientific research needs proofs and evidence. It is the site of development of a distinct kind of science, regulatory science. This special issue addresses the question of the standards of knowledge governing how we test, assess and monitor technologies and their effects. This topic is relevant and timely in the light of problematics of regulation of innovation, regulatory failure and capture. Given the enormous decisions and stakes regulatory science (...) commends, it becomes crucial to ask where its standards come from and gain credibility, but also what valuations of technology and appreciations of their risks or benefits do they embed, and who controls them? This paper introduces the four contributions comprising the special issue, and outlines a perspective from which to question the construction of regulatory science or, in the terminology adopted here, the authorization and standardization of regulatory knowledge, particularly the role of networks of scientific experts therein. (shrink)

When scientists are asked to give expert advice on risk-related questions, such as the authorization of medical drugs, deliberation often does not eliminate all disagreements. I propose to model these remaining discrepancies as differences in risk assessments and/or in risk acceptability thresholds. The normative question I consider, then, is how the individual expert views should best be aggregated. I discuss what “best” could mean, with an eye to some robustness considerations. I argue that the majority rule, which (...) is currently often used in expert panels, has significant drawbacks. (shrink)

The decision to accept or to reject an empirical hypothesis concerning the risks and hazards of a pesticide requires assessing the cost's of error if the wrong decision is taken. The assessment of such costs involves scientists in problems which are closely related to those which policy‐makers face in deciding what to do in view of the information provided by scientists. These problems include the unforeseeable effects of agricultural technologies, the assessments of costs and benefits, and the choice of (...) decision rule to use in policy formation. I conclude that the combined impact of these problems motivates the use of prudentially weighted decision rules in forming policies which regulate the use of pesticides, and it motivates the development of bio‐environmental alternatives to chemically based pest control policies. (shrink)

Exposure to pesticides during infancy is associated with numerous adverse health outcomes. The assessment of knowledge and perception of pesticides exposure and risk among children has not been thoroughly studied. The aim of the study was to evaluate the reliability and validity of a questionnaire that measures the knowledge and perception of exposure to organophosphate pesticides among rural schoolchildren. The questionnaire was administered to 151 schoolchildren between 9 and 13years from four Chilean rural schools. An internal consistency analysis (...) of the ordinal alpha coefficient and a polychoric factor analysis for categorical data were used. The results show that the ordinal alpha was 0.95. Polychoric matrices of rotated components show the 17 questions summarized pesticide knowledge in five factors extracted after promax rotation. This factorial model explains 56.3% of the variance. The questions were grouped as follows: knowledge about pesticides ; knowledge of health effects related to pesticides exposure ; pesticide exposure through the growing of fruits and vegetables ; perception and action against pesticides exposure at school ; and perception and action against pesticides exposure at home. The questionnaire provides a useful tool for examining pesticide exposure in agricultural regions, allowing younger community members to participate. (shrink)

Risk assessment studies of herbicide resistant sugarbeet have revealed no risks to human health or the environment.Indeed it appears that commercial growth of this crop mightsecure benefits such as decreased pesticide use and increasedbiodiversity. However, widespread resistance to GM crops such asherbicide resistant sugar beet still persists in Europe. It isargued that this is not just because people do not know therelevant facts. Rather it is because popular resistance to GMfood is driven in part by concerns other than (...) the fear ofnarrowly defined risks to health and the environment. These otherconcerns include an aversion to commercial monopoly and anegative view of pesticide use in general. Herbicide resistantsugar beet may also be perceived as a ``Trojan horse,'''' i.e., acrop whose licensing would create a precedent and make it morelikely that other, less environmentally friendly, crops will beapproved within the current strictly technical and science-basedrisk assessment procedures. To meet these public concerns, a kindof technology assessment reflecting factors such as benefits andconsumer choice is called for. (shrink)

The weaponizing of scientific expertise to oppose regulation has been extensively studied. However, the relevant studies, belonging to the emerging discipline of agnotology, remain focused on the analysis of empirical corruption: of misinformation, doubt mongering, and other practices that cynically deploy expertise to render audiences ignorant of empirical facts. This paper explores the wrongful deployment of expertise beyond empirical corruption. To do so, I develop a broader framework of morally subversive expertise, building on recent work in political philosophy (Howard, 2016). (...) Expertise is subversive if it sets up its audience to fail morally, either intentionally or negligently. I distinguish three modes of subversive expertise: empirical subversion (the focus of agnotology), normative subversion and motivational subversion. Drawing on these distinctions, I offer a revisionary account of the Trump Administration’s regulatory science as a case study. I show that the Trump Administration’s use of expertise to dismantle climate regulation, contra the standard charge, cannot be explained using the resources of agnotology alone: the Administration produced highly reliable climate assessments, detailing the risks of climate change, candidly admitting the harms of its proposed policies, and still successfully deployed these findings to justify massive climate deregulation. The lesson of the analysis is that dismissing the expertise that underpins climate deregulation as empirically corrupt ‘anti-science’ both obscures its actual role in the politics of climate change and understates its wrongfulness: it misses the breadth of the assault on moral agency that sustains climate injustice. (shrink)

One way to do socially relevant investigations of science is through conceptual analysis of scientific terms used in special-interest science (SIS). SIS is science having welfare-related consequences and funded by special interests, e.g., tobacco companies, in order to establish predetermined conclusions. For instance, because the chemical industry seeks deregulation of toxic emissions and avoiding costly cleanups, it funds SIS that supports the concept of "hormesis" (according to which low doses of toxins/carcinogens have beneficial effects). Analyzing the hormesis concept of its (...) main defender, chemical-industry-funded Edward Calabrese, the paper shows Calabrese and others fail to distinguish three different hormesis concepts, H, HG, and HD. H requires toxin-induced, short-term beneficial effects for only one biological endpoint, while HG requires toxin-induced, net-beneficial effects for all endpoints/responses/subjects/ages/conditions. HD requires using the risk-assessment/regulatory default rule that all low-dose toxic exposures are net-beneficial, thus allowable. Clarifying these concepts, the paper argues for five main claims. (1) Claims positing H are trivially true but irrelevant to regulations. (2) Claims positing HG are relevant to regulation but scientifically false. (3) Claims positing HD are relevant to regulation but ethically/scientifically questionable. (4) Although no hormesis concept (H, HG, or HD) has both scientific validity and regulatory relevance, Calabrese and others obscure this fact through repeated equivocation, begging the question, and data-tri mm ing. Consequently (5) their errors provide some undeserved rhetorical plausibility for deregulating low-dose toxins. (shrink)

The Adverse Outcome Pathway (AOP) concept is a knowledge assembly and communication tool to facilitate the transparent translation of mechanistic information into outcomes meaningful to the regulatory assessment of chemicals. The AOP framework and associated knowledgebases (KBs) have received significant attention and use in the regulatory toxicology community. However, it is increasingly apparent that the potential stakeholder community for the AOP concept and AOP KBs is broader than scientists and regulators directly involved in chemical safety assessment. In this (...) paper we identify and describe those stakeholders who currently—or in the future—could benefit from the application of the AOP framework and knowledge to specific problems. We also summarize the challenges faced in implementing pathway-based approaches such as the AOP framework in biological sciences, and provide a series of recommendations to meet critical needs to ensure further progression of the framework as a useful, sustainable and dependable tool supporting assessments of both human health and the environment. Although the AOP concept has the potential to significantly impact the organization and interpretation of biological information in a variety of disciplines/applications, this promise can only be fully realized through the active engagement of, and input from multiple stakeholders, requiring multi-pronged substantive long-term planning and strategies. (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)

A key question for evidence-based medicine is how best to model the way in which EBM should‘[integrate] individual clinical expertise and the best external evidence’. We argue that the formulations and models available in the literature today are modest variations on a common theme and face very similar problems when it comes to risk analysis, which is here understood as a decision procedure comprising a factual assessment of risk, the risk assessment, and the decision what (...) to do based on this assessment, the risk management. Both the early and updated models of evidence-based clinical decisions presented in the writings of Haynes, Devereaux and Guyatt assume that EBM consists of, among other things, evidence from clinical research together with information about patients’ values and clinical expertise. On this A-view, EBM describes all that goes on in a specific justifiable medical decision. There is, however, an alternative interpretation of EBM, the B-view, in which EBM describes just one component of the decision situation and in which, together with other types of evidence, EBM leads to a justifiable clincial decision but does not describe the decision itself. This B-view is inspired by a 100-years older version of EBM, a Swedish standard requiring medical decision-making, professional risk-taking and practice to be in accordance with‘science and proven experience’. In the paper, we outline how the Swedish concept leads to an improved understanding of the way in which scientific evidence and clinical experience can and cannot be integrated in light of EBM. How scientific evidence and clinical experience is integrated influences both the way we do risk assessment and risk management. In addition, the paper sketches the as yet unexplored historical background to VBE and EBM. (shrink)

Risk communication poses a challenge to ordinary norms of truth-telling because it can easily mislead. Analyzing this challenge in terms of a systematic divergence between expertise and public attitudes fails to recognize how two specific features of the concept of risk play a role in managing daily affairs. First, evaluating risk always incorporates an estimate of the reliability of information. Since risk communication is an effort at providing information, audiences will naturally and appropriately incorporate their (...) class='Hi'>assessment of the reliability of the risk communicator into their assessment of the risk as such. Second, one conceptual and grammatical feature of the concept of risk is to categorize experience as non-routine and demanding further deliberation. That is, the whole point of calling something a risk can be to distinguish it from activities or phenomena that need no further attention. Risk communications that stress relative comparisons of measured probabilities and expected utilities can be inconsistent with both features of our concept of risk. At best they mislead; at worst they undermine our society’s capacity to cope with risk. While there are no simple answers to these two conundrums, technical experts should bear them in mind when communicating with the broader public. (shrink)

Un des effets de la radicalisation de la modernité tient à la montée de l’incertitude qui déstabilise les institutions les plus solides de notre culture, dont notamment la science, et à la généralisation de la sémantique du risque qui affecte les processus de prise de décision. Parmi les centres de recherche en sciences sociales spécialisés sur les risques en Europe, deux grands établissements ont retenu plus particulièrement notre attention en raison de leur polarité. Nous établirons des comparaisons entre deux projets (...) menés par Wolfgang Van den Daele, Wissenschaftszentrum , Berlin, et Robin Grove-White et Brian Wynne, Centre for the Study of Environmental Change , Lancaster. L’expérience menée par le WZB autour de l’évaluation des risques associés à la diffusion des organismes génétiquement modifiés dans l’agriculture et l’alimentation a conduit l’équipe à défendre une procédure strictement technique favorable à la normalisation des biotechnologies. Pour les chercheurs du CSEC, au contraire, l’élargissement des évaluations des innovations technologiques à des considérations éthiques, économiques, politiques et sociales s’impose. Le différend atteste de l’immersion des sciences et de leurs controverses dans des visions du monde et des Weltanschauungen : il compromet l’éventualité d’une entente entre les protagonistes du conflit.One of the consequences of advanced modernity is the intensification of uncertainty, which destabilizes the main institutions of our world. The production of knowledge and the legitimacy of decisions are mainly affected by this transformation, as the semantics of risk shows. We spent several stays at different research institutions in France, Germany and the United Kingdom to study the variations in the social sciences framing of risk issues. We will focus our attention on two teams of researchers, because of the exemplariness of their positions structuring the field. We follow a comparison between two projects led by Wolfgang Van den Daele at the Wissenschaftszentrum Berlin , and Robin Grove-White and Brian Wynne at the Centre for the Study of Environmental Change in Lancaster . Their conclusions based on an experiment to evaluate the risks associated with the introduction of GMOs in agriculture and food, differ radically. The WZB argues for a strict delimitation and restriction of risk assessment, while the CSEC argues for the integration of ethical and sociopolitical considerations in the discussions about the diffusion of technical innovations in society. The strength of both arguments illustrates the articulation of science and its controversies with Weltanschauungen and sociophilosophical background, which contribute to the stabilization of each position and thus reduces the chances for a resolution of controversy. (shrink)

What is risk? How do we assess risk? What are the ethical implications of risk? The concept of risk is important – sometimes even crucial – for many philosophical domains, from philosophy of science and technology to ethics and sustainability. Philosophy and Science of Risk is a clear, wide-ranging introduction to this urgent and fast-growing subject. It covers the following key topics: -/- • The philosophical and historical background to understanding and interpreting risk -/- (...) • The meaning of risk and how it differs from closely related concepts, such as uncertainty or dangers -/- • The social construction of risk -/- • Risk perception and risk as an object of scientific study -/- • The measurement of risk, its probability and severity -/- • Risk and scientific modeling -/- • Risk, value judgments, and expertise -/- • Risk management, including cost-benefit analysis and the precautionary approach -/- • Risk communication, including deliberative models -/- • Ethics of risk, including duties toward nonhuman animals and future generations -/- • Risk and sustainability -/- • Decision-making under risk -/- Including helpful additional features such as text boxes, chapter summaries, review, and discussion questions, Philosophy and Science of Risk: An Introduction is an ideal textbook for students of the philosophy of risk. It is also suitable for students studying the conceptual questions surrounding risk in related subjects, such as sociology, psychology, economics, politics, geography, sustainability, and environmental studies. (shrink)

An excellent critical analysis and scientific assessment of the nature and actual level of risk leading environmental health hazards pose to the public. Issues such as radiation from nuclear testing, radon in the home, and the connection between electromagnetic fields and cancer, environmental factors and asthma, pesticides and breast cancer and leukemia clusters around nuclear plants are discussed and how scientists assess these risks is illuminated.

This commentary on Isabelle Stengers's article, “Comparison as a Matter of Concern” is an assessment of her stance toward experimental psychology. At the various points in her work where she considers that discipline, she tends to accuse it of failing to embrace the “risk” that she sees as defining the “collective games” of science. Brown invokes the behavioral approach to experimental psychology of the early to mid-twentieth century to contextualize Stengers's treatment of continuous comparison conducted by scientists around (...) “matters of concern.” Her use of the metaphor of predator/prey relationships between practices is seen as reversing the usual direction of critique within psychology, such that experimental psychology appears to have, in the Wistar rat, an object grounding a community that is capable of performing continuous comparison, which its critics contrastingly lack. Stengers's ecological view of practices may then ultimately lead to a reappraisal of branches of the human sciences, such as experimental psychology, which she tends, on occasion, to dismiss. (shrink)

Cet article illustre les différences entre les processus d’expertise en France et aux États-Unis par une comparaison des procédés d’évaluation des risques du perchlorate, un contaminant environnemental détecté dans les eaux de consommation et dans l’alimentation. Ce cas atteste d’une opposition entre deux modèles, l’un fondé sur la confrontation et l’ouverture aux parties prenantes, l’autre fondé sur le consensus et la centralisation de l’expertise. Les différences principales concernent la formalisation de l’interaction entre différentes instances évaluatives et les autres parties prenantes, (...) les processus permettant des évaluations externes de la qualité des évaluations des risques et le rôle du chercheur dans leur élaboration. Après avoir décrit les différences, l’article développe les avantages et les désavantages des deux systèmes d’expertise, et conclut sur la possibilité de développement d’une voie intermédiaire pour l’expertise institutionnelle européenne, alliant centralisme, collégialité et pluralité.This article illustrates the differences between expert assessment procedures in France and the United States by comparing their respective procedures for the risks raised by perchlorate, an environmental contaminant detected in drinking water and food. This example highlights the contrast between the two models, one based on confrontation and stakeholder involvement, the other on consensus and the centralisation of experience. The main differences lie in the way interactions between the various bodies responsible for the assessments and the other stakeholders are formalised, in the procedures governing audits of the risk assessments, and in the role of researchers in the production of these assessments. After describing the differences, the article describes the advantages and drawbacks of the two systems and concludes with a proposal for the development of an intermediate method for EU institutional expert appraisals, combining a centralising approach with pluralist and collegial principles. (shrink)

In a recent paper in Science and Engineering Ethics (SEE) Elliott proposed an ethics of expertise, providing its theoretical foundation along with its application in a case study devoted to the topic of hormesis. The application is based on a commentary in the journal Nature, and it includes assertions of ethical breaches. Elliott concludes that the authors of the commentary failed to promote the informed consent of decision makers by not providing representative information about alternative frequency estimates of hormesis in (...) the literature, thereby hindering the capacity of the scientific community to promote informed consent relating to chemical regulation. This paper argues that Elliott should have incorporated due process into his system of evaluation. His argument is also seriously deficient technically, in that it misinterprets the toxicological issues, misrepresents the scientific literature with respect to the frequency of hormesis, and incorrectly assesses the extent to which the Nature paper revealed opposing/alternative views on hormesis. Given the seriousness of assertions of noncompliance to ethical norms, there must be procedures to protect those whose ethics were called into question, to fairly evaluate the technical justification for an assertion, and to enable corrections in the event of errors. If a journal is willing to publish assertions that individuals acted in an ethically questionable way, it should be guided by a documented code of ethics and meet a standard of responsibility far greater than normal peer-review processes for papers that do not entail such ethical judgments. (shrink)

Dans le domaine biomédical, qui est l’objet principal de cet article, la littérature montre une corrélation directe entre le financement d’une recherche par un industriel et la communication de résultats qui lui sont favorables. Cet effet, appelé « le biais de financement », persiste depuis les travaux des années 1990 jusqu’aux travaux récents. Il peut être élargi à d’autres domaines tels que l’agro-alimentaire, l’étude des risques environnementaux et sanitaires, etc. Les conflits d’intérêts peuvent influencer la recherche par des voies inconscientes (...) ou volontaires. Nous analysons les modes d’action possibles des conflits d’intérêts sur le déroulement de l’activité scientifique, ainsi que l’efficacité des diverses solutions qui ont été proposées pour gérer ces influences.In the field of biomedicine, which is the main object addressed in this article, the literature shows a direct correlation between industrial funding for research and the communication of results that are favourable to the industry. This effect, known as the “ funding effect”, has been persistenly found since the 1990s. It can also affect other fields such as agri-foods or environmental and health risk assessments. Conflicts of interest can influence research subconsciously or deliberately. In this article, we analyse the various ways in which conflicts of interest can influence the way scientific activities proceed, as well as the effectiveness of the different solutions put forward to manage the influence exerted. (shrink)

Scientists have been arguing for more than 25 years about whether it is a good idea to collect voucher specimens from particularly vulnerable biological populations. Some think that, obviously, scientists should not be harvesting organisms from, for instance, critically endangered species. Others think that, obviously, it is the special job of scientists to collect precisely such information before any chance of retrieving it is forever lost. The character, extent, longevity, and span of the ongoing disagreement indicates that this is likely (...) to be a hard problem to solve. Nonetheless, the aim of this paper is to help field biologists figure out what do to when collecting a voucher specimen risks extinction. Here I present and assess varying practices of specimen collection for both extant and extinct species in order to compare and contrast cases where extinction risk both is and is not a problem. When it comes to taking vouchers from extant species at some risk of extinction, I determine that those advocating for conservative approaches to collection as well as those advocating for liberal information-gathering practices have good reasons to assess things in the way they each do. This means that there is unlikely to be a decisive, one-size-fits-all response to this problem. Still, progress can be made. We can acknowledge the risks of proceeding in either manner, as well as the uncertainty about how best to proceed. We can proceed as thoughtfully as possible, and be ready to articulate a rationale for whichever procedure is used in any particular case. (shrink)

I examine how Heather Douglas’ account of values in science applies to the assessment of actual cases of scientific practice. I focus on the case of applied toxicologists’ acceptance of molecular evidence-gathering methods and evidential sources. I demonstrate that a set of social and institutional processes plays a philosophically significant role in changing toxicologists’ inductive risk judgments about different kinds of evidence. I suggest that Douglas’ inductive risk framework can be integrated with a suitable account of evidence, (...) such as Helen Longino’s contextual empiricism, to address the role of social context in the cases like the one examined here. I introduce such an integrated account and show how Longino’s contextual empiricism and inductive risk framework fruitfully complement each other in analyzing the novel aspects of the toxicology case. (shrink)

Le différend commercial sur les OGM dans le cadre de l’OMC a mobilisé une expertise scientifique de façon quelque peu inédite. Dès le départ, le Groupe spécial a situé le différend dans le cadre de l’Accord sur l’application des mesures sanitaires et phytosanitaires de l’OMC grâce à une nouvelle ontologie juridique. Ce groupe a mis en scène l’expertise scientifique en suivant des approches spécifiques définissant de quelle manière les experts seraient interrogés, les réponses qu’ils donneraient, leur rôle spécifique dans le (...) domaine juridique et la façon dont leurs déclarations viendraient compléter ses conclusions. De plus, le Groupe spécial a procédé à un tournant procédural en présentant ses conclusions sous forme d’un jugement purement juridico-administratif tout en gardant implicites ses propres jugements sur les questions de fond liées aux risques.The high-profile WTO trade dispute on GMOs brought in scientific expertise in somewhat novel ways. From the outset, the Panel placed the dispute under the WTO Sanitary and Phytosanitary Agreement by drawing on a new legal ontology. The Panel brought scientific expertise into play in specific ways that defined how experts were questioned, the answers they would give, their specific role in the legal arena, and the way their statements would complement the Panel’s findings. Furthermore, the Panel created a procedural turning point in WTO jurisprudence by representing its findings as a purely legal and administrative assessment of whether the EC’s regulatory procedures violated the SPS Agreement, with its own assessments on substantive risk issues remaining implicit. (shrink)

Corporate social responsibility (CSR) is a comprehensive concept that aims at the promotion of responsible business practices closely linked to the strategy of enterprises. Although there is no single accepted definition of CSR, it remains an inspiring, challenging and strategic development that is becoming an increasingly important priority for companies of all sizes and types, particularly in Europe. Promotion of well-being at work is an essential component of CSR; however, the link between CSR, working conditions and work organisation is still (...) found to be unfamiliar to stakeholders. As CSR is strategic and is regarded by many companies and corporate leaders as an important development, it offers opportunities for psychosocial risk management, an area that is currently among the top priorities in working environment and well-being at work debates. However, the link between CSR and psychosocial risk management has not been addressed clearly before. This paper aims to explore the potential role of CSR in promoting well-being at work through the development of a framework for the management of psychosocial risks. As part of the research, key stakeholders [including the World Health Organization (WHO), the International Labour Organization (ILO), the European Agency for Safety and Health at Work (EU-OSHA), the European Commission (EC), employers’ associations, trade unions and other policy experts] across Europe participated in a survey, interviews and focus groups to assess and clarify the link between CSR and psychosocial risk management. On the basis of the findings, a CSR-inspired approach to the management of psychosocial issues at work is proposed. Such an approach can be a useful tool in contexts where, up until now, expertise and tradition in dealing with psychosocial issues have been lacking. (shrink)

Social policies are used to regulate how members of a society interact and share resources. If we expand our sense of community to include the ecosystem of which we are a part, we begin to develop an ethical obligation to this broader community. This ethic recognizes that the environment has intrinsic value, and each of us, as members of society, are ethically bound to preserve its sustainability. In assessing the environmental risks of new agricultural methods and technologies, society should not (...) freely trade economic gains for ecological damage, but rather seek practices that are compatible with ecosystem health. This approach is used to evaluate the environmental risks associated with genetically engineered insect-resistant trees. The use of insect-resistant trees is a biologically based pest control strategy that has several advantages over pesticide use. However, the use of genetically engineered trees presents particular ecological concerns because the trees are long lived and often are not highly domesticated. The main environmental concerns reviewed include: (1) adaptation of pests to the trees, leading to a non-sustainable agricultural practice, (2) transgenic trees producing environmental toxins, (3) insect resistance enhancing the invasiveness of the tree, causing it to become weedy or invade wild habitats, and (4) transfer of the transgene to wild or feral relatives of the tree, possibly increasing the invasiveness of weeds or wild plants. Some methods are available to offset these risks; however, the environmental risks associated with this technology have been poorly researched and need to be more clearly identified so that when we evaluate the risks, it is based on the best information obtainable. To fulfil an ethical obligation to the environment, public policies and government regulations are needed to preserve the sustainability of both the environment and the future of our production systems. A better understanding of both the ecological issues and of genetic engineering in general are needed on the part of citizens and policy makers alike to ensure that sound environmental decisions are made. Otherwise, the environmental benefits of this technology, mainly decreasing the use of more toxic pesticides in tree crops and forests, will either be lost or traded for other environmental hazards. (shrink)

Les décisions politiques sur les risques environnementaux complexes font fréquemment intervenir des éléments scientifiques contestés. Il n’y a généralement pas de « faits » qui conduisent à une politique correcte unique. Les éléments de preuve qui sont intégrés dans les avis scientifiques destinés à une décision politique nécessitent une évaluation de leur qualité. En 2003, l’Agence néerlandaise d’évaluation environnementale a adopté une méthode standardisée, désignée sous le nom de « guide », dans le cadre de laquelle les principaux aspects de (...) la production et de l’utilisation des connaissances sont présentés grâce à une liste de contrôle visant à l’évaluation et à la communication des incertitudes. Dans cet article, nous présentons des résultats de l’application de ce guide à la controverse sur les risques des particules en suspension. La délibération active sur l’incertitude dans un contexte d’expertise entraîne un processus d’apprentissage commun entre les experts et les décideurs politiques, ce qui conduit à une meilleure prise de conscience du phénomène d’incertitude et de ses implications politiques.Policy decisions on complex environmental risks often involve disputed science. Typically, there are no “ facts” to support a single unequivocally correct policy. The evidence provided in scientific studies for policy-making decisions requires high-quality assessment. In 2003, the Netherlands Environmental Assessment Agency adopted a standardized method, referred to as “guidelines”, whereby key quality aspects of knowledge production and use are presented in the form of a checklist for uncertainty assessments and communication. In this article, we present the outcomes of applying the guidelines in controversies on the risks of ambient particulate matter. In the policy–advisory context, active deliberation on uncertainty produces a common learning process for advisors and policy makers, which leads to a deeper understanding and increased awareness of the phenomenon of uncertainty and its policy implications. (shrink)

A participatory rural appraisal inthree West African countries examined thepossibility for replacing chemical pesticidesto control locusts and grasshoppers with abiological control method based on anindigenous fungal pathogen. The fungus iscurrently being tested at different sites inthe Sahel and in the humid tropics of WestAfrica. Structured group interviews, individualdiscussions, and field visits, were used toobtain farmers' perceptions of locust andgrasshoppers as crop pests, their quantitativeestimation of crop losses, and theirwillingness to pay for locust control. Farmersas well as plant protection officers generallyperceived (...) locusts and grasshoppers as importantpests that cause significant damage. Farmerswere aware of some of the risks of the use ofchemical pesticides, but not of the potentialalternatives. The use of the fungus in anoil-formulation and standard Ultra Low Volume(ULV) equipment was demonstrated, and theresults discussed with farmers. Theirimpressions of biological control werefavorable, and they expressed an interest inusing the technology. Farmers' expressedwillingness to pay for locust control is small,but not negligible. Locusts and grasshoppersare very visible pests and thus amenable topressure from farmers to local administrators,as well as by farmers' relatives in the city onthe national government. Therefore, politicalpressure for locust control is strong, althoughnational governments spend little on it,depending mostly on foreign donors. Donors areincreasingly worried about the environmentaleffect of the large amounts of chemicalpesticides used on locust control, and arepushing for more benign alternatives. Theresults of the present survey indicate thatthere may be a potential market for abiopesticide against grasshoppers and locustson cash crops in the humid areas. The potentialmarket in the Sahel depends on a reduction ofcosts or a subsidy of its price. This subsidycould be justified by the expected reduction inenvironmental and health costs when replacingchemical pesticides. Since donors are thecurrent purchasers of chemical pesticides forthe Sahel, they would also be expected to beinvolved in the purchase of the biologicalproduct. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Democratizing Psychiatric ResearchRecognizing the Potential and the Limits of Experiential ExpertiseThe author reports no conflict of interests.First, I want to express my gratitude for such thoughtful and generative responses to the manuscript "Why Democratize Psychiatric Research?," which has been in development for several years and is the product of much reflection that has taken place in academic, advocacy, and interpersonal contexts. I am delighted to see such insightful engagement (...) with the piece and to have a chance to respond to both Drs. David Crepaz-Keay and Sam Fellowes here. Given that the authors raise such different questions within their commentaries, I consider each in turn.In his illuminating commentary, Crepaz-Keay makes three important points in response to the epistemic and ethical reasons I lay out as justifications for democratizing efforts in mental health research. First of all, Crepaz-Keay warns that there is "more subjectivity across much of medicine" than in the picture I've painted, and that we might do better to focus on this shared territory, taking up the goal of democratization across all of medicine, rather than risk "othering" psychiatry as uniquely subjective. In this way, Crepaz-Keay emphasizes, mental health service user researchers might "become leaders in progressive medical thinking."I appreciate this call to emphasize the ways in which the importance of subjective experiences cuts across all of medicine and to learn broad lessons from the pioneering participatory work that has been accomplished in the domain of mental health. I agree that much of medicine suffers from a focus on the objective to the neglect of the subjective, and wonder if this focus can sometimes create a distinct kind of worry in territories in which objective measures are widely available. Consider the focus on reducing the size of a tumor at all costs that can sometimes obscure important considerations related to what a good end of life might look like (Gawande, 2014). Particularly [End Page 143] within the process of determining what is worth measuring within research (and what is worth treating within clinical contexts), patient voices are essential to making an informed and beneficial decision. I agree with Crepaz-Keay here—this point applies to all realms of medicine.In contrast, I think other kinds of risks arise in domains in which objective measures are not widely available and therefore subjective reports of patients make up an essential part of any diagnosis or assessment. Another area I often think about is placebo studies, and in this space, stereotypes related to 'real' suffering and 'real' healing circulate widely (Friesen, 2019b). Largely, these stereotypes tend to support the importance and reality of that which occurs at the level of the physical or biological and take much less seriously suffering or healing which is thought to be located 'all in the head' (Friesen & Dionne, 2022). These biases also cut across medicine, influencing which patients are seen as trustworthy, dramatic, or worthy of one's compassion. I would argue that they show up especially in the setting of mental health care and research, in part because of the lack of objective measures and physiological explanations. A psychiatrized patient often has nothing physical or objective to point to with regard to their suffering, and so may be at the whim of a provider in relation to whether they are likely to be believed or discredited. As such, we must be especially alert to the unique risks that arise when evidence for suffering comes in a subjective form, and how efforts toward democratization might help reduce such risks.Second, Crepaz-Keay offers an essential intervention in relation to the importance of anti-racism within participatory practices in psychiatry. Although I do make mention of the lack of representation of racialized communities in participatory psychiatric research in discussing the important role that values play in the development of psychiatric knowledge, Crepaz-Keay accurately points out that this point related to representation is cross-cutting, and highly relevant to several of the other reasons I offer for why psychiatry research ought to be democratized. I am grateful for this invitation to look more broadly at how the exclusion of some voices from participatory efforts might apply across... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Democratizing Psychiatric ResearchRecognizing the Potential and the Limits of Experiential ExpertiseThe author reports no conflict of interests.First, I want to express my gratitude for such thoughtful and generative responses to the manuscript "Why Democratize Psychiatric Research?," which has been in development for several years and is the product of much reflection that has taken place in academic, advocacy, and interpersonal contexts. I am delighted to see such insightful engagement (...) with the piece and to have a chance to respond to both Drs. David Crepaz-Keay and Sam Fellowes here. Given that the authors raise such different questions within their commentaries, I consider each in turn.In his illuminating commentary, Crepaz-Keay makes three important points in response to the epistemic and ethical reasons I lay out as justifications for democratizing efforts in mental health research. First of all, Crepaz-Keay warns that there is "more subjectivity across much of medicine" than in the picture I've painted, and that we might do better to focus on this shared territory, taking up the goal of democratization across all of medicine, rather than risk "othering" psychiatry as uniquely subjective. In this way, Crepaz-Keay emphasizes, mental health service user researchers might "become leaders in progressive medical thinking."I appreciate this call to emphasize the ways in which the importance of subjective experiences cuts across all of medicine and to learn broad lessons from the pioneering participatory work that has been accomplished in the domain of mental health. I agree that much of medicine suffers from a focus on the objective to the neglect of the subjective, and wonder if this focus can sometimes create a distinct kind of worry in territories in which objective measures are widely available. Consider the focus on reducing the size of a tumor at all costs that can sometimes obscure important considerations related to what a good end of life might look like (Gawande, 2014). Particularly [End Page 143] within the process of determining what is worth measuring within research (and what is worth treating within clinical contexts), patient voices are essential to making an informed and beneficial decision. I agree with Crepaz-Keay here—this point applies to all realms of medicine.In contrast, I think other kinds of risks arise in domains in which objective measures are not widely available and therefore subjective reports of patients make up an essential part of any diagnosis or assessment. Another area I often think about is placebo studies, and in this space, stereotypes related to 'real' suffering and 'real' healing circulate widely (Friesen, 2019b). Largely, these stereotypes tend to support the importance and reality of that which occurs at the level of the physical or biological and take much less seriously suffering or healing which is thought to be located 'all in the head' (Friesen & Dionne, 2022). These biases also cut across medicine, influencing which patients are seen as trustworthy, dramatic, or worthy of one's compassion. I would argue that they show up especially in the setting of mental health care and research, in part because of the lack of objective measures and physiological explanations. A psychiatrized patient often has nothing physical or objective to point to with regard to their suffering, and so may be at the whim of a provider in relation to whether they are likely to be believed or discredited. As such, we must be especially alert to the unique risks that arise when evidence for suffering comes in a subjective form, and how efforts toward democratization might help reduce such risks.Second, Crepaz-Keay offers an essential intervention in relation to the importance of anti-racism within participatory practices in psychiatry. Although I do make mention of the lack of representation of racialized communities in participatory psychiatric research in discussing the important role that values play in the development of psychiatric knowledge, Crepaz-Keay accurately points out that this point related to representation is cross-cutting, and highly relevant to several of the other reasons I offer for why psychiatry research ought to be democratized. I am grateful for this invitation to look more broadly at how the exclusion of some voices from participatory efforts might apply across... (shrink)

Despite their growing usage in commercial and industrial applications, nanomaterials have yet to be been thoroughly researched as to their potential health, safety, and environmental risk to human life after incorporation into new product improvement, development, design, and manufacturing processes. Identifying the appropriate governance framework for effective risk assessment analysis of toxicological risk to human beings—specifically manufacturing employees and consumers—and other living organisms, resulting from the development and application of these nanotechnology-based products, has yet to be (...) scientifically determined. With major regulatory gaps in the public regulation framework at national and international levels of governance, a proposed private governance framework is needed to assist the existing public regulatory framework with the proliferation of products and manufacturing processes utilizing nanomaterials. There are three distinct (yet complimentary) approaches available to develop a private governance framework to complement existing national public regulatory frameworks: responsible innovation, risk management, and voluntary guidelines/industry standards. The case for supporting a hybrid governance framework, combining public and private governance mechanisms, for nanotechnology is reflective of the current public policy environment that has emerged to best address health, safety, and environmental risk assessment issues concerning nanotechnology and nanomaterials. (shrink)

The EU Artificial Intelligence Act (AIA) defines four risk categories for AI systems: unacceptable, high, limited, and minimal. However, it lacks a clear methodology for the assessment of these risks in concrete situations. Risks are broadly categorized based on the application areas of AI systems and ambiguous risk factors. This paper suggests a methodology for assessing AI risk magnitudes, focusing on the construction of real-world risk scenarios. To this scope, we propose to integrate the AIA (...) with a framework developed by the Intergovernmental Panel on Climate Change (IPCC) reports and related literature. This approach enables a nuanced analysis of AI risk by exploring the interplay between (a) risk determinants, (b) individual drivers of determinants, and (c) multiple risk types. We further refine the proposed methodology by applying a proportionality test to balance the competing values involved in AI risk assessment. Finally, we present three uses of this approach under the AIA: to implement the Regulation, to assess the significance of risks, and to develop internal risk management systems for AI deployers. (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)

Violence risk assessment tools are increasingly used within criminal justice and forensic psychiatry, however there is little relevant, reliable and unbiased data regarding their predictive accuracy. We argue that such data are needed to (i) prevent excessive reliance on risk assessment scores, (ii) allow matching of different risk assessment tools to different contexts of application, (iii) protect against problematic forms of discrimination and stigmatisation, and (iv) ensure that contentious demographic variables are not prematurely removed (...) from risk assessment tools. (shrink)

At workplaces where nanomaterials are produced or used, risk assessment and risk management are extremely difficult tasks since there is still limited evidence about the risks of nanomaterials. Measurement methods for nanoparticles are contested and safety standards have not yet been developed properly. To support compliance with the legal obligation of the employer to care for safe workplaces a large number of ‘soft’ regulatory tools have been proposed (e.g. codes of conduct, benchmarks, standards). However, it is not (...) clear whether and under which conditions soft regulation is complied with. This article discusses the potential advantages and drawbacks of soft regulation. It explores compliance issues when exposure measurement devices and other technology-related factors are involved. The exploration of three examples of soft regulation on occupational health and safety (a ministerial recommendation on preliminary exposure benchmarks, a nano-specific guidance of a chemical company and a public–private OHS guideline) shows that the capacity of the regulated parties to comply depends on the availability of appropriate technological devices and methods, technical expertise and other resources. When technological prerequisites are met, compliance is likely to increase. (shrink)

Substantial equivalence has beenintroduced to assess novel foods, includinggenetically modified food, by means ofcomparison with traditional food. Besides anumber of objections concerning its scientificvalidity for risk assessment, the maindifficulty with SE is that it implies that foodcan be qualified on a purely substantial basis.SE embodies the assumption that only reductivescientific arguments are legitimate fordecision-making in public policy due to theemphasis on legal issues. However, the surge ofthe food debate clearly shows that thistechnocratic model is not accepted anymore. Food (...) is more than physico-chemical substanceand encompasses values such as quality andethics. These values are legitimate in theirown right and require that new democraticprocesses are set up for transverse,transdisciplinary assessment in partnershipwith society. The notion of equivalence canprovide a reference scale in which to examinethe various legitimate factors involved:substance, quality, and ethics. QE requires that newqualitative methods of evaluation that are notbased on reductive principles are developed. EEcan provide a basis for the development of anEthical Assurance as a counterpart of QualityAssurance in the food sector. In France, asecond circle of expertise is being set up toaddress the social issues in food public policybeside classical risk assessment by the firstcircle of expertise. Since ethics is likely tobecome an organizing principle of the secondcircle, the equivalence ethical framework canprove instrumental in this context. (shrink)

Recent political developments and disclosures of serious adverse events in human gene therapy (HGT) with the death of 18‐year old Jesse Gelsinger in the USA have shown that the clinical application of HGT raises some severe ethical issues. These have either been neglected or not yet been discussed to a satisfactory extent. In this paper, we will address this deficiency and develop strategies for a safer application of HGT. Such a study must first look closely at the science of HGT (...) itself. We will evaluate the latest preclinical research, especially data on the viruses that are used as vectors and on modes of administration of vectors. We will put forward new arguments concerning the toxicity assessment of so‐called ‘gene drugs‘, the tissue and cell type specificity of the vectors, and the duration and on‐set of gene expression. Secondly, we will look at procedural aspects of applied research ethics on the way to clinical application of HGT. There, informed consent (IC) and the patient‐researcher relationship are of utmost concern. Furthermore, we will explore the problem of expertise in risk assessment and will show how current regulations foster conflicts of interests that create dilemma situations even for those researchers who act in the best interest of the patients. We will conclude the article with a set of questions for ethicists who have to decide about the quality of HGT protocols. This may contribute to the safety of patients participating in HGT trials and to achieving the aim of efficient application of HGT. (shrink)

The primary responsibility of the US Food and Drug Administration is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified food. The FDA describes its regulatory review of GM food as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the FDA’s (...) policy stance on GM food is shaped by neoliberal considerations. The agency’s review of a genetically engineered animal, the AquAdvantage salmon, is used as a case study to track the influence of neoliberalism on its regulatory review protocol. After that, an epistemic argument justifying public engagement in the risk assessment of new GM food is outlined. It is because risk evaluations involve normative judgments, in a democracy, layperson representatives of informal epistemic communities that could be affected by a new GM food should have the opportunity to decide the ethical, political or other normative questions that arise during the regulatory review of that entity. (shrink)

There are widely held premises that suicide is almost exclusively the result of mental illness and there is “strong evidence for successfully detecting and managing suicidality in healthcare”. In this context, ‘zero-suicide’ policies have emerged, and suicide risk assessment tools have become a normative component of psychiatric practice. This essay discusses how suicide evolved from a moral to a medical problem and how, in an effort to reduce suicide, a paternalistic healthcare response emerged to predict those at high (...) risk. The evidence for the premises is critiqued and shown to be problematic; and it is found that strong paternalistic interventions are being used more often than acknowledged. Using a Principles approach, the ethics of overriding autonomy in suicide prevention is considered. Ethical concerns are identified with the current approach which are potentially amplified by the use of these risk assessments. Furthermore, it is identified that the widespread use of risk assessments in health settings is equivalent to screening without regard to the ethical principles of screening. The essay concludes that this is unethical; that we should abandon the use of standardized suicide risk assessments and ‘zero-suicide’ policy; and that this may improve outcomes. (shrink)

ArgumentThis paper challenges three assumptions common in the literature on expertise: that expertise is linearly derived from scientific knowledge; that experts always align with the established institutional order; and that expertise is a property acquired by individuals. We criticize these ideas by juxtaposing three distinct expert practices involved with flood risk management in England. Virtual engineering is associated with commercial consultancy and relies on standardized software packages to assess local flood inundation. Mathematical experimentation refers to academic scientists creating new (...) digital renderings of the physical dynamics of flooding. Participatory modeling denotes research projects that aim to transform the relationships between experts and local communities. Focusing on different modes of modeling we contribute an analysis of how particular models articulate with specific politics of knowledge as experts form relationships with flood risk management actors. Our empirical study also shows how models can contribute to re-distribution of expertise in local flood risk management. (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)

In this paper, we distinguish between different sorts of assessments of algorithmic systems, describe our process of assessing such systems for ethical risk, and share some key challenges and lessons for future algorithm assessments and audits. Given the distinctive nature and function of a third-party audit, and the uncertain and shifting regulatory landscape, we suggest that second-party assessments are currently the primary mechanisms for analyzing the social impacts of systems that incorporate artificial intelligence. We then discuss two kinds of (...) as-sessments: an ethical risk assessment and a narrower, technical algo-rithmic bias assessment. We explain how the two assessments depend on each other, highlight the importance of situating the algorithm within its particular socio-technical context, and discuss a number of lessons and challenges for algorithm assessments and, potentially, for algorithm audits. The discussion builds on our team’s experience of advising and conducting ethical risk assessments for clients across dif-ferent industries in the last four years. Our main goal is to reflect on the key factors that are potentially ethically relevant in the use of algo-rithms, and draw lessons for the nascent algorithm assessment and audit industry, in the hope of helping all parties minimize the risk of harm from their use. (shrink)