One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Second, (...) class='Hi'>risk thresholds serve to demarcate risk categories that streamline risk-adapted systems of ethical oversight. But although risk thresholds play such an important role in research governance, there is a need both to better define the existing risk thresholds and to delineate new thresholds in order to develop more risk-adapted systems of research oversight. The present paper examines the existing minimal risk threshold and the surrounding debates with the goal of deriving a systematic approach to setting thresholds of research risk. (shrink)

To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of “daily life.” But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics (...) often argue that “minimal risk” should refer to healthy children or the subjects of the research. I argue that neither of these interpretations is successful. I propose a new interpretation in which minimal risk refers to children who are not unduly burdened by their daily lives. I argue that children are not unduly burdened when they fare well, and I defend a substantive goods account of children’s welfare. (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)

It has been argued that the precautionary principle is incoherent and thus useless as a guide for regulatory policy. In a recent paper in Bioethics, Wareham and Nardini propose a response to the ‘precautionary paradox’ according to which the precautionary principle's usefulness for decision making in policy and regulation contexts can be justified by appeal to a probability threshold discriminating between negligible and non‐negligible risks. It would be of great significance to debates about risk and precaution if there were (...) a sound method for determining a minimum probability threshold of negligible risk. This is what Wareham and Nardini aim to do. The novelty of their approach is that they suggest that such a threshold should be determined by a method of public deliberation. In this article I discuss the merits of Wareham and Nardini’s public deliberation method for determining thresholds. I raise an epistemic worry about the public deliberation method they suggest, and argue that their proposal is inadequate due to a hidden assumption that the acceptability of a risk can be completely analysed in terms of its probability. (shrink)

To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.

When research poses risks to non‐participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsenting research participants and for nonconsensual risks imposed outside the research setting. For nonconsenting participants, US research regulations typically limit risks to those deemed to be “minimal.” Outside the research context, US tort law tolerates a more (...) flexible “reasonable” risk threshold. This article advances a preliminary case that nonconsenting participants and nonconsenting bystanders exposed to similar research risks may be entitled to the same level of protection, but that risks generated by research may not be special in kind. Thus, limiting research risks to those that are “reasonable,” rather than demanding that they be held to the “minimal” standard, may be the best approach for both nonconsenting participants and nonconsenting bystanders. Further work is needed to establish whether the descriptive standards used to support the analogies relied on here are normatively justifiable, as well as the extent to which the minimal risk standard and the reasonable risk standard would lead to meaningfully different outcomes in practice. (shrink)

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible (...) risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies. (shrink)

We applaud Notini and colleagues for highlighting the clinical and ethical complexities of a case in which a non-binary individual desires indefinite treatment with puberty blockers.1 While we agree discontinuing treatment may cause psychological distress, we believe there are potential physical and neurocognitive harms caused by prolonged treatment that have been underestimated given the limited research conducted to date. Specifically, the impact of permanent pubertal suppression on the brain and decision-making capacity should be considered. In this context, we outline the (...) potential risks of ongoing pubertal suppression on bone and cardiovascular health, sexual and reproductive function, and brain development—all noted in the article but perhaps in an overly simplistic manner.1 First, the authors’ note OPS will almost certainly result in reduced bone density.1 Although we agree the absolute fracture risk is low in studies among older adults, there is less clarity about implications during adolescence and young adulthood when peak bone accrual occurs.2 Further, the authors propose ongoing monitoring with bone density scans, but no clear guidelines for clinicians if bone density becomes critically low—so we ask, at what point would a potential fracture risk outweigh the proposed benefits …. (shrink)

We applaud Notini and colleagues for highlighting the clinical and ethical complexities of a case in which a non-binary individual desires indefinite treatment with puberty blockers. 1 While we agree discontinuing treatment may cause psychological distress, we believe there are potential physical and neurocognitive harms caused by prolonged treatment that have been underestimated given the limited research conducted to date. Specifically, the impact of permanent pubertal suppression on the brain and decision-making capacity should be considered. In this context, we outline (...) the potential risks of ongoing pubertal suppression on bone and cardiovascular health, sexual and reproductive function, and brain development—all noted in the article but perhaps in an overly simplistic manner. 1 First, the authors’ note OPS will almost certainly result in reduced bone density. 1 Although we agree the absolute fracture risk is low in studies among older adults, there is less clarity about... (shrink)

While genomic and proteomic information describe the overall cellular machinery available to an organism, the metabolic profile of an individual at a given time provides a canvas as to the current physiological state. Concentration levels of relevant metabolites vary under different conditions, in particular, in the presence or absence of different disorders. Metabolite concentrations thus mediate an important link between chemistry and biology, contributing to a systems-wide understanding of biological processes and pathways. However, there are a number of challenges in (...) the ontological representation of such information. Firstly, concentration information is numeric and ranges over continuous values, while ontologies consist of discrete classes. Secondly, ontologies usually model only what is certain, and their logical formalisms are adapted to reasoning from certain axioms to logical deductions, however, the link between chemicals and diseases via concentration levels, like many threshold phenomena, is both uncertain and vague. In this paper we evaluate the representation of this knowledge using a combination of concrete domains and probabilistic reasoning. We parse concentration values from HMDB and create an ontology able to distinguish normal from abnormal concentrations and able to evaluate a probabilistic risk category for the presence of an associated disorder. (shrink)

International regulation of autonomous weapon systems (AWS) is increasingly conceived as an exercise in risk management. This requires a shared approach for assessing the risks of AWS. This paper presents a structured approach to risk assessment and regulation for AWS, adapting a qualitative framework inspired by the Intergovernmental Panel on Climate Change (IPCC). It examines the interactions among key risk factors—determinants, drivers, and types—to evaluate the risk magnitude of AWS and establish risk tolerance thresholds (...) through a risk matrix informed by background knowledge of event likelihood and severity. Further, it proposes a methodology to assess community risk appetite, emphasizing that such assessments and resulting tolerance levels should be determined through deliberation in a multistakeholder forum. The paper highlights the complexities of applying risk-based regulations to AWS internationally, particularly the challenge of defining a global community for risk assessment and regulatory legitimization. (shrink)

Should the assessment of decision‐making capacity (DMC) be risk sensitive, that is, should the threshold for DMC vary with risk? The debate over this question is now nearly five decades old. To many, the idea that DMC assessments should be risk sensitive is intuitive and commonsense. To others, the idea is paternalistic or incoherent, or both; they argue that the riskiness of a given decision should increase the epistemic scrutiny in the evaluation of DMC, not increase the (...) threshold for DMC. We respond to the critics’ main concerns by providing a comprehensive account of how risk‐sensitive DMC is coherent, avoids paternalism, and best fulfills the epistemic goal of DMC evaluations. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies (...) do not hold out direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

On the standard view we assess a person’s competence by considering her relevant abilities without reference to the actual decision she is about to make. If she is deemed to satisfy certain threshold conditions of competence, it is still an open question whether her decision could ever be overruled on account of its harmful consequences for her (‘hard paternalism’). In practice, however, one normally uses a variable, risk dependent conception of competence, which really means that in considering whether or (...) not to respect a person’s decision-making authority we weigh her decision on several relevant dimensions at the same time: its harmful consequences, its importance in terms of the person’s own relevant values, the infringement of her autonomy involved in overruling it, and her decision-making abilities. I argue that we should openly recognize the multi-dimensional nature of this judgment. This implies rejecting both the threshold conception of competence and the categorical distinction between hard and soft paternalism. (shrink)

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent published (...) between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study as minimal risk, probably minimal risk, or probably more than minimal risk. RESULTS: Seventy studies using a waiver of/exception from informed consent were identified. A majority of reviewers classified nontherapeutic procedures in 62 studies (88.6%) as minimal risk. Reviewers classified nontherapeutic procedures in six studies (8.6%) as minimal risk or probably minimal risk. In two studies (2.9%), nontherapeutic procedures were classified as probably more than minimal risk. The intraclass correlation coefficient was 0.89 (95% CI = 0.85 to 0.93), indicating very high interrater reliability. CONCLUSIONS: Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue. (shrink)

This paper considers the moral status of bystanders affected by medical research trials. Recent proposals advocate a very low threshold of permissible risk imposition upon bystanders that is insensitive to the prospective benefits of the trial, in part because we typically lack bystanders' consent. I argue that the correct threshold of permissible risk will be sensitive to the prospective gains of the trial. I further argue that one does not always need a person's consent to expose her to (...) significant risks of even serious harm for the sake of others. That we typically need the consent of participants is explained by the fact that trials risk harmfully using participants, which is very hard to justify without consent. Bystanders, in contrast, are harmed as a side-effect, which is easier to justify. I then consider whether the degree of risk that a trial may impose on a bystander is sensitive to whether she is a prospective beneficiary of that trial. (shrink)

This paper aims to develop a framework for distributing risks. Based on a distinction between risks with reversible losses and risks with irreversible losses, I defend the following composite allocation principle: first, irreversible risks should be allocated on the basis of needs and only after some threshold level has been achieved can the remaining risks distributed in such a way that the total disvalue of these losses is minimized. An important advantage of this allocation framework is that it does not (...) require the aggregation of incommensurable values into one measure. (shrink)

Social decision-making involving risks ideally results in obligations to avoid expected harms or keep them within acceptable limits. Ambitious goals aimed at avoiding or greatly reducing risks might not be feasible, forcing the acceptance of higher degrees of risk (i.e. unrealistic levels of risk reduction are revised to comport with beliefs regarding abilities). In this paper, the philosophical princi- ple ‘ought implies can’ is applied to the management of complex risks, exempli- fied by the risks associated with climate (...) change. In its common interpretation, the principle states that we cannot expect an agent to perform something that lies beyond his or her abilities. However, it is here argued that this principle requires setting thresholds for legitimate claims of inabilities that justify the waiving of normative demands. This paper discuss three claims: (1) that caution is required before revising a risk-reducing goal that is perhaps exceedingly ambitious; (2) that claims on abilities are not only descriptive, but also value-laden; and (3) that the function of a goal has to be clarified before risk-reducing goals are revised. Risk-reducing goals that initially seem unrealistic arguably serve performance- enhancing purposes in risk management. Neglecting such goals could lead to choosing less desirable, but certainly feasible, risk-reducing goals. (shrink)

I evaluate two contractualist approaches to the ethics of risk: mutual constraint and the probabilistic, ex ante approach. After explaining how these approaches address problems in earlier interpretations of contractualism, I object that they fail to respond to diverse risk preferences in populations. Some people could reasonably reject the risk thresholds associated with these approaches. A strategy for addressing this objection is considering individual risk preferences, similar to those Buchak discusses concerning expected-utility approaches to (...) class='Hi'>risk. I defend the risk-preferences-adjusted contractualist approach, which calculates a population’s average risk preference and permits risk thresholds below that preference, only. (shrink)

The de minimis principle states that some risks are so trivial that they can be ignored or treated categorically differently from non-trivial risks. Lundgren and Stefánsson criticize the de minimis principle, arguing that it either has to be applied locally or globally and that problems arise whichever application is chosen. Aven and Seif respond to Lundgren and Stefánsson’s argument and defend the de minimis principle as a “meaningful and useful perspective for handling risk in practice.” The response highlights some (...) aspects of the argument in Lundgren and Stefánsson that needs clarification, which is what we do in this note. (shrink)

BackgroundThe boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as “non-research” are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and (...) determination of risk level across a broad range of projects and health-related contexts. This paper describes the development of the Public Health Ontario Risk Screening Tool.MethodDevelopment of the PHO Risk Screening Tool included: preparation of a draft risk tool ; expert appraisal; internal stakeholder validation; external validation; pilot testing and evalution of the draft tool; and revision after 1 year of testing.ResultsA risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.ConclusionsThe PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions. (shrink)

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people’s acceptance or otherwise of risks, and the scope individuals (...) have to influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson’s framework to three such practices: an ‘ideal’ breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them. (shrink)

In this paper I examine the prospects for a rights-based approach to the morality of pure risk-imposition. In particular, I discuss a practical challenge to proponents of the thesis that we have a right against being imposed a risk of harm. According to an influential criticism, a right against risk-imposition will rule out all ordinary activities. The paper examines two strategies that rights theorists may follow in response to this “Paralysis Problem”. The first strategy introduces a threshold (...) for when a risk-imposition is a rights violation. The second strategy drops the claim that rights are absolute and maintains that all rights infringements generate compensation duties. It is argued that both strategies face significant practical problems of their own and that the Paralysis Problem seems fatal for a right against risk-imposition in the absence of an adequate account of the morally relevant threshold risk. (shrink)

This paper mainly analyzes the theories related to the financial risk of the company and combines the principles of principal component analysis, particle swarm optimization algorithm, and artificial neural network to derive the financial risk index system of the company. To improve the accuracy of financial risk prediction, principal component analysis and particle swarm algorithm are applied to optimize the BP neural network model, the input data of the prediction model is improved, and the optimal initial weights (...) and thresholds are given to the BP neural network by using particle swarm algorithm search, whereby the financial risk prediction model of particle swarm optimization BP neural network is constructed. The empirical results show that the model constructed by BP neural network not only has a high accuracy rate for static financial risk evaluation but also has a better prediction effect. After training and testing, the BP neural network-based enterprise financial risk evaluation model can accurately determine the existing financial situation of enterprise financial management and has a good prediction effect. Our research method is a fusion of the processing of the two methods, which belongs to the first integration of results. (shrink)

Many philosophers have challenged the ideal of value-free science on the grounds that social or moral values are relevant to inferential thresholds. But given this view, how precisely and to what extent should scientists adjust their inferential thresholds in light of nonepistemic values? We suggest that signal detection theory provides a useful framework for addressing this question. Moreover, this approach opens up further avenues for philosophical inquiry and has important implications for philosophical debates concerning inductive risk. For (...) example, the signal detection theory framework entails that considerations of inductive risk and inferential-threshold placement cannot be conducted in isolation from base-rate information. (shrink)

Nearly all contributors to the philosophical analysis of hope agree that if an agent hopes that p, she both desires that p and assigns to p a probability which is greater than zero, but less than one. According to the widely‐endorsed Standard Account, these two conditions are also (jointly) sufficient for ‘hoping that’. Ariel Meirav has recently argued, however, that the Standard Account fails to distinguish hoping for a prospect from despairing of it – due to cases where two agents (...) equally desire an outcome and assign to it the same probability, yet one hopes for the outcome while the other despairs of it. I argue, against Meirav, that these putative counterexamples depend crucially on the assumption – previously unquestioned – that the degree of probability necessary for hope is invariant across individuals. If the probability threshold is instead understood as agent‐relative, the difficulty disappears. Further, I argue that there is strong independent reason for taking the probability threshold of hope to be agent‐relative, based on similarities to the widely‐accepted agent‐relative probability thresholds of industriousness and risk aversion. And I conclude by noting how the agent‐relative modification to the Standard Account is better equipped than is Meirav's positive view to yield intuitive results.1. (shrink)

Most agree that clinical research offers one of the best prospects of improving pediatric medicine. Most also agree that children may be exposed to some degree of risk while participating in clinical trials. But the degree of risk that should be permitted and the reasons for which it should be permitted remain controversial. In this paper, I examine a central risk threshold in research with children—the threshold constraining risks that do not offer research subjects the prospect of (...) direct medical benefit. That is, the threshold for research risks undertaken in the interests of deriving valuable knowledge that may benefit future children, but not the research subjects themselves. I examine competing... (shrink)

Many scientists, businessmen, and government regulators believe that the criteria for acceptable societal risk are too stringent. Those who subscribe to this belief often accept the view which I call the probability-threshold position. Proponents of this stance maintain that society ought to ignore very small risks, i.e., those causing an average annual probability of fatality of less than 10–6.After examining the three major views in the risk-evaluation debate, viz., the probability-threshold position, the zero-risk position, and the weighted- (...) class='Hi'>risk position, I focus on the arguments for the first of these views, since it is the position which currently undergirds most public policy (especially in the U.S.) regarding acceptable risk. After analyzing Arrow's argument from decision theory, Comar's and Gibson's argument from ontology, and Starr's and Whipple's argument from epistemology, I conclude that these defenses of the probability-threshold position err in a variety of ways. Most commonly, they fail because they tacitly accept the assumption that magnitude of probability, alone, provides a sufficient condition for judging the acceptability of a given risk. In the light of these errors, I suggest that it might be more desirable for risk assessors, decision theorists, and policymakers to weight various risk-cost-benefit parameters according to alternative ethical criteria, rather than to evaluate risks solely in terms of mathematical considerations. (shrink)

One topic of growing interest in the debate on intergenerational justice is the duty to respect the freedom of future generations. One consideration in favor of such a duty is that the decisions of present generations will affect the range of decisions that will be available to future people. As a consequence, future generations’ freedom to direct their lives may be importantly restricted such that present generations can be seen as taking future people’s lives into their hands and disempowering them. (...) This article defends the idea that present generations have an obligation to sustain a certain threshold of freedom for members of present and future generations alike. It argues that we should regard sustainability policies as a way to redistribute freedom across members of different generations. It starts by explaining the centrality of social freedom to the way we conceive of moral persons, then explains how freedom can be understood as an object of redistribution. It then argues that by imposing some risks—such as that of resource depletion or destruction of the ecosystem—on future generations, present generations push future generations’ freedom below an acceptable threshold. The paper concludes with examples of how this focus on freedom can offer guidance in selecting and justifying sustainability policies—for example, measures for conserving biodiverse environments—even when it is not clear how they will directly contribute to the well-being of future persons. (shrink)

The financial risk information diffuses through various kinds of social networks, such as Twitter and Facebook. Individuals transmit the financial risk information which can migrate among different platforms or forums. In this paper, we propose a financial risk information spreading model on metapopulation networks. The subpopulation represents a platform or forum, and individuals migrate among them to transmit the information. We use a discrete-time Markov chain approach to describe the spreading dynamics’ evolution and deduce the outbreak threshold (...) point. We perform numerical simulation on artificial networks and discover that the financial risk information can be promoted once increasing the information transmission probability and active subpopulation fraction. The weight variance and migration probability cannot significantly affect the financial risk spreading size. The discrete-time Markov chain approach can reasonably predict the above phenomena. (shrink)

This paper discusses differences between two major schools in philosophy of criminal law, retributivism and consequentialism, with regard to the risk of punishing the innocent. As it is argued, the main point of departure between these two camps in this respect lies in their attitude towards the high evidentiary threshold in a criminal trial: while retributivism seems to strongly support setting this standard high, consequentialists may find it desirable to relax it in some cases. This discussion is set in (...) the context of proxy criminalization, i.e. a situation, in which some suspicious behaviour is criminalized. Since proxy criminalization may be understood as an effective lowering of the evidentiary threshold, its employment is justifiable from the consequentialist perspective, while being highly problematic for the retributivists. (shrink)

Strongly grounded in scientific knowledge, the instrument known as occupational exposure limits or threshold limit values has changed government modalities of exposure to hazardous chemicals in workplaces, transforming both the substance of the problem at hand and the power dynamics between the actors involved. Some of the characteristics of this instrument favor the interests of industries at the expense of employees, their representatives, and the authorities in charge of regulating these risks. First, this instrument can be analyzed as a boundary (...) object that has very different uses in space and time. In particular, it is increasingly masking its industrial origins to appear as an instrument that is almost exclusively based on scientific rationale. In the case of asbestos and its substitutes, the use of an instrument relying on scientific expertise generates a specific temporality of implementation that allows manufacturers to take advantage of periods during which regulations are either nonexistent or very loose. Finally, the choice of a technoscientific definition of the issues contributes to shifting the negotiations to a field where companies are in a position of strength and their opponents are weakened. (shrink)

Family income is associated with gray matter morphometry in children, but little is known about the relationship between family income and white matter structure. In this paper, using Tract-Based Spatial Statistics (TBSS), a whole brain, voxel-wise approach, we examined the relationship between family income (assessed by income-to-needs ratio) and white matter organization in middle childhood (N = 27, M = 8.66 years). Results from a nonparametric, voxel-wise, multiple regression (threshold-free cluster enhancement, p < 0.05, FWE corrected) indicated that lower family (...) income was associated with lower white matter organization (assessed by fractional anisotropy) for several clusters in white matter tracts involved in cognitive and emotional functions including fronto-limbic circuitry (uncinate fasciculus and cingulum bundle), association fibers (inferior longitudinal fasciculus, superior longitudinal fasciculus), and corticospinal tracts. Further, we examined the possibility that cumulative risk exposure might function as one of the potential pathways by which family income influences neural outcomes. Using multiple regressions, we found lower fractional anisotropy in portions of these tracts, including those found in the left cingulum bundle and left superior longitudinal fasciculus, was significantly related to greater exposure to cumulative risk (β = -0.47, p < 0.05 and β = -0.45, p < 0.05). (shrink)

Psychosocial work factors are implicated in the development of stress and job satisfaction. This relationship has been scarcely studied in so-called singular activities, as is the case of professional drivers. This cross-sectional study of 601 professional drivers assesses psychosocial risks and job satisfaction using Copenhagen Psychosocial Questionnaire and Overall Job Satisfaction questionnaire models. The values of the psychosocial scales of professional drivers were compared with thresholds values of the Spanish working population. The relationships of the psychosocial scales with the (...) level of job satisfaction were examined using logistic regression models, adjusted for age, gender, length of driving license and years of experience. In general, professional drivers have an unfavorable psychosocial environment compared to the average Spanish workers. The relationship between psychosocial scales and job satisfaction is observed, with the most influential variables being the meaning and development of work, integration in the company, social relations, esteem and level of psychological demands. (shrink)

The introduction of automated vehicles promises an increase in traffic safety. Prior to its launch proof of the anticipated reduction in the sense of a positive risk balance compared with human driving performance is required from various stakeholders such as the European Union Commission, the German Ethic Commission, and the ISO TR 4804. To meet this requirement and to generate acceptance by the public and the regulatory authorities, a qualitative Risk- Benefit framework has been defined. This framework is (...) based on literature research on approaches applied in other disciplines. This report depicts the framework, adapted from the pharmaceutical sector called PROACT-URL which serves as a structured procedure to demonstrate a positive risk balance in an understandable and transparent manner. The qualitative framework needs to be turned in quantitative methods once it should be applied. Therefore, two steps of the framework are discussed in more detail: First, the definition of adequate development thresholds that are required at an early stage of the development. Second the simulation-based assessment to prove the positive risk balance prior to the market introduction. (shrink)

The notions of risk and hazard, concepts borrowed from the natural and social sciences by way of intersectionality, have found active usage in artistic practices that address creative work in its widest possible usage. This paper will philosophically reflect on the shifts in the meanings of risk when understood in the context of artistic work. Curatorial work, for instance, is conceptually rooted in a care-based ethic, while creative work can be argued to be conceptually rooted in transcendental action. (...) This subtle tension between curating and creating is the threshold on which risk resides. What does this mean for the artist and the curator? Key to understanding implications of risk in art is to contextualize meanings of risk in various kinds of human action. If artistic practice is that kind of human action that aims to create new experiences or understandings of our condition, then institutional approaches to risk must be tuned to this understanding of practice. Thus, blanket superimpositions of general ethical norms employed in non-artistic frameworks such as educational, scientific, or/and sociological institutions may not do justice to artistic practice. First, institutional intervention in this regard must conceptually understand the affordances and the commitments of artistic practice in order to do justice to the ways in which risk is defined in the arts. In this essay, I argue that institutions must engage with a contextual understanding of the nature of the threshold between caring and creating in order to explore a justified incorporation or risk-oriented vocabulary in artistic institutional practices. (shrink)

:A good deal of contemporary moral nonconsequentialism assumes that agents have perfect knowledge about the various features and consequences of their options. This assumption is unrealistic. More often than not, moral agents can only assess with a certain degree of probability the factual circumstances that are morally relevant for their decision making. My aim in this essay is to discuss the problem of moral decisions under risk from the point of view of nonconsequentialism. Basically, I analyze how objective moral (...) principles can be transformed into subjective, decisional prescriptions, and argue that the standard nonconsequentialist approach to moral decision making, which focuses on probability thresholds, is wrong. In accordance with the fundamental postulates of nonconsequentialism, I seek to solve the problem of risk in moral choice by proposing a theory about the marginal moral value of various options. Actions can vary along various dimensions, and each of these dimensions can offer a different moral value function. Nonconsequentialist marginalism can level the playing field with consequentialism. Whereas consequentialism can simply borrow the notion of expected utility from economics, nonconsequentialism must introduce the notion of expectational obligation to formulate a general principle of moral choice under risk. I finally suggest that further empirical work is needed to delineate the shape of various moral value functions that are critical for applying the general principle of moral decision making under risk to well-known cases. View HTML Send article to KindleTo send this article to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle. Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply. Find out more about the Kindle Personal Document Service.DECISIONAL NONCONSEQUENTIALISM AND THE RISK SENSITIVITY OF OBLIGATIONVolume 32, Issue 2Horacio Spector DOI: https://doi.org/10.1017/S0265052516000121Your Kindle email address Please provide your Kindle [email protected]@kindle.com Available formats PDF Please select a format to send. By using this service, you agree that you will only keep articles for personal use, and will not openly distribute them via Dropbox, Google Drive or other file sharing services. Please confirm that you accept the terms of use. Cancel Send ×Send article to Dropbox To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about sending content to Dropbox. DECISIONAL NONCONSEQUENTIALISM AND THE RISK SENSITIVITY OF OBLIGATIONVolume 32, Issue 2Horacio Spector DOI: https://doi.org/10.1017/S0265052516000121Available formats PDF Please select a format to send. By using this service, you agree that you will only keep articles for personal use, and will not openly distribute them via Dropbox, Google Drive or other file sharing services. Please confirm that you accept the terms of use. Cancel Send ×Send article to Google Drive To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about sending content to Google Drive. DECISIONAL NONCONSEQUENTIALISM AND THE RISK SENSITIVITY OF OBLIGATIONVolume 32, Issue 2Horacio Spector DOI: https://doi.org/10.1017/S0265052516000121Available formats PDF Please select a format to send. By using this service, you agree that you will only keep articles for personal use, and will not openly distribute them via Dropbox, Google Drive or other file sharing services. Please confirm that you accept the terms of use. Cancel Send ×Export citation Request permission. (shrink)

Limitarianism holds that there is an upper limit to how many resources, such as wealth and income, people can permissibly have. In this article, I examine the conceptual structure of limitarianism. I focus on the upper limit and the idea that resources above the limit are ‘excess resources’. I distinguish two possible limitarian views about such resources: (i) that excess resources have zero moral value for the holder; and (ii) that excess resources do have moral value for the holder but (...) that their claim to such resources is outweighed by other normative concerns. Moreover, I argue that, depending on the values limitarianism seeks to promote, limitarians should care about the number of people with excess resources or the total amount of excess resources (or both), that they can adopt redistributive measures and/or predistributive measures, and that some versions of limitarianism should take into account the distribution of risk among those above the riches line. (shrink)

The early warning of financial risk is to identify and analyze existing financial risk factors, determine the possibility and severity of occurring risks, and provide scientific basis for risk prevention and management. The fragility of financial system and the destructiveness of financial crisis make it extremely important to build a good financial risk early-warning mechanism. The main idea of the K-means clustering algorithm is to gradually optimize clustering results and constantly redistribute target dataset to each clustering (...) center to obtain optimal solution; its biggest advantage lies in its simplicity, speed, and objectivity, being widely used in many research fields such as data processing, image recognition, market analysis, and risk evaluation. On the basis of summarizing and analyzing previous research works, this paper expounded the current research status and significance of financial risk early-warning, elaborated the development background, current status and future challenges of the K-means clustering algorithm, introduced the related works of similarity measure and item clustering, proposed a financial risk indicator system based on the K-means clustering algorithm, performed indicator selection and data processing, constructed a financial risk early-warning model based on the K-means clustering algorithm, conducted the classification of financial risk types and optimization of financial risk control, and finally carried out an empirical experiments and its result analysis. The study results show that the K-means clustering method can effectively avoid the subjective negative impact caused by artificial division thresholds, continuously optimize the prediction process of financial risk and redistribute target dataset to each cluster center for obtaining optimized solution, so the algorithm can more accurately and objectively distinguish the state interval of different financial risks, determine risk occurrence possibility and its severity, and provide a scientific basis for risk prevention and management. The study results of this paper provide a reference for further researches on financial risk early-warning based on K-means clustering algorithm. (shrink)

Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this would make the research (...) incompatible with the widely endorsed principle of the primacy of the human subject, which stipulates that the interests of the participating individual should prevail over the interests of science and society. This paper deals with this conflict. It analyses solutions to this problem developed in the literature, and shows that they are unsuccessful. Finally, it offers a new idea of how to reconcile the conduct of non-beneficial paediatric research with the PP. The paper argues for a new formula of the PP, and shows that it implies a specific non-comparative definition of the minimal risk threshold. (shrink)

In this paper I shall defend the idea that there is an abstract and general core meaning of objectivity, and what is seen as a variety of concepts or conceptions of objectivity are in fact criteria of, or means to achieve, objectivity. I shall then discuss the ideal of value-free science and its relation to the objectivity of science; its status can be at best a criterion of, or means for, objectivity. Given this analysis, we can then turn to the (...) problem of inductive risk. Do the value judgements regarding inductive risk really pose a threat to the objectivity of science? I claim that this is not the case because they do not lower the thresholds scientifically postulated for objectivity. I shall conclude the paper with a discussion of under-appreciated influences of values on science, which indeed pose a serious threat to the objectivity of some scientific disciplines. (shrink)

In this paper, we present a Capabilities -based Approach to the acceptability and the tolerability of risks posed by natural and man-made hazards. We argue that judgments about the acceptability and/or tolerability of such risks should be based on an evaluation of the likely societal impact of potential hazards, defined in terms of the expected changes in the capabilities of individuals. Capabilities refer to the functionings, or valuable doings and beings, individuals are able to achieve given available personal, material, and (...) social resources. The likely impact of a hazard on individuals’ capabilities should, we argue, be compared against two separate thresholds. The first threshold specifies the minimum level of capabilities attainment that is acceptable in principle for individuals to have in the aftermath of a hazard over any period of time. This threshold captures the level that individuals’ capabilities ideally should not fall below. A risk is acceptable if the probability that the attained capabilities will be less than the acceptable level is sufficiently small. In practice, it can be tolerable for some individuals to temporarily fall below the acceptable threshold, provided this situation of lower capabilities attainment is temporary, reversible, and the probability that capabilities will fall below a tolerability threshold is sufficiently small. This second, tolerable threshold delimits an absolute minimum level of capabilities attainment below which no individual in a society should ever fall, regardless of whether that level of capabilities attainment is temporary or reversible. In this paper, we describe and justify this Capabilities -based Approach to the acceptability and tolerability of risks. We argue that the proposed theoretical framework avoids the limitations in current approaches to acceptable risk. The proposed approach focuses the attention of risk analysts directly on what should be our primary concern when judging the acceptability and the tolerability of risks, namely, how risks impact the well-being of individuals in a society. Also, our Capabilities -based Approach offers a transparent, easily communicable way for determining the acceptability and the tolerability of risks. (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)

In its American context the case of baby Messenger, a preterm infant disconnected from life-support by his father and allowed to die has generated debate about neonatal treatment protocols. Limited by the legal and ethical norms of the United States, this case did not consider treatment protocols that might be available in other countries such as Denmark and Israel: threshold protocols whereby certain classes of newborns are not treated, and preemptive abortion allowing one to choose late-term abortion rather than (...) class='Hi'>risk delivery. Each offers a viable and ethically sound avenue for dealing with the economic and social expense of anomalous newborns by aborting or not treating those most likely to burden the health care system. Objections that these protocols are antithetical to American bioethical principles are considered but rejected as each policy answers to economic justice, utility and respect for autonomy. (shrink)

This article discusses implicit conceptions of reticence in the early philosophical writings of Mikhail Bakhtin. Contrary to the image of Bakhtin as a thinker of dialogue, polyphony, and voice, it finds a strand in Bakhtin's thought that suggests that there might be good reasons for remaining silent and not stepping into the world in speech: in reticence, the human being avoids both judgment and being judged, eludes the risk of the addressee's absence or unreliability, and resists the finality of (...) utterance that shares in the finality of death. This essay makes a case for a Bakhtinian apology for quietism and seeks to contribute to recent work in Common Knowledge on that subject. Bakhtin's conception of reticence is usefully understood with reference to threshold situations: in withholding a future word, a human being hovers on the borders of nonbeing and being, on the borders of the present, future, and past. In this sense, reticence is allied to conceptions of fuzziness and blur that have also been concerns of this journal in recent years. In making these claims, the essay relates Bakhtin's thought to a Russian literary tradition of thinking about silence (Tiutchev's and Mandelstam's Silentium poems), as well as to a more broadly European intellectual context (Arendt and Heidegger, for example), where thinkers understand being in terms of becoming and understand disclosure through speech. (shrink)

Financing guarantee is an important means and key link to solve the financing difficulties of small- and medium-size enterprises. However, while financial guarantees alleviate the financing difficulties of SMEs, the complex guarantee relationships also constitute a new channel for credit risk contagion in the financial guarantee network. In this paper, we construct a model of credit risk contagion process of guarantee network based on SEIR and analyse the equilibrium point and stability of the model. Then, we find the (...) threshold value of risk contagion and further simulate the SEIR model dynamically to analyse the influence of each parameter of the model. The results show that the risk of the financing guarantee network begins to be widely contagious only when risk contagion threshold is greater than 1, and the conversion rate of exposed enterprises, removal rate of infected enterprises, nodal enterprises degree, and risk contagion rate have significant effects on the changes of individual density of susceptible, exposed, infected, and recovered enterprises. Combining the above findings, it is of great theoretical and practical significance to propose relevant countermeasures for credit risk control of financial guarantee network. (shrink)

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there (...) should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-risk research’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees. (shrink)