There has been relatively little empirical research into the causes of research misconduct. To begin to address this void, the authors collected data from closed case files of the Office of Research Integrity (ORI). These data were in the form of statements extracted from ORI file documents including transcripts, investigative reports, witness statements, and correspondence. Researchers assigned these statements to 44 different concepts. These concepts were then analyzed using multidimensional scaling and cluster analysis. The authors chose a solution consisting (...) of seven clusters: (1) personal and professional stressors, (2) organizational climate, (3) job insecurities, (4) rationalizations A, (5) personal inhibitions, (6) rationalizations B and, (7) personality factors. The authors discuss the implications of their findings for policy and for future research. (shrink)

Restrictive visitation policies produce inequities in healthcare that have meaningful consequences for patients’ health and well-being. There is a surplus of existing literature exploring the consequences of reduced visitation in the setting of pediatric patients lacking decision-making capacity, but relatively little scholarship addressing visitation restriction for less vulnerable adults possessing capacity. Here, we present the case of a patient who suffered serious complications of childbirth, during the delivery of her healthy newborn, leading to prolonged hospitalization. During her treatment course, she (...) was subsequently denied visitation with her newborn, who had been discharged from the hospital, and this had detrimental effects on her recovery. Hospital policies restricting visitation during the COVID-19 pandemic were intended to reduce the risk of disease exposure for both patients and staff, despite conflicting evidence demonstrating this benefit. In contrast, they often have negative effects on patient stress, mood, and physical recovery. The sequelae of this US-based case study argue the need for more holistic hospital visitation policies, placing a specific lens on adult patients receiving a visitation from their newborn children. (shrink)

© 2015, Springer-Verlag Berlin Heidelberg.Genetic studies have identified single nucleotide polymorphisms associated with the risk of prostate cancer. It remains unclear whether such genetic variants are associated with disease aggressiveness. The NCI-SPORE Genetics Working Group retrospectively collected clinicopathologic information and genotype data for 36 SNPs which at the time had been validated to be associated with PC risk from 25,674 cases with PC. Cases were grouped according to race, Gleason score and aggressiveness. Statistical analyses were used to compare (...) the frequency of the SNPs between different disease cohorts. After adjusting for multiple testing, only PC-risk SNP rs2735839 was significantly and inversely associated with aggressive and high-grade disease in European men. Similar associations with aggressive and high-grade disease were documented in African-American subjects. The G allele of rs2735839 was associated with disease aggressiveness even at low PSA levels in both European and African-American men. Our results provide further support that a PC-risk SNP rs2735839 near the KLK3 gene on chromosome 19q13 may be associated with aggressive and high-grade PC. Future prospectively designed, case-case GWAS are needed to identify additional SNPs associated with PC aggressiveness. (shrink)

Introduction and ObjectiveThe early identification of depressive patients having a poor evolution, with frequent relapses and/or recurrences, is one of the priority challenges in this study of high prevalence mental disorders, and specifically in depression. So, this study aims to analyze the factors that may be associated with an increased risk of recurrence of major depression episodes in patients treated in primary care.MethodsA retrospective, descriptive study of cases-controls was proposed. The cases consisted of patients who had been diagnosed (...) with major depression and who had presented recurrences, in comparison with patients who had experienced a single major depression episode with no recurrence. The variables of the study are age at first episode; number of episodes; perception of severity of the depression episode suffered prior to recurrence; number of residual symptoms; physical and psychiatric comorbidity; history of anxiety disorders; family psychiatric history; high incidence of stressful life events ; and experiences of physical, psychological, or sexual abuse in childhood. The differences of the variables were compared between the case subjects and the control subjects, using the Mann–Whitney, chi-square, and Fisher’s U statistics. A multivariate analysis was performed.ResultsThe average age of those suffering more than one depressive episode is significantly older, and a higher percentage of subjects who have experienced more than one depressive episode have a history of anxiety disorders. In the multivariate analysis, the variables that obtained a significant value in the logistic regression analysis were age and having suffered sexual abuse during childhood.ConclusionThese indicators should be considered by primary care physicians when attending patients suffering from major depression. (shrink)

The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted to the (...) Faculty of Tropical Medicine, Ethics Committee. This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase the consent process elements that were considered to involve inadequate information exchange between researcher and study participant. This study aimed to describe lessons for malaria researchers about common informed-consent process issues in different types of malaria proposals. The information and analysis of informed-consent elements should assist the preparation of malaria-research proposals. (shrink)

BackgroundThis study aimed to elucidate the influence of dementia etiologies on the degree of caregiver burden and determine which factors predict a high caregiving burden.MethodsThis 18-month retrospective cohort study enrolled 630 patients and their caregivers from the Dementia Center of Changhua Christian Hospital. The care team performed face-to-face interviews every 6 months, for 18 months from when a diagnosis of dementia was made. The primary outcome was the change in Zarit Burden Interview scores. Generalized estimating equations were used for (...) the longitudinal data analysis.ResultsParticipants with Lewy body disease had a significantly higher caregiving burden compared with those with Alzheimer's disease after adjusting for patient and caregiver features. Caregivers of mixed-type dementia and frontotemporal dementia experienced a greater burden than caregivers of AD, at 6- and 18-month follow-up. Patients with more severe dementia, neuropsychiatric symptoms, being cared for by more than two caregivers, or utilizing social resources were associated with higher ZBI scores; the depressive mood of caregiver also predicted higher ZBI scores.ConclusionThis longitudinal study demonstrated that caregiver burden was influenced by the underlying dementia etiology of patients. The dementia care team should provide personalized education and transfer patients and caregivers to appropriate resources, especially for high-risk populations. (shrink)

Electroacupuncture (EA) and electroconvulsive therapy (ECT) are often used in the management of schizophrenia. This study sought to determine whether additional EA and ECT could augment antipsychotic response and reduce related side effects. In this retrospective controlled study, 287 hospitalized schizophrenic patients who received antipsychotics (controls, n = 50) alone or combined with EA (n = 101), ECT (n = 55) or both (EA+ECT, n = 81) were identified. EA and ECT were conducted for 5 and 3 sessions per (...) week, respectively, with a maximum of 12 sessions for ECT during hospitalization. The Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) were used to assess the severity of psychotic symptoms. Clinical response on SAPS and SANS, weight gain, and adverse events were compared. Survival analysis revealed that the ECT and EA+ECT groups had markedly greater clinical response rate than controls on SAPS [72.7% and 90.1% vs. 64.0%; relative risk (RR), 1.974 and 2.628, respectively, P ≤ 0.004] and on SANS (67.3% and 70.4% vs. 42.0%; RR, 1.951 and 2.009, respectively, P ≤ 0.015). A significantly greater response rate on SANS than controls was also observed in the EA group (64.4% versus 42.0%; RR = 1.938, P = 0.008). EA-containing regimens remarkably reduced weight gain and incidences of headache, insomnia, dry mouth, and electrocardiographic abnormalities. These results suggest that EA and ECT can serve as additional treatment for enhancing antipsychotic response and reduce the side effects in hospitalized patients with schizophrenia. (shrink)

IntroductionCerebral visual impairment results from damage to cerebral visual processing structures. It is the most common cause of pediatric visual impairment in developed countries and rising in prevalence in developing nations. There is currently limited understanding on how neurologic, developmental, and ophthalmic factors predict outcome for pediatric CVI.MethodA retrospective manual chart review of pediatric CVI patients seen at the tertiary pediatric hospital neurology and neuro-ophthalmology service between 2010 and 2019 was conducted. Patients were stratified into severity groups, and followed (...) over time to identify outcome predictors. Collected baseline characteristics included perinatal, genetic, developmental, and neurologic history, along with neuroimaging and fundoscopic findings on examination. Longitudinal data collected included age, seizure control, and type of therapy received. Linear mixed-effect models were used for longitudinal CVI grade outcome analysis.ResultsA total of 249 individuals spanning 779 patient visits were identified. Mean age at diagnosis was 18.8 ± 16.8 months. About 64.3% were born at term age. Perinatal history revealed hypoxic ischemic encephalopathy in 16.5%, intraventricular hemorrhage in 11.6%, and seizures in 21.7%. At presentation, 60.3% had a diagnosis of cerebral palsy and 84.7% had developmental delay. Among all subjects, 78.6% had epilepsy; 33.8% had an epileptic encephalopathy, with spasms/hypsarrhythmia being most common. Abnormal neuroimaging was present in 93.8%. Genetic anomalies were present in 26.9%. Baseline visual examination revealed no blink-to-light in 24.5%; only BTL in 34.5%, fixation/tracking in 26.5%, and optokinetic drum follow in 14.4%. Longitudinal data analysis showed that perinatal history of HIE, a positive epilepsy history, using multiple epilepsy medications, cerebral palsy, and abnormal fundoscopic findings were all negatively associated with CVI grade change over time. After controlling for significant confounders, receiving any type of therapy [early childhood intervention, physical and occupational therapy, refractive error correction or glasses] was significantly associated with longitudinal improvement in CVI grade compared to patients who did not receive any therapy, with glasses yielding the largest benefit.ConclusionThis study offers extensive insights into neurologic, developmental and ophthalmologic features in patients with moderate to severe CVI. In concordance with previous findings, aspects of perinatal history and epilepsy/seizure control may help inform severity and prognosis in the general neurology or ophthalmology clinic. Conversely, these aspects, as well as genetic and specific epilepsy traits may alert vision health care providers in the clinic to pursue visual evaluation in at-risk individuals. Longitudinal follow-up of CVI patients showed that interventional therapies demonstrated vision function improvement greater than no therapy and maturational development. (shrink)

Precaution is a relevant and much-invoked value in environmental risk analysis, as witnessed by the ongoing vivid discussion about the precautionary principle (PP). This article argues (i) against purely decision-theoretic explications of PP; (ii) that the construction, evaluation, and use of scientific models falls under the scope of PP; and (iii) that epistemic and decision-theoretic robustness are essential for precautionary policy making. These claims are elaborated and defended by means of case studies from climate science and conservation biology.

Recommender systems are recently developed computer-assisted tools that support social and informational needs of various communities and help users exploit huge amounts of data for making optimal decisions. In this study, we present a new recommender system for assessment and risk prediction in child welfare institutions in Israel. The system exploits a large diachronic repository of manually completed questionnaires on functioning of welfare institutions and proposes two different rule-based computational models. The system accepts users’ requests via a simple graphical (...) interface, calculates the institutions’ profiles according to user preferences, and presents assessment scores, trends and comparative analyses of the corresponding data using assorted visual aids. Based on the analysis, the system offers three different strategies for objective assessment of the institutions’ functioning and risks. Qualitative and quantitative evaluation of the system’s effectiveness and accuracy demonstrates that it substantially improves the assessment process of a welfare institution. Moreover, it provides an effective tool for objective large-scale analysis of the institution’s overall state and trends, which were previously based primarily on the institution supervisors’ subjective judgment and intuition. In addition, the proposed recommender system has great practical and social impact as it may help identify and avert potential problems, malfunctions, flaws, risks and even tragic incidents in child welfare institutions, as well as increase their overall functioning levels. As a result, as a long-term social implication, the system may also help reduce inequality and social gaps in the Israeli society. (shrink)

The strict lockdown experienced in Spain during March–June 2020 as a consequence of the COVID-19 crisis has led to strong negative emotions. Music can contribute to enhancing wellbeing, but the extent of this effect may be modulated by both personal and context-related variables. This study aimed to analyze the impact of the two types of variables on the perceived efficacy of musical behaviors to fulfill adults’ emotional wellbeing-related goals during the lockdown established in Spain. Personal variables included age, gender, musical (...) training, personality, resilience, and perception of music’s importance. Contextual variables referred to living in a region with a high COVID-19 impact, perception of belonging to a risk group, being alone, having caring responsibilities during confinement, and amount of time of music listening as compared to prior to the crisis. The study was conducted retrospectively during August–December 2020, when the strict lockdown was over in Spain. An online survey was disseminated among the general population and groups of musicians, and the answers of 507 adults were analyzed. Only personal, but not COVID-19 context-related variables, showed an impact on music’s efficacy. The youngest age group of adults and those with musical training reported the highest efficacy of music for wellbeing enhancement, and music’s importance was found to be the main significant predictor of music’s perceived efficacy. Our findings suggest that the people who have been reported to be emotionally more vulnerable during the lockdown, due to either a strong impact on their daily lives or their lower resilience, perceive a higher benefit from musical behaviors. Being musically trained, even for a small number of years, also leads to a perception of higher efficacy of music for the achievement of emotional wellbeing goals. However, this effect is explained by the musically trained individuals’ higher perception of music’s importance. Although musical behaviors can be generally considered as important for wellbeing enhancement, our study highlights who are the potential individuals who could benefit the most from music-related activities for obtaining better levels of wellbeing, at least within the current context of the COVID-19 crisis. (shrink)

Mainstream risk analysis deviates in at least two important respects from the rationality ideal of mainstream economics. First, expected utility maximization is not applied in a consistent way. It is applied to endodoxastic uncertainty, i.e. the uncertainty (or risk) expressed in a risk assessment, but in many cases not to metadoxastic uncertainty, i.e. uncertainty about which of several competing assessments is correct. Instead, a common approach to metadoxastic uncertainty is to only take the most plausible assessment (...) into account. This will typically lead to risk-prone deviations from risk-neutrality. Secondly, risks and benefits for different persons are added to form a total value of risk. Such calculations are used to support the view that one should accept being exposed to a risk if it brings greater benefits for others. This is in stark contrast to modern Paretian welfare economics, that refrains from interindividual comparisons and does not require people to accept a disadvantage because it brings a larger advantage for others. (Published Online July 11 2006). (shrink)

With the development of distributed networks, the remote controllability of the distributed energy objects and the vulnerability of user-side information security protection measures make distributed energy objects extremely vulnerable to malicious control by attackers. Hence, the large-scale loads may produce abnormal operation performance, such as load casting/dropping synchronously or frequent and synchronous casting and dropping, and hence, it can threaten the security and stable operation of the distribution networks. First, we analyze the security threats faced by industrial controllable load, civil (...) controllable load, and the gains and losses of attacks on the distribution networks. Considering the factors of cyber attacks, we propose a control model and cyber attack model in active distribution networks. And, three types of attacks that the target suffered are defined on the basis of “on” and “off” modes for control. Then, the controllable load was maliciously controlled as the research object, and a suitable scenario is selected. The impact of malicious control of the controllable load on the power supply reliability and power quality of the distribution networks are simulated and analyzed, and risk consequences for different types of attacks are provided. (shrink)

The relatively new discipline of risk analysis promises to provide objective guidance in some of the most controversial issues in modern high‐technology societies. Four conditions are discussed that must be satisfied for this promise to be fulfilled. Since none of these conditions is satisfied, risk analysis does not keep its promise. In its attempts to reduce genuinely political issues to technocratic calculations, it neglects many of the factors that should influence decisions on risk acceptance. A (...) list of tentative guidelines is given for numerical decision support that encourages democratic decision‐making instead of trying to evade it. (shrink)

The dynamic of changes in the rules in team games materialize from research and debate between experts and coaches before being implemented by the International Federations. In Handball, the last changes occurred in 2016, and one of them was to substitute the goalkeeper with an additional field player allowing teams to play “empty goal” while using the additional field player.This study aimed to analyze and characterize the use of the 7 vs. 6 strategical-tactical option for the attack in the 2020 (...) Men’s European Championship. We also analyzed whether the game time and partial score influenced the use of 7 vs. 6 and its efficiency. Observational methodology and a mixed ad hoc instrument combining field format and category systems validated by experts were used. Data were taken from 28 matches involving teams in the first 12 positions in the 2020 Men’s European Championship. The total number of offensive sequences in an organized attack method in 7 vs. 6 with an empty goal were analyzed. Sequential analysis techniques with lags, prospective and retrospective, and polar coordinate analysis were used. The results showed that these solutions had poor efficiency, except for the Portuguese National Team; teams using the 7 vs. 6 tactic option had no negative consequences or increased risk with the opponent response; partial score influenced the decision to use 7 vs. 6 strategic option, and game time was associated with 7 vs. 6 play options and detected patterns. (shrink)

Recent attempts to develop and apply digital ethics principles to address the challenges of the digital transformation leave organisations with an operationalisation gap. To successfully implement such guidance, they must find ways to translate high-level ethics frameworks into practical methods and tools that match their specific workflows and needs. Here, we describe the development of a standardised risk assessment tool, the Principle-at-Risk Analysis (PaRA), as a means to close this operationalisation gap for a key level of the (...) ethics infrastructure at many organisations – the work of an interdisciplinary ethics panel. The PaRA tool serves to guide and harmonise the work of the Digital Ethics Advisory Panel at the multinational science and technology company Merck KGaA in alignment with the principles outlined in the company’s Code of Digital Ethics. We examine how such a tool can be used as part of a multifaceted approach to operationalise high-level principles at an organisational level and provide general requirements for its implementation. We showcase its application in an example case dealing with the comprehensibility of consent forms in a data-sharing context at Syntropy, a collaborative technology platform for clinical research. (shrink)

Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how (...) non-utilitarian principles are prominent in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)

In recent years, risk management and analysis has attracted a great deal of attention from both researchers and practitioners. Enterprise risk management has become an important topic in today’s more complex, interrelated global business environment, replete with threats from natural, political, economic, and technical sources. This survey and introductory article addresses computerized tools used for risk management and analysis. Risks are studied from perspectives of different disciplines, with a discussion of how various methods and tools (...) are used to optimize risk management. (shrink)

Digital currency is considered a form of currency which is used in the digital world such as digital forms or electronic devices. Several terms are synonyms for digital currency like digital money, electronic money, and cyber cash. Accurate prediction of the digital currency is an urgent necessity due to its impacts on the economic community. The electronic economy is very dangerous and must be approached with great caution, so as to avoid or minimize the risks that occur in such cases. (...) Deep neural network algorithm was improved to predict the Bitcoin price and then achieve the main goal of reducing financial risks to proceed with electronic business, and good estimation was achieved by using informative data such as transactions and currency return. The proposed method extracted features of related Bitcoin and used the informative ones. Transaction plan considered building nodes in terms of network. Development of deep learning algorithms opens the horizons for the development of electronic businesses that use digital currency. The proposed method achieved worthy results in terms of accuracy and correct prediction and offers the prospect of other research in this area. (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)

The potential negative impacts of biological pest control on non-target species have become the focus of a contentious debate. In this article, we use examples from both classical and augmentative biological control of fruit fly pests in Hawaii to address several important factors in assessing non-target risks of fruit fly parasitoids. Several fruit fly parasitoids have been introduced to Hawaii and contribute substantially to the reduction of pest populations in the state's farms and forests. However, an historical lack of host-specificity (...) testing of these parasitoids with non-target species has raised concerns about their impact on non-pest fruit flies, including some flies deliberately introduced for biological control of weeds and others that are endemic Hawaiian species. When developing protocols to assess risks of introduced fruit fly parasitoids, we need first to define an appropriate range of species against which host specificity should be tested. For assessing susceptibility of a non-target species to parasitoids, behavioral tests are as important as suitability tests. Experimental factors, such as host-exposure substrate, absence or presence of preferred hosts, and laboratory vs. natural conditions, are shown to affect the results of host-specificity tests and risk analysis. Still, assessing long-term, indirect ecological impacts of parasitoids and weighing potential risks and benefits in multiple dimensions (besides dollar values) remains a challenge to environmentalists, conservationists, applied ecologists, and biocontrol practitioners. (shrink)

A capability approach has been proposed to risk analysis, where risk is conceptualized as the probability that capabilities are reduced. Capabilities refer to the genuine opportunities of individuals to achieve valuable doings and beings, such as being adequately nourished. Such doings and beings are called functionings. A current debate in risk analysis and other fields where a capability approach has been developed concerns whether capabilities or actual achieved functionings should be used. This paper argues that (...) in risk analysis the consequences of hazardous scenarios should be conceptualized in terms of capabilities, not achieved functionings. Furthermore, the paper proposes a method for assessing capabilities, which considers the levels of achieved functionings of other individuals with similar boundary conditions. The capability of an individual can then be captured statistically based on the variability of the achieved functionings over the considered population. (shrink)

Discussions of socioeconomic liability and compensation must necessarily start from an understanding of the socioeconomic, legal, and scientific basis for identifying, assessing, managing, and apportioning blame for hazards related to innovations. Public discussions about the nature of the liability challenge related to genetically modified (GM) crops and other modified organisms have focused less on direct, traditional health, public safety, technical, or environmental failures (e.g., innovations that generate hazards directly for users or indirectly to bystanders) and more on socioeconomic concerns, such (...) as comingled product that offends product quality standards. This article examines the theoretical and legal underpinnings of the current risk analysis framework used in most Organization for Economic Cooperation and Development countries and uses it to assess two areas of significant controversy—the release of herbicide-tolerant canola and flax varieties in Western Canada. The article offers lessons for the management of liabilities arising from the introduction of GM crops. (shrink)

For more than 10 years, Ulrich Beck has dominated discussion of risk issues in the social sciences. We argue that Beck's criticisms of the theory and practise of risk analysis are groundless. His understanding of what risk is is badly flawed. His attempt to identify risk and risk perception fails. He misunderstands and distorts the use of probability in risk analysis. His comments about the insurance industry show that he does not understand (...) some of the basics of that industry. And his assertions about the wrongness of allowing acceptable levels of exposure to toxic chemicals do not stand up to scrutiny. Key Words: Beck • risk analysis • risk perception • probability • insurance. (shrink)

In this paper, I raise a problem for standard precisifications of the Relational Analysis of attitude reports. The problem I raise involves counterfactual attitude verbs. such as ‘wish’. In short, the trouble is this: there are true attitude reports ‘ S wishes that P ’ but there is no suitable referent for the term ‘that P ’. The problematic reports illustrate that the content of a subject’s wish is intimately related to the content of their beliefs. I capture (...) this fact by moving to a framework in which ‘wish’ relates subjects to sets of pairs of worlds, or paired propositions, rather than—as is standardly assumed—sets of worlds. Although other types of counterfactual attitude reports, for example those involving ‘imagine’, may be similarly problematic, at this stage it is unclear whether they can be handled the same way. (shrink)

The articles included in this thesis centre on what can be called the normative basis of risk analysis. Since risk analyses are decision procedures, they should adhere to norms of rational decision-making, and this they do. Most risk analysis schemes are built on a notion of the decision theoretic maxim that the goal of every decision is to maximize expected utility. However, for some thirty years now this maxim has been called into question. The idea (...) is not that it is unreasonable in itself, but that the theoretical construct of which it is a consequence is in some way inappropriate. Idealizations of the theories are criticized for being too excessive. They do not properly cover cases where the decision maker has poor or, as it were, imprecise knowledge. These are situations where risks are not only about the consequences of the decision but also there are risks with the knowledge itself, epistemic risks. If it is important for a normative decision theory to be not only ideal as a theoretical construct, but to have, in addition, a prescriptive purpose, that theory should also be applicable to actual decision makers and to somehow deal with epistemic risks. The first two papers are about what kinds of decision theory there are, and how best to construe them. The first describes the differences between normative, descriptive and prescriptive decision theories. The second asks whether there is anything intrinsic to the theory that makes it normative or descriptive. Paper 3 asks on what grounds risk assessment is required to be separated from risk management in the risk analysis process. It is argued that the separation is there to ensure that epistemic values are held apart from non-epistemic values. The paper ends by arguing that, in efforts to improve risk management decision-making, it is more important to be explicit about scientific uncertainty than it is to separate sets of values. Paper 4 argues for a more complete decision-theoretic basis for risk analysis. The contrast here is with the bifurcated process of maximizing expected utility when sufficient knowledge is available and using the precautionary principle in cases where knowledge is more limited. Paper 5 investigates the notion of epistemic risk in detail. (shrink)

The integration of ethics into the day-to-day work of research and innovation is an important but difficult challenge. However, with the Aachen method for identification, classification and risk analysis of innovation-based problems an approach from an engineering perspective is presented that enables the integration of ethical, legal and social implications into the day-to-day work of R&I practitioners. AMICAI appears in particular capable of providing a procedural guidance for R&I practitioners based on a method established in engineering science, breaking (...) down the object of consideration into partial aspects and prioritizing the innovation-based problems in dependence of potential risk. This enables the user to apply AMICAI continuously during all stages of the research and development process and to analyze and choose between certain sociotechnical alternatives. In this way, problems that affect ethical, legal, and social aspects can be understood, reflected and considered in the mostly technically focused R&D process. The paper gives a general guidance about AMICAI by describing principles and assumptions, providing the steps of analysis and application aids, giving an example application, explaining the necessary adjustments of AMICAI compared to the methodical basis of failure mode, effects, and criticality analysis and discussing the advantages and limits. AMICAI’s simple applications can stimulate interdisciplinary cooperation in the R&D process and be a starting point for the development of an “open RRI risk analysis platform” allowing society to evaluate innovation-based problems. (shrink)

Some have characterized patients living with intractable pain as a vulnerable population in both clinical and research settings. Labeling the population as vulnerable, however, does not provide clarity regarding the potential risks that they face when they participate in research. Instead, research vulnerability for patients in pain is a function of an interaction between their pain conditions and elements of the research enterprise. Therefore, the identification of potential risks requires consideration not only of characteristics of patients with chronic pain, but (...) also consideration of features of researchers, the quality of institutional oversight, and the medical/social environment within which the research is conducted. This paper provides an analysis of those risks and provides some suggestions as to how the risks might be better managed. (shrink)

On David Lewis's original analysis of causation, c causes e only if c is linked to e by a chain of distinct events such that each event in the chain (counter-factually) depends on the former one. But this requirement precludes the possibility of late pre-emptive causation, of causation by fragile events, and of indeterministic causation. Lewis proposes three different strategies for accommodating these three kinds of cases, but none of these turn out to be satisfactory. I offer a single (...) analysis of causation that resolves these problems in one go but which respects Lewis's initial insights. One distinctive feature of my account is that it accommodates indeterministic causation without resorting to probabilities. (shrink)

Thought experiments are ubiquitous in science and especially prominent in domains in which experimental and observational evidence is scarce. One such domain is the causal analysis of singular events in history. A long‐standing tradition that goes back to Max Weber addresses the issue by means of ‘what‐if’ counterfactuals. In this paper I give a descriptive account of this widely used method and argue that historians following it examine difference makers rather than causes in the philosopher’s sense. While difference making (...) is neither necessary nor sufficient for causation, to establish difference makers is more consistent with the historians’ more ultimate purposes. †To contact the author, please write to: Department of Philosophy, Erasmus University, 3000 DR Rotterdam, The Netherlands; e‐mail: [email protected]. (shrink)

The concept of vulnerability has been the topic of considerable discussion in research bioethics, largely because of dissatisfaction with early constructions of the concept that were based on subpopulations of research subjects. These subpopulations have attributes likely to undermine their capacity to provide autonomous informed consent: persons who are relatively or absolutely incapable of protecting their own interests through negotiations for informed consent. Several subpopulations were seen as requiring special protections, including children, pregnant women, prisoners, racial minorities, the economically disadvantaged, (...) the very sick, and the institutionalized. Recent years have witnessed the identification of other subpopulations with attributes that could render them vulnerable, as well. For example, the Council for the International Organization of Medical Societies has named such potentially vulnerable groups as the homeless, nursing home residents, patients with incurable diseases, patients in the emergency department, employees, students, and members of communities who are unfamiliar with modern medicine. (shrink)

Questions concerning mediated causal effects are of great interest in psychology, cognitive science, medicine, social science, public health, and many other disciplines. For instance, about 60% of recent papers published in leading journals in social psychology contain at least one mediation test (Rucker, Preacher, Tormala, & Petty, 2011). Standard parametric approaches to mediation analysis employ regression models, and either the “difference method” (Judd & Kenny, 1981), more common in epidemiology, or the “product method” (Baron & Kenny, 1986), more common (...) in the social sciences. In this article, we first discuss a known, but perhaps often unappreciated, fact that these parametric approaches are a special case of a general counterfactual framework for reasoning about causality first described by Neyman (1923) and Rubin (1924) and linked to causal graphical models by Robins (1986) and Pearl (2006). We then show a number of advantages of this framework. First, it makes the strong assumptions underlying mediation analysis explicit. Second, it avoids a number of problems present in the product and difference methods, such as biased estimates of effects in certain cases. Finally, we show the generality of this framework by proving a novel result which allows mediation analysis to be applied to longitudinal settings with unobserved confounders. (shrink)