Machine learning operates at the intersection of statistics and computer science. This raises the question as to its underlying methodology. While much emphasis has been put on the close link between the process of learning from data and induction, the falsificationist component of machine learning has received minor attention. In this paper, we argue that the idea of falsification is central to the methodology of machine learning. It is commonly thought that machine learning algorithms infer general prediction rules from past (...) observations. This is akin to a statistical procedure by which estimates are obtained from a sample of data. But machine learning algorithms can also be described as choosing one prediction rule from an entire class of functions. In particular, the algorithm that determines the weights of an artificial neural network operates by empirical risk minimization and rejects prediction rules that lack empirical adequacy. It also exhibits a behavior of implicit regularization that pushes hypothesis choice toward simpler prediction rules. We argue that taking both aspects together gives rise to a falsificationist account of artificial neural networks. (shrink)

Risk preferences of Australian academics are elicited by analyzing the aggregate distribution of their retirement funds across available investment options. Not more than 10 % of retirement funds are invested as if their owners maximize expected utility under the assumption of constant relative risk aversion with an empirically plausible level of risk aversion. An implausibly high level of risk aversion is required to rationalize any investment into bonds when stocks are available. Not more than 36.54 % (...) of all investments can be rationalized by a model of loss averse preferences. Moreover, the levels of loss aversion typically reported in the experimental studies imply overinvestment in bonds, which is not observed in the data. Up to 67.18 % of all investments can be rationalized by rank-dependent utility or Yaari’s dual model with empirically plausible parameters. A median Australian academic behaves as if maximizing rank-dependent utility with parameter γ∈[0.76,0.79]\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\gamma \in [0.76, 0.79]$$\end{document} in a Tversky and Kahneman probability weighting function. (shrink)

One of the classic debates in cognitive science is between nativism and empiricism about the development of psychological capacities. In principle, the debate is empirical. However, in practice nativist hypotheses have also been challenged for relying on an ill-defined, or even unscientific, notion of innateness as that which is “not learned”. Here this minimal conception of innateness is defended on four fronts. First, it is argued that the minimal conception is crucial to understanding the nativism-empiricism debate, when properly construed; (...) Second, various objections to the minimal conception—that it risks overgeneralization, lacks an account of learning, frustrates genuine explanations of psychological development, and fails to unify different notions of innateness across the sciences—are rebutted. Third, it is argued that the minimal conception avoids the shortcomings of primitivism, the prominent view that innate capacities are those that are not acquired via a psychological process in development. And fourth, the minimal conception undermines some attempts to identify innateness with a natural kind. So in short, we have little reason to reject, and good reason to accept, the minimal conception of innateness in cognitive science. (shrink)

In bargaining environments with uncertain disagreement or “impasse” outcomes (e.g., litigation or labor strike outcomes), there is an identification problem that confounds data interpretation. Specifically, the minimally acceptable settlement value from a risk-averse (risk-loving) but unbiased-belief bargainer is empirically indistinguishable from what one could get with risk-neutrality and pessimistically (optimistically) biased beliefs. This article reports results from a controlled bargaining experiment where data on both risk attitude and beliefs under uncertainty are generated in order to assess (...) their relative importance in bargaining experiment outcomes. The average lab subject is risk-averse, yet optimistic with respect to uncertainty, which is consistent with existing studies that examine each in isolation. I also find that the effects of optimism dominate those of risk-aversion. Optimistic bargainers are significantly more likely to dispute and have aggressive final bargaining positions. Dispute rates are not statistically affected by risk attitude, but there is some evidence that risk aversion leads to a weakened bargaining position. Though additional research is needed to understand the limits of extending these results, a key implication follows. In uncertainty environments where optimism dominates, increased settlement rates are more likely achieved by minimizing impasse uncertainty (to limit the potential for optimism) rather than maximizing uncertainty (to weaken the reservation point of risk-averse bargainers), as has been argued in the dispute resolution literature. (shrink)

The rash of high-profile accounting frauds involving internal corporate accountants calls into question the individual accountant’s perceptions of the ethical climate within their organization and the limits to which these professionals will tolerate unethical behavior and/or accept it as the norm. This study uses social cognitive theory to examine the antecedents of individual corporate accountant’s perceived personal fit with their organization’s ethical climate and empirically tests how these factors impact organizational attitudes. A survey was completed by 203 corporate accountants to (...) assess their perception of relevant variables. The results of the structural equation model indicate three significant antecedents relating to ethical climate fit: higher internal levels of locus of control; greater numbers of prior job changes; and higher perceptions of an increasingly better fit with the firm’s ethical climate. Our results also indicate that higher levels of perceived fit to the ethical climate of a firm are associated with higher levels of perceived job satisfaction and organizational commitment. We also theorize that perceptions of an organization’s ethical climate may be reflections of client narcissism and serve a potential indicator of fraud risk. This is an important topic of study, since current auditing standards call for auditors to examine organizational attitudes toward fraud, but offer minimal guidance in doing so. (shrink)

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

Motivated by the analysis of a general optimal portfolio selection problem, which encompasses as special cases an optimal consumption and an optimal debt-arrangement problem, we are concerned with the questions of how a personality trait like risk-perception can be formalized and whether the two objectives of utility-maximization and risk-minimization can be both achieved simultaneously. We address these questions by developing an axiomatic foundation of preferences for which utility-maximization is equivalent to minimizing a utility-based shortfall risk measure. (...) Our axiomatization hinges on a novel axiom in decision theory, namely the risk-perception axiom. (shrink)

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, 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)

Transcranial direct current stimulation (tDCS) is a brain stimulation technique known for its relative safety and minimal invasiveness. tDCS has demonstrated efficacy as a potential treatment for certain neurological disorders, such as Parkinson’s disease, and has been shown to enhance a range of cognitive abilities under certain contexts. As a result, this technique has captured the interest of both the research community and the public at large. However, efforts to gather information about the effects of tDCS on the brain are (...) still in their infancy, leading to concerns about informed consent as it pertains to the possible risks associated with tDCS treatment. The ability to purchase tDCS equipment in the form of commercial, direct-to-consumer devices, generates even more cause for ethical concern, given the unknowns surrounding this technology and its potential broader societal impact. Previous research has touched on the many ethical issues raised by the emergence of this technology, including under what circumstances its use is justifiable and appropriate. In this paper, we survey recent normative and empirical works pertaining to the ethics of tDCS with the goal of summarizing the current state of ethical debate surrounding its use in the contexts of both therapy and cognitive enhancement, with a particular emphasis on the latter. Our analysis of the collected research finds that issues pertaining to user safety are paramount within existing scholarship; that tDCS use in children is an emerging area of concern entailing special considerations; and that regulatory bodies and legal agencies have struggled to implement appropriate, impactful regulation pertaining to tDCS and related technologies in order to balance public welfare against individual autonomy. This analysis will facilitate future efforts to develop bioethical approaches to tDCS by highlighting the ethical dimensions of tDCS prioritized in existing literature and identifying areas where further ethical consideration is needed. (shrink)

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)

Research risks have to meet minimal risk requirements in order for the research to qualify for expedited ethics review, to be exempted from ethics review, or to be granted consent waivers. The definition of “minimal risk” in the Common Rule (45 CFR 46) relies on the risks-of-daily-life and risks-of-routine-tests as comparators against which research activities are assessed to meet minimal risk requirements. While either or both comparators have been adopted by major ethics codes, they have also been (...) criticized. In response to criticisms, elaborations, and alternative comparators have been proposed. In this paper, I approach the search for workable comparators from the point of view that ethical reasoning about minimal risk involves analogical reasoning using comparators. In this regard, I develop two necessary conditions for an adequate minimal risk conception, which I use to assess three comparators. I conclude that the risks-of-routine-tests best fits the analogical reasoning operating in minimal risk assessments. (shrink)

BackgroundHIV molecular epidemiology is increasingly recognized as a vital source of information for understanding HIV transmission dynamics. Despite extensive use of these data-intensive techniques in both research and public health settings, the ethical issues associated with this science have received minimal attention. As the discipline evolves, there is reasonable concern that existing ethical and legal frameworks and standards might lag behind the rapid methodological developments in this field. This is a follow-up on our earlier work that applied a predetermined analytical (...) framework to examine the perspectives of a sample of scientists from the fields of epidemiology, public health, virology and bioethics on key ethical issues associated with HIV molecular epidemiology in HIV network research.MethodsFourteen in-depth interviews were conducted with scientists from the fields of molecular epidemiology, public health, virology and bioethics. Inductive analytical approaches were applied to identify key themes that emerged from the data.ResultsOur interviewees acknowledged the potential positive impact of molecular epidemiology in the fight against HIV. However, they were concerned that HIV phylogenetics research messages may be incorrectly interpreted if not presented at the appropriate level. There was consensus that HIV phylogenetics research presents a potential risk to privacy, but the probability and magnitude of this risk was less obvious. Although participants acknowledged the social value that could be realized from the analysis of HIV genetic sequences, there was a perceived fear that the boundaries for use of HIV sequence data were not clearly defined.ConclusionsOur findings highlight distinct ethical issues arising from HIV molecular epidemiology. As the discipline evolves and HIV sequence data become increasingly available, it is critical to ensure that ethical standards keep pace with biomedical advancements. We argue that the ethical issues raised in this study, whether real or perceived, require further conceptual and empirical examination. (shrink)

This dissertation compares the notions of homo rationalis in Philosophy and homo oeconomicus in Economics. Particularly, in Part I, we claim that both notions are close methodological substitutes. Accordingly, we show that the constraints involved in the notion of economic rationality apply to the philosophical notion of rationality. On these premises, we explore the links between the notions of Kantian and Humean rationality in Philosophy and the constructivist and ecological approaches to rationality in economics, respectively. Particularly, we show that the (...) constraints involved in both approaches to rationality in economics apply to the notions of Kantian and Humean rationality. That is why we introduce the notion of minimal global rationality. In a nutshell, the latter links one’s rationality to one’s ability to make good use of their cognitive apparatus to process contextual variables. On this basis, in Part II, we present two empirical tests showing that minimal global rationality is at work in philosophical experiments because systematic manipulations of contextual variables predictably affect philosophical judgment in the Trolley Problem and in some Knobe-like vignettes. In the first case, the manipulation of the information provided to subjects predictably causes inconsistent judgments. More precisely, subjects’ response to information shocks predictably causes them to issue inconsistent judgments. Instead, in the second case, our experimental results reveal that the Knobe Effect activates only if the perpetrator of an action is likely to be perceived as evil and unfriendly. Besides, when the Knobe-like vignettes include probabilistic outcomes, the Knobe Effect does not activate or is reduced in magnitude. For these reasons, we maintain that the availability heuristic bias arguably affects one’s judgment in Knobe-like experiment settings. Eventually, in Part III, we survey the general implications of the findings presented in Part II. First and foremost, we show that when manned social media algorithms produce wide-ranging availability cascades, agents predictably respond to those cascades by herding around biased claims. Interestingly, we find that the exposure to similarly redundant online content makes new social groups emerge unhindered. That is why populists and conspiracy theorists obtain such a large follow-up online. Secondly, we find that manned social media algorithms can exploit the flaws of minimal global rationality at a faster pace than humans. Yet, given that latter algorithms cannot do so on their own, we argue that the Turing Test is still an open game. Specifically, we argue so because state-of-the-art technology can request a service to be supplied (e.g., Google Duplex) but cannot operate direct sales. This constraint of state-of-the-art technology is linked to its inability to exploit the flaws of global minimal rationality as well as humans can. Importantly, we show that if algorithms were able to do so, the involved sociopolitical risk would be high. Therefore, we argue that only some form of regulation over state-of-the-art technology can prevent and reduce such sociopolitical risks. -/- In case you want a copy of this dissertation, please email me. (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)

Although there is clearly a need for evidenced‐based behavioral or biomedical prevention or treatment programs for suicide, substance abuse, and sexual health targeted to members of the LGBT population under the age of eighteen, few such programs exist, due in substantial part to limited research knowledge. Ambiguities in regulations that govern human subjects protections and the related inconsistencies in institutional review board (IRB) interpretations of regulatory language are the key reason for the lack of rigorous clinical trial evidence to support (...) treatment choices and prevention approaches to reducing health disparities for this population. Given the socially sensitive nature of suicide, substance abuse, and HIV and STI research in general and LGBT research specifically, in the absence of empirical data to guide their decisions, IRBs must often rely on subjective judgments of minimal risk, which can lead to overestimation of the magnitude and probability of psychological, social, and informational harms that might arise from LGBT youth participation in clinical trials. In addition, more than other youth, LGBT adolescents whose families are unaware of their sexual orientation or gender identity or whose families have victimized them on account of it may be reluctant to participate in studies that require guardian permission. This, in turn, intensifies problems of recruitment and unbiased sampling. However, many IRBs are reluctant to apply federal regulations permitting waiver of guardian permission under conditions in which such permission is clearly not “feasible” or “reasonable” to require. Consequently, many investigators have excluded LGBT individuals under eighteen years of age in health intervention research proposals because of anticipated or actual difficulties obtaining IRB approval. This situation is in conflict with current ethical discourse focusing on the right of youths to participate in trials that will protect them from receiving developmentally untested, inappropriate, and unsafe treatments. In this article, we describe these barriers and recommendations for providing LGBT youth safe and fair access to health research. (shrink)

Deep brain stimulation as investigational intervention for symptomatic relief from Alzheimer disease has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical. We performed a systematic search on MEDLINE and EMBASE. We included 166 publications about DBS for AD into the analysis of (...) research rationale, risks and ethical aspects. Fifty-eight patients were reported in peer-reviewed journals with very mixed results. A grey literature search revealed hints for 75 yet to be published, potentially enrolled patients. The results of our systematic review indicate methodological shortcomings in the literature that are both scientific and ethical in nature. According to our analysis, research with human subjects was performed before decisive preclinical research was published examining the specific research question at stake. We also raise the concern that conclusions on the potential safety and efficacy have been reported in the literature that seem premature given the design of the feasibility studies from which they were drawn. In addition, some publications report that DBS for AD was performed without written informed consent from some patients, but from surrogates only. Furthermore, registered ongoing trials plan to enroll severely demented patients. We provide reasons that this would violate Art. 28 of the Declaration of Helsinki, because DBS for AD involves more than minimal risks and burdens, and because its efficacy and safety are not yet empirically established to be likely. Based on our empirical analysis, we argue that clinical research on interventions of risk class III should not be exploratory but grounded on sound, preclinically tested, and disease-specific a posteriori hypotheses. This also applies to DBS for dementia as long as therapeutic benefits are uncertain, and especially when research subjects with cognitive deficits are involved, who may foreseeably progress to full incapacity to provide informed consent during the required follow-up period. (shrink)

We created paired moral dilemmas with minimal contrasts in wording, a research strategy that has been advocated as a way to empirically establish principles operative in a domain‐specific moral psychology. However, the candidate “principles” we tested were not derived from work in moral philosophy, but rather from work in the areas of consumer choice and risk perception. Participants were paradoxically less likely to choose an action that sacrifices one life to save others when they were asked to provide more (...) reasons for doing so (Experiment 1), and their willingness to sacrifice lives depended not only on how many lives would be saved, but on the number of lives at risk (Experiment 2). The latter effect was also found in a within‐subjects design (Experiment 3). These findings suggest caution in the use of artificial dilemmas as a key testbed for revealing principled bases for moral judgment. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Anorexia and the MacCAT-T Test for Mental Competence:Validity, Value, and EmotionLouis C. Charland (bio)Keywordsmental competence, decisional capacity, anorexia, value, emotionValidity of the MacCAT-THow does one scientifically verify a psychometric instrument designed to assess the mental competence of medical patients who are asked to consent to medical treatment? Aside from satisfying technical requirements like statistical reliability, results yielded by such a test must conform to at least some accepted pretheoretical (...) desiderata; for example, determinations of competence, as measured by the test, must capture a minimal core of accepted basic intuitions about what competence means and what a theory of competence is supposed to do. The concepts of "face validity" and "content validity" are both important here. Face validity "indicates that an instrument appears to test what it is supposed to and that it is a plausible method for doing so" (Portney and Watkins 2000, 82). Content validity "means that the test contains all the elements that reflect the variable being studied" (Portney and Watkins 2000, 83). An adequate instrument for measuring mental competence must at minimum satisfy both of these requirements.What Tan and her colleagues (2006) have shown is that the MacArthur Competence Assessment Tool—Treatment (MacCAT-T) test for mental competence may not be an empirically valid measure of mental competence for some cases of anorexia. The data they report show that "competence," as measured by the MacCAT-T, does not conform sufficiently well with what is wanted of a clinical medical theory of competence. More specifically, the MacCAT-T is deficient in both face and content validity. This result is extremely significant; previous challenges to the validity of the MacCAT-T have often been largely theoretical in nature. My own objection that the MacCAT is inadequate because it omits the influence of emotion is based on a combination of empirical theory (Charland 1998a) and philosophical argument (Charland 1998b). However, it is entirely theoretical in nature. So is my argument that in ignoring emotion the MacCAT misses a crucial contributing ingredient in competence, namely, value (Charland 2001, see especially 136 note 2). Tan's study provides valuable empirical evidence for the second of these challenges, which deals more specifically with value. On the one hand, the study clearly demonstrates that patients sometimes do [End Page 283] base their treatment decisions on reasons derived from values. And on the other hand, it also nicely illustrates the centrality of values—"utilities" or "preferences"—in the decision-making process generally; a basic assumption of standard decision theory for which, paradoxically, there appears to be no satisfactory counterpart in the MacCAT-T model of reasoning and decision making.Thus, values figure among the reasons that patients actually use in reasoning when they weigh the risks and benefits of proposed treatment options. The MacCAT-T must be amended to incorporate this fact if it is to be a satisfactory clinical medical tool. Without such a correction, the concept of mental competence it measures is empirically invalid. At the root of the problem is a clash of intuitions. Tan's data provide convincing evidence that some of the patients who are deemed to be mentally competent by MacCAT-T standards should not in fact be considered competent. Note that the language in which this clash is expressed—"should not in fact"—involves a combination of descriptive and prescriptive elements, reminding us that the concept of competence is dual in nature: it is both prescriptive and descriptive (Freedman 1981). These problems underscore the need for greater clarity about what pretheoretically we want a clinical theory and test of competence to capture. It is of course reasonable to say that such a test must be consistent with major tenets of the relevant case law (Appelbaum 1998). But a legally valid concept of competence of this sort is too thin and arbitrary a foundation on which to build a clinical medical theory of competence. An empirically valid theory and test of the latter sort must incorporate the role of values if it is be truly helpful in medical practice.Value and the MacCAT-TI agree with Tan and her colleagues that some notion of "pathological value" needs to be... (shrink)

Female genital cutting (FGC) is generally understood as a gendered harm, abusive cultural practice and human rights violation. By contrast, male genital cutting (MGC) is held to be minimally invasive, an expression of religious identity and a legitimate parental choice. Yet scholars increasingly problematize this dichotomy, arguing that male and female genital cutting can occasion comparable levels of harm. In 2015 this academic critique received judicial endorsement, with Sir James Munby's acknowledgement that all genital cutting can cause ‘significant harm’. This (...) article investigates the harm occasioned by MGC. It is informed by a Freedom of Information (FoI) study which provides some empirical evidence of the nature and frequency of physical harm caused by MGC in U.K. hospitals. While acknowledging the challenges and limitations of FoI research, we outline important lessons that this preliminary study contains for medical ethics, law and policy. It provides some empirical evidence to support claims regarding the risks which accompany the procedure and the obligation of health professionals to disclose them, and reveals the paucity of measures in place to ensure that harms are recorded, disclosed and monitored. (shrink)

Solar radiation management (SRM) has been proposed as a means of mitigating climate change. Although SRM poses new risks, it is sometimes proposed as the ‘lesser evil’. I consider how research and implementation of SRM could be regulated, drawing on what I call a ‘precautionary checklist’, which includes consideration of the longer term political implications of technical change. Particular attention is given to the moral hazard of ‘regulatory drift’, in which strong initial regulation softens through complacency, deliberate deregulation (‘regulatory gift’) (...) and the limited constituency of people with the skills to regulate (‘thin markets’). I propose the strengthening of civil society groups to keep regulators in check. (shrink)

BackgroundIn the ruling inY[2018], the UK Supreme Court has confirmed that there is no general requirement for the courts in England and Wales to authorise the withdrawal of clinically assisted nutrition and hydration from patients with prolonged disorders of consciousness. The perceived requirement, which originated in a court ruling in 1993, encompassed those in the vegetative state and those in the minimally conscious state. The ruling inYconfirms that the court may still be approached to decide difficult or contested cases, but (...) there is otherwise no routine requirement that the judges be approached.Main bodyThere is much to welcome in this ruling, particularly as it means that these decisions for these patients are no longer (unusually) singled out for a judicial decision, with all the financial and emotional costs that court proceedings can entail. However, there is also a risk that the ruling might have unwelcome consequences. First, there is the possibility that patients might die too soon, particularly if doctors should now adopt the courts’ previous reasoning, which has suggested that patients in the vegetative state lack interests, so treatment may – perhaps must – be withdrawn. Secondly, there is the converse possibility that patients might live too long, since empirical research suggests that – whether intentionally or not – patients’ families, clinicians, and the health system appear to promote treatment-by-default.ConclusionRather than adopt general positions, which may be contestable and potentially risky, this article argues, on a pluralistic basis, that the individual patient should be the focus of any decision made in his or her ‘best interests’. The existing legal framework in England and Wales, which is provided by the Mental Capacity Act 2005, already points in this direction, although more efforts may be needed to ensure that those involved in making these decisions are suitably educated and supported. Fortunately, new guidance from the British Medical Association could help clinicians and families to make decisions in the future, which are appropriate for the incapacitated individual patient in question. (shrink)

Risk attitude is known to be a key determinant of various economic and financial choices. Behavioral studies that aim to evaluate the role of risk attitudes in contexts of this type, therefore, require tools for measuring individual risk tolerance. Recent developments in decision theory provide such tools. However, the methods available can be time consuming. As a result, some practitioners might have an incentive to prefer “fast and frugal” methods to clean but more costly methods. In this (...) article, we focus on a tractable procedure initially proposed by Holt and Laury (2002) to elicit risk attitude. We generalize this method to measure utility and risk aversion as follows. First, we allow measurement of probabilistic risk attitude through violations of expected utility due to probability weighting. Second, we use the outcome scale rather than the probability scale in the menu of choices. Third, we compare sure payoffs with lotteries instead of comparing non-degenerate lotteries. A within-subject experimental study illustrates the gains in tractability and bias minimization that can result from such an extension. (shrink)

Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research progresses beyond (...) computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk–benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established. (shrink)

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative (...) focus group study at the National Center for Tumor Diseases (NCT). Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients’ prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest (1) comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, (2) establishing independent governance entities in order to minimize the informational risks of genomic research, and (3) implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research. (shrink)

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative (...) focus group study at the National Center for Tumor Diseases. Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients’ prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, establishing independent governance entities in order to minimize the informational risks of genomic research, and implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research. (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)

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)

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value (...) judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

While the Academic sceptics followed the plausible as a criterion of truth and guided their practice by a doxastic norm, so thinking that agential performances are actions for which the agent assumes responsibility, the Pyrrhonists did not accept rational belief-management, dispensing with judgment in empirical matters. In this sense, the Pyrrhonian Sceptic described himself as not acting in any robust sense of the notion, or as ‘acting’ out of sub-personal and social mechanisms. The important point is that the Pyrrhonian (...) advocacy of a minimal conception of ‘belief’ was motivated by ethical concerns: avoiding any sort of commitment, he attempted to preserve his peace of mind. In this article, I argue for a Cartesian model of rational guidance that, in line with some current versions of an agential virtue epistemology, does involve judgment and risk, and thus which is true both to our rational constitution and to our finite and fallible nature. Insofar as epistemic humility is a virtue of rational agents that recognise the limits of their judgments, Pyrrhonian scepticism, and a fortiori any variety of naturalism, is unable to accommodate this virtue. This means that, in contrast to the Cartesian model, the Pyrrhonist does not provide a satisfactory answer to the problem of cognitive disintegration. The Pyrrhonist thus becomes a social rebel, one that violates the norm of serious personal assent that enables the flourishing of a collaborative and social species which depends on agents that, however fallible, are accountable for their actions and judgments. (shrink)

Surrogate (proxy) decision makers must make research decisions for people with dementia who lack decision-making capacity. Proxies’ decision-making processes are minimally understood. We randomly assigned 82 proxies of AD patients to informed consent for one of three hypothetical protocols with differing levels of risk and benefit. Proxies answered questions about potential benefits of the described research to the patient and society, as well as about whether they would enroll their relative and why or why not. Proxies interested in enrolling (...) their relative cited the potential for direct benefit to their relative, altruism, and trust in researchers. Those declining cited risks, inconvenience, and stage of illness. Proxies weighed numerous factors, incorporating both substituted judgment and best interests standards in their decision-making processes. Although further empirical work is needed to understand the influences on and adequacy of proxies’ decision making regarding research, these findings can help inform policy regarding surrogate consent. (shrink)

Bioethicists broadly agree that there is a limit to the level of net risk that biomedical research may permissibly impose on participants, even in cases where the potential of that research to improve the health of the population health would be great. Although some may permissibly volunteer to take on some degree of pro‐social risk, no one, not even a willing volunteer, may ever be outright sacrificed for others. One might think this perspective, if correct, makes it effectively (...) impossible to study interventions with high intrinsic risks. But I describe a method – risk dilution – by which an extremely high‐risk intervention can nonetheless be effectively studied in the context of an acceptably low‐risk trial. I then defend risk dilution from objections. (shrink)

Package leaflets belong to the complex communication system related to the minimization and prevention of pharmaceutical risk. Their legal nature is not exhausted by safety regulation though: as a privileged form of product instruction, they are also subject to liability regulation with a consequent reallocation of damage responsibility through risk disclosure. This article presents the results of a doctoral dissertation devoted to the legal and communicative analysis of PL information. After illustrating the articulation of pharmaceutical risk (...) through risk prevention norms, the paper goes on with a discussion of the PL role within the therapeutic decision as a complementary vehicle to doctor’s information. It results that the liability framework in which both information channels are embedded determines a communication model, which far from promoting a shared decision process, radicalizes the two-step communication structure typical of the informed consent model inherited by surgery judicature. The second part investigates PL information as a source of knowledge updating through the methodological tools provided by Bayesian decision theory. Finally, an empirical study conducted over a sample of 55 drug consumers investigates the impact of PL information on drug risk perception and its perceived value to therapeutic decision. (shrink)

Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the tasks mimic (...) clinical care and are often conducted in clinical settings. Investigators should anticipate which measures could yield clinically-important findings and should describe explicit plans for data monitoring, disclosure, and follow-up. Protocols that include reliable and valid clinical measures should prompt a more detailed risk assessment by the IRB, even when the tasks meet the regulatory criteria for minimal physical, psychological, or emotional risk. (shrink)

Empirical data can be an extremely powerful and influential tool in bioethical research. However, when researchers or policy makers look for answers to ethical questions by engaging with empirical research, there can be a tendency (conscious or unconscious) to shape, report, and use empirical research in a way that confirms their own preferred ethical conclusions. This skewing effect - what we call ‘normative bias’ - is often so subtle it falls short of clear misconduct and thus can (...) be difficult to call out. However, we argue that this subtle influence of bias has the potential to significantly influence debate and policy around highly sensitive ethical issues and must be guarded against. In this paper we share the lessons we have learned through a journey of self-reflection around the effect that normative bias can have when reporting on and referring to empirical data relating to ethical issues. We use a variety of papers from our area of the ethics of routine prenatal screening to illustrate these subtle but often powerfully distorting effects of bias. Our aim in doing so is not to criticise the work of others, as we recognise our own normative bias, but to improve awareness of this issue, remind the need for reflexivity to guard against our own biases, and introduce a new criterion - the idea of a ‘limitation prominence assessment’ - that can work as a practical way to evaluate the seriousness of the limitations of an empirical study and thus, the risks of the study being misread or misinterpreted through superficial reading. (shrink)

The concept of minimal risk plays a key role in federal regulations on the protection of human research subjects. Although there has been considerable discussion of the meaning of minimal risk, the question of how this concept should be interpreted in research involving pregnant women and fetuses has not been addressed. This essay reviews the literature on minimal risk and argues for an interpretation of that concept in the context of research involving pregnant women and fetuses.

Research in empirical moral psychology has consistently found negative correlations between morality and both risk-taking, as well as psychopathic tendencies. However, prior research did not sufficiently explore intervening or moderating factors. Additionally, prior measures of moral preference have a pronounced lack of ecological validity. This study seeks to address these two gaps in the literature. First, this study used Preference for Precepts Implied in Moral Theories, which offers a novel, more nuanced and ecologically valid measure of moral judgment. (...) Second, the current study examined if risk taking moderates the relationships between psychopathic tendencies and moral judgment. Results indicated that models which incorporated risk-taking as a moderator between psychopathic tendencies and moral judgment were a better fit to the data than those that incorporated psychopathic tendencies and risk-taking as exogenous variables, suggesting that the association between psychopathic tendencies and moral judgment is influenced by level of risk-taking. Therefore, future research investigating linkages between psychopathic tendencies and moral precepts may do well to incorporate risk-taking and risky behaviors to further strengthen the understanding of moral judgment in these individuals. (shrink)

One of the central problems concerning research with children is the delineation of appropriate levels of risk exposure. In the U.S. Code of Federal Regulations, the "minimal risk" concept serves as an anchoring measure for allowable risk. While the regulations sought to promote a balance between scientific advances and the protection of children's vulnerable status, ambiguities in the language of the regulations and the regulatory definition of "minimal risk" have given rise to a great deal of (...) confusion. Research ethics boards and the medical community espouse a multitude of varying opinions regarding the interpretation and application of the federal regulations with more recent research demonstrating an apparent increase in risk without corresponding benefit in pediatric research. Informed by ethical theory, law, and science, this project analyzes the apparent increase in allowable risk, calls for a reassessment of the concept of "minimal risk," and recommends modifications to the federal regulations. (shrink)

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort (...) anticipated in research are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks “. . . ordinarily encountered in daily life . . . .” But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation or the relative interpretation of minimal risk. We argue that describing the debate over minimal (...) risk as a disagreement between the uniform and the relative interpretation impedes progress on the identification of a justifiable referent for minimal risk. There are two main problems with this approach: constructing the debate over minimal risk as a disagreement between a uniform and a relative interpretation misconstrues the main difference between competing interpretations and neither the uniform nor the relative interpretation identifies one unique and consistent group of children as the referent for minimal risk. We conclude that progress on the debate over minimal risk requires that we abandon the uniform and relative interpretations and address the main moral problem at stake: whether healthy children or the subjects of the research should be the referent for minimal risk. (shrink)

How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies of work (...) can one find an analysis of minimal risk in regard to fetuses or pregnant women.The concept of minimal risk is defined in the regulations as follows:Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (shrink)

The product rule has been used to calculate the risk of a research study, in which the risk of harm is calculated as the product of the degree of harm multiplied by the likelihood that the harm will occur. This article challenges the product rule, especially when used to calculate "minimal risk" studies.

This essay examines the sanitary policies for the protection of overseas communities that Italian fascism employed during the empire. From 1935–1936, the vast scale of the Ethiopian campaign, as well as intensive colonisation programmes, gave new political visibility to the issue of safeguarding Italian settlers from the risks of the tropical climate. In this period, the problem of how Italians could adapt to overseas environments moved beyond the boundaries of scientific discussion to become a major concern of colonial rule. Analysing (...) both the medical literature and archival sources, this essay examines the concepts and practices that underpinned the fascist project for the “reclamation” of the empire: from the intensification of hygienic propaganda, to the redefinition of the medical-geographical boundaries of tropical risk, and to the expansion of social security benefits, which were extended to harms caused by tropical diseases. Finally, it investigates how the notion of acclimatisation was transformed within the context of the regime's imperial ideology, showing how the conception of the tropics as a pathogenic space remained widespread, fuelled by the regime's organicistic vision and its concerns for upholding the racial prestige of Italians in the colony. (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.

The American Journal of Bioethics, Volume 11, Issue 6, Page 25-27, June 2011.

Using empirical evidence to attack intuitions can be epistemically dangerous, because various of the complaints that one might raise against them (e.g., that they are fallible; that we possess no non-circular defense of their reliability) can be raised just as easily against perception itself. But the opponents of intuition wish to challenge intuitions without at the same time challenging the rest of our epistemic apparatus. How might this be done? Let us use the term “hopefulness” to refer to the (...) extent to which we possess a good capacity for the detection and correction of the errors of any fallible source of evidence. I argue that we should not trust putative sources of evidence that are substantially lacking in hopefulness (even if they are basically reliable), and that we are indeed already operating under such a norm in our ordinary and scientific practices. I argue further that the philosophical practice of the appeal to intuitions is, in these terms, badly hopeless... (shrink)

This paper uses the 5-five-minute high-frequency data of energy-listed companies in China's A-share market to extract the jump of energy stock prices and build a dynamic stock price jump complex network. Then, we analyze the clustering effect of the complex network. The research shows that the energy stock price jump is an important part of stock price volatility, and the complex network of energy stock jump risk has obvious time-varying characteristics. However, the infection problem of stock price jump risks (...) needs specific analysis. China's coal industry has an important influence on the development of China's energy industry. According to the clustering analysis results of the network community, the clustering effect of the network community has time-varying characteristics. After October 2017, the clustering effect of the jumping risk of the coal industry and the new energy industry is obvious. The risk contagion within the new energy industry community is a key point for the development of the new energy industry. (shrink)

ABSTRACT Despite Institutional Review Board concerns about psychological harm arising from research participation, evidence from trauma-questionnaire research suggests that participation is typically well-tolerated by participants. Yet, it is unclear how participant experiences of in-lab trauma simulations align with IRB ethical guidelines. Thus, we compared reactions to a trauma film paradigm with reactions to a positive film task or cognitive tasks. Overall, relative to other conditions, the trauma film was well-tolerated by participants: they generally reported low-to-moderate negative emotions, moderate benefits, and (...) that participation was not worse than everyday stressors. Our results have implications for the research community in designing trauma-based research. (shrink)