Progressive supranuclear palsy is a movement disorder with prominent tau neuropathology. Brain diseases with abnormal tau deposits are called tauopathies, the most common of which is Alzheimer's disease. Environmental causes of tauopathies include repetitive head trauma associated with some sports. To identify common genetic variation contributing to risk for tauopathies, we carried out a genome-wide association study of 1,114 individuals with PSP and 3,247 controls followed by a second stage in which we genotyped 1,051 cases and 3,560 controls for (...) the stage 1 SNPs that yielded P ≤ 10-3. We found significant previously unidentified signals associated with PSP risk at STX6, EIF2AK3 and MOBP. We confirmed two independent variants in MAPT affecting risk for PSP, one of which influences MAPT brain expression. The genes implicated encode proteins for vesicle-membrane fusion at the Golgi-endosomal interface, for the endoplasmic reticulum unfolded protein response and for a myelin structural component. © 2011 Nature America, Inc. All rights reserved. (shrink)

Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans mandates that all research involving human subjects be reviewed and approved by a research ethics board . We have little evidence on how researchers are dealing with this requirement in multisite studies, which involve more than one REB. We retrospectively examined 22 REB submissions for two minimal-risk, multisite studies in leading Canadian institutions. Most REBs granted expedited review to the studies, while one declared the application to (...) be exempt from review. Time between submission and approval ranged greatly, from four to 546 days. We received a total of 155 REB queries for changes and clarifications, most of which asked for further information, clarification, or additional documents. Less than a third of the REB queries were requests for specific changes, and a vast majority had a very limited impact on the research projects. Institutions also varied broadly in their description of what was required of local principal investigators. We conclude that the organizational and practical challenges these results imply could deter researchers from embarking on multisite research projects, and that recently proposed changes to the TCPS will not solve these problems. (shrink)

This article introduces the concept of technological citizenship as a status for individuals consisting of rights and obligations within bounded technological polities enforced by statist structures. The model reconciles freedom to innovate with the affirmation of the autonomy and dignity of laypersons and the assimilation of laypersons with their world. It seeks lay control over the introduction and ongoing management of environmental hazards and self-verification of safety. The rights and obligations of TC compose a "new social contract of complexity." Even (...) with different values stressed, the name, concept, and terms of TC would streamline studies of peril. (shrink)

As the frequency of internet-based research has increased, it is important for researchers to consider how the conditions in which data are collected may influence the risks to participants. In particular, because internet-based data collection often occurs outside a clinical or research setting, there may be unintentional disclosures of a participant's involvement in a research study of which the researcher is unaware. The current analysis examined the responses of men who have sex with men participating in an internet-based HIV behavioural (...) risk study when queried about the possible disclosure of their participation in the study. Fewer than 2% of participants indicated that their participation in the research study was disclosed, and all but one indicated no negative outcomes associated with the disclosure. As the field of online research continues to expand, it is important to consider risks that are unique to internet-based research, and to monitor these risks to ensure that the confidentiality of research subjects is maintained. (shrink)

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

Purpose This paper aims to expose the challenges facing the attempt by Jamaica to introduce a new digital ID system without adequate regard to public consultation and the rights of citizens. Design/methodology/approach The method used is critical text analysis and policy analysis, providing background and relevant factors leading up to the legislative changes under review. Extensive literature sources were consulted and the relevant sections of the Jamaican constitution referenced and analysed. Findings The case study may have national peculiarities not applicable (...) in other jurisdictions. Its introduction acknowledges that the Jamaican Government may amend and re-submit the legislation, absent the flawed clauses. The paper however will remain valid given its detailed analysis and exposure of risks associated with biometric data collection, face recognition technology and data storage flaws. Practical implications It will be a practical example of the risks associated with flawed biometric data collection and the role of Courts in reviewing such legislation. Referrals to the Courts can be used as a remedy, as occurred not only in Jamaica but also in many other jurisdictions, including India and Kenya. Social implications The paper foregrounds the rights of citizens to be consulted on the collection and storage of their sensitive biometric data. The social implications and risks of violating the constitutional rights of citizens were made evident, and can be an example to other jurisdictions. Originality/value The paper is the first of its kind to provide detailed data and analysis on an outright rejection by the Courts of a country's ID legislation on grounds that it violated the constitution and rights of citizens. It shows the ethical and social challenges in proposing and implementing legislation without adequate public consultation on such sensitive matters as biometric data. It also exposes some of the challenges of artificial intelligence and face recognition technologies in ID data collection, including flaws related to race, gender and coding. (shrink)

Whether risk events can be effectively controlled and mitigated is largely influenced by people’s perceptions of risk events and their behavioral cooperation. Therefore, this study used a web-based questionnaire to investigate the specific factors influencing people’s risk perceptions and behaviors, and included a test for the difference in the effect of positive and negative emotions of the audiences. The results show that the overall model has good explanatory power for the behavioral variables, and how people’s use of (...) different media significantly influenced their positive and negative emotions; how people’s frequency of TV use significantly influenced their risk susceptibility and how online media use significantly influenced their risk severity ; how people’s sense of efficacy for risky events is the strongest predictor of their risk control behavior; and that there are different mediating effects of different emotions and risk severity and sense of efficacy between the frequency of media use and risk control behavior. (shrink)

The aviation industry is the center of gravity for tourism-dependent countries seeking to uplift their economic activities. The COVID-19 pandemic in the early part of 2020 threatened people and the air industry to the maximum extent. This paper investigated the sustainable air travel behavior of passengers under the risk knowledge path. The mediating role of risk perception, i.e., physical risk, psychological risk, and service quality, was also tested for the risk knowledge-air travel behavior association. We (...) surveyed 339 travelers at six airports in Thailand from January to June 2021 to record their responses. We applied covariance–variance-based structural equation modeling, and the study results revealed a direct effect of risk knowledge with an indirect impact via risk perception paths on air travel behavior. This paper highlights knowledge as a remedial response to the perceptual makeup of air services sustainability. The study has solid managerial implications for aviation management in the design of ideal pathways for retaining air services during the current public emergency of COVID-19. (shrink)

AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and (...) 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (shrink)

Are risk-takers more likely to engage in unethical behaviors? We examined the relationship between risk-taking propensity and cheating in two experimental studies. In Study 1, we examined the relationship between subjects’ risk-taking propensity and their actual self-serving dishonesty using a gambling-like task. The results suggested that risk-taking propensity, measured using a behavioral approach, was positively correlated with actual self-serving dishonest behavior. In Study 2, we measured participants’ performances using a matrices test and found that the (...) positive correlation still held. We found that participants with high risk-taking propensity reported a lower perceived probability of being detected, which might drive their dishonest behavior. (shrink)

This book brings together eleven case studies of inductive risk-the chance that scientific inference is incorrect-that range over a wide variety of scientific contexts and fields. The chapters are designed to illustrate the pervasiveness of inductive risk, assist scientists and policymakers in responding to it, and productively move theoretical discussions of the topic forward.

BackgroundCurrent preimplantation genetic testing (PGT) technologies enable embryo genotyping across the whole genome. This has led to the development of polygenic risk scoring of human embryos (PGT-P). Recent implementation of PGT-P, including screening for intelligence, has been extensively covered by media reports, raising major controversy. Considering the increasing demand for assisted reproduction, we evaluated how information about PGT-P is communicated in press media and explored the diversity of ethical themes present in the public debate.MethodsLexisNexis Academic database and Google News (...) were searched to identify articles about polygenic embryo screening. This led to 535 news articles. 59 original articles met the inclusion criteria. Inductive content analysis was used to analyse these articles.Results8.8% of articles gave embryo polygenic scoring a positive portrayal, while 36.8% expressed a negative attitude. 54.4% were neutral, mostly highlighting limited practical value of the technology in in vitro fertilization settings. We identified five main ethical themes that are also present in academic literature and the broader debate on reproductive technologies: a slippery slope towards designer babies, well-being of the child and parents, impact on society, deliberate choice and societal readiness.ConclusionsImplementation of embryo polygenic profiling engenders a need for specific recommendations. Current media analysis discloses important ethical themes to consider when creating future guidelines for PGT-P. (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 use of social media is becoming a necessary daily activity in today’s society. Excessive and compulsive use of social media may lead to social media addiction. The main aim of this study was to investigate whether demographic factors, impulsivity, self-esteem, emotions, and attentional bias were risk factors associated with SMA. The study was conducted in a non-clinical sample of college students, ranging in age from 16 to 23 years, including 277 females and 243 males. All participants completed a (...) survey measuring impulsivity, self-esteem, anxiety, depression, social anxiety, loneliness, and attentional bias. The final hierarchical regression model indicated significant risk factors for SMA with an accuracy of 38%. The identified set of associated risk factors included female gender, impulsivity, self-esteem, anxiety, social anxiety, and negative attentional biases. Finally, a discussion of the results is presented, followed by corresponding recommendations for future studies. (shrink)

On March 28, 2017, the national Academy of Sciences, Engineering, and Medicine released a much-anticipated report on the Environmental Protection Agency's controlled human inhalation exposure studies. To understand the genesis of the document, a quick review of recent events is in order.Prior to 2006, the EPA adopted the Common Rule for intramural or extramural research funded by the agency.1 Although the EPA did not have a formal policy that applied to research sponsored by private companies, it applied scientific and (...) ethical standards to these studies on a case-by-case basis. In the 1990s, in support of requests to the agency to loosen its restrictions on pesticide residues on... (shrink)

Some early phase clinical studies of candidate HIV cure and remission interventions appear to have adverse medical risk–benefit ratios for participants. Why, then, do people participate? And is it ethically permissible to allow them to participate? Recent work in decision theory sheds light on both of these questions, by casting doubt on the idea that rational individuals prefer choices that maximise expected utility, and therefore by casting doubt on the idea that researchers have an ethical obligation not to (...) enrol participants in studies with high risk–benefit ratios. This work supports the view that researchers should instead defer to the considered preferences of the participants themselves. This essay briefly explains this recent work, and then explores its application to these two questions in more detail. (shrink)

IntroductionChildhood maltreatment is a developmental risk factor and can negatively influence later psychological functioning, health, and development in the next generation. A comprehensive understanding of the biopsychosocial underpinnings of CM transmission would allow to identify protective factors that could disrupt the intergenerational CM risk cycle. This study examined the consequences of maternal CM and the effects of psychosocial and biological resilience factors on child attachment and stress-regulatory development using a prospective trans-disciplinary approach.MethodsMother-child dyads participated shortly after parturition, after (...) 3 months, and 12 months later. Mothers’ CM experiences were assessed at t0, attachment representation at t1 and psychosocial risk and social support were assessed at t1 and t2. At t2, dyads participated in the Strange Situation Procedure. Children’s attachmen status were classified as organized vs. disorganized, including their level of disorganized behavior, and heart rate and respiratory sinus arrhythmia were recorded as stress response measures of the autonomic nervous system. Maternal caregiving during SSP was assessed using the AMBIANCE scale. Child’s single nucleotide polymorphisms rs2254298 within the oxytocin receptor and rs2740210 of the oxytocin gene were genotyped using DNA isolated from cord blood.ResultsMaternal CM experiences were significantly associated with an unresolved attachment status, higher perceived stress and more psychological symptoms. These negative effects of CM were attenuated by social support. As expected, maternal unresolved attachment and child disorganized attachment were significantly associated. Maternal caregiving did not mediate the relationship between maternal and child attachment but influenced children’s HR and RSA response and disorganized behavior. Moreover, the rs2254298 genotype of the OXTR gene moderated the stress response of children from mothers with CM. Children carrying the rs2740210 risk allele of the OXT gene showed more disorganized behavior independent from maternal CM experiences.ConclusionWe replicated and extended existing CM and attachment models by co-examining maternal attachment, social support, and child genetic susceptibility on child attachment and cardiovascular stress regulation. The findings contribute to an extended understanding of risk and resilience factors and enable professionals to target adequate services to parents and children at risk. (shrink)

We argue that two long-term goals of AI research stand in tension with one another. The first involves creating AI that is safe, where this is understood as solving the problem of value alignment. The second involves creating artificial general intelligence, meaning AI that operates at or beyond human capacity across all or many intellectual domains. Our argument focuses on the human capacity to make what we call “existential choices”, choices that transform who we are as persons, including transforming what (...) we most deeply value or desire. It is a capacity for a kind of value misalignment, in that the values held prior to making such choices can be significantly different from (misaligned with) the values held after making them. Because of the connection to existentialist philosophers who highlight these choices, we call the resulting form of risk “existentialist risk.” It is, roughly, the risk that results from AI taking an active role in authoring its own values rather than passively going along with the values given to it. On our view, human-like intelligence requires a human-like capacity for value misalignment, which is in tension with the possibility of guaranteeing value alignment between AI and humans. (shrink)

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)

As traditional methods such as questionnaires for measuring risk propensity are not applicable in some scenarios, a nonintrusive method that could automatically identify individuals' risk propensity could be valuable. This study utilized Defense of the Ancients 2 single match data and historical statistics to train predictive models to identify risk propensity by machine learning methods. Self-reported risk propensity scores from 218 DOTA 2 players were paired with their behavioral metrics. The best-performing model occurred with Gaussian process (...) regression. The root mean square error of this model was 1.10, the correlation between predicted scores and self-reported questionnaire scores was 0.44, the R-squared was 0.17, and the test–retest reliability was 0.67. We discussed how selected behavioral features could contribute to predicting risk propensity and how the approach could be of potential value in the application of perceiving individuals' risk propensities. Moreover, the limitations of our study were discussed, and recommendations were made for future studies in this field. (shrink)

Due to the limited work safety resources and the poor awareness of work safety from business owners with absolute decision-making power, safety accidents frequently occur in Chinese micro and small enterprises in high-risk industries. This study identifies the influencing factors of work safety behavior from MSEs, government safety supervision departments, and work safety service agencies. Based on the theory of planned behavior, the mechanism model of work safety behavior is built from the aspects of behavior attitude, subjective norms, behavior (...) control cognition, past behaviors, and risk awareness of the enterprise. Based on the interview with nearly 600 MSEs in the east of China over 6 months, the results show that the work safety awareness of the business owner determines the work safety lever of the enterprise, and the work safety behavior of MSEs is a passive restraint behavior. Our findings provide a new perspective on the formation of MSEs’ work safety behavior in high-risk industries. (shrink)

BackgroundThe risk of child sexual abuse among non-forensic, non-correctional patients with Pedophilic Disorder is largely unknown.MethodsWe recruited a consecutive sample of 55 help-seeking, non-correctional adult men diagnosed with DSM-5 PD at a university-affiliated sexual medicine outpatient unit in Sweden. PD participants were compared with 57 age-matched, non-clinical control men on four literature-based dynamic risk domains and self-rated child sexual abuse risk.ResultsPD participants scored higher than controls on all tested domains ; expectedly so for pedophilic attraction : [1.91–2.89]), (...) but also for sexual preoccupation, impaired self-regulation, impaired cognitive empathy and antisocial traits, and self-rated child sexual abuse risk. When summarizing all five domains into a pre-specified composite score, PD subjects scored substantially higher than matched control men. Five PD participants self-reported any previous conviction for a contact child sexual offense and eight for possession of child sexual abuse material or non-contact sexual offending. Eighteen subjects acknowledged past week, child-related sexual behaviors.ConclusionSelf-referred, help-seeking men with PD scored higher than non-clinical control men on psychiatric measures of dynamic risk of child sexual abuse suggested in prior research with correctional samples diagnosed with PD. Our findings, including the composite risk measure, might inform clinical practice, but needs validation against actual sexual offending behavior. (shrink)

’Catastrophes are not accidents.’All complex organizations can take steps to prevent catastrophe by enlisting the new scientific study of danger. The author is a member of the Scientific Committee of 1′Institut Européen de Cindyniques and Directeur général adjoint of L'Union des Assurances de Paris. This article is part of a presentation made to the 1992 Paris Conference of the European Business Ethics Network, of which the author is a Council member. The subject of the Conference was the role of business (...) in the shaping of cities, but the author's reflections on learning from risks are of considerably wider application. (shrink)

’Catastrophes are not accidents.’All complex organizations can take steps to prevent catastrophe by enlisting the new scientific study of danger. The author is a member of the Scientific Committee of 1′Institut Européen de Cindyniques and Directeur général adjoint of L'Union des Assurances de Paris. This article is part of a presentation made to the 1992 Paris Conference of the European Business Ethics Network, of which the author is a Council member. The subject of the Conference was the role of business (...) in the shaping of cities, but the author's reflections on learning from risks are of considerably wider application. (shrink)

Genetic counselling is an important aspect of prenatal care in many developed countries. This tendency has also begun to emerge in Br.

Ethical dilemmas involving tax issues were identified by members of the American Institute of Certified Public Accountants as posing the most difficult ethical problem for them (Finn et al., Journal of Business Ethics 7(8), pp. 607–609, 1988). The KPMG tax shelter fraud case proves that the tax profession has not gone untainted in the age of numerous accounting and corporate scandals, such as the Enron débâcle (Sikka and Hampton, Accounting Forum 29(3), 325–343, 2005). High-profile scandals serve to highlight the problems (...) caused by differences in ethical judgement among accountants and tax practitioners and the issue of ethics has been brought publicly to the forefront of the profession. Nevertheless, the nature and dimension of ethical issues in tax practice have been largely unexplored (Erard, Journal of Public Economics 52(2), 163–197, 1993; Marshall et al., Journal of Business Ethics 17(12), 1265–1279, 1998; Frecknall Hughes, Unpublished PhD Thesis, The University of Leeds, 2002). This research aims to contribute to the debate on ethics in tax practice by reporting interview data on tax practitioners’ perceptions of ethics in the jurisdictions of Ireland and the United Kingdom and exploring the link or equation of ethics with risk management. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant (...) to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

This article is a revised version of a talk given in lieu of the Ph.D. dissertation: "Huntington´s Disease in Everyday Life. Knowledge, Ignorance and Genetic Risk". The dissertation evolves around the analysis of modern living with risk for a late onset genetic disorder. Here, three aspects of everyday lives faced with Huntington´s Disease (HD) are discussed. First, HD is one aspect of everyday living along with a variety of other aspects. The importance of risk is analysed as (...) personal and changing in changing circumstances. Second, genetic knowledge and technology are not solid universals, but situated and changing, and of varying importance in lives at risk. Last, the ethical rationalities of everyday living, research and clinical practice concerned with a hereditary condition are discussed as complex and contradictory in and across structures of social practice. (shrink)

Controlled Human Infection Model (CHIM) research involves the infection of otherwise healthy participants with disease often for the sake of vaccine development. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clear ethical guidance for their conduct. The payment of CHIM participants is a controversial issue involving stakeholders across ethics, medicine and policymaking with allegations circulating suggesting exploitation, coercion and other violations of ethical principles. There are multiple approaches to payment: reimbursement, wage (...) payment and unlimited payment. We introduce a new Payment for Risk Model, which involves paying for time, pain and inconvenience and for risk associated with participation. We give philosophical arguments based on utility, fairness and avoidance of exploitation to support this. We also examine a cross-section of the UK public and CHIM experts. We found that CHIM participants are currently paid variable amounts. A representative sample of the UK public believes CHIM participants should be paid approximately triple the UK minimum wage and should be paid for the risk they endure throughout participation. CHIM experts believe CHIM participants should be paid more than double the UK minimum wage but are divided on the payment for risk. The Payment for Risk Model allows risk and pain to be accounted for in payment and could be used to determine ethically justifiable payment for CHIM participants.Although many research guidelines warn against paying large amounts or paying for risk, our empirical findings provide empirical support to the growing number of ethical arguments challenging this status quo. We close by suggesting two ways (value of statistical life or consistency with risk in other employment) by which payment for risk could be calculated. (shrink)

Net‐risk pediatric research encompasses interventions and studies that pose risks and do not offer a compensating potential for clinical benefit. These interventions and studies are central to efforts to improve pediatric clinical care. Yet critics argue that it is unethical to expose children to research risks for the benefit of unrelated others. While a number of ethical justifications have been proposed, none have received widespread acceptance. This leaves funders with uncertainty over whether they should support and institutional (...) review boards with uncertainty over whether they should approve net‐risk pediatric research. To try to answer these questions, this article describes a justification that I previously proposed and considers two objections to it. This analysis reveals that the opportunity to contribute to a valuable project can justify exposing children to risks even though some trials turn out to be valueless and others turn out to be harmful. It follows that, to protect pediatric participants, institutional review boards need to assess whether trials have the potential to collect socially valuable information and whether they are likely to enroll and retain a sufficient number of participants. (shrink)

Alzheimer’s Disease (AD) provides an excellent case study to investigate emerging conceptions of health, disease, pre-disease, and risk. Two scientific working groups have recently reconceptualized AD and created a new category of asymptomatic biomarker positive persons, who are either said to have preclinical AD, or to be at risk for AD. This article examines how prominent theories of health and disease would classify this condition: healthy or diseased? Next, the notion of being “at risk”—a state somewhere in-between (...) health and disease—is considered from various angles. It is concluded that medical-scientific developments urge us to let go of dichotomous ways of understanding disease, that the notion of “risk,” conceptualized as an increased chance of getting a symptomatic disease, might be a useful addition to our conceptual framework, and that we should pay more attention to the practical usefulness and implications of the ways in which we draw lines and define concepts. (shrink)

This study examines the role of corporate philanthropy in the management of reputation risk and shareholder value of the top 100 ASX listed Australian firms for the 3 years 2011–2013. The results of this study demonstrate the business case for corporate philanthropy and hence encourage corporate philanthropy by showing increasing firms’ investment in corporate giving as a percentage of profit before tax, increases the likelihood of an increase in shareholder value. However, the proviso is that firms must also manage (...) their reputation risk at the same time. There is a negative association between corporate giving and shareholder value which is mitigated by firms’ management of reputation. The economic significance of this result is that for every cent in the dollar the firm spends on corporate giving, Tobin’s Q will decrease by 0.413 %. In contrast, if the firm increase their reputation by 1 point then Tobin’s Q will increase by 0.267 %. Consequently, the interaction of corporate giving and reputation risk management is positively associated with shareholder value. These results are robust while controlling for potential endogeneity and reverse causality. This paper assists both academics and practitioners by demonstrating that the benefits of corporate philanthropy extend beyond a gesture to improve reputation or an attempt to increase financial performance, to a direct collaboration between all the factors where the benefits far outweigh the costs. (shrink)

COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 (...) CHIs. Such evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment. (shrink)