The governance of nanotechnology seeks to limit its risks, without constraining opportunities. The literature on the effectiveness of approaches to governance has neglected approaches that impact directly on the behavior of a researcher. We analyze the effectiveness of legal regulations versus regulation via self-commitment. Then, we refine this model by analyzing competition and autonomy as key contingency factors. In the first step, qualitative interviews with nanotechnology researchers are conducted to reflect this model. In the second step, its empirical relevance is (...) tested using a survey of 90 nanotech researchers. The results indicate that legal regulations, as well as self-commitment to an informal CoC reduce the scope of behavior. Finally, that competition and autonomy affect the relative strength of these governance factors. (shrink)

During the COVID-19 pandemic, universities had to shift from face-to-face to emergency remote education. Students were forced to study online, with limited access to facilities and less contact with peers and teachers, while at the same time being exposed to more autonomy. This study examined how students adapted to emergency remote learning, specifically focusing on students’ resource-management strategies using an individual differences approach. One thousand eight hundred university students completed a questionnaire on their resource-management strategies and indicators of successful adaptation (...) to emergency remote learning. On average, students reported being less able to regulate their attention, effort, and time and less motivated compared to the situation before the crisis started; they also reported investing more time and effort in their self-study. Using a k-means cluster analysis, we identified four adaptation profiles and labeled them according to the reported changes in their resource-management strategies: the overwhelmed, the surrenderers, the maintainers, and the adapters. Both the overwhelmed and surrenderers appeared to be less able to regulate their effort, attention, and time and reported to be less motivated to study than before the crisis. In contrast, the adapters appreciated the increased level of autonomy and were better able to self-regulate their learning. The resource-management strategies of the maintainers remained relatively stable. Students’ responses to open-answer questions on their educational experience, coded using a thematic analysis, were consistent with the quantitative profiles. Implications about how to support students in adapting to online learning are discussed. (shrink)

Environmental, social and ethical issues have become increasingly important for businesses due to changed customer expectations, more regulation and stakeholder pressure, amongst others. This led to the development of concepts such as sustainability management, corporate social responsibility, stakeholder management and business ethics. Though mostly developed in isolation, scholars have increasingly worked on their integration. This editorial sheds light on overlaps between these concepts. We find that sustainability management and CSR have become more integrated and are increasingly grounded in an “embedded (...) view“ in which business and society is part of the natural environment. In contrast, business ethics has not been integrated to the same extent, expect for the subfield of environmental ethics. After this general overview, we introduce the individual contributions to the special issue which are advancing the conceptual and empirical foundation of sustainability management, CSR, and business ethics. (shrink)

Mary Kate McGowan’s Just Words offers an interesting account of exercitives. On McGowan’s view, one of the things we do with words is change what’s permitted, and we do this ubiquitously, without any special authority or specific intention. McGowan’s account of exercitives is meant to identify a mechanism by which ordinary speech is harmful, and which justifies the regulation of such speech. It is here that I part ways. I make three main arguments. First, McGowan’s focus on harm is (...) misguided; that ordinary speech is harmful is harder to support, and in turn does not less to support conclusions about whether it is wrong and warrants regulation, than Just Words suggests. Second, if the speech is harmful, McGowan’s account of exercitives is ill-suited to explain why; the relevant instances of ordinary speech seem to express speakers’ views about moral norms, not change social norms. Third, McGowan’s argument for why ordinary speech should be regulated because it is a form of discrimination presupposes a great deal that is controversial about what makes discrimination wrong and legally actionable, and even if it is right it may license the regulation of more speech than many, including McGowan, would deem acceptable. (shrink)

A regulative norm for permissible defense distinguishes the conditions under which we will hold defenders to be innocent of any wrongdoing from those in which we hold them responsible for assault or manslaughter. The norm must strike a fair balance between defenders' security, on the one hand, and other agents’ legitimate claim to live without fear of suffering mistaken defensive harm, on the other. Since agents must make defensive decisions under high pressure and on only partial information, they will (...) sometimes make mistakes. We have reason to want a norm that considers a mistake permissible when it was highly likely on the evidence that defense was proportionate and necessary to avert a threat. However, adopting an evidentialist norm under non-ideal conditions is treacherous business. I briefly survey empirical data suggesting that the type and extent of bias prevalent in the US renders a straightforward evidentialist norm unjust, and thus since the legal practice in the US relies on such a norm, we must explore avenues for reform. Preferably this will take the form of adopting a modified evidential norm, and I explore some promising options. If this proves impossible, however, then we have to accept a strict regulative norm (which does not consider any mistakes permissible), as the sole just alternative. (shrink)

States are in the process of creating controversial legislation aimed at subjecting ‘harmful’ online communication on social media and search engines to new regulatory regimes. Critics argue that these measures are serious threats to the right to freedom of expression and freedom from surveillance. This article first draws on elements of systems theory to reframe the right to freedom of expression in democracy as a means of protecting the value of generalised second-order observation. Taking the UK’s Online Safety bill as (...) the paradigm example of the new laws, the article analyses the concept of harmful communication at three levels: society, organisation, and subject. It identifies a shift in the law’s epistemic approach to communication, by which individuals are reconfigured from agential subjects into contingent users, whose capacities are determined by the structure of online communication platforms. In this configuration, norms previously considered indispensible are relegated to second-order effects of the affordances of media. Arguing that it is insufficient to merely reaffirm subjective rights in light of this shift, the article suggests systems theoretical analysis as a means of identifying lines of critique. (shrink)

Advocates of paid living kidney donation frequently argue that kidney sellers would benefit from paid donation under a properly regulated kidney market. The poor outcomes experienced by participants in existing markets are often entirely attributed to harmful black-market practices. This article reviews the medical and anthropological literature on the physical, psychological, social, and financial harms experienced by vendors under Iran's regulated system of donor compensation and black markets throughout the world and argues that this body of research not only documents (...) significant harms to vendors, but also provides reasons to believe that such harms would persist under a regulated system. This does not settle the question of whether or not a regulated market should be introduced, but it does strengthen the case against markets in kidneys while suggesting that those advocating such a system cannot appeal to the purported benefits to vendors to support their case. (shrink)

In his important recent book, Aaron James has defended a principle ? Collective Due Care ? for determining when a form of economic integration is morally objectionable because it causes unjustified harm (including unemployment, wage suppression and diminished working conditions). This essay argues that Collective Due Care would yield implausible judgements about trade practices and would be too indeterminate to play the practical role for which it is intended.

Julian Koplin, drawing extensively on empirical data, has argued that vendors, even in well-regulated kidney markets, are likely to be significantly harmed. I contend that his reasoning to this conclusion is dangerously mistaken. I highlight two failures. First, Koplin is insufficiently attentive to the differences between existing markets and the regulated markets proposed by advocates. On the basis of this error, he wrongly concludes that many harms will persist even in a well-regulated system. Second, Koplin misunderstands the utilitarian assessment of (...) the market. He focuses on the costs and benefits of the transaction for the vendor. But, the relevant comparison is between an individual’s welfare across different courses of action, namely, vending and the nonvending alternative. Although Koplin’s empirically informed contribution is a welcome addition to this literature, the mistakes that pervade his interpretation of the data demand correction. (shrink)

In April 2018, the International Association of Athletics Federations released new regulations placing a ceiling on women athletes’ natural testosterone levels to “ensure fair and meaningful competition.” The regulations revise previous ones with the same intent. They require women with higher natural levels of testosterone and androgen sensitivity who compete in a set of “restricted” events to lower their testosterone levels to below a designated threshold. If they do not lower their testosterone, women may compete in the male category, in (...) an intersex category, at the national level, or in unrestricted events. Women may also challenge the regulation, whether or not they have lowered their testosterone, or quit sport. Irrespective of IAAF’s stated aims, the options forced by the new regulations are impossible choices. They violate dignity, threaten privacy, and mete out both suspicion and judgement on the sex and gender identity of the athletes regulated. (shrink)

The dignity approach to racist hate speech regulation maintains that hate speech ought to be regulated because it impugns targets’ dignity and poses a threat to their equal treatment. This approach faces the significant causal challenges of showing that hate speech has the power to erode its targets’ dignity and that regulations can successfully protect that dignity. My aim is to show how a friend of the dignity approach can resolve these challenges. To do so, I borrow insights from the (...) critical legal studies (CLS) approach to hate speech. Specifically, I argue that hate speech can erode its targets’ dignity 1) by constituting an act of discrimination, and 2) by enacting norms that call for treating targeted groups as inferior. Yet while I maintain that the CLS approach offers valuable resources for shoring up the dignity approach, I reject the CLS approach in favor of the dignity approach. (shrink)

Questions concerning what hate speech is, how it harms, whether it is protected by free speech principles, and how it might be legally regulated have been at the centre of debates about free speech...

Like all interventions in health care, direct-to-consumer advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-unde-monstrated benefits of the advertising.

Like all interventions in health care, direct-to-consumer advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-undemonstrated benefits of the advertising.DTC advertising must be seen in the context of overall pharmaceutical company expenditures on advertising. In 2005, the industry spent $29.9 billion dollars on promotions, (...) of which a relatively small fraction, $4.2 billion, was spent on DTC advertising. The percentage spent on DTC advertising has been relatively constant this decade. Promotions to professionals and samples accounted for far larger percentages of total promotional spending in 2005. (shrink)

In her Pharmaceutical Freedom, Jessica Flanigan argues that antibiotics can be regulated consistent with her otherwise largely deregulatory view with respect to pharmaceuticals and recreational drugs. I contend in this essay that the reasons for justifying antibiotic regulation are reasons that can be offered to justify the regulation of many other drugs, both pharmaceutical and recreational. After laying out the specifics of Flanigan’s view, I suggest that it is amenable to the regulation of drugs like varenicline. Though such drugs can (...) legitimately improve the quality of a patient’s life by helping them quit smoking, they could be permissibly regulated if they expose others to impermissible risks. I then argue that recreational drugs like alcohol could be regulated using the same reasoning. In the penultimate section of this essay, I anticipate objections that one might have to my extension of arguments favoring antibiotic regulation to drugs correlated with aggression. Flanigan might find my extrapolation of her view as entirely plausible and accept that her view is relatively friendly to these regulations, or she might reconsider her antibiotic caveat if these regulations are overly paternalistic on her understanding. I conclude by briefly considering the benefits and drawbacks of adopting each view. (shrink)

The standard economic and ethical case in defense of sweatshops employs the standard of the “welfare of their workers and potential workers” to argue that sweatshop regulations harm the very people they intend to help. Scholars have recently contended that once the benefits and costs are balanced, regulations do, in fact, raise worker welfare. This paper describes the short and long-run tradeoffs associated with sweatshop regulation and then examines how reasonable constructions of measures of “worker welfare” would evaluate these (...) tradeoffs finding that the standard economic and ethical case against sweatshop regulations is well supported. (shrink)

Activists and progressive governments sometimes interfere in the working conditions of sweatshops. Their methods may include boycotts of the products produced in these facilities, bans on the import of these products or tariffs imposed by the home country, and enforcing the host country’s laws that aim at regulating sweatshops. Some argue that such interference in sweatshop conditions is morally wrong since it may actually harm workers. The reason is that the enterprise that runs the sweatshop may choose to (...) lay off some workers as the result of effective interference in order to maintain their profit at the desired level. If successful, this argument would prohibit any interference in sweatshop conditions on moral grounds. In this article, I argue in dissent and build a contractualist argument in favor of the moral permissibility of interference in sweatshops. I base my argument on an ex ante interpretation of T.M. Scanlon’s contractualism. (shrink)

I aim in this paper to provide defense of one way to look at what should be regulated in the market place. In particular, I discuss what should be tolerated and argue against corporate welfare. I begin by endorsing John Stuart Mill’s harm principle as a normative principle of toleration. I call strict commitment to the harm principle when considering the regulatory structure of markets market libertarianism and oppose that to promotionism, the view that endorses government interference to (...) promote business interests. I next discuss the widespread use of promotionist policies, arguing against them and for market libertarianism. I also consider problems for my view, recognizing that one of my responses may leave some thinking the paper is a reductio of the market libertarian view because of the sort of slow-growth state it endorses. Others will recognize it as a view promoted by some of the U.S. founding fathers and find it attractive in its own right. (shrink)

The Code of Federal Regulations permits harmful research on children who have not agreed to participate, but I will argue that it should be no more permissive of harmful research on such children than of harmful research on adults who have not agreed to participate. Of course, the Code permits harmful research on adults. Such research is not morally problematic, however, because adults must agree to participate. And, of course, the Code also permits beneficial research on children without needing their (...) explicit agreement. This sort of research is also not problematic, this time because paternalism towards children may be justifiable. The moral problem at the center of this paper arises from the combination of two potential properties of pediatric research, first that it might be harmful and second that its subjects might not agree to participate. In Section 2 of this article I explain how the Code permits harmful research on non-agreeing children. Section 3 contains my argument that we should no more permit harmful research on non-agreeing children than on non-agreeing adults. In Section 4, I argue that my thesis does not presuppose that pediatric assent has the same moral force that adult consent does. In Section 5, I argue that the distinction between non-voluntary and involuntary research is irrelevant to my thesis. In Section 6, I rebut an objection based on the power of parental permission. In Section 7 I suggest how the Code of Federal Regulations might be changed. (shrink)

Existing regulation of end-of-life care is flawed. Problems include poorly-designed laws, policies, ethical codes, training, and funding programs, which often are neither effective nor helpful in guiding decision-making. This leads to adverse outcomes for patients, families, health professionals, and the health system as a whole. A key factor contributing to the harms of current regulation is a siloed approach to regulating end-of-life care. Existing approaches to regulation, and research into how that regulation could be improved, have tended to focus (...) on a single regulatory instrument (e.g., just law or just ethical codes). As a result, there has been a failure to capture holistically the various forces that guide end-of-life care. This article proposes a response to address this, identifying “regulatory space” theory as a candidate to provide the much-needed holistic insight into improving regulation of end-of-life care. The article concludes with practical implications of this approach for regulators and researchers. (shrink)

This paper critiques the version of the argument that the regulation of hateful speech by the state undermines its democratic legitimacy made by Ronald Dworkin and James Weinstein. It argues that in some cases the harmful effects of hateful speech on the democratic process outweigh those of restriction. It does not challenge the central premise of the Legitimacy Argument, that a wide-ranging right to freedom of expression is an essential political right in a liberal democracy. Instead, it uses ideal and (...) nonideal theory as a framework for judgements about the regulation of hate speech. The mistake underpinning the Legitimacy Argument is that it assumes that other conditions pervade that make an ideal democratic procedure possible when they do not. In reality the state can be put in a position where, whatever course of action it takes with regard to the regulation or non-regulation of hate speech, some citizens will not be able to participate fully in political deliberation. Under such conditions there remain strong pro tanto reasons not to regulate hate speech on democratic grounds, but they are not all-things-considered reasons, and there are also pro tanto reasons to regulate hate speech that might outweigh them in some cases. This leads to the cautious conclusion that while there might be a normative justification for the regulation of hate speech in individual instances, the debate is best understood as one between competing pro tanto reasons, and must be approached on a case-by-case basis. (shrink)

This paper provides a systematic account of how artificial intelligence (AI) technologies could harm nonhuman animals and explains why animal harms, often neglected in AI ethics, should be better recognised. After giving reasons for caring about animals and outlining the nature of animal harm, interests, and wellbeing, the paper develops a comprehensive ‘harms framework’ which draws on scientist David Fraser’s influential mapping of human activities that impact on sentient animals. The harms framework is fleshed out with examples inspired (...) by both scholarly literature and media reports. This systematic account and framework should help inform ethical analyses of AI’s impact on animals and serve as a comprehensive and clear basis for the development and regulation of AI technologies to prevent and mitigate harm to nonhumans. (shrink)

Stakeholder theory focuses on how more value is created if stakeholder relationships are governed by ethical principles such as integrity, respect, fairness, generosity and inclusiveness. However, it has not adequately addressed strategies that stakeholders perceive as harmful to their interests and how this perception can even lead some stakeholders to view the firm’s strategies as unethical. To fill the void, this paper directly addresses strategies that stakeholders perceive as harmful to their interests, or what we refer to as harmful stakeholder (...) strategies. Specifically, it identifies factors associated with stakeholder perceptions of harm that are likely to cause them to consider a strategy unethical, examines the negative implications for firms that pursue such strategies in terms of likely stakeholder responses and damage to stakeholder relationships, and provides theory to help explain how firms are likely to respond to stakeholder claims that a strategy is unethical, based on factors such as the strategic importance of the claim to the firm, how long the strategy has been in use, the costs of remediation, the risk of stakeholder mobilization or new regulation, and whether firms can reasonably rationalize their actions. Assessing harm allows a firm to make a more accurate estimate of the costs of a strategy and can assist managers in allocating resources intended to reduce or remediate harm. (shrink)

For the purposes of conservation or suppression of species, gene drive technology has significant potential. Theoretically speaking, with the release of even relatively few animals with gene drive systems in an ecosystem, beneficial or harmful genes could be introduced into the entire wild-type population of that species. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. Communities and groups have differing beliefs about nature and its conservation or preservation, as (...) well as concerns about the ecological safety of the eradication, replacement or enhancement of particular species of animals by means of genetic engineering. For all those reasons, the rigorous regulation of insects and other animals with gene drive systems is crucial. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. (shrink)

It is suggested that the Harm Principle can be viewedas the moral basis on which genetically modified (GM) food iscurrently regulated. It is then argued (a) that the concept ofharm cannot be specified in such a manner as to render the HarmPrinciple a plausible political principle, so this principlecannot be used to justify existing regulation; and (b) that evenif the Harm Principle were a plausible political principle, itcould not be used alone in the regulation of GM food, since (...) itdoes not express a concern for the expected benefits of suchfood. (shrink)

Research on organizational epistemic vice alleges that some organizations are epistemically malevolent, i.e. they habitually harm others by deceiving them. Yet, there is a lack of empirical research on epistemic malevolence. We connect the discussion of epistemic malevolence to the empirical literature on organizational deception. The existing empirical literature does not pay sufficient attention to the impact of an organization’s ability to control compromising information on its deception strategy. We address this gap by studying eighty high-penalty corporate misconduct cases (...) between 2000 and 2020 in the United States. We find that organizations use two different strategies to deceive: Organizations ‘sow doubt’ when they contest information about them or their impacts that others have access to. By contrast, organizations ‘exploit trust’ when they deceive others by obfuscating, concealing, or falsifying information that they themselves control. While previous research has focused on cases of ‘sowing doubt’, we find that organizations ‘exploit trust’ in the majority of cases that we studied. This has important policy implications because the strategy of ‘exploiting trust’ calls for a different response from regulators and organizations than the strategy of ‘sowing doubt’. (shrink)

Aesthetic medicine has become a booming industry in the world. However, there are widespread social and health risks posed by aesthetic medicine, including illegal practice, and misleading information from aesthetic medicine institutes. Social media and advertisement play important roles in leading to appearance anxiety among young people nowadays. Regarding the chaotic situation in the aesthetic medical field, there is a fact that the practice of aesthetic medicine has been marginally regulated, even in some developed countries. China has the largest population (...) in the world as well as the large number of aesthetic medical customers. Regarding the protection of people from harm, there is a great challenge for the Chinese government. So, China has enacted the toughest governance these years both on the supply and demand side. Some of the strategies may be useful for health authorities in certain countries. (shrink)

Drug regulation is fraught with inductive risk. Regulators must make a prediction about whether or not an experimental pharmaceutical will be effective and relatively safe when used by typical patients, and such predictions are based on a complex, indeterminate, and incomplete evidential basis. Such inductive risk has important practical consequences. If regulators reject an experimental drug when it in fact has a favourable benefit/harm profile, then a valuable intervention is denied to the public and a company’s material interests are (...) needlessly thwarted. Conversely, if regulators approve an experimental drug when it in fact has an unfavourable benefit/harm profile, then resources are wasted, people are needlessly harmed, and other potentially more effective treatments are underutilized. Given that such regulatory decisions have these practical consequences, non-epistemic values about the relative importance of these consequences impact the way such regulatory decisions are made (similar to the analysis of laboratory studies on the toxic effects of dioxins presented in Douglas [2000]). To balance the competing demands of the pertinent non-epistemic values, regulators must perform what I call an “inductive risk calculus.” At least in the American context this inductive risk calculus is not well-managed. (shrink)

ABSTRACT In this paper I argue that liberal democratic communities are justified in regulating the activities of their members because of the inevitable existence of conflicting conceptions of what is considered as morally right. This will often lead to tension and disputes, and in such circumstances, reliance on peaceful or orderly co‐existence will not normally suffice. In such pluralistic societies, the boundary between permissible and impermissible activities will be unclear; and this becomes a particular concern in controversial issues which (...) raise specific anxieties and uncertainty. One context that has repeatedly raised issues in this regard is that of biotechnology and, in particular, the recent stem cell debate, on which this paper concentrates. While such developments have the potential to make significant improvements to therapeutic progress, we should also be sceptical because predicting the impact of these developments remains uncertain and complex. For the sake of socio‐political stability, it will therefore be necessary to enact and enforce rules which limit these competing claims in public policy but which may not be compatible with what individual moral commitments ideally permit. One way to achieve this is to establish procedural frameworks to resolve potential disputes in the public sphere about what is right, wrong, or permissible conduct. I argue that for one to commit to authoritative regulation, an idea of harm prevention through state intervention is necessary; and that this requires optimum mechanisms of procedure which allow the individual the opportunity to compromise and yet to continue to oppose or fight for changes as demanded by his or her moral position. (shrink)

This chapter contains sections titled: Introduction History of Experimentation on Human Beings Regulation of Human Experimentation Guidelines, Regulations and Directives to Regulate Human Experimentation Regulation of Experimentation in Surgery and Clinical Medicine Discussion References.

In this paper I argue that liberal democratic communities are justified in regulating the activities of their members because of the inevitable existence of conflicting conceptions of what is considered as morally right. This will often lead to tension and disputes, and in such circumstances, reliance on peaceful or orderly co‐existence will not normally suffice. In such pluralistic societies, the boundary between permissible and impermissible activities will be unclear; and this becomes a particular concern in controversial issues which raise (...) specific anxieties and uncertainty. One context that has repeatedly raised issues in this regard is that of biotechnology and, in particular, the recent stem cell debate, on which this paper concentrates. While such developments have the potential to make significant improvements to therapeutic progress, we should also be sceptical because predicting the impact of these developments remains uncertain and complex.For the sake of socio‐political stability, it will therefore be necessary to enact and enforce rules which limit these competing claims in public policy but which may not be compatible with what individual moral commitments ideally permit. One way to achieve this is to establish procedural frameworks to resolve potential disputes in the public sphere about what is right, wrong, or permissible conduct. I argue that for one to commit to authoritative regulation, an idea of harm prevention through state intervention is necessary; and that this requires optimum mechanisms of procedure which allow the individual the opportunity to compromise and yet to continue to oppose or fight for changes as demanded by his or her moral position. (shrink)

This volume draws on a range of approaches in order to explore the problem and determine what ought to be done about allegedly harmful speech.Most liberal societies are deeply committed to a principle of free speech. At the same time, however, there is evidence that some kinds of speech are harmful in ways that are detrimental to important liberal values, such as social equality. Might a genuine commitment to free speech require that we legally permit speech even when it is (...) harmful, and even when doing so is in conflict with our commitment to values like equality? Even if such speech is to be legally permitted, does our commitment to free speech allow us to provide material and institutional support to those who would contest such harmful speech? And finally, and perhaps most importantly, which kinds of speech are harmful in ways that merit response, either in the form of legal regulation or in some other form? This collection explores these and related questions. Drawing on expertise in philosophy, sociology, political science, feminist theory, and legal theory, the contributors to this book investigate these themes and questions. By exploring various categories of speech (including pornography, hate speech, Holocaust denial literature, 'Whites Only' signs), and attending to the precise functioning of speech, the essays contained here shed light on these questions by clarifying the relationship between speech and harm. Understanding how speech functions can help us work out which kinds of speech are harmful, what those harms are, and how the speech in question brings them about. All of these issues are crucially important when it comes to deciding what ought to be done about allegedly harmful speech. (shrink)

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, (...) late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products. (shrink)

This article draws on an ethnography of road construction in the Peruvian Andes to explore how engineering projects operate as sites of contemporary governance. Focusing on the way in which engineering projects entail a confrontation with dangers of various kinds, we explore how people caught up in road construction processes become preoccupied with the problem of anticipated harm. Drawing on the notion of ‘codes of conduct’, we suggest that the governmental effects of practices which attempt to deal with the (...) uncertainty of the future might be analysed as a tension between the enactment of two different kinds of codification. Building on the notion of coding as a situated material practice, we investigate the appearance of two different ways of encoding a relationship with an uncertain future which we term ‘machinic’ and ‘emergent’. The article builds on a description of these two ways of encoding uncertainty to explore how formal mechanisms of dealing with anticipated harm, such as the regulations of health and safety, are both unsettled and reinvigorated by more affective and relational dimensions of practice. (shrink)

There is no doubt that industry-sponsored biomedical research is under the microscope. Unfortunately, this new era of skepticism prematurely rushes in doubts of the ethos of science. Skepticism can lead to positive changes, but only when timely and supported by sound reasoning. Snapshot views and theories, especially those that result in costly new regulations and inefficient policies often do more harm than good. Many critics would have the reader doubt scientific integrity because they believe that the relationship between the (...) pharmaceutical industry and biomedical research poses an unavoidable and dangerous conflict of interest. However, these conflicts are neither unavoidable nor dangerous per se. (shrink)

Purpose– This paper aims to consider selected results from the Arts and Humanities Research Council -funded “Managing Access to the internet in Public Libraries” project, from 2012-2014. MAIPLE has explored the ways in which public library services manage use of the internet connections that they provide for the public. This included the how public library services balance their legal obligations and the needs of their communities in a public space and the ethical dilemmas that arise.Design/methodology/approach– The researchers used a mixed-method (...) approach involving a review of the literature, legal analysis, a questionnaire survey and case studies in five public library authorities.Findings– UK public library services use a range of methods to regulate internet access. The research also confirms previous findings that filtering software is an ubiquitous tool for controlling access to and protecting library users from “inappropriate”, illegal and harmful internet content. There is a general, if sometimes reluctant, acceptance of filtering software as a practical tool by library staff, which seems to contrast with professional codes of ethics and attitudes in other countries. The research indicates that public library internet access will be a valued service for some time to come, but that some aspects of how public library services regulate internet access is currently managed can have socially undesirable consequences, including blocking legitimate sites and preventing users from accessing government services. Education could play a greater part in helping the general population to exercise judgement in selection of materials to view and use. This does not preclude implementing stricter controls to protect children, whilst allowing public libraries to continue providing a social good to those who are unable to otherwise participate in the digital age.Research limitations/implications– The response to the survey was 39 per cent meaning that findings may not apply across the whole of the UK. The findings of this study are compared with and supplemented by other quantitative sources, but a strength of this study is the depth of understanding afforded by the use of case studies.Originality/value– This paper provides both a quantitative and qualitative analysis of how internet access is managed in UK public libraries, including how library services fulfil their legal obligations and the ethical implications of how they balance their role in facilitating access to information with their perceived role as a safe and trusted environment for all members of their communities. The findings add to the international discussion on this issue and stimulate debate and policy making in the UK. (shrink)

The benefits of homeschooling are now protected through legalization of the practice. Most of its harms could be prevented through its responsible regulation.

We contribute to the growing literature on white fragility by examining how the distinctively emotional manifestations of white fragility (which we dub ‘emotional white fragility’) make it more difficult for white people to have constructive, meaningful thoughts and conversations about race. We claim that emotional white fragility typically involves a failure of emotion regulation, or the ability to manage one’s emotions in real time. We suggest that this lack of emotion regulation can contribute to an unjust distribution of burdens that (...) can further entrench moral damage in the context of relationships as well as help support large-scale patterns of white supremacy. Given the serious implications of emotional white fragility, we suggest a number of emotion regulation techniques that one can deploy to mitigate the potential harms wrought by emotional white fragility. (shrink)

The debate over international trade has long pitted “free trade” advocates against those who argue that particular reasons support trade restraints. The newest argument is that open trade leads to a “race to the bottom” in the regulation of health, safety, welfare, and especially labor and environmental concerns, harming the nation’s citizens and undermining national sovereignty. One predicate for this argument – that trade increases competitive pressure on domestic industry – is accurate. That, in turn, will raise the cost of (...) some national policies that otherwise would win political approval. But the remainder of the race to the bottom argument rests on assumptions about regulation, the political process, and trade that do not stand up to examination. While responses to increased international competition will vary, the effects of such competition will generally be consistent with any meaningful notion of sovereignty and also will improve national welfare judged by common economic norms.Le débat sur le commerce international a longtemps opposé les défenseurs du libre échange à ceux qui soutiennent qu’il existe des raisons particulières en faveur de barrières à l’échange. L’argument le plus récent est que le libre échange conduit à une course au “nivellement par le bas” au niveau de la réglementation de la santé, de la sécurité, du bienêtre, et plus particulièrement dans les domaines du travail et de l’environnement. Selon ses tenants, elle aurait pour conséquence de léser les citoyens de la nation et d’affaiblir la souveraineté nationale.Un présupposé de cet argument – selon lequel le commerce accroît la pression concurrentielle subie par l’industrie nationale – est fondé. A son tour cela entraînera une augmentation du coût de certaines politiques nationales qui auraient par ailleurs obtenu un assentiment politique.Mais le reste de l’argumentation du nivellement par le bas repose sur des hypothèses à propos de la réglementation, du processus politique, et du commerce qui ne résistent pas à un examen critique.Bien que les réactions à une concurrence internationale accrue varient, les effets d’une telle concurrence seront généralement cohérents avec toute notion pertinente de souveraineté et amélioreront le bien-être national tel que jugé par les normes économiques standard. (shrink)

This article compares the landscape of tobacco regulations to the landscape of gun regulations, with a focus on regulations that target youth. This article argues that guns are significantly less regulated compared to tobacco, despite the frequency with which each product causes significant harm to both self and other. Many of the specific ways tobacco is regulated can be applied analogously to firearms while plausibly surviving potential Second Amendment challenges. This article compares the regulatory landscape of tobacco and firearms (...) across six categories: minimum age for purchase, sale by unlicensed individuals, taxation, advertising, graphic warning labels, and zoning. At one time, tobacco was as central — or more so — to American culture as guns are today. However, many decades of public health advocacy led to historic tobacco regulations. Tobacco's regulatory history provides a valuable blueprint for gun regulation, despite Constitutional differences. (shrink)

The article concerns the claim of a handicapped child for having come into the world in a harmed state, called the wrongful life claim. The article first presents an analysis of the legal construction of a claim, which has to do with such aspects as the subject of the relationship of restitution and the legal conditions for restitution, including the problem of the legal protection of the good of the child, the cause and effect relationship, and the harm. The (...) conclusion of the analysis is that on the basis of current Polish law the wrongful life claim would be rejected as unfounded. After carrying out a legal analysis the article also considers problems of a philosophical nature to which the above claim gives rise, such as the problem of nonexistence, the problem of the right not to have been conceived and not to have been born, the problem of measuring the value of a human life, and the problem of procreative freedom and autonomy. At the end the author presents the ethical and social aspects of the claim, such as the promotion of a proeugenic and proabortion attitude, the stigmatization of handicapped children, discrimination on the basis of health, the change of the standard of medical services, and the issue of social care. These analyses lead to the conclusion of the necessity of establishing legal regulations that exclude the possibility of these kinds of claims. At the same time she postulates the strengthening of parental awareness and responsibility and the creation of appropriate legal and social structures to support handicapped children and their families. (shrink)

Victims of oppression are often called to let go of their anger in order to facilitate better discussion to bring about the end of their oppression. According to Amia Srinivasan, this constitutes an affective injustice. In this paper, we use research on emotion regulation to shed light on the nature of affective injustice. By drawing on the literature on emotion regulation, we illustrate specifically what kind of work is put upon people who are experiencing affective injustice and why it is (...) damaging. We begin by explaining affective injustice and how it can amount to a call for emotion regulation. Then we explain the various techniques that can be used to regulate emotions and explain how each might be harmful here. In the penultimate section of the paper, we explain how the upshot of this is that victims of affective injustice are left with a dilemma. Either they try to regulate their anger in a way that involves ignoring the fact of their oppression or they regulate it in a way that is likely to be harmful for them. Finally, we consider whether there are any good solutions to this dilemma, and how this issue opens up the possibility for further research into emotion regulation and moral philosophy. (shrink)

Many are calling for transformative food systems changes to promote population and planetary health. Yet there is a lack of research that considers whether current food policy frameworks and regulatory approaches are suited to tackle whole of food systems challenges. One such challenge is responding to the rise of ultra-processed foods (UPF) in human diets, and the related harms to population and planetary health. This paper presents a narrative review and synthesis of academic articles and international reports to critically examine (...) whether current food policy frameworks and regulatory approaches are sufficiently equipped to drive the transformative food systems changes needed to halt the rise of UPFs, reduce consumption and minimise harm. We draw on systems science approaches to conceptualise the UPF problem as an emergent property of complex adaptive food systems shaped by capitalist values and logics. Our findings reveal that current food policy frameworks often adjust or reform isolated aspects of food systems (e.g., prices, labels, food composition), but under-emphasise the deeper paradigms, goals and structures that underlie the rise of UPFs as a systems phenomenon, and its socio-ecological implications. We propose that a ‘leverage points’ framework illuminates where to intervene in food systems to generate multi-level changes, while the theory of ecological regulation highlights how to respond to complex multi-factorial problems, like the rise of UPFs, in diverse ways that respect planetary boundaries. More research is needed to better understand the transformative potential of ecological regulation to advance food systems transformation and attenuate whole of food systems challenges. (shrink)

Antimicrobial resistance (AMR) has become one of the defining challenges of the twenty-first century. Food production and farming are a key if troubling component of that challenge. Livestock production accounts for well over half of annual global consumption of antimicrobials, though the contribution of the sector to drug resistance is less clear. As a result, there is an injunction to act in advance of incontrovertible evidence for change. In this paper we engage with the role of market actors in the (...) precautionary regulation of farming practices and AMR threats. The paper takes the UK poultry sector as exemplary of an audit-led process that has, in recent years, achieved impressive reductions in antimicrobial use. Using qualitative interview data with farmers and veterinarians we chart the changing practices that have accompanied this reduction in treatments. We use this analysis to raise some cautions around audit-led systems of regulation. Audits can lock farms and animals into particular versions of farming and animal health; they can elevate harmful compensatory practices (including disinfectant uses); and they can reproduce an actuarial approach to an issue that does not fit the conventions of risk management. The paper presents the considerable successes that have been achieved over a short period of time in a livestock sector, while generating notes of caution concerning the audit-led management of livestock-related AMR threats. (shrink)

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be (...) generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals. (shrink)

Dignity is an expansive ideal, figuring in international covenants, codes of research involving human participants, and debates about decision making at the end of life. One result of this expansiveness is that human dignity can be appropriated by proponents on both sides of many issues, thereby appearing more as a rhetorical flourish than as a serious element in argumentation. However, an appreciation of narrative inquiry shows that opposing representations of dignity constitute alternative assessments of responsible action, both of which can (...) be morally reasonable. One implication is that normative disagreements, as between deathbed decisions about palliative care or euthanasia, can be expected to occur, so that the ideal of dignity should be legally expressed in a practice of supportive laissez-faire in preference to any undue regulation of dying. (shrink)