An increasing number of financial services (FS) companies are adopting solutions driven by artificial intelligence (AI) to gain operational efficiencies, derive strategic insights, and improve customer engagement. However, the rate of adoption has been low, in part due to the apprehension around its complexity and self-learning capability, which makes auditability a challenge in a highly regulated industry. There is limited literature on how FS companies can implement the governance and controls specific to AI-driven solutions. AI auditing cannot be performed (...) in a vacuum; the risks are not confined to the algorithm itself, but rather permeates the entire organization. Using the risk of unfairness as an example, this paper will introduce the overarching governance strategy and control framework to address the practical challenges in mitigating risks AI introduces. With regulatory implications and industry use cases, this framework will enable leaders to innovate with confidence. (shrink)

The increasing availability of brain data within and outside the biomedical field, combined with the application of artificial intelligence (AI) to brain data analysis, poses a challenge for ethics and governance. We identify distinctive ethical implications of brain data acquisition and processing, and outline a multi-level governance framework. This framework is aimed at maximizing the benefits of facilitated brain data collection and further processing for science and medicine whilst minimizing risks and preventing harmful use. The framework consists of (...) four primary areas of regulatory intervention: binding regulation, ethics and soft law, responsible innovation, and human rights. (shrink)

The use of Genetic Modification in food is the subject of deep political disagreement. Much of the disagreement involves different perceptions of the kinds of risks posed by pursuing GM food, and how these are to be tolerated and regulated. As a result, a primary institutional site of GM food politics is regulatory agencies tasked with risk assessment and regulation. Locating GM food politics in administrative areas of governance regimes produces unique challenges of democratic legitimacy, conventionally secured through (...) legislative channels. In particular, debate over the ends of a society’s policy on GM food inevitably continues in these institutional locations, despite conventional instrumental understandings of administrative legitimacy resting on effective application of ‘ends-means’ norms. This paper assesses the two major regulatory frameworks currently applied to GM food—the ‘precautious’ and ‘proof of harm’ approaches—and presents their respective limits in securing the procedural and substantive dimensions of the legitimacy of administrative deference in democratic societies. On the basis of these criticisms, a synthesized and emergent approach—‘experiential precaution’—is presented as having the resources to deepen the legitimacy of risk governance institutions in the case of GM food. It is characterized by deepened participatory practices of negotiated rulemaking and inclusion of further substantive requirements in approval criteria. (shrink)

In this article, a framework is suggested to deal with the analysis of global environmental risk governance. Climate Change is taken as a particular form of contemporary environmental risk, and mobilised to refine and characterize some salient aspects of new governance challenges. A governance framework is elaborated along three basic features: (1) a close relationship with science, (2) an in-built reflexivity, and (3) forms of governmentality. The UNFCCC-centered system is then assessed according to this three-tier (...) framework. While the two-first requisites are largely met, the analysis of governmentality points to some institutional weak spots. (shrink)

Risk and crisis communication (RCC) is a current ethical issue subject to controversy, mainly due to the tension between individual liberty (a core component of fairness) and effectiveness. In this paper we propose a consistent definition of the RCC process in public health emergencies (PHERCC), which comprises six key elements: evidence, initiator, channel, publics, message, and feedback. Based on these elements and on a detailed analysis of their role in PHERCC, we present an ethical framework to help design, govern (...) and evaluate PHERCC strategies. The framework aims to facilitate RCC, incorporating effectiveness, autonomy, and fairness. It comprises five operational ethical principles: openness, transparency, inclusivity, understandability, and privacy. The resulting matrix helps understanding the interplay between the PHERCC process and the principles of the framework. The paper includes suggestions and recommendations for the implementation of the PHERCC matrix. (shrink)

Under conditions of growing interconnectedness of the global economy, more and more stakeholders are exposed to risks and costs resulting from business activities that are neither regulated nor compensated for by means of national governance. The changing distribution of risks poses a threat to the legitimacy of business firms that normally derive their legitimacy from operating in compliance with the legal rules of democratic nation states. However, during the process of globalization, the regulatory power of nation states has been (...) weakened and many production processes have been shifted to states with weak regulatory frameworks where businesses operate outside the reach of the democratic nation state. As a result, business firms have to address the various legitimacy challenges of their operations directly and cannot rely upon the legitimacy of their regulatory environment. These developments challenge the dominant approach to corporate governance that regards shareholders as the only stakeholder group in need of special protection due to risks not covered by contracts and legal regulations. On the basis of these considerations, we argue for a democratization of corporate governance structures in order to compensate for the governance deficits in their regulatory environment and to cope with the changing allocation of risks and costs. By way of democratic involvement of various stakeholders, business firms may be able to mitigate the redistribution of individual risk and address the resulting legitimacy deficits even when operating under conditions of regulatory gaps and governance failure. (shrink)

We subject others and are ourselves subjected to risk all the time - risk permeates life. Despite the ubiquity of risk and its imposition, philosophers and legal scholars have devoted little of their attention to the difficult questions stimulated by the pervasiveness of risk. When we impose risk upon others, what is it that we are doing? What is risking's moral significance? What moral standards govern the imposition of risk? And how should the law (...) respond to it? This book highlights these important but neglected questions and offers novel answers to them in a systematic way, constructing a normative framework of risk imposition that draws upon a wide range of insights from diverse sources within philosophy and legal theory.Oxford Legal Philosophy publishes the best new work in philosophically-oriented legal theory. It commissions and solicits monographs in all branches of the subject, including works on philosophical issues in all areas of public and private law, and in the national, transnational, and international realms; studies of the nature of law, legal institutions, and legal reasoning; treatments of problems in political morality as they bear on law; and explorations in the nature and development of legal philosophy itself. The series represents diverse traditions of thought but always with an emphasis on rigour and originality. It sets the standard in contemporary jurisprudence. (shrink)

With the improvement of citizens’ risk perception ability and environmental protection awareness, social conflicts caused by environmental problems in large-scale construction projects are becoming more and more frequent. Traditional social risk prevention management has some defects in obtaining risk data, such as limited coverage, poor availability, and insufficient timeliness, which makes it impossible to realize effective early warning of social risks in the era of big data. This paper focuses on the three environments of diversification of stakeholders, (...) risk media, and big data era. The evolution characteristics of the social risk of environmental damage of large-scale construction projects are analyzed from the four stages of incubation, outbreak, mitigation, and regression in essence. On this basis, a social risk early warning model is constructed， and the multicenter network governance mode of social risk of environmental damage in large-scale construction projects and practical social risk prevention strategies in different stages are put forward. Experiments show that the long short-term memory neural network model is effective and feasible for predicting the social risk trend of environmental damage of large-scale construction projects. Compared with other classical models, the long short-term memory model has the advantages of strong processing capability and high early warning accuracy for time-sensitive data and will have broad application prospects in the field of risk control research. By using the network governance framework and long short-term memory model, this paper studies the environmental mass events of large-scale construction projects on the risk early warning method, providing reference for the government to effectively prevent and control social risk of environmental damage of large-scale construction project in China. (shrink)

Humanity at Risk compares diverse approaches to the theme of global threats using the tools of philosophy, critical theory, and political thought alongside more practical, socio-political observations. By defining the idea of "global risk" more specifically, Editors Innerarity and Solana, and their contributors, believe we can understand how these risks should be evaluated, predicted, and managed within the framework of democratic societies.The goal of this book is to highlight more precisely the necessity, in the face of new global (...) risks, for new governance at a national, European, and global level. (shrink)

Risk assessment is an evidence-based analytical framework used to evaluate research findings related to environmental and public health decision-making. Different routines have been adopted for assessing the potential risks posed by substances and products to human health. In general, the traditional paradigm is a hazard-driven approach, based on a monocausal toxicological perspective. Questions have been raised about the applicability of the general chemical risk assessment approach in the specific case of nanomaterials. Most scientists and stakeholders assume that the (...) current standard methods are in principle suitable, but point out that experimental aspects and practical guidelines need specific adaptations. Beyond this laboratory level, risk assessment of nanomaterials also faces a number of substantive and procedural limitations, which are intrinsically attributed to the general orthodoxy of the risk assessment concept. Moreover, the developed formalism used to organize scientific knowledge is closely interlinked with the underlying governance design and the mode of interaction between the two spheres of ‘science’ and ‘decisions’. This contribution will provide a closer look at the evolution of different institutional settings for risk assessment in the context of decision-making. Improved risk governance frameworks with different narratives, process designs and procedural elements will be compared. The question of a general principle of enhanced organization of risk assessment will be discussed taking account of the barriers of substantive and procedural limitations in the special case of nanomaterials. (shrink)

Adolescent sexuality is one of the most important reproductive health issues that confronts healthcare professionals with moral dilemmas and legal issues. In this study, we aim to justify the at-risk adolescents’ regulations on access to key reproductive health services (KRHSs) based on principles of Islamic biomedical ethics and jurisprudence. Despite the illegitimacy and prohibition of sexuality for both girls and boys in Islamic communities, in this study, using 5 principles or universal rules of purpose; certainty, no-harm; necessity; and custom, (...) we argue that first, applying these principles in the context of the no-harm principle can provide the best interests of at-risk adolescents; second, it is permissible to provide KRHSs to these adolescents with their own assent, as long as necessary, only with the intention of preventing or reducing harm. In this framework, while preventing harm, it tries to provide the best interests of at-risk adolescent. Thus, the principle of no-harm requires that the government, by designating the responsibility to healthcare professionals, protects at-risk adolescents from harm, and obliges these professionals to choose and implement the option that best suits adolescents’ interests. (shrink)

This article explores the links between strategic goals, enterprise risk management, and ethics. We offer a typology of managerial attitudes toward strategic goals and rationality and explore the interaction between strategic and ethical decision making. In so doing, we offer a practical framework for managers to approach ethical dilemmas in the highly complex, volatile, and risky economy that we currently find ourselves in.

This paper examines regulatory responses to the presence of previously undetected and unlabelled nanoparticles in the Australian food system. Until 2015, the Australian regulatory body Food Standards Australia New Zealand denied that nanoparticles were present in Australian food. However, and despite repeated claims from Australia’s food regulator, research commissioned by civil society group Friends of the Earth has demonstrated that nanoparticles are deliberately included as ingredients in an array of food available for sale in Australia. This paper critically examines how (...) nanoparticles have come to be integrated into Australia’s food system under the radar of Australia’s food regulator. Our case study of FSANZ—including its responses to the civil society-led science that determined the existence of nanoparticles in Australian food—raises a number of important questions about the governance of risk in relation to emerging technologies such as nanotechnology. In this paper, we argue that FSANZ’ response to the presence of nanotechnology in Australia’s food system is an example of ‘governing with ignorance’. This is demonstrated via the denial and dismissal of science claims as a basis for limited regulatory intervention. FSANZ’ response intersects with the centrality of commercial interests in shaping science research and commercialisation, alongside the ‘hands off’ approach to regulation that is characteristic of neoliberal governance approaches. We conclude by arguing that in the current food governance framework, and alongside a paucity of impact science, civil society plays a vital role in attempts to democratise the Australian food system. (shrink)

There is interest in more and better interaction between civil society and actors developing nanotechnologies, nano-materials and nano-enabled products: government agencies but also branch organizations in the chemical sector position civil society organizations (CSOs) as ‘voices of civil society’, and invite CSOs to participate in multistakeholder events. In such events, CSOs are expected to articulate societal needs, issues and values so that these can be taken up by actors with institutional roles and mandates to develop and embed newly emerging nanosciences (...) and nanotechnologies (NEST). This article argues that such a division of moral labor between CSOs and nanotechnology actors is not productive to address NEST and its emerging societal issues. There is an assumption that societal issues are ‘out there’ and can be recognized by CSOs, while in fact, societal issues might co-evolve with new development trajectories and thus have to be discovered and articulated. More productive deliberation requires, ideally, overcoming the traditional division of moral labor between these two groups of actors: technology developers should also inquire into and articulate emerging societal issues, and CSOs should inquire into and reflect on actual development trajectories. In order to explore issues and repercussions that arise in such a repositioning, this article will discuss a bottom up experiment of such an interaction between a nanotechnology developer (DuPont) and a CSO (Environmental Defense Fund). Based on the empirical analysis of this bottom up experiment, tentative requirements will be developed for how joint inquiries between technology developers and CSOs can be realized on a larger scale in our society. (shrink)

Risk analysis as a regulatory driver has now become firmly entrenched in public health and environmental protection. Risk analysis at any level essentially has to accommodate two gut feelings of the constituency: whether society should be risk-prone or risk averse, and whether government and its institutions can be trusted to make the necessary decisions with a high or a low degree of discretion. The precautionary principle (or rejection thereof) arguably is the ultimate reflection of the promotion (...) of risk to a societal value. There is no doubt that especially amongst the representatives of the Member States (as opposed to the officials at the European Commission), public (pre)caution with respect to the long-term environmental and public health implications of gene technology influenced the reluctance to allow marketing of GM foods and feeds until a strict regulatory regime had been rolled out. Industry would argue that the delay in regulation, as well as the eventual regime was of such a nature as to stifle the technology. This contribution reviews a number of features of standard EU risk analysis decisions, so as to assess its current propensity towards smothering rather than smoothing the introduction of new technology. The current development of a regulatory framework for nanotechnology serves as a case study. (shrink)

When comparing both GDP loss and mortality across countries, it appears that countries that have managed to save more lives during the Covid-19 pandemic have also managed to save their economies better. What accounts for these stark differences in country performances? In this article, we argue that a salient feature of economic and health performance is the degree of trust populations have in their governments. We set up a heuristic analytical framework that models this relation, under particular assumptions about what (...) drives government and individual behavior, in order to better understand the mechanisms that may be at work. We identify three key roles that trust in government may play in enforcing social distancing policies, conveying credible information for individual decision-making, and shaping government attitudes towards risk. We argue that these implications are consistent with the empirical evidence. We also discuss the relevance of other forms of trust, namely, interpersonal trust and trust in science. (shrink)

This paper discusses the relationship between obesity, law, and public health preparedness as well as the relevant roles of public health practitioners, policymakers, and lawyers. Each group believes they have a unique role in this relationship although there can be overlap and/or lack of clarity as to what that role may be.The role of the lawyer in the public policy process is to identify relevant legal issues, to analyze them and give advice on the risks of taking a given action, (...) and to communicate legal advice in a clear manner. Simply put, the lawyer’s role is to dive deep into the law surrounding the topic at hand and to offer advice regarding the permissible limits of policymakers’ options and the associated risks. (shrink)

This paper discusses the relationship between obesity, law, and public health preparedness as well as the relevant roles of public health practitioners, policymakers, and lawyers. Each group believes they have a unique role in this relationship although there can be overlap and/or lack of clarity as to what that role may be.The role of the lawyer in the public policy process is to identify relevant legal issues, to analyze them and give advice on the risks of taking a given action, (...) and to communicate legal advice in a clear manner. Simply put, the lawyer’s role is to dive deep into the law surrounding the topic at hand and to offer advice regarding the permissible limits of policymakers’ options and the associated risks. (shrink)

With the proliferation of private standards many significant decisions regarding public health risks, food safety, and environmental impacts are increasingly taking place in the backstage of the global agro-food system. Using an analytical framework grounded in political economy, we explain the rise of private standards and specific actors – notably supermarkets – in the restructuring of agro-food networks. We argue that the global, political-economic, capitalist transformation – globalization – is a transition from a Fordist regime to a regime of flexible (...) accumulation (Harvey, 1989). We also argue that the standard making process of this new regulatory regime is increasingly moving from the front stage – where it is open to public debate and democratic decision-making bodies – to the backstage – where it is dominated by large supermarket procurement offices. We assert that transnational supermarket chains are increasingly controlling what food is grown where, how, and by whom. We also contend that the decision-making processes of transnational supermarket chains are typically “black-boxed.” The Euro-Retailer Produce Working Group (EUREP) is presented as a case of private governance by transnational supermarket chains. We conclude by examining the limitations and long-term efficacy of a system of private governance in the global agro-food system. (shrink)

In light of the World Anti Doping Agency’s 2013 Code Revision process, we critically explore the applicability of two of three criteria used to determine whether a method or substance should be considered for their Prohibited List, namely its (potential) performance enhancing effects and its (potential) risk to the health of the athlete. To do so, we compare two communities of human guinea pigs: (i) individuals who make a living out of serial participation in Phase 1 pharmacology trials; and (...) (ii) elite athletes who engage in what is effectively ‘unregulated clinical research’ by using untested prohibited or non-prohibited performance enhancing substances and methods, alone or in combination. Our comparison sheds light on norms of research ethics that these practices exacerbate with respect to the concepts of multiplicity, visibility, and consistency. We argue for the need to establish a proper governance framework to increase the accountability of these unregulated research practices in order to protect the human guinea pigs in elite sports contexts, and to establish reasonable grounds for the performance enhancing effects, and the risks to the health of the athlete, of the methods and substances that might justify their inclusion on the Prohibited List. (shrink)

This article examines whether and how the participation of women in the firm’s board of directors and senior management enhances financial performance. We use the Fama and French (1992, 1993) valuation framework to take the level of risk into consideration, when comparing firm performances, whereas previous studies used either raw stock returns or accounting ratios. Our results indicate that firms operating in complex environments do generate positive and significant abnormal returns when they have a high proportion of women officers. (...) Although the participation of women as directors does not seem to make a difference in this regard, firms with a high proportion of women in both their management and governance systems generate enough value to keep up with normal stock-market returns. These findings tend to support the policies currently being discussed or implemented in some countries and organizations to foster the advancement of women in business. (shrink)

Institute a proactive reputational management framework that matches individual behaviour to organizational values The Business Ethics Twin-Track is a practical guide to reputational risk management. A deep exploration of the concept of reputation, the ways in which it can suffer, and the consequences when it does, the book outlines an ethics controls framework that can mitigate risk and improve business performance. Readers will learn how to identify and manage weaknesses, and how to institute a system of governance (...) that embeds proper, ethical conduct into the corporate culture. A clear set of controls and procedures provides actionable instruction that can be customised to suit the organisational structure, and discussion of historical and international ethics provides the context for implementation. Case studies illustrate the real-world applications, while interviews with executives from a variety of sectors provide important practical insights into some of the key issues discussed in the book. The law regulates behaviour in health and safety and financial crime, but otherwise, conduct is largely determined by the culture, ethics and values of an organisation. Effective reputation management is complex, and often difficult to achieve, as much of the available information on the topic is more theoretical than practical. This book bridges the gap by providing the tools that will help managers to: Implement a modern ethics control framework, encompassing codes, officers, reporting lines and training Consider the role of the media and social media in reputational damage to individuals and organisations Analyse the key controls in responsibility and governance frameworks from around the world Determine the causes and controls of conduct risk, including incompetence, negligence and criminality Today's fast-paced media environment means corporate reputations can be obliterated in moments, and damage limitation is often too little, too late. Adopting the measures set out in this book will embed ethics into the culture, and match people's behaviours to the organisation's values. (shrink)

Prior to its election to office in 2007, the Australian Labor Party announced a commitment to introduce Trade Training Centres (TTCs) into all Australian secondary schools as an initiative of its Education Revolution. TTCs were proposed as a key element of Federal Labor's education and training policy that aimed to manage future risks to Australia's competitiveness in the emerging global economy and to support school-to-employment transitions for young people. This analysis adopts a governmentality framework to conceptualise the Federal Government's introduction (...) of TTCs alternatively as a key strategy for nationalising social investment politics in Australia. The paper draws on recent Australian policy documents to argue that TTCs are social technologies that work to open up social spaces in and around schools for governing relationships between schools and other community stakeholders, particularly businesses and families. The paper concludes by examining policy implications, including those of social justice, for promoting school community partnerships through TTCs. (shrink)

The Author presents the theoretical framework of the special issue on the fear of nature. The main goal of the essays in the special issue is reflecting on catastrophe and on its perception within the areas of contemporary human and social sciences; that is, revising the specific forms of the relationship between man, nature, society, as well as the relationship risk-fear-security, between society and government.

This paper discusses the establishment of a governance framework to secure the development and deployment of “good AI”, and describes the quest for a morally objective compass to steer it. Asserting that human rights can provide such compass, this paper first examines what a human rights-based approach to AI governance entails, and sets out the promise it propagates. Subsequently, it examines the pitfalls associated with human rights, particularly focusing on the criticism that these rights may be too Western, (...) too individualistic, too narrow in scope and too abstract to form the basis of sound AI governance. After rebutting these reproaches, a plea is made to move beyond the calls for a human rights-based approach, and start taking the necessary steps to attain its realisation. It is argued that, without elucidating the applicability and enforceability of human rights in the context of AI; adopting legal rules that concretise those rights where appropriate; enhancing existing enforcement mechanisms and securing an underlying societal infrastructure that enables human rights in the first place, any human rights-based governance framework for AI risks falling short of its purpose. (shrink)

COVID-19 vaccines are likely to be scarce for years to come. Many countries, from India to the U.K., have demonstrated vaccine nationalism. What are the ethical limits to this vaccine nationalism? Neither extreme nationalism nor extreme cosmopolitanism is ethically justifiable. Instead, we propose the fair priority for residents framework, in which governments can retain COVID-19 vaccine doses for their residents only to the extent that they are needed to maintain a noncrisis level of mortality while they are implementing reasonable public (...) health interventions. Practically, a noncrisis level of mortality is that experienced during a bad influenza season, which society considers an acceptable background risk. Governments take action to limit mortality from influenza, but there is no emergency that includes severe lockdowns. This “flu-risk standard” is a nonarbitrary and generally accepted heuristic. Mortality above the flu-risk standard justifies greater governmental interventions, including retaining vaccines for a country's own citizens over global need. The precise level of vaccination needed to meet the flu-risk standard will depend upon empirical factors related to the pandemic. This links the ethical principles to the scientific data emerging from the emergency. Thus, the FPR framework recognizes that governments should prioritize procuring vaccines for their country when doing so is necessary to reduce mortality to noncrisis flu-like levels. But after that, a government is obligated to do its part to share vaccines to reduce risks of mortality for people in other countries. We consider and reject objections to the FPR framework based on a country: having developed a vaccine, raising taxes to pay for vaccine research and purchase, wanting to eliminate economic and social burdens, and being ineffective in combating COVID-19 through public health interventions. (shrink)

The precautionary principle (PP) is fundamentally a claim that acting to avoid and/or mitigate threats of serious harm should be accorded high priority in public policy. Over the last three decades, governments and international bodies have endorsed it in principle, and some of them have incorporated it into some areas of policy practice. Yet, PP is controversial in policy circles, public discussion and scholarly discourse. Here the PP literature is reviewed from the perspective of economics, where the tendency is to (...) see theory and methods for rational decision-making under risk and uncertainty as well-established and risk management tools as well developed, and to view the PP with some circumspection. Following a brief introduction to PP concepts, history, applications, and controversies, I review and critique the standard economic approach to decision-making and risk management (here labeled ordinary risk management, ORM), identifying areas of incompleteness especially in the treatment of disproportionate and asymmetric threats. After reviewing some of the more prominent PP controversies in the scholarly literature, I suggest a conceptual framework for a PP that may withstand the major criticisms levied against the PP and make a unique and valid contribution to a decision and risk management arsenal that includes ORM. The framework relates the nature of the threat, the evidence, and the remedy indicated; and each of these elements is discussed in some detail. The scope of this PP is identified in general terms and distinguished from the quantity restrictions and regulatory safety margins that often serve as practical heuristics when ORM-based policies are implemented. Because the PP is clearly identified as a principle, I discuss the role of principles in policy design and implementation, and conclude with some suggestions as to how this PP could guide policy and management. (shrink)

Current research on corporate social responsibility (CSR) illustrates the growing sense of discord surrounding the ‘business of doing good’ (Dobers and Springett, Corp Soc Responsib Environ Manage 17(2):63–69, 2010). Central to these concerns is that CSR risks becoming an over-simplified and peripheral part of corporate strategy. Rather than transforming the dominant corporate discourse, it is argued that CSR and related concepts are limited to “emancipatory rhetoric…defined by narrow business interests and serve to curtail interests of external stakeholders.” (Banerjee, Crit Sociol (...) 34(1):52, 2008). The paper addresses gaps in the literature and challenges current thinking on corporate governance and CSR by offering a new conceptual framework that responds to the concerns of researchers and practitioners. The limited focus of existing analyses is extended by a holistic approach to corporate governance and social responsibility that integrates company, shareholder and wider stakeholder concerns. A defensive stance is avoided by delineating key stages of the governance process and aligning profit centred and social responsibility concerns to produce a business-based rationale for minimising risk and mainstreaming CSR. (shrink)

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in (...) the nanomedicine translation arena. (shrink)

Despite their growing usage in commercial and industrial applications, nanomaterials have yet to be been thoroughly researched as to their potential health, safety, and environmental risk to human life after incorporation into new product improvement, development, design, and manufacturing processes. Identifying the appropriate governance framework for effective risk assessment analysis of toxicological risk to human beings—specifically manufacturing employees and consumers—and other living organisms, resulting from the development and application of these nanotechnology-based products, has yet to be (...) scientifically determined. With major regulatory gaps in the public regulation framework at national and international levels of governance, a proposed private governance framework is needed to assist the existing public regulatory framework with the proliferation of products and manufacturing processes utilizing nanomaterials. There are three distinct (yet complimentary) approaches available to develop a private governance framework to complement existing national public regulatory frameworks: responsible innovation, risk management, and voluntary guidelines/industry standards. The case for supporting a hybrid governance framework, combining public and private governance mechanisms, for nanotechnology is reflective of the current public policy environment that has emerged to best address health, safety, and environmental risk assessment issues concerning nanotechnology and nanomaterials. (shrink)

The governance of pharmaceutical medicines entails complex ethical decisions that should, in theory, be the responsibility of democratically accountable government agencies. However, in many Low- and Middle-Income Countries (LMICs), regulatory and health systems constraints mean that many people still lack access to safe, appropriate and affordable medication, posing significant ethical challenges for those working on the “front line”. Drawing on 18 months of fieldwork in Ghana, we present three detailed case studies of individuals in this position: an urban retail (...) pharmacist, a rural over-the-counter medicine retailer, and a local inspector. Through these case studies, we consider the significant burden of “ethical labour” borne by those operating “on the ground”, who navigate complex moral, legal and business imperatives in real time and with very real consequences for those they serve. The paper ends with a reflection on the tensions between abstract, generalised ethical frameworks based on high-level principles, and a pragmatic, contingent ethics-in-practice that foregrounds immediate individual needs – a tension rooted in the gap between the theory and the reality of pharmaceutical governance that shifts the burden of ethical labour downwards and perpetuates long-term public health risks. (shrink)

This article draws on research undertaken by the authors as part of the Administrative Data Research Centre in England. Between 2014 and 2017, we conducted four case studies on government administrative data for education, transport, energy and health. The purpose of the research was to examine stakeholder perspectives about the sharing, linking and re-use of government administrative data. In relation to the role and nature of consent given by data subjects for re-use, our study revealed significant variations in data provider (...) and researcher attitudes. Although our study setting was England, we believe that the findings have wider resonance. Our analysis identified six factors which might account for the variations around consent: the specificities of the legislative framework governing the collection and processing of particular data; the type of data being collected and the relational context in which it is created; the broader information governance framework in which the data resides; the creating organization's approach to data release; the relative levels of risk aversity within the creating organization; and public perceptions and social attitudes. In conclusion, we consider whether consent is still the best mechanism available for data re-use, or whether a social contract model of data sharing should be developed. (shrink)

It is perhaps not coincidental that, at the same time the apparent institutional risks associated with the conduct of human research are increasing, so are the complaints from researchers about research ethics committees. Rather than seeking to implement systems that more efficiently catch wrong-doing, in 2003 Griffith University began implementing an alternative approach. This new approach focused on resourcing the reflective practice of researchers through every stage of their work — well before, and long after, they seek ethical clearance for (...) that work. Institutions have a key role to play in human research ethics, and this can be usefully situated within the broader framework of the institution’s governance framework. This paper summarises the new approach that Griffith University adopted in 2003, the implementation of this ‘model’, the experience to date, and the road ahead. (shrink)

This article focuses on key roles that the ill-defined concept of ‘public benefit’ plays in accessing the public health data held by the UK’s National Health Service. Using the concept of the ‘trade-off fallacy’, this article argues that current data access and governance structures, based on particular construals of public benefit in the context of public health data, largely negate the possibility of effective control by individuals over future uses of personal health data. This generates a health data version (...) of the trade-off fallacy that enables widespread involvement of commercial actors in personal data, despite public concerns over commercial involvement in, and potential exploitation of, public health data. The article suggests that, despite ostensibly robust regulatory and governance structures, this publicly held data is potentially subject to similar logics of accumulation as seen elsewhere in the digital economy, highlighting the inadequacies of current data regulatory frameworks in the digital era. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues relating (...) to the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

Background The ownership status of individual-level health data affects the manner in which it is used. In this paper we analyze two competing models of the ownership status of the data discussed in the literature recently: private ownership and public ownership. Main body In this paper we describe the limitations of these two models of data ownership with respect to individual-level health data, in particular in terms of ethical principles of justice and autonomy, risk mitigation, as well as technological, (...) economic, and conceptual issues. We argue that undifferentiated application of neither private ownership nor public ownership will allow us to resolve all the problems associated with effective, equitable, and ethical use of data. We suggest that, instead of focusing on data ownership, we should focus on the institutional and procedural aspects of data governance, such as using Data Access Committees (DACs) or equivalent managed access processes, which can balance the elements of these two ownership frameworks. Conclusion Undifferentiated application of the ownership concept (private or public) is not helpful in resolving problems associated with sharing individual-level health data. DACs or equivalent managed access processes should be an integral part of data governance. They can approve or disapprove data access requests after considering the potential benefits and harms to data subjects, their communities, primary researchers, and the wider society. (shrink)

Although the concept of “AI governance” is frequently used in the debate, it is still rather undertheorized. Often it seems to refer to the mechanisms and structures needed to avoid “bad” outcomes and achieve “good” outcomes with regard to the ethical problems artificial intelligence is thought to actualize. In this article we argue that, although this outcome-focused view captures one important aspect of “good governance,” its emphasis on effects runs the risk of overlooking important procedural aspects of (...) good AI governance. One of the most important properties of good AI governance is political legitimacy. Starting out from the assumptions that AI governance should be seen as global in scope and that political legitimacy requires at least a democratic minimum, this article has a twofold aim: to develop a theoretical framework for theorizing the political legitimacy of global AI governance, and to demonstrate how it can be used as a compass for critially assessing the legitimacy of actual instances of global AI governance. Elaborating on a distinction between “governance by AI” and “governance of AI” in relation to different kinds of authority and different kinds of decision-making leads us to the conclusions that much of the existing global AI governance lacks important properties necessary for political legitimacy, and that political legitimacy would be negatively impacted if we handed over certain forms of decision-making to artificial intelligence systems. (shrink)

Concussion in professional football is a topic that has generated a significant amount of interest for many years, partly due in recent times to the filing of the class-action litigation and the uncapped compensation injury fund and settlement involving 4,500 retired professional players and the National Football League. The proceedings claimed that the NFL, as the governing body of American football, failed in its duty to protect players’ health during their professional playing careers by exposing players to risks of repetitive (...) concussions and actively concealing links to potential long-term consequences. The NFL litigation sharpened the focus on the fundamental regulatory, governance and ethical considerations for football governing bodies, as self-regulated organisations, when governing the delicate balance between the dynamics of contact and collision sports, entertainment and player-health considerations. It also raised questions about public accountability and responsibilities to all levels of the sport through a framework of public health ethics. The NFL litigation and Congressional hearings have led to changes within the NFL and its regulatory and governance responses. A case study of the NFL responses to concussion in the sport of American football can provide insight into concussion regulation. Australian football governing bodies can align their regulatory and governance responses to concussion within their sports with the aim to avoid similar accusations, and circumvent a more coercive form of intervention. (shrink)

In order to understand how the environment influences business owner/managers’ attitudes towards tax morale, we build a theoretical model based on a neo-institutionalist framework. Our model combines three complementary perspectives on institutions—normative, cultural–cognitive and regulatory–instrumental. This enables a broader understanding of factors that influence business owner–managers’ attitudes towards tax evasion. We test the resulting hypotheses using regression analysis on survey data on business owner/managers in Latvia—a transition country, which has undergone massive institutional changes since it was part of the Soviet (...) Union over 25 years ago. We find that legitimacy of the tax authorities and the government, feeling of belonging to the nation and perceptions of the risk and severity of punishment are all associated with higher tax morale for business owners and managers. (shrink)

Purpose This study aims to identify and analyse the issues faced by internet-based small businesses in developing countries regarding cybersecurity and document how these businesses address the risks. Design/methodology/approach This study used the qualitative method. Respondents were internet-based small businesses selected by using theoretical sampling. Data were collected by using interviews and observations. The validity of the analysis was ensured by using triangulation and member checking. Findings This study reveals that small businesses managed to identify the loss of physical and (...) monetary assets as possible damage. However, only a few businesses identified loss of intangible assets as possible cyber risks. Most small businesses had used basic cybersecurity measures to protect data access and some primary business activities. Unfortunately, they rarely take initiatives in preventing and early detecting cyber risks. Research limitations/implications Findings of this study cannot be generalised as it aims to obtain new insights and document unexplored findings. Thus, if this study’s findings are going to be generalised, it is necessary to conduct an additional study. Secondly, this study did not assess how far small business had fulfilled the relevant information security framework as assessment required additional research, and this study only aimed to map the current situation in small businesses. Practical implications This study emphasised the importance of identifying valuable assets or resources when implementing cybersecurity measures. Focusing on security measures to protect identified assets from cyber risk will make the efforts more efficient and effective than using standardised cybersecurity measures. Third-party developers can also use this study to understand small businesses’ current cybersecurity implementation and their characters to design online platforms that suit these needs. Governments can also design educational activities that address small businesses’ lack of knowledge. Originality/value Most studies which focus on small businesses and information technology usually only discuss how they use IT. This study also brings new contributions by focusing on developing countries and specifically addresses internet-based technology cyber risk faced by e-commerce businesses. The qualitative method is used as most studies in e-commerce adoption were positivistic in nature, and inductive-based studies were rarely found on the topic. (shrink)

It has become almost a truism to describe the interaction between research ethics committees and researchers as being marred by distrust and conflict. The ethical conduct of researchers is increasingly a matter of institutional concern because of the degree to which non-compliance with national standards can expose the entire institution to risk. This has transformed research ethics into what some have described as a research ethics industry. In an operational sense, there is considerable focus on modifying research behaviour through (...) a combination of education and sanctions. The assessment of whether a researcher is ethical is too often based on whether they submit their work for review by an ethics committee. However, is such an approach making a useful contribution to the actual ethical conduct of research and the protection of the interests of participants? Does a focus on ethical review minimise institutional risk? Instead it has been suggested that ethics committees may be distorting or frustrating useful research and are promoting a culture of either mindless rule following or frustrated resistance. An alternative governance approach is required. There is a need for a strong institutional focus on promoting and supporting the reflective practice of researchers through every stage of their work. By situating research ethics within the broader framework of institutional governance, this paper suggests it is possible to establish arrangements that actually facilitate excellent and ethical research. (shrink)

The United Nations ‘Protect, Respect and Remedy’ Framework,developed by the U.N. Special Representative JohnRuggie, brings together social expectations and law into anemerging policy framework of direct relevance to corporate social responsibility, CSR. The principle source of the Framework’s significance for the policy and practice of CSR is its definition of the theory of business responsibility for human rights as arising from business activities and relationships, and its deployment of due diligence for human rights risk as the core operational concept (...) of this theory of responsibility. The article considers the responsibility to respect human rights in light of theories about polycentric regulatory regimes and draws the conclusion that the Ruggie Framework creates a regulator dynamic in which both voluntarism and law have relevant and reinforcing roles to play in governing business behavior. In the wake of the adaptation of the Framework by the UN, the challenge for the field of CSR will be to adapt to an emerging reality in which business responsibility for ‘the social’ is increasingly a question of compliance and beyond. (shrink)

Environmental, Social, and Governance criteria are now considered significant, global non-financial evaluating factors of corporate value. However, no attention is given to what influences the integration of ESG information by individual investors in their investment decisions. This study first identifies different types of information investors use to make investment decisions. Risks identified in information integration in investment decision making is reviewed. Next, the Unified Theory of Acceptance and Use of Technology model is used to identify individual investors’ investment tendencies (...) and the factors affecting integration of ESG information into investment decisions. Each of four categories for UTAUT innovation adoption factors are discussed in relation to how they affect individual investors’ integration of ESG information. Standardization of ESG reporting and evaluation frameworks would reduce efforts to adopt ESG information and could build a strong foundation for facilitating ESG information integration. Corporates’ efforts to further communicate their ESG management through their investor relations and active governmental well as non-governmental organizations’ participation are recommended. (shrink)

Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of (...) information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs. (shrink)

Synthetic biology has generated extensive discussion about a wide range of risks and potential benefits, the intrinsic value of the technology, and the soci­etal distribution of its risks and benefits. However, be­fore these questions can be resolved, it is important to first ask a critical question: Is synthetic biology different enough from the technologies that came before it that it raises new questions or concerns? By putting synthetic biology into context, we gain a better understanding of the issues, both old (...) and new, that it raises. We can then consider practical governance questions, including ways to improve current practices. (shrink)

In recent years, companies receive pressure to release environmental, social, and governance disclosure, since these are perceived as critical issues by society. Despite this pressure, ESG disclosure practices considerably vary by firm. Prior academic literature investigated country- and firm-level factors determining such variation, alternatively adopting the institutional and legitimacy theory. By combining these theories in a unique framework, this study investigates the extent to which social structures and social legitimization influence ESG disclosure practices and each pillar. Results obtained using (...) a cross-country sample of 14,174 firm-year observations during 2005–2012 provide evidence that country-level characteristics such as a political system, labor system, and cultural system significantly affect firms’ ESG disclosure practices. However, their impact is heterogeneous in that they either reduce or enhance disclosure levels and may differ by pillar. Results for firm-level characteristics related to a firm’s visibility demonstrate a positive and homogeneous effect on ESG disclosure and each pillar. These results inform policy makers and regulators aiming to enhance ESG disclosure levels of the risk they incur when managing variables related to social structure and the benefits of exposing firms to higher visibility. (shrink)

Our exploratory study considers whether the internal audit function is an efficient “third line of defense” for risk management and control as proposed by The Institute of Internal Auditors. To that end, we interview chief audit executives and experienced internal auditors to examine whether CAEs manage the impressions of audit committee members in the annual accountability process. We also provide an illustration of impression management techniques through a documentary case that explores a unique and exclusive dataset consisting of the (...) main guidance, framework, and accountability documents of one of these organizations. Our analysis highlights how several macro- and microimpression management techniques were used to burnish the image of internal auditors and, more importantly, the management team. Rather than monitoring managers, the CAEs team up with them. Our findings cast doubts on the conceptualization of internal audit as the independent third line of defense envisioned to be a keystone of the governance mosaic. This study supports other research that questions the effectiveness of internal auditing as a governance mechanism. It also contributes to the impression management literature by exposing impression management practices that occur through a private reporting channel—the internal audit function’s annual accountability to the audit committee. Last but not least, significant ethical concerns are raised in regard to internal audit, and research is urged in that area. (shrink)

BackgroundResearch has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore (...) if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance.MethodsWe conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research.Results10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review.ConclusionLA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies. (shrink)

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to (...) keep this “essential industry” producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry’s implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities. (shrink)

Anticipation is one of the main goals of new governance models, such as Responsible Research and Innovation. However, there is not a single mode of anticipation in this model. Two approaches can be addressed within the RRI framework: a socio-empirical one, which tends to underline the role of the democratic processes, aimed at identifying values on which governance needs to be anchored ; and a normative one, which stresses the role of EU goals as ‘normative anchor points’ in (...) governance. These two approaches also address two different models of anticipation: one based on the construction of shared pathways for reflexivity on the purposes of innovation, the other based on the progressive implementation of constitutional goals in risk assessment and management tools. However, both can be deemed partially unsatisfactory from the standpoint of human rights since one puts individual rights in the middle of the ‘values lottery’ where any participatory process ultimately leads; the other can be inadequate since fundamental rights are balanced alongside other goals and thus can be sacrificed, exposing the system to possible adverse court decisions. The normative framework of human rights can help to counterbalance both models aimed at maximising inclusion and those aimed at pursuing constitutional normative principles at the basis of technologically advanced societies, strengthening their dimension of anticipation according to a rights-based perspective. (shrink)