The primary responsibility of the US Food and Drug Administration is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified food. The FDA describes its regulatory review of GM food as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the FDA’s (...) policy stance on GM food is shaped by neoliberal considerations. The agency’s review of a genetically engineered animal, the AquAdvantage salmon, is used as a case study to track the influence of neoliberalism on its regulatory review protocol. After that, an epistemic argument justifying public engagement in the risk assessment of new GM food is outlined. It is because risk evaluations involve normative judgments, in a democracy, layperson representatives of informal epistemic communities that could be affected by a new GM food should have the opportunity to decide the ethical, political or other normative questions that arise during the regulatory review of that entity. (shrink)

Violence risk assessment tools are increasingly used within criminal justice and forensic psychiatry, however there is little relevant, reliable and unbiased data regarding their predictive accuracy. We argue that such data are needed to (i) prevent excessive reliance on risk assessment scores, (ii) allow matching of different risk assessment tools to different contexts of application, (iii) protect against problematic forms of discrimination and stigmatisation, and (iv) ensure that contentious demographic variables are not prematurely removed (...) from risk assessment tools. (shrink)

This paper discusses ethical issues surrounding Integrated Assessment Models (IAMs) of the economic effects of climate change, and how climate economists acting as policy advisors ought to represent the uncertain possibility of catastrophe. Some climate economists, especially Martin Weitzman, have argued for a precautionary approach where avoiding catastrophe should structure climate economists’ welfare analysis. This paper details ethical arguments that justify this approach, showing how Weitzman’s “fat tail” probabilities of climate catastrophe pose ethical problems for widely used IAMs. The (...) main claim is that economists who ignore or downplay catastrophic risks in their representations of uncertainty likely fall afoul of ethical constraints on scientists acting as policy advisors. Such scientists have duties to honestly articulate uncertainties and manage (some) inductive risks, or the risks of being wrong in different ways. (shrink)

In this paper, we distinguish between different sorts of assessments of algorithmic systems, describe our process of assessing such systems for ethical risk, and share some key challenges and lessons for future algorithm assessments and audits. Given the distinctive nature and function of a third-party audit, and the uncertain and shifting regulatory landscape, we suggest that second-party assessments are currently the primary mechanisms for analyzing the social impacts of systems that incorporate artificial intelligence. We then discuss two kinds of (...) as-sessments: an ethical risk assessment and a narrower, technical algo-rithmic bias assessment. We explain how the two assessments depend on each other, highlight the importance of situating the algorithm within its particular socio-technical context, and discuss a number of lessons and challenges for algorithm assessments and, potentially, for algorithm audits. The discussion builds on our team’s experience of advising and conducting ethical risk assessments for clients across dif-ferent industries in the last four years. Our main goal is to reflect on the key factors that are potentially ethically relevant in the use of algo-rithms, and draw lessons for the nascent algorithm assessment and audit industry, in the hope of helping all parties minimize the risk of harm from their use. (shrink)

Algorithmic risk assessment tools, such as COMPAS, are increasingly used in criminal justice systems to predict the risk of defendants to reoffend in the future. This paper argues that these tools may not only predict recidivism, but may themselves causally induce recidivism through self-fulfilling predictions. We argue that such “performative” effects can yield severe harms both to individuals and to society at large, which raise epistemic-ethical responsibilities on the part of developers and users of risk (...) class='Hi'>assessment tools. To meet these responsibilities, we present a novel desideratum on algorithmic tools, called explainability-in-context, which requires clarifying how these tools causally interact with the social, technological, and institutional environments they are embedded in. Risk assessment practices are thus subject to high epistemic standards, which haven't been sufficiently appreciated to date. Explainability-in-context, we contend, is a crucial goal to pursue in addressing the ethical challenges surrounding risk assessment tools. (shrink)

Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks (...) biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place. (shrink)

Over the past year, technology companies have made headlines claiming that their artificially intelligent (AI) products can outperform clinicians at diagnosing breast cancer, brain tumours, and diabetic retinopathy. Claims such as these have influenced policy makers, and AI now forms a key component of the national health strategies in England, the United States, and China. While it is positive to see healthcare systems embracing data analytics and machine learning, concerns remain about the efficacy, ethics, and safety of some commercial, (...) AI health solutions. This paper argues that improved regulation and guidance is urgently required to mitigate risks, ensure transparency and best practice, Without this, patients, clinicians, and other stakeholders cannot be assured of an app’s efficacy, and safety. (shrink)

If states are permitted to create and maintain a military force, by what means are they permitted to do so? This paper argues that a theory of just recruitment should incorporate a concern for moral risk. Since the military is a morally risky profession for its members, recruitment policies should be evaluated in terms of how they distribute moral risk within a community. We show how common military recruitment practices exacerbate and concentrate moral risk exposure, using the (...) UK as a case study. We argue that the British state wrongs its citizens by subjecting them to excessively morally risky recruitment practices. Since, we argue, this risk exposure cannot be justified by appealing to the benefits of a military career for recruits, our argument calls for reform of existing practices. Our method of evaluation is generalizable and thus can be used to assess other states’ practices. (shrink)

The paper explores how the framework of systemic risks can help govern the risks imposed through solar climate engineering research. The central argument is that a systemic perspective of risk is a useful tool for analysing and assessing the risks imposed through Stratospheric Aerosol Injection (SAI) research. SAI is a form of climate engineering that could cool the planet by enhancing its albedo through the injection of aerosols into the stratosphere. Researching such a technology creates systemic risks with a (...) strong sociotechnical component. This component consists of the potential societal harm that a developing or new technology might cause to existing norms, values, institutions, and politics. The systemic risk framework is a valuable heuristic for this case, given the complex interdependencies of societal systems, infrastructures, markets, etc. At the same time, the systemic risk framework can be enhanced through the inclusion of a more robust and reflected ethical considerations on technological risks. Consequently, this article seeks to supplement the systemic risk governance framework with insights from technology ethics. Specifically, the paper offers an ethically reflective conception of societal value dynamism and stakeholder engagement and participation, tying it to existing systemic risk governance approaches. (shrink)

Metaphors for describing the introduction, impacts, and management of non-native species are numerous and often quite outspoken. Policy-makers have adopted increasingly disputed metaphorical terms from scientific discourse. We performed a critical analysis of the use of strong metaphors in reporting scientific findings to policy-makers. Our analysis shows that perceptions of harm, invasiveness or nativeness are dynamic and inevitably display multiple narratives in science, policy or management. Improving our awareness of multiple expert and stakeholder narratives that exist in the context of (...) non-native species management, as well as metaphorical alternatives, is critical. (shrink)

The American justice system, from police departments to the courts, is increasingly turning to information technology for help identifying potential offenders, determining where, geographically, to allocate enforcement resources, assessing flight risk and the potential for recidivism amongst arrestees, and making other judgments about when, where, and how to manage crime. In particular, there is a focus on machine learning and other data analytics tools, which promise to accurately predict where crime will occur and who will perpetrate it. Activists and (...) academics have begun to raise critical questions about the use of these tools in policing contexts. In this chapter, I review the emerging critical literature on predictive policing and contribute to it by raising ethical questions about the use of predictive analytics tools to identify potential offenders. Drawing from work on the ethics of profiling, I argue that the much-lauded move from reactive to preemptive policing can mean wrongfully generalizing about individuals, making harmful assumptions about them, instrumentalizing them, and failing to respect them as full ethical persons. I suggest that these problems stem both from the nature of predictive policing tools and from the sociotechnical contexts in which they are implemented... (shrink)

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) (...) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. (shrink)

An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it requires us (...) to know more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits. (shrink)

Algorithms influence every facet of modern life: criminal justice, education, housing, entertainment, elections, social media, news feeds, work… the list goes on. Delegating important decisions to machines, however, gives rise to deep moral concerns about responsibility, transparency, freedom, fairness, and democracy. Algorithms and Autonomy connects these concerns to the core human value of autonomy in the contexts of algorithmic teacher evaluation, risk assessment in criminal sentencing, predictive policing, background checks, news feeds, ride-sharing platforms, social media, and election interference. (...) Using these case studies, the authors provide a better understanding of machine fairness and algorithmic transparency. They explain why interventions in algorithmic systems are necessary to ensure that algorithms are not used to control citizens' participation in politics and undercut democracy. This title is also available as Open Access on Cambridge Core. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (...) (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people’s acceptance or otherwise of risks, and the scope (...) individuals have to influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson’s framework to three such practices: an ‘ideal’ breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them. (shrink)

In “Risk Based Passenger Screening in Aviation Security: Implications and Variants of a New Paradigm”, Sebastian Weydner-Volkmann describes the current paradigm shift from ‘traditional’ forms of screening to ‘risk based passenger screening’ (RBS) in aviation security. This paradigm shift is put in the context of the wider historical development of risk management approaches. Through a discussion of Michel Foucault, Herfried Münkler and Ulrich Beck, Weydner-Volkmann analyses the shortcomings of such approaches in public security policies, which become especially (...) evident in the aviation security context. As he shows, the turn towards methods of RBS can be seen as an attempt to address a trade-off ‘trilemma’ between the effective provision of security, the implied costs for industry and passengers, and the ethical, legal and societal implications of the screening procedures. In order to analyse foreseeable outcomes of embracing RBS, he differentiates three prototypical variants of the new paradigm on the basis of their main referent and rationale. For each variant, he then subsequently assesses the implications for the ‘trilemma’, after having unveiled the criteria of analysis that will necessarily have to be followed within a serious appraisal of RBS methods. (shrink)

The main aim of this article is to reflect on the impact of biases related to artificial intelligence (AI) systems developed to tackle issues arising from the COVID-19 pandemic, with special focus on those developed for triage and risk prediction. A secondary aim is to review assessment tools that have been developed to prevent biases in AI systems. In addition, we provide a conceptual clarification for some terms related to biases in this particular context. We focus mainly on (...) nonracial biases that may be less considered when addressing biases in AI systems in the existing literature. In the manuscript, we found that the existence of bias in AI systems used for COVID-19 can result in algorithmic justice and that the legal frameworks and strategies developed to prevent the apparition of bias have failed to adequately consider social determinants of health. Finally, we make some recommendations on how to include more diverse professional profiles in order to develop AI systems that increase the epistemic diversity needed to tackle AI biases during the COVID-19 pandemic and beyond. (shrink)

This article reports the findings of AI4People, an Atomium—EISMD initiative designed to lay the foundations for a “Good AI Society”. We introduce the core opportunities and risks of AI for society; present a synthesis of five ethical principles that should undergird its development and adoption; and offer 20 concrete recommendations—to assess, to develop, to incentivise, and to support good AI—which in some cases may be undertaken directly by national or supranational policy makers, while in others may be led by other (...) stakeholders. If adopted, these recommendations would serve as a firm foundation for the establishment of a Good AI Society. (shrink)

How should contractualists assess the permissibility of risky actions? Both main views on the question, ex ante and ex post, fail to distinguish between different kinds of risk. In this article, I argue that this overlooks a third alternative that I call “objective ex ante contractualism”. Objective ex ante substitutes discounting complaints by epistemic risk in favor of discounting by objective risk. I further argue in favor of this new view. Objective ex ante contractualism provides the best (...) model of justifiability to each. (shrink)

This paper presents an overview of the risks and benefits of Social AI, understood as conversational AI systems that cater to human social needs like romance, companionship, or entertainment. Section 1 of the paper provides a brief history of conversational AI systems and introduces conceptual distinctions to help distinguish varieties of Social AI and pathways to their deployment. Section 2 of the paper adds further context via a brief discussion of anthropomorphism and its relevance to assessment of human-chatbot relationships. (...) Section 3 of the paper provides a survey of potential and in some cases demonstrated harms associated with user interactions with Social AI systems. Finally, Section 4 discusses how the benefits and harms of Social AI can best be addressed, with a primary focus on how frameworks from AI ethics can inform their development. (shrink)

Uncertainty, insufficient information or information of poor quality, limited cognitive capacity and time, along with value conflicts and ethical considerations, are all aspects thatmake risk managementand riskcommunication difficult. This paper provides a review of different risk concepts and describes how these influence risk management, communication and planning in relation to forest ecosystem services. Based on the review and results of empirical studies, we suggest that personal assessment of risk is decisive in the management of forest (...) ecosystem services. The results are used together with a reviewof different principles of the distribution of risk to propose an approach to risk communication that is effective aswell as ethically sound. Knowledge of heuristics and mutual information on both beliefs and desires are important in the proposed risk communication approach. Such knowledge provides an opportunity for relevant information exchange, so that gaps in personal knowledge maps can be filled in and effective risk communication can be promoted. (shrink)

International regulation of autonomous weapon systems (AWS) is increasingly conceived as an exercise in risk management. This requires a shared approach for assessing the risks of AWS. This paper presents a structured approach to risk assessment and regulation for AWS, adapting a qualitative framework inspired by the Intergovernmental Panel on Climate Change (IPCC). It examines the interactions among key risk factors—determinants, drivers, and types—to evaluate the risk magnitude of AWS and establish risk tolerance thresholds (...) through a risk matrix informed by background knowledge of event likelihood and severity. Further, it proposes a methodology to assess community risk appetite, emphasizing that such assessments and resulting tolerance levels should be determined through deliberation in a multistakeholder forum. The paper highlights the complexities of applying risk-based regulations to AWS internationally, particularly the challenge of defining a global community for risk assessment and regulatory legitimization. (shrink)

To speak of being religious lucky certainly sounds odd. But then, so does “My faith holds value in God’s plan, while yours does not.” This book argues that these two concerns — with the concept of religious luck and with asymmetric or sharply differential ascriptions of religious value — are inextricably connected. It argues that religious luck attributions can profitably be studied from a number of directions, not just theological, but also social scientific and philosophical. There is a strong tendency (...) among adherents of different faith traditions to invoke asymmetric explanations of the religious value or salvific status of the home religion vis-à-vis all others. Attributions of good/bad religious luck and exclusivist dismissal of the significance of religious disagreement are the central phenomena that the book studies. Part I lays out a taxonomy of kinds of religious luck, a taxonomy that draws upon but extends work on moral and epistemic luck. It asks: What is going on when persons, theologies, or purported revelations ascribe various kinds of religiously-relevant traits to insiders and outsiders of a faith tradition in sharply asymmetric fashion? “I am saved but you are lost”; “My religion is holy but yours is idolatrous”; “My faith tradition is true, and valued by God, but yours is false and valueless.” Part II further develops the theory introduced in Part I, pushing forward both the descriptive/explanatory and normative sides of what the author terms his inductive risk account. Firstly, the concept of inductive risk is shown to contribute to the needed field of comparative fundamentalism by suggesting new psychological markers of fundamentalist orientation. The second side of what is termed an inductive risk account is concerned with the epistemology of religious belief, but more especially with an account of the limits of reasonable religious disagreement. Problems of inductively risky modes of belief-formation problematize claims to religion-specific knowledge. But the inductive risk account does not aim to set religion apart, or to challenge the reasonableness of religious belief tout court. Rather the burden of the argument is to challenge the reasonableness of attitudes of religious exclusivism, and to demotivate the “polemical apologetics” that exclusivists practice and hope to normalize. Lexington Books Pages: 290 978-1-4985-5017-8 • Hardback • December 2018 • $95.00 • (£65.00) 978-1-4985-5018-5 • eBook • December 2018 • $90.00 • (£60.00) ISBN 978-1-4985-5018-5 (pbk: alk. paper) (coming 2020) [Download the 30% personal use Discount Order Form I uploaded for hardcover or e-book, and please ask your library to purchase a copy for their collection.]. (shrink)

Common mental health disorders are rising globally, creating a strain on public healthcare systems. This has led to a renewed interest in the role that digital technologies may have for improving mental health outcomes. One result of this interest is the development and use of artificial intelligence for assessing, diagnosing, and treating mental health issues, which we refer to as ‘digital psychiatry’. This article focuses on the increasing use of digital psychiatry outside of clinical settings, in the following sectors: education, (...) employment, financial services, social media, and the digital well-being industry. We analyse the ethical risks of deploying digital psychiatry in these sectors, emphasising key problems and opportunities for public health, and offer recommendations for protecting and promoting public health and well-being in information societies. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research (...) but largely silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

This thesis explores the ethical challenges that a potential research program for solar climate engineering via Stratospheric Aerosol Injection (SAI) could incur. These ethical challenges are comprised of epistemic hurdles in relation to the research process, as well as societal questions of justice and the value of nature. The thesis proposes a variety of tools and approaches to assess and possibly govern the risks and uncertainties invoked by the research of SAI and its societal implications. The methodological approach is based (...) mainly on ethical and philosophical analysis and reflection and the main findings take the form of discursive argumentation and normative reflection. (shrink)

A current advance within the agricultural industry is the use of genetic engineering to produce novel crops for food production. This technology raises questions about how societies should position themselves with respect to genetically modified (GM) crop development and implementation; namely, how should the potentials and risks of this technology be evaluated? We argue that current methods to evaluate the risks and benefits of GM crops are inadequate and not conducive to the strategic development of this technology, where a way (...) to ameliorate technology assessments for GM crops is to include farmers in the research process of evaluating these crops prior to their commercialization. However, particularities concerning the ethical status of such research require special consideration and vigilance. For example, in such technology assessment initiatives, farmers would occupy both the roles of research participant and research investigator. Other particularities surface due to factors related to the nature of GM crops. These particularities are examined with reference to concepts drawn from the field of research ethics, namely informed consent, compensatory decisions, and issues of participant inclusion/exclusion. (shrink)

In this article, I show why it is necessary to abolish the use of predictive algorithms in the US criminal justice system at sentencing. After presenting the functioning of these algorithms in their context of emergence, I offer three arguments to demonstrate why their abolition is imperative. First, I show that sentencing based on predictive algorithms induces a process of rewriting the temporality of the judged individual, flattening their life into a present inescapably doomed by its past. Second, I demonstrate (...) that recursive processes, comprising predictive algorithms and the decisions based on their predictions, systematically suppress outliers and progressively transform reality to match predictions. In my third and final argument, I show that decisions made on the basis of predictive algorithms actively perform a biopolitical understanding of justice as management and modulation of risks. In such a framework, justice becomes a means to maintain a perverse social homeostasis that systematically exposes disenfranchised Black and Brown populations to risk. (shrink)

The Adverse Outcome Pathway (AOP) concept is a knowledge assembly and communication tool to facilitate the transparent translation of mechanistic information into outcomes meaningful to the regulatory assessment of chemicals. The AOP framework and associated knowledgebases (KBs) have received significant attention and use in the regulatory toxicology community. However, it is increasingly apparent that the potential stakeholder community for the AOP concept and AOP KBs is broader than scientists and regulators directly involved in chemical safety assessment. In this (...) paper we identify and describe those stakeholders who currently—or in the future—could benefit from the application of the AOP framework and knowledge to specific problems. We also summarize the challenges faced in implementing pathway-based approaches such as the AOP framework in biological sciences, and provide a series of recommendations to meet critical needs to ensure further progression of the framework as a useful, sustainable and dependable tool supporting assessments of both human health and the environment. Although the AOP concept has the potential to significantly impact the organization and interpretation of biological information in a variety of disciplines/applications, this promise can only be fully realized through the active engagement of, and input from multiple stakeholders, requiring multi-pronged substantive long-term planning and strategies. (shrink)

Important decisions that impact humans lives, livelihoods, and the natural environment are increasingly being automated. Delegating tasks to so-called automated decision-making systems can improve efficiency and enable new solutions. However, these benefits are coupled with ethical challenges. For example, ADMS may produce discriminatory outcomes, violate individual privacy, and undermine human self-determination. New governance mechanisms are thus needed that help organisations design and deploy ADMS in ways that are ethical, while enabling society to reap the full economic and social benefits of (...) automation. In this article, we consider the feasibility and efficacy of ethics-based auditing as a governance mechanism that allows organisations to validate claims made about their ADMS. Building on previous work, we define EBA as a structured process whereby an entity’s present or past behaviour is assessed for consistency with relevant principles or norms. We then offer three contributions to the existing literature. First, we provide a theoretical explanation of how EBA can contribute to good governance by promoting procedural regularity and transparency. Second, we propose seven criteria for how to design and implement EBA procedures successfully. Third, we identify and discuss the conceptual, technical, social, economic, organisational, and institutional constraints associated with EBA. We conclude that EBA should be considered an integral component of multifaced approaches to managing the ethical risks posed by ADMS. (shrink)

Some patients, following brain injury, do not outwardly respond to spoken commands, yet show patterns of brain activity that indicate responsiveness. This is “cognitive-motor dissociation” (CMD). Recent research has used machine learning to diagnose CMD from electroencephalogram (EEG) recordings. These techniques have high false discovery rates, raising a serious problem of inductive risk. It is no solution to communicate the false discovery rates directly to the patient’s family, because this information may confuse, alarm and mislead. Instead, we need a (...) procedure for generating case-specific probabilistic assessments that can be communicated clearly. This article constructs a possible procedure with three key elements: (1) a shift from categorical “responding or not” assessments to degrees of evidence; (2) the use of patient-centred priors to convert degrees of evidence to probabilistic assessments; and (3) the use of standardized probability yardsticks to convey those assessments as clearly as possible. (shrink)

I came late to philosophy and even later to normative ethics. When I started my undergraduate studies at the University of Toronto in 1970, I was interested in mathematics and languages. I soon discovered, however, that my mathematical talents were rather meager compared to the truly talented. I therefore decided to study actuarial science (the applied mathematics of risk assessment for insurance and pension plans) rather than abstract math. After two years, however, I dropped out of university, (...) went to work for a life insurance company, and started studying on my own for the ten professional actuarial exams. When not studying, I would often go to the public library and I was drawn to the philosophy section—although I had no idea of what philosophy was about. I there saw Logical Positivism, edited by A.J. Ayer. I was interested in logical thinking and I also favored an optimistic attitude towards life (!) and so I thought that the book might be interesting. I checked it out and was absolutely enthralled with the writings of Bertrand Russell, Rudolf Carnap, Carl Hempel and others (if I’m remembering correctly). Of course, I didn’t really understand much of what they were doing, but I did see that they were addressing important problems in a systematic and rigorous manner. I liked it! (shrink)

Biomarker-based predictive tests for subjectively asymptomatic Alzheimer’s disease (AD) are utilized in research today. Novel applications of artificial intelligence (AI) promise to predict the onset of AD several years in advance without determining biomarker thresholds. Until now, little attention has been paid to the new ethical challenges that AI brings to the early diagnosis in asymptomatic individuals, beyond contributing to research purposes, when we still lack adequate treatment. The aim of this paper is to explore the ethical arguments put forward (...) for AI aided AD prediction in subjectively asymptomatic individuals and their ethical implications. The ethical assessment is based on a systematic literature search. Thematic analysis was conducted inductively of 18 included publications. The ethical framework includes the principles of autonomy, beneficence, non-maleficence, and justice. Reasons for offering predictive tests to asymptomatic individuals are the right to know, a positive balance of the risk-benefit assessment, and the opportunity for future planning. Reasons against are the lack of disease modifying treatment, the accuracy and explicability of AI aided prediction, the right not to know, and threats to social rights. We conclude that there are serious ethical concerns in offering early diagnosis to asymptomatic individuals and the issues raised by the application of AI add to the already known issues. Nevertheless, pre-symptomatic testing should only be offered on request to avoid inflicted harm. We recommend developing training for physicians in communicating AI aided prediction. (shrink)

Two general ethical problems in psychiatry are thrown into sharp relief by long term care. This article discusses each in turn, in the context of two anonymised case studies from actual clinical practice. First, previous mental health legislation soothed doubts about patients' refusal of consent by incorporating time limits on involuntary treatment. When these are absent, as in the provisions for long term care which have recently come into force, the justification for compulsory treatment and supervision becomes more obviously problematic. (...) Second, Anglo-American law does not normally allow the preventive detention of someone who may be dangerous but has not actually committed any crime. The justification for detaining a possibly dangerous user of mental health services without his or her consent can only be based on risk assessment, but this raises issues of moral luck. Is the psychiatrist who decides not to take out a supervision order for a possibly dangerous patient with an initial psychotic diagnosis morally at fault if that person harms someone in the community, or himself? Or is the psychiatrist merely unlucky? (shrink)

Over the years, companies have adopted hiring algorithms because they promise wider job candidate pools, lower recruitment costs and less human bias. Despite these promises, they also bring perils. Using them can inflict unintentional harms on individual human rights. These include the five human rights to work, equality and nondiscrimination, privacy, free expression and free association. Despite the human rights harms of hiring algorithms, the AI ethics literature has predominantly focused on abstract ethical principles. This is problematic for two (...) reasons. First, AI principles have been criticized for being vague and not actionable. Second, the use of vague ethical principles to discuss algorithmic risks does not provide any accountability. This lack of accountability creates an algorithmic accountability gap. Closing this gap is crucial because, without accountability, the use of hiring algorithms can lead to discrimination and unequal access to employment opportunities. This paper makes two contributions to the AI ethics literature. First, it frames the ethical risks of hiring algorithms using international human rights law as a universal standard for determining algorithmic accountability. Second, it evaluates four types of algorithmic impact assessments in terms of how effectively they address the five human rights of job applicants implicated in hiring algorithms. It determines which of the assessments can help companies audit their hiring algorithms and close the algorithmic accountability gap. (shrink)

This project has been supported by the Australian Government through the Australian Research Council (project number CS170100008); the Department of Industry, Innovation and Science; and the Department of Prime Minister and Cabinet. ACOLA collaborates with the Australian Academy of Health and Medical Sciences and the New Zealand Royal Society Te Apārangi to deliver the interdisciplinary Horizon Scanning reports to government. The aims of the project which produced this report are: 1. Examine the transformative role that artificial intelligence may play in (...) different sectors of the economy, including the opportunities, risks and challenges that advancement presents. 2. Examine the ethical, legal and social considerations and frameworks required to enable and support broad development and uptake of artificial intelligence. 3. Assess the future education, skills and infrastructure requirements to manage workforce transition and support thriving and internationally competitive artificial intelligence industries. (shrink)

A small but growing number of studies have aimed to understand, assess and reduce existential risks, or risks that threaten the continued existence of mankind. However, most attention has been focused on known and tangible risks. This paper proposes a heuristic for reducing the risk of black swan extinction events. These events are, as the name suggests, stochastic and unforeseen when they happen. Decision theory based on a fixed model of possible outcomes cannot properly deal with this kind of (...) event. Neither can probabilistic risk analysis. This paper will argue that the approach that is referred to as engineering safety could be applied to reducing the risk from black swan extinction events. It will also propose a conceptual sketch of how such a strategy may be implemented: isolated, self-sufficient, and continuously manned underground refuges. Some characteristics of such refuges are also described, in particular the psychosocial aspects. Furthermore, it is argued that this implementation of the engineering safety strategy safety barriers would be effective and plausible and could reduce the risk of an extinction event in a wide range of possible scenarios. Considering the staggering opportunity cost of an existential catastrophe, such strategies ought to be explored more vigorously. (shrink)

The EU Artificial Intelligence Act (AIA) defines four risk categories for AI systems: unacceptable, high, limited, and minimal. However, it lacks a clear methodology for the assessment of these risks in concrete situations. Risks are broadly categorized based on the application areas of AI systems and ambiguous risk factors. This paper suggests a methodology for assessing AI risk magnitudes, focusing on the construction of real-world risk scenarios. To this scope, we propose to integrate the AIA (...) with a framework developed by the Intergovernmental Panel on Climate Change (IPCC) reports and related literature. This approach enables a nuanced analysis of AI risk by exploring the interplay between (a) risk determinants, (b) individual drivers of determinants, and (c) multiple risk types. We further refine the proposed methodology by applying a proportionality test to balance the competing values involved in AI risk assessment. Finally, we present three uses of this approach under the AIA: to implement the Regulation, to assess the significance of risks, and to develop internal risk management systems for AI deployers. (shrink)

This article addresses the question of how ‘Country of Origin Information’ reports—that is, research developed and used to support decision-making in the asylum process—can be published in an ethical manner. The article focuses on the risk that published COI reports could be misused and thereby harm the subjects of the reports and/or those involved in their development. It supports a situational approach to assessing data ethics when publishing COI reports, whereby COI service providers must weigh up the benefits (...) and harms of publication based, inter alia, on the foreseeability and probability of harm due to potential misuse of the research, the public good nature of the research, and the need to balance the rights and duties of the various actors in the asylum process, including asylum seekers themselves. Although this article focuses on the specific question of ‘how to publish COI reports in an ethical manner’, it also intends to promote further research on data ethics in the asylum process, particularly in relation to refugees, where more foundational issues should be considered. (shrink)

In a recent commentary, Kim and colleagues argued that minimal-risk research should be deregulated so that such studies do not require review by an institutional review board. They claim that regulation of minimal-risk studies provides no adequate counterbalancing good and instead leads to a costly human subjects oversight system. We argue that the counterbalancing good of regulating minimal-risk studies is that oversight exists to ensure that respect for persons and justice requirements are satisfied when they otherwise might (...) not be. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to (...) improve emergency care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

Background: Use of patients’ medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform ethical (...) and privacy debates. Methods: We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. Results: Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party’s competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. Conclusions: The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data. (shrink)

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, (...) with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.”. (shrink)

The COVID-19 global pandemic has shone a light on several important ethical questions, ranging from fairness in resource allocation to the ethical justification of government mandates. In addition to these institutional issues, there are also several ethical questions that arise at the interpersonal level. This essay focuses on several of these issues. In particular, I argue that, despite the insistence in public health messaging that avoiding infecting others constitutes ‘saving lives’, virus transmission that results in death constitutes an act of (...) killing. Whether this killing is wrongful depends on several factors. I consider one intuitively plausible view—namely, that in many cases, killing via unintentional transmission is not wrongful, because the parties in question have implicitly waived their rights against this harm, often via reciprocal risk imposition. I argue that this view is mistaken, but that its central insight can be better captured by identifying the appropriate standards of blame that we ought to apply during a pandemic. I conclude by showing how these conclusions can be fruitfully applied to certain institutional questions, such as helping to justify restricting government mandates. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques (1) and the standard discussion of risk for these (2), in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements (...) (3): therapeutic, preventive, and pure enhancements. This demands a revision of the Assumption (4), alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought (5). While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decisionmaking. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges (...) stem from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. (shrink)

In this article we argue that the social value of health research should be conceptualized as a function of both the expected benefits of the research and the priority that the beneficiaries deserve. People deserve greater priority the worse off they are. This conception of social value can be applied for at least two important purposes: in health research priority setting when research funders, policy-makers, or researchers decide between alternative research projects; and in evaluating the ethics of proposed research (...) proposals when research ethics committees assess whether the social value of the research is sufficient to justify the risks and burdens to research participants and others. In assessing how far a proposed research project will advance the interests of people who are more disadvantaged, research priority setters and RECs should examine the diseases that the research targets and the type of research. Just as certain diseases impose a greater burden on people who are more disadvantaged, so certain types of intervention and forms of research are more likely to benefit people who are more disadvantaged. We outline which populations are likely to be representative of the global worst off and identify what types of health research, and which disease categories, are priorities for these populations. (shrink)

A bi-level account of trust is developed and defended, one with relevance in ethics as well as epistemology. The proposed account of trust—on which trusting is modelled within a virtue-theoretic framework as a performance-type with an aim—distinguishes between two distinct levels of trust, apt and convictive, that take us beyond previous assessments of its nature, value, and relationship to risk assessment. While Ernest Sosa (2009; 2015; 2017), in particular, has shown how a performance normativity model may be (...) fruitfully applied to belief, my objective is to apply this kind of model in a novel and principled way to trust. I conclude by outlining some of the key advantages of the performance-theoretic bi-level account of trust defended over more traditional univocal proposals. (shrink)

In our reply to critiques of our GLP-1 receptor agonist allocation framework, we explain that using potential years of life lost (PYLL) as a metric addresses racial health disparities without explicitly allocating resources based on race. This approach is "racism-conscious" and has legal and ethical challenges over race-based approaches. Meanwhile, though acknowledging the importance of cardiovascular risk assessment, we maintain in response to other interlocutors that focusing solely on immediate risk would ignore the broader goal of mitigating (...) disadvantage. We emphasize that our framework balances multiple ethical objectives beyond just maximizing medical benefits. (shrink)