Risks and burdens in the study participation, as well as an adequate risk-benefit balance, are key concepts for the evaluation of clinical studies by research ethics committees. An adequate assessment and continuous monitoring to ensure compliance of risks and burdens in clinical trials have long been described as a central task in research ethics. However, there is currently no uniform and solid theoretical approach to risk assessment by RECs. Regulatory standards of research ethics (...) such as the Declaration of Helsinki provide only minimal guidance on how risk decisions are considered. Due to discrepancies in the existing literature and guidance documents, adequate risk assessment by RECs remains to be elusive. In this article, we address current definitions of risk and present our own concept of aggregate risk definition. Moreover, we highlight the concept of benefit, the standard of reasonableness with respect to ethics literature and different approaches of risk-benefit assessment. In order to present a comprehensive theoretical approach of risk assessment by RECs, further understanding of the definitions of risk may improve adequate decision-making tasks by RECs. To improve the process of risk assessment by RECs, a dynamic framework will be illustrated, showing step-by-step risk assessment functions. This approach may be a promising tool to ensure adequacy in risk assessment by RECs. (shrink)

For the purpose of this analysis, risk assessment becomes the primary term and risk management the secondary term. The concept of risk management as a primary term is based upon a false ontology. Risk management implies that risk is already there, not created by the decision, but lies already inherent in the situation that the decision sets into motion. The risk that already exists in the objective situation simply needs to be “managed”. By (...) considering risk assessment as the primary term, the ethics of responsibility for risking the lives of others, the environment and future generations in the first place comes into the forefront. The issue of risk heeding is especially important as it highlights the need to pay attention to warnings of danger and to take action to redress problems before disasters occur. In this paper, the decision making that led to the choice of technology utilized and the implementation of such technology in the case of the space shuttle Challenger disaster will be used as a model to illustrate the need to take ethical factors into account when making decisions regarding the safety of technological systems and the heeding of danger warnings. While twenty-five years separates the decision to launch the Challenger and the Fukushima Daiichi nuclear plant disaster, the lessons of the Challenger disaster are still to be learned. (shrink)

For the purpose of this analysis, risk assessment becomes the primary term and risk management the secondary term. The concept of risk management as a primary term is based upon a false ontology. Risk management implies that risk is already there, not created by the decision, but lies already inherent in the situation that the decision sets into motion. The risk that already exists in the objective situation simply needs to be “managed”. By (...) considering risk assessment as the primary term, the ethics of responsibility for risking the lives of others, the environment and future generations in the first place comes into the forefront. The issue of risk heeding is especially important as it highlights the need to pay attention to warnings of danger and to take action to redress problems before disasters occur. In this paper, the decision making that led to the choice of technology utilized and the implementation of such technology in the case of the space shuttle Challenger disaster will be used as a model to illustrate the need to take ethical factors into account when making decisions regarding the safety of technological systems and the heeding of danger warnings. While twenty-five years separates the decision to launch the Challenger and the Fukushima Daiichi nuclear plant disaster, the lessons of the Challenger disaster are still to be learned. (shrink)

This paper is devoted to showing that a safety priority should be accorded the highest priority in decision-making and that such a prioritisation is an ethical responsibility. The connection between a safety-first priority and ethics is that an ultimate concern for safety is an integral feature of respect for human life. This paper exposes the illogic behind the misleading phrase "risky technology" and the fallacies which underlie the seemingly morally neutral phrase "risk assessment". It is argued that (...) human beings ultimately possess the responsibility of the choice to employ one technological system as over another and hence the decision to employ unsafe technology is a case of "risky assessment" rather than "risky technology". The phrase "risky technology" implies that the risk factor is inherent to the technology when the risk factor is inherent to the choice of which technology to employ. Risk assessment has been portrayed as amoral numerical calculation without clarifying the basis of the assessment. It is argued here that risk assessment must include the basis of its figures and that, to be epistemologically sound, the basis should be past engineering performance and not "subjective engineering judgement". To be ethically sound, risk assessment must take into account not only probabilities of occurrence but consequences of occurrence, such as life or death risks to risk takers and all those on whom the risk taken will ultimately make an impact. It is argued that risk takers possess a right to know of the specific risks to which they are exposing themselves and that risk makers possess the corresponding duty to inform risk takers. The Challenger case is utilised as a lesson in unsound and unethical risk assessment. It is also utilised as a case in which the right of the astronauts and civilian passengers to know of the risk they were taking was not respected and the ethical duty to inform the astronauts and civilian passengers of the risk they were taking was not observed. Distinctions are drawn between general and unknown risks of space travel and the specifically foreknown risks of a design deficient O-ring which malfunctioned below specific temperature readings. The belief that progress requires risk taking is exposed as an oversimplification since progress can be made as in the case of the development of commercial air travel without taking reckless risks. Passenger aircraft must meet certain criteria of safety to be operable but this is not an obstacle to progress. The observance of the right to know and the duty to inform is an asset to business. In the case of Delta Airlines and Northwest Airlines, the decision to notify the public of bomb threats may have given business a boost since passengers have deduced in absence of such a threat that their flight was a safe one as they trusted these airlines. (shrink)

We identify three distinct ethical problems that can arise with risk displacement. Risk displacement is the shifting of extant risk from one or more individuals to other individual(s) such that the reduction of risk to the first group is causally implicated in increasing risk to the second group. These problems are: concentration of risk in inequitable ways; transfer of risk to already vulnerable or disadvantaged populations; and exercise of undue influence over potential research (...) participants. The first two arise in both public policy and research initiatives, whereas the third is a special concern that only applies to research initiatives. We argue that when one or more of these is of high magnitude, then the study or policy intervention may be ethically wrong. Finally, we conclude that although some risk displacement is ethically permissible, researchers and policymakers still have ethical reasons to reduce the magnitude of these problems. (shrink)

The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to issuing a final ruling on animal cloning is not part of its mission. In this article, the authors reject the FDA's claim that its mission to protect (...) and advance public health can be accomplished without considering ethical issues or without making value judgments. The authors offer two arguments in support of their position. First, the agency's mission statement presupposes significant normative commitments and judgments. Second, the FDA's risk assessment of food products from cloned animals and their offspring is itself clearly shaped by a variety of normative commitments. (shrink)

Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how non-utilitarian principles (...) are prominent in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)

In‐vitro fertilization clinics across the world currently use the body mass index (BMI) to assess risk for and determine access to in‐vitro fertilization (IVF); however, clinics vary widely in both setting specific BMI limits for access to IVF and articulating the reasons for their policies. Given that scholars have begun to question the usefulness of BMI for individual health risk assessment, it is striking that ethicists have not yet systematically evaluated the reasons given for using BMI in (...) assessing individuals' risk in IVF treatments. In this paper, I provide the first systematic analysis of the chief arguments currently offered by IVF programs for using BMI as a criterion for risk assessment. Specifically, I articulate empirical concerns about the success of IVF in high‐BMI patients, practical concerns about the ability of high‐BMI patients to safely undergo procedures associated with IVF, and ethical concerns about the risk‐to‐reward ratio for high‐BMI patients and their potential children. I advance a series of objections to those arguments, using empirical data regarding IVF procedures and analogies with other high‐risk conditions including systemic lupus erythematosus, and science regarding the diagnosis of BMI‐correlated comorbidities such as high blood pressure or diabetes to argue that BMI alone is not a reasonable criterion for risk assessment in IVF; moreover, the usage of BMI may involve unacceptable violations of the bioethical principles of justice and respect for autonomy. Instead, I hold that IVF programs should rely on more precise laboratory and clinical measurements to evaluate risk in IVF. (shrink)

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal (...) decision-making study nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

There are widely held premises that suicide is almost exclusively the result of mental illness and there is “strong evidence for successfully detecting and managing suicidality in healthcare”. In this context, ‘zero-suicide’ policies have emerged, and suicide risk assessment tools have become a normative component of psychiatric practice. This essay discusses how suicide evolved from a moral to a medical problem and how, in an effort to reduce suicide, a paternalistic healthcare response emerged to predict those at high (...) risk. The evidence for the premises is critiqued and shown to be problematic; and it is found that strong paternalistic interventions are being used more often than acknowledged. Using a Principles approach, the ethics of overriding autonomy in suicide prevention is considered. Ethical concerns are identified with the current approach which are potentially amplified by the use of these risk assessments. Furthermore, it is identified that the widespread use of risk assessments in health settings is equivalent to screening without regard to the ethical principles of screening. The essay concludes that this is unethical; that we should abandon the use of standardized suicide risk assessments and ‘zero-suicide’ policy; and that this may improve outcomes. (shrink)

'A comprehensive and important collection that includes essays by some of the leading figures in the field....Essential reading for anyone interested in risk assessment.' Professor Kristin Shrader-Frechette, University of Notre Dame 'The editors are to be congratulated for bringing together a distinguished international group of theorists to reflect on the issues. This volume will be sure to raise the level of debate while at the same time showing the importance of philosophical reflection in approaches to the problems of (...) the age.' Professor Jonathan Wolff, University College London This volume brings together top authors from the fields of risk, philosophy, social sciences and psychology to address the issue of how we should decide how far technological risks are morally acceptable or not. The underlying principles are examined, along with methodological challenges, public involvement and instruments for democratization. A strong theoretical basis is complemented by a range of case studies from some of the most contentious areas, including medical ethics and GM crops. This book is a vital new resource for researchers, students and anyone concerned that traditional approaches to risk management don't adequately address ethical considerations. (shrink)

The process of risk assessment of biotechnologies, such as genetically modified organisms (GMOs), has normative dimensions. However, the US’ Food and Drug Administration (FDA) seems committed to the idea that such evaluations are objective. This essay makes the case that the agency’s regulatory approach should be changed such that the public is involved in deciding any ethical or social questions that might arise during risk assessment of GMOs. It is argued that, in the US, neither aggregative (...) nor deliberative (representative) democracy ought to be used to make such determinations. Instead, participatory (deliberative) democracy should be the means by which members of the polity decide which normative concerns ought to underlie FDA’s assessment of GMOs. This paper uses a hypothetical case involving a new GM seed to make that argument. (shrink)

As the field of vascularized composite allotransplantation (VCA) continues to evolve and technological approaches improve, VCA programs must focus on promoting greater consistency in psychosocial assessment across programs to support the equitable selection of patients. Based on a summary of published reports of VCA, we address the ethical considerations raised by the present heterogeneity of approaches to psychosocial assessment, including weighing risks and benefits, informed consent and the role of decisional capacity, and potential or perceived bias in the (...) assessment process. We propose transparency of process across the field and encourage VCA programs to work collaboratively to share approaches to psychosocial assessment both pre- and posttransplant to promote health equity. (shrink)

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)

This article proposes to identify risk factors for moral distress from the literature, validate them through expert analysis and provide the basis for a new tool to assess the risk of moral distress among nurses. Moral distress is related to the psychological, emotional and physiological aspects of nursing. It arises from constraints caused by various circumstances and can lead to significant negative consequences. A scoping review and validation through expert analysis were used. The research question guiding this study (...) was as follows: What is known about risk factors for moral distress in nursing? The research was conducted using multiple sources including electronic databases and lists of references from relevant literature. The final sample consisted of 38 studies. A validation analysis was conducted by experts during December 2014 and June 2015. To exclude a risk factor item, at least 80% of the experts had to agree with the exclusion. In total, 53 risk factors for moral distress were identified, reviewed by the experts and grouped to form a new instrument that may help to identify risk for moral distress and to address its consequences. (shrink)

In 2017, the German ethics commission for automated and connected driving released 20 ethical guidelines for autonomous vehicles. It is now up to the research and industrial sectors to enhance the development of autonomous vehicles based on such guidelines. In the current state of the art, we find studies on how ethical theories can be integrated. To the best of the authors’ knowledge, no framework for motion planning has yet been published which allows for the true implementation of any (...) practical ethical policies. This paper makes four contributions: Firstly, we briefly present the state of the art based on recent works concerning unavoidable accidents of autonomous vehicles (AVs) and identify further need for research. While most of the research focuses on decision strategies in moral dilemmas or crash optimization, we aim to develop an ethical trajectory planning for all situations on public roads. Secondly, we discuss several ethical theories and argue for the adoption of the theory “ethics of risk.” Thirdly, we propose a new framework for trajectory planning, with uncertainties and an assessment of risks. In this framework, we transform ethical specifications into mathematical equations and thus create the basis for the programming of an ethical trajectory. We present a risk cost function for trajectory planning that considers minimization of the overall risk, priority for the worst-off and equal treatment of people. Finally, we build a connection between the widely discussed trolley problem and our proposed framework. (shrink)

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

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)

As technology advances, and the life and death consequences of its failure become more and more removed from proximate human action, technology management requires greater degrees of ethical awareness and the management of safety becomes a matter of corporate ethical imperative. The corporate ethical imperative includes ethical mandates to take no action which places the lives of others at risk and to inform persons of dangers to their physical safety of which they may otherwise be unaware when one possesses (...) information relevant to the safety of others such that, with the possession of that knowledge, the others can make decisions relevant to protecting their safety, or if others fail to take such action, to take upon oneself the responsibility of taking such action. The ethical duty of primum non nocere implies the corresponding right of the life risking participant to be informed of the kind and degree of risk to which they are to be exposed and the freedom to refuse to take such risk without prejudice. The corporate ethical imperative is to hold human life precious and to uphold that imperative through selectively non-acting, properly informing and acting. The case of the Challenger disaster is utilised as an illustration of decision making which violated these ethical precepts. (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)

Risk communication poses a challenge to ordinary norms of truth-telling because it can easily mislead. Analyzing this challenge in terms of a systematic divergence between expertise and public attitudes fails to recognize how two specific features of the concept of risk play a role in managing daily affairs. First, evaluating risk always incorporates an estimate of the reliability of information. Since risk communication is an effort at providing information, audiences will naturally and appropriately incorporate their (...) class='Hi'>assessment of the reliability of the risk communicator into their assessment of the risk as such. Second, one conceptual and grammatical feature of the concept of risk is to categorize experience as non-routine and demanding further deliberation. That is, the whole point of calling something a risk can be to distinguish it from activities or phenomena that need no further attention. Risk communications that stress relative comparisons of measured probabilities and expected utilities can be inconsistent with both features of our concept of risk. At best they mislead; at worst they undermine our society’s capacity to cope with risk. While there are no simple answers to these two conundrums, technical experts should bear them in mind when communicating with the broader public. (shrink)

Background Scientific and technological advancements in mapping and understanding the interrelated pathways through which biological and environmental exposures affect disease development create new possibilities for detecting disease risk factors. Early detection of such risk factors may help prevent disease onset or moderate the disease course, thereby decreasing associated disease burden, morbidity, and mortality. However, the ethical implications of screening for disease risk factors are unclear and the current literature provides a fragmented and case-by-case picture. Methods To identify (...) key ethical considerations arising from the early detection of disease risk factors, we performed a systematic scoping review. The Scopus, Embase, and Philosopher’s Index databases were searched for peer-reviewed, academic records, which were included if they were written in English or Dutch and concerned the ethics of (1) early detection of (2) disease risk factors for (3) disease caused by environmental factors or gene-environment interactions. All records were reviewed independently by at least two researchers. Results After screening 2034 titles and abstracts, and 112 full papers, 55 articles were included in the thematic synthesis of the results. We identified eight common ethical themes: (1) Reliability and uncertainty in early detection, (2) autonomy, (3) privacy, (4) beneficence and non-maleficence, (5) downstream burdens on others, (6) responsibility, (7) justice, and (8) medicalization and conceptual disruption. We identified several gaps in the literature, including a relative scarcity of research on ethical considerations associated with environmental preventive health interventions, a dearth of practical suggestions on how to address expressed concerns about overestimating health capacities, and a lack of insights into preventing undue attribution of health responsibility to individuals. Conclusions The ethical concerns arising with the early detection of risk factors are often interrelated and complex. Comprehensive ethical analyses are needed that are better embedded in normative frameworks and also assess and weigh the expected benefits of early risk factor detection. Such research is necessary for developing and implementing responsible and fair preventive health policies. (shrink)

Comparative risk assessment is playing an ever-increasing role in environmental policy priority setting, as manifested in national and numerous subnational comparative risk projects. It is widely accepted that public values, interests, and concerns should play an important role in CRA. However, the philosophical basis for public involvement in CRA has not been adequately explored, nor have comparative risk projects always made explicit their rationales for public involvement. The author examines the political, normative, and epistemic rationales for (...) public involvement and explores the case for public involvement in the making of ethical, valuation, and evidentiary judgments. The author considers key issues each rationale raises, problems eachfaces, and some of the implications of each for specific aspects of CRA. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to (...) the novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (shrink)

Background:Moral courage is defined as courage to act according to one’s own ethical values and principles even at the risk of negative consequences for the individual. In a complex nursing practice, ethical considerations are integral. Moral courage is needed throughout nurses’ career.Aim:To analyse graduating nursing students’ moral courage and the factors associated with it in six European countries.Research design:A cross-sectional design, using a structured questionnaire, as part of a larger international ProCompNurse study. In the questionnaire, moral courage was assessed (...) with a single question (visual analogue scale 0–100), the questionnaire also covered several background variables.Participants and research context:The sample comprised graduating nursing students (n = 1796) from all participating countries. To get a comprehensive view about graduating nursing students’ moral courage, the views of nurse managers (n = 538) and patients (n = 1327) from the same units in which the graduating nursing students practised were also explored, with parallel questionnaires.Ethical considerations:Ethical approvals and research permissions were obtained according to national standards in every country and all participants gave their informed consent.Results:The mean of graduating nursing students’ self-assessed moral courage was 77.8 (standard deviation 17.0; on a 0–100 scale), with statistically significant differences between countries. Higher moral courage was associated with many factors, especially the level of professional competence. The managers assessed the graduating nursing students’ moral courage lower (66.5; standard deviation 18.4) and the patients slightly higher (80.6; standard deviation 19.4) than the graduating nursing students themselves.Discussion and conclusions:In all countries, the graduating nursing students’ moral courage was assessed as rather high, with differences between countries and populations. These differences and associations between moral courage and ethics education require further research. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We (...) first propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (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)

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)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles (...) published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles (...) published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

In this article, I challenge the risk assessment approach to the ethics of pre-exposure prophylaxis (PrEP) as HIV prevention among men who have sex with men (MSM). Traditional risk assessment focuses on the medical risks and benefits of using medical technologies, but this emphasizes certain risks and benefits over others. The medical risks of using PrEP are presently being overblown and its social and political risks are being overlooked. By recontextualizing risk within the history (...) of HIV and considering the lived experiences of MSM with sex, HIV, and HIV prevention, we can broaden the present risk assessment framework to include all of the relevant risks involved in using PrEP. We can also better situate risk as one of several moral concepts, including trust and solidarity, which move us towards a more nuanced analysis of the social and political effects of PrEP on the relationships and communities of MSM. (shrink)

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal (...) therapies. Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research. Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study’s social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. (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)

Handling the impacts and consequences of technology has become a problem of political, social and scientific relevance since the Sixties. The earlier assumption that technological evolution would automatically lead to social and human progress in an emphatic sense can no longer be sustained. The ambivalence of technology has become a standing topic in the public, philosophical and scientific debate .In this situation new challenges to technology policy are emerging. Functions of an `early warning' with respect to the risks or potentials (...) of new technologies or to ways of avoiding or, at least, resolving technology conflicts by compromise have been postulated . Technology policy pursued by parliament or government, therefore, is in need of scientific consultation . Since the Seventies a number of institutions in this field have been founded , either primarily as parliamentary bureaus of knowledge-transfer to the decision-makers , as networks with a low degree of institutionalization or as independent scientific institutes .The scientific discussion on how to acquire and establish orientational knowledge for decision-makers facing the ambivalence of technology is sectoralized into two branches: the ethics of technology and technology assessment . These two branches are based on fundamentally different assumptions concerning how to give orientation to technology policy: the philosophical ethics, of course, emphasizes the normative implications of decisions on technology and the importance of moral conflicts , while technology assessment relies mainly on sociological or economic research .Both approaches have largely been developed and practised without regard to one another. In Germany, at the beginning of the Nineties the conceptual discussion around these questions was initiated. At first, a lot of misunderstandings appeared, both parties fundamentally criticizing each other, often one denying the competence of the other to deal appropriately with technology problems . In this paper the conflict is analyzed by looking at the situation in Germany, summarizing and weighing the main arguments which have been brought up by TA and the ethical approach to technology.As a result it will be shown that both are partly right, whereby the relative weight of both approaches in their capacity to give orientation is dependent on contextual circumstances. A non-reductionistic overall approach must take into account the normative aspects of the ethics of technology when handling moral conflicts as well as the need for operationalization, concreteness and established knowledge about the processes of “managing technology in society” postulated by TA. (shrink)

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal (...) therapies. Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research. Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study’s social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. (shrink)

In this paper we explore whether or not the use of risk assessment tools in criminal sentencing can be made compatible with a retributivist justification of punishment. While there has been considerable discussion of the accuracy and fairness of these tools, such discussion assumes that one’s recidivism risk is relevant to the severity of punishment that one should receive. But this assumption only holds on certain accounts of punishment, and seems to conflict with retributivist justifications of punishment. (...) Drawing on the broader desert literature, we explain the source of this conflict, and suggest that a retributivist approach on which the severity of punishment partly depends on one’s character in addition to their acts offers some hope of reconciling retributivism with the use of risk assessment tools in considerations of sentencing reduction in particular. Ultimately, however, even this limited attempt at reconciliation fails, so long as risk assessment tools fail to distinguish between risk that one is responsible for, and risk that one is not responsible for. (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)

Assessing social risks has proven difficult for IRBs. We undertook a novel effort to empirically investigate social risks before an HIV prevention trial among drug users in Thailand and China. The assessment investigated whether law, policies and enforcement strategies would place research subjects at significantly elevated risk of arrest, incarceration, physical harm, breach of confidentiality, or loss of access to health care relative to drug users not participating in the research. The study validated the investigator's concern that drug (...) users were subject to serious social risks in the site localities, but also suggested that participation in research posed little or no marginal increase in risk and might even have a protective effect. Our experience shows that it is feasible to inform IRB deliberations with actual data on social risks, but also raises the question of whether and when such research is an appropriate use of scare research resources. (shrink)

To make more responsible decisions regarding risk and to understand disagreements and controversies in risk assessments, it is important to know how and where values are infused into risk assessment and how they are embedded in the conclusions. In this article an attempt is made to disentangle the relationship of science and values in decision-making concerning the deliberate release of genetically modified organisms (GMOs) into the environment. This exercise in applied philosophy of science is based on (...) Helen Longino's contextual empiricism which attempts to reconcile the objectivity of science with its social and cultural construction. Longino distinguishes different levels of research on which values apparently contextual with respect to a given research program can shape the knowledge emerging from that program. Her scheme is applied for locating and identifying the values that affect environment risk assessments of the field experiments with GMOs. The article concludes with some provisional suggestions for the decision process and the role of scientists in it. (shrink)

In 2004, prenatal risk assessment (PRA) was implemented as a routine offer in Denmark, in order to give all pregnant women an informed choice about whether to undergo prenatal testing. PRA is a non-invasive intervention performed in the first trimester of pregnancy and measures the risk of a fetus having Down's syndrome or other chromosomal disorders. The risk figure provides the basis for action, i.e. the decision about whether or not to undergo invasive fetal testing via (...) the maternal route (amniocentesis or chorionic villus sampling), which, however, involves the risk of inducing a miscarriage. On the basis of ethnographic fieldwork in an ultrasound clinic in Denmark and interviews with pregnant women and their partners, this paper investigates how ideals such as autonomy and non-directiveness are practised in processes of decision-making. We view such ideals as forming social practice rather than neutral instruments to reach a certain goal. Focusing on one couple's trajectory through the clinical practices of PRA and the process through which a decision is reached, we call into question the assumption that more choice and more objective information is a source of empowerment and control. We make evident how decisions are made through a complicated process of meaning-making, which emerges through the relationship between professionals, the clinical setting and the social life of the couples. In the face of complex risk knowledge, PRA users are reluctant to make choices and seek to re-install authority in the health professionals. However, when assumptions about autonomy and self-determination are inscribed into the social practice of PRA, authority is transferred to the couple undergoing PRA and a new configuration of responsibility evolves between the couple and their relationship to the fetus. It is argued that PRA performs a form of government that works not through compulsion or persuasion but through choice. An ethic of a shared responsibility for PRA and its outcome between pregnant women and health professionals would be more in agreement with how decisions are actually made. (shrink)

Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of (...) time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally. (shrink)

Both the Sarbanes–Oxley Act of 2002 and the Dodd-Frank Act of 2010 include clawback provisions that require executives to pay back incentive compensation earned on financial statements that are restated in a subsequent period. Such provisions intend to reduce unethical reporting behavior by executives who otherwise might be more inclined to misstate financial statements to boost incentive-based compensation. However, such provisions could promote rather than deter unethical behavior. In particular, Pyzoha :2515–2536, 2015) finds that, under certain conditions, executives are less (...) willing to restate financial statements in the presence of a clawback policy. Similarly, auditors might also act unethically by being less likely to propose restatements in the presence of clawbacks to avoid upsetting management. To examine this possibility, this study reports the results of three experiments that examine the effect of clawback provisions on auditor judgment. Contrary to expectations, our three experiments, along with supplemental qualitative evidence consistently indicate that clawbacks do not affect auditors’ propensity to propose restatements. These results suggest that a decrease in the number of restatements in a clawback environment will not be due to auditors acting unethically to appease management. The effects of clawbacks on auditors’ risk assessments, however, are less conclusive. As such, we offer potential post hoc explanations to guide future research. (shrink)

Recruiting patients to participate in health research is challenging, and most studies struggle. Failure to recruit can jeopardise the quality of research, and threatens efforts to improve healthcare. Despite this, recruitment materials tend to be conservatively designed and unimaginative. One reason for this is ethical concerns regarding the risk of coercion and offence posed by recruitment materials. The OXTEXT research programme gave patients a leading role in the design of new recruitment materials, in an area where stigma and discrimination (...) make ethical risks particularly acute. We discovered that our patient-designed recruitment materials were much bolder than usual, and they put the existing ethical boundaries to the test. The materials were effective and well liked – patients regarded them as neither unacceptable nor coercive. This suggests we may need to rethink the ethics of recruitment to research such that we permit more creative recruitment materials. In addition, it suggests a new role for patient input into research as designers of recruitment materials. (shrink)

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced (...) including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area. (shrink)