In this paper I am concerned with risk–benefit analysis; that is, the comparison of the risks of a situation to its related benefits. We all face such situations in our daily lives and they are very common in medicine too, where risk–benefit analysis has become an important tool for rational decision-making. This paper explores risk–benefit analysis from a logical point of view. In particular, it seeks a better understanding of the common view that decisions should be made (...) by weighing risks against benefits and that an option should be chosen if its benefits outweigh its risks. I devote a good deal of this paper scrutinizing this popular view. Specifically, I demonstrate that this mode of reasoning is logically faulty if “risk” and “benefit” are taken in their absolute sense. But I also show that arguing in favour of an action because its benefits outweigh its risks can be valid if we refer to incremental risks and benefits. (shrink)

In this chapter, Kelly Oliver argues that while risk-benefit analysis may be necessary in a crisis situation such as the Covid-19 pandemic, that does not make it ethical. To the contrary, risk-benefit analysis is antithetical to ethics defined as responsibility to the singularity of each living being. Triage medicine, developed for the battlefield during wartime, relies on risk-benefit calculations. For example, calculations about which patient has the best chance for survival, or which patient has the best chance of (...) quality of life or continued longevity. In the current pandemic, these calculations were based on population categories of health such as diabetes, coronary disease, obesity, and age, along with assessments of the individual patient’s condition. While such assessments may meet practical policy demands, ultimately, they are not ethical. In the end, she argues for what she calls “response ethics” as an alternative to utilitarian risk-benefit analysis. (shrink)

Risks and benefit evaluation for controlled human infection studies, where healthy volunteers are deliberately exposed to infectious agents to evaluate vaccine efficacy, should be explicit, systematic, thorough, and non‐arbitrary. Decision analysis promotes these qualities using four steps: (1) determining explicit criteria and measures for evaluation, (2) identifying alternatives to the study, (3) defining the models used to estimate the measures for each alternative, and (4) running the models to produce the estimates and compare the alternatives. In this paper, we (...) describe how decision analysis might be applied by funders and regulators, as well as by others contemplating the use of novel controlled human infection studies for vaccine development and evaluation. (shrink)

An offshoot of decision analysis, risk-cost-benefit analysis (RCBA) dominates US policymaking regarding science and technology. In this paper a central normative presupposition of RCBA, called "the linearity assumption" is argued against. This is that there is a linear relationship between the actual probability of fatality and the value of avoiding a social risk or the cost of a social risk. The main object of this essay is to show that the presuppositions underlying the linearity assumption are highly questionable. (...) It is maintained that assessors ought to give more consideration to broadening their interpretations of "unit cost" and "societal risk" and to abandoning their claims about linearity. (shrink)

Much of the contemporary debate about the propriety of non-therapeutic circumcision of male infants and boys revolves around the question of risks vs. benefits. With its headline conclusion that the benefits outweigh the risks, the current circumcision policy of the American Academy of Pediatrics [AAP] (released 2012) is a typical instance of this line of thought. Since the AAP states that it cannot assess the true incidence of complications, however, critics have pointed out that this conclusion is unwarranted. In this (...) paper it is argued that the AAP’s conclusion is untenable not only for empirical reasons related to lack of data, but also for logical and conceptual reasons: the concept of risk employed—risk of surgical complications—is too narrow to be useful in the circumcision debate. Complications are not the only harms of circumcision: the AAP and other parties debating the pros and cons of circumcision should conceptualize their analysis more broadly as risk of harm vs. prospect of benefit, thereby factoring in the value of the foreskin to the individual and the physical and ethical harms of removing it from a non-consenting child. (shrink)

Modern antiretroviral therapies are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical (...) prospect associated with participation in cure research thus look poor. Are the risks and burdens that HIV cure research places on participants so high that it is unethical, at present, to conduct it? In this paper, I answer ‘no’. I start my argument by describing a foundational way of thinking about the ethical justification for regulatory limits on research risk; I then apply this way of thinking to HIV cure trials. In offering this analysis, I confine my attention to studies enrolling competent adults and I also do not consider risks research may pose to third parties or society. Rather, my concern is to engage with the thought that some trials are so risky that performing them is an ethically unacceptable way to treat the participants themselves. I reject this thought and instead argue that there is no level of risk, no matter how high, that inherently mistreats a participant. (shrink)

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at (...) least 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

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

In this paper the coherence of the precautionary principle as a guide to public health policy is considered. Two conditions that any account of the principle must meet are outlined, a condition of practicality and a condition of publicity. The principle is interpreted in terms of a tripartite division of the outcomes of action . Such a division of outcomes can be justified on either “consequentialist” or “deontological” grounds. In the second half of the paper, it is argued that the (...) precautionary principle is not necessarily opposed to risk–cost–benefit analysis, but, rather, should be interpreted as suggesting a lowering of our epistemic standards for assessing evidence that there is a link between some policy and “special bad” outcomes. This suggestion is defended against the claim that it mistakes the nature of statistical testing and against the charge that it is unscientific or antiscientific, and therefore irrational. (shrink)

Cost-benefit analysis (CBA) is inappropriate as an aid to Covid policy-making because the plural, incommensurable values at stake are not all amenable to monetary measurement. CBA for Covid policy is also undermined by pervasive uncertainty and ignorance, and has some troubling distributional implications. However, non-consequentialist alternatives to CBA tend towards implausibly absolutist prohibitions on risk imposition. Arguments for setting aside consequentialism for special circumstances (the precautionary principle, or a medical rule of rescue) are also problematic when applied to Covid (...) policy. A broad consequentialist approach to policy guidance is defended, one which does not demand commensuration on a common monetary scale. Despite the absence of commensuration, policy guidance is still possible. (shrink)

What is the proper role of cost-benefit analysis in understanding the tort concept of negligence or reasonable care? A straightforward question, you might think. But it is a question that manages to elicit groans of exasperation from those on both sides of the controversy. For most utilitarians and adherents to law and economics, the answer is obvious: to say that people should not be negligent is to say that they should minimize the sum of the costs of accidents and (...) the costs of preventing accidents. Under the economic formulation of the famous Learned Hand test, they should take a precaution if but only if the marginal costs (or burden, B) of that precaution are less than its marginal benefits (in the form of reduced risks of injury, measured by multiplying the probability (P) of the injury times the magnitude (L) of the injury if it occurs). If B>PxL, it would be absurd to require the greater expenditure, B. For many advocates of a fairness, corrective justice, rights-based, or contractualist perspective, the opposite answer is equally obvious. Permitting a person to impose risks of harm on others merely because he would thereby obtain a benefit (or would otherwise incur a burden) greater than the discounted value of the harm he might inflict, amounts to authorizing him to dump the costs of his risky activities on innocent victims. To permit this type of sacrifice of individuals on the altar of aggregate social welfare is morally abhorrent. Both sets of criticism have important elements of truth. Neither an unqualified cost-benefit analysis nor an unqualified rights-based rejection of tradeoffs is defensible - either as a description of tort doctrine and practice or as a normative prescription. However, a qualified (sensitive) consequentialist approach can accommodate legitimate criticisms of cost-benefit analysis: the consequentialist can launder preferences, and can consider the distribution of risk both in the social welfare calculus and in determining whether to compensate. At the same time, a qualified (tough-minded) deontological approach can accommodate the legitimate need to recognize tradeoffs: the deontologist can permit intrapersonal but not interpersonal aggregation of risks and benefits, can apply the concept of threshold deontology to risky activity, and can consider individual rather than population risk. I conclude that the formulation of the Learned Hand test found in the Restatement Third of Torts is broad enough to encompass each of these qualified approaches. (shrink)

Fracking or the extraction of shale gas through hydraulic fracturing of rock has become a contested topic, especially in the United States, where it has been deployed on a large scale, and in Europe where it is still largely speculative. Research is beginning to investigate the environmental and economic costs and benefits as well as public perceptions of this new energy technology. However, so far the social and psychological impact of fracking on those involved in it, such as gas workers, (...) or those living in the vicinity of fracking sites, has escaped the attention of the social science research community. In this article we begin to fill this gap through a small-scale thematic analysis of representations of fracking in fifty YouTube videos, where the trailer of a controversial film, Gasland (Fox, 2010), has had a marked impact. Results show that the videos discuss not only environmental and economic costs and benefits of fracking but also social and psychological impacts on individuals and communities. These videos reveal a human face of fracking that remains all too often hidden from view. (shrink)

For many innovations, oversight fits nicely within existing governance mechanisms; nevertheless, others pose unique public health, environmental, and ethical challenges. Synthetic artemisinin, for example, has many precursors in laboratory‐developed drugs that emulate natural forms of the same drug. The policy challenges posed by synthetic artemisinin do not differ significantly in kind from other laboratory‐formulated drugs. Synthetic biofuels and gene drives, however, fit less clearly into existing governance structures. How many of the new categories of products require new forms of regulatory (...) oversight, or at least extensive forms of testing, remains unclear.Any effort to improve the governance of synthetic biology should start with a rich understanding of the different possible science‐policy interfaces that could help to inform governance. CBA falls into a subset of the overall range of possibilities, and which interface is appropriate may turn out to depend on context, on the demands of the decision at hand. In what follows, we lay out a typology of interfaces. After that, we turn to the question of how to draw upon the range of possible interfaces and effectively address the factual and moral complexities of emerging technologies. We propose a governance model built around structures that we call “governance coordinating committees.” GCCs are intended to be mechanisms for accommodating the complexities of innovations that have far‐ranging societal impacts. The production of biofuels, for example, could contaminate water supplies and have a destructive environmental impact if not managed correctly. The introduction of a gene drive could have economic and environmental impacts that are not restricted to one nation. Forging appropriate means for determining and evaluating those societal impacts, to the best of a corporation's, industry's, or government's ability, is central to responsible research and innovation. Public policy must be shaped in a manner that accommodates as many concerns as possible and minimizes risks. (shrink)

For each research protocol that they review, institutional review boards must assess whether the risks of the protocol are acceptable in relation to the potential direct benefits to study participants and/or society. This requirement means that an IRB should first identify risks that are not compensated by direct benefits to the subjects and then judge whether these so-called net risks are acceptable in relation to the benefits to society. We argue that the conventional approach to risk-benefit assessment is not accurate (...) enough to identify all net risks involved in any given protocol. Two relatively new approaches—the component analysis approach and the net risks test—can be of much more use to review boards, especially when used together. (shrink)

With the arrival of new methods of genome editing, especially CRISPR/cas 9, new perspectives on germline interventions have arisen. Supporters of germ line genome editing claim that the procedure could be used as a means of disease prevention. As a possible life-saving therapy, it provides benefits that outweigh its risks. Opponents of GGE claim that the medical and societal risks, especially the use of GGE for genetic enhancement, are too high. In our paper, we analyze the risks and benefits of (...) GGE. We show that the medical risk on an individual level might be reduced by further research in the near future so that they may be outweighed by the benefits. We also show that the societal risks of the procedure, i.e. genetic enhancement, are manageable by establishing a regulative framework before the GGE is implemented. Since the effects of modifying genes for the genepool of a given population are extremely difficult to model, the medical risks on the population level might be too high. (shrink)

The repertory grid method was used to determine what terminology respondents use to distinguish between different applications of genetic engineering drawn from food- related, agricultural, and medical applications. Respondents were asked to react to fifteen applications phrased in general terms, and results compared with a second study where fifteen more specific applications were used as stimuli. Both sets of data were submitted to generalized Procrustes analysis. Applications associated with animals or human genetic material were described as causing ethical concern, (...) being unnatural, harmful, and dangerous. Those involving plants or microorganisms were described as beneficial, progressive, and necessary. The results were validated in survey research, which indicated that general applications ofgenetic engineering were perceived as either positive or negative, whereas specific applications were more highly differentiated in perceptual terms. The results imply that the public debate about genetic engineering must take due account of the complexity of public concerns. (shrink)

Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without (...) direct benefit that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

Background In a previous paper in Philos Ethics Humanit Med, the 1937 Swedish novel Sömnlös (Swedish for sleepless) by Vilhelm Moberg was used as background for a thought experiment, in which last century’s progresses concerning the safety of sleeping pills were projected into the future. This gave rise to a theoretical discussion about broad medico-philosophical questions such as (among other things) the concept of pharmaceuticalisation. Methods In this follow-up paper, the theme of insomnia in Sömnlös is complemented by a discussion (...) of the concept of nostalgia. The core of the paper is a theoretical discussion about the benefits and risks of nostalgia, bringing together some aspects of recent psychological research about the construct of nostalgia with the main story line of the novel. Results and Conclusion Nostalgia is portrayed as being, in some sense at least, ultimately beneficial for the protagonist of Sömnlös. This is congruent with recent psychological research. However, the story also shows that nostalgia may lead to problematic behaviours, at least when viewed from a virtue ethics perspective. Hence, nostalgia is both what leads the protagonist into ethically problematic behaviour and that which (paradoxically) ultimately saves him from his initial lack of courage, justice, temperance and practical wisdom. Moreover, the protagonist does not only “grow” ethically but also existentially. Hence, the novel opens up the possibility that insomnia and nostalgia might be viewed as bearers of important existential information (cf. sociologist of religion Peter L. Berger and his concept of “signals of transcendence”). (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)

Although the standard theory and actual practice of cost-benefit analysis are seriously defective, the general idea of making social policy in accord with an aggregative, maximizing, consequentialist criterion is a sensible one. Therefore it is argued, against Bantz, that interpersonal utility comparisons can be meaningful, and, against both Bantz and MacLean, that quantitative overall assessments of expected value provide a presumptively rational basis for social choice. However, it does not follow that introducing cost-benefit tests into the political or legal (...) process would always be optimal: recognizing some quite stringent legal rights against involuntary exposure to pollution or risk may actually promote cost-beneficial results more reliably than cost-benefit tests employed in very imperfect circumstances. (shrink)

This paper defends two main claims. First: although it is easy to lose sight of this, what cost-benefit analysis really demands, in order to approve of a prospective policy, is that it be possible for those who would gain through the policy change to compensate those who would lose through it. And second: in cases where a policy change does, or can reasonably be expected to, lead to someone's death, the demand of compensability is much harder to satisfy than (...) economists typically think. More specifically, their standard move—maintaining that compensability should be judged ex ante, and that it is thus really just risk of death, not death itself, that must be (and often is) compensable—is unsuccessful. Then, the implications of these claims are briefly explored. (shrink)

In a number of writings, Cass Sunstein has argued that we should use cost-benefit analysis as our primary approach to risk management, because cost-benefit analysis corrects for the cognitive biases that mar our thinking about risk. The paper critically evaluates this ‘cognitive argument for cost-benefit analysis’ and finds it wanting. Once we make distinctions between different cognitive errors and between different aspects of cost-benefit analysis, it becomes apparent that there are really two cognitive arguments, neither of (...) which is successful as arguments for cost-benefit analysis as a whole. One argument shows that the analysis aspect of cost-benefit analysis is warranted because it corrects for false beliefs about the magnitudes of risk and for the neglect of some costs. While this is a sound argument, it does not provide an argument for other aspects of cost-benefit analysis. The second argument purports to show that commensurating and monetizing the values of the effects of regulation is warranted because it corrects for the use of widely diverging values of a statistical life. This argument fails because the use of widely diverging values of a statistical life is not a cognitive error: It is neither precluded by considerations of instrumental rationality, nor by the requirement of treating like cases alike. (shrink)

COVID-19 vaccination of children has begun in various high-income countries with regulatory approval and general public support, but largely without careful ethical consideration. This trend is expected to extend to other COVID-19 vaccines and lower ages as clinical trials progress. This paper provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we argue that it is currently unclear whether routine COVID-19 vaccination of healthy children is ethically justified in most contexts, given the minimal direct benefit that COVID-19 (...) vaccination provides to children, the potential for rare risks to outweigh these benefits and undermine vaccine confidence, and substantial evidence that COVID-19 vaccination confers adequate protection to risk groups, such as older adults, without the need to vaccinate healthy children. We conclude that child COVID-19 vaccination in wealthy communities before adults in poor communities worldwide is ethically unacceptable and consider how policy deliberations might evolve in light of future developments. (shrink)

IntroductionHigh healthcare costs make illness precarious for both patients and their families’ economic situation. Despite the recent focus on the interconnection between health and financial risk at the systemic level, the ethical conflict between concerns for potential health benefits and financial risk protection at the household level in a low-income setting is less understood.MethodsUsing a seven-step ethical analysis, we examine a real-life dilemma faced by families and health workers at the micro level in Ethiopia and analyse the acceptability of (...) limiting treatment for an ill newborn to protect against financial risk. We assess available evidence and ethical issues at stake and discuss the dilemma with respect to three priority setting criteria: health maximisation, priority to the worse-off and financial risk protection.ResultsGiving priority to health maximisation and extra priority to the worse-off suggests, in this particular case, that limiting treatment is not acceptable even if the total well-being gain from reduced financial risk is taken into account. Our conclusion depends on the facts of the case and the relative weight assigned to these criteria. However, there are problematic aspects with the premise of this dilemma. The most affected parties—the newborn, family members and health worker—cannot make free choices about whether to limit treatment or not, and we thereby accept deprivations of people’s substantive freedoms.ConclusionIn settings where healthcare is financed largely out-of-pocket, families and health workers face tragic trade-offs. As countries move towards universal health coverage, financial risk protection for high-priority services is necessary to promote fairness, improve health and reduce poverty. (shrink)

This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?

An individual's health, genetic, or environmental-exposure data, placed in an online repository, creates a valuable shared resource that can accelerate biomedical research and even open opportunities for crowd-sourcing discoveries by members of the public. But these data become “immortalized” in ways that may create lasting risk as well as benefit. Once shared on the Internet, the data are difficult or impossible to redact, and identities may be revealed by a process called data linkage, in which online data sets are matched (...) to each other. Reidentification, the process of associating an individual's name with data that were considered deidentified, poses risks such as insurance or employment discrimination, social stigma, and breach of the promises often made in informed-consent documents. At the same time, re-ID poses risks to researchers and indeed to the future of science, should re-ID end up undermining the trust and participation of potential research participants. The ethical challenges of online data sharing are heightened as so-called big data becomes an increasingly important research tool and driver of new research structures. Big data is shifting research to include large numbers of researchers and institutions as well as large numbers of participants providing diverse types of data, so the participants’ consent relationship is no longer with a person or even a research institution. In addition, consent is further transformed because big data analysis often begins with descriptive inquiry and generation of a hypothesis, and the research questions cannot be clearly defined at the outset and may be unforeseeable over the long term. In this article, we consider how expanded data sharing poses new challenges, illustrated by genomics and the transition to new models of consent. We draw on the experiences of participants in an open data platform—the Personal Genome Project—to allow study participants to contribute their voices to inform ethical consent practices and protocol reviews for big-data research. (shrink)

Examining those risk and benefit perceptions utilised in the formation of attitudes and opinions about emerging technologies such as nanotechnology can be useful for both industry and policy makers involved in their development, implementation and regulation. A broad range of different socio-psychological and affective factors may influence consumer responses to different applications of nanotechnology, including ethical concerns. A useful approach to identifying relevant consumer concerns and innovation priorities is to develop predictive constructs which can be used to differentiate applications of (...) nanotechnology in a way which is meaningful to consumers. This requires elicitation of attitudinal constructs from consumers, rather than measuring attitudes assumed to be important by the researcher. Psychological factors influencing societal responses to 15 applications of nanotechnology drawn from different application areas were identified using repertory grid method in conjunction with generalised Procrustes analysis. The results suggested that people differentiate nanotechnology applications based on the extent to which they perceive them to be beneficial, useful, necessary and important. The benefits may be offset by perceived risks focusing on fear and ethical concerns. Compared to an earlier expert study on societal acceptance of nanotechnology, consumers emphasised ethical issues compared to experts but had less concern regarding potential physical contact with the product and time to market introduction. Consumers envisaged fewer issues with several applications compared to experts, in particular food applications. (shrink)

It is almost universally acknowledged that risks have to be weighed against benefits, but there are different ways to perform the weighing. In conventional risk analysis, collectivist risk-weighing is the standard. This means that an option is accepted if the sum of all individual benefits outweighs the sum of all individual risks. In practices originating in clinical medicine, such as ethical appraisals of clinical trials, individualist risk-weighing is the standard. This implies a much stricter criterion for risk acceptance, namely (...) that the risk to which each individual is exposed should be outweighed by benefits for that same individual. The different choices of risk-weighing methods in different policy areas seem to have emerged from traditional thought patterns and social relations, rather than from explicit deliberations on possible justifications for the alternative ways to weigh risks against benefits. It is not obvious how the prevalent differences in risk-weighing practices can be reconstructed in terms of consistent underlying principles of preventive health or social priority-setting. (shrink)

The growth of self-tracking and personal surveillance has given rise to the Quantified Self movement. Members of this movement seek to enhance their personal well-being, productivity, and self-actualization through the tracking and gamification of personal data. The technologies that make this possible can also track and gamify aspects of our interpersonal, romantic relationships. Several authors have begun to challenge the ethical and normative implications of this development. In this article, we build upon this work to provide a detailed ethical (...) class='Hi'>analysis of the Quantified Relationship. We identify eight core objections to the QR and subject them to critical scrutiny. We argue that although critics raise legitimate concerns, there are ways in which tracking technologies can be used to support and facilitate good relationships. We thus adopt a stance of cautious openness toward this technology and advocate the development of a research agenda for the positive use of QR technologies. (shrink)

Public decisions on environmental risk have traditionally been weighed in terms of the principle of efficiency and its methodologies, such as cost-benefit and risk-benefit analysis. These original essays argue for moving beyond the market paradigm toward making policy that incorporates environmental values. Scholars representing a broad range of disciplines present a thorough analysis and methodological investigation of environmental risk and the potential for integrating environmental values into the policymaking process. They address the normative and theoretical roots of environmental (...) risk, describe the distinct domain that exists for environmental values as opposed to economic values, and look at the conflicts between economic and environmental values within the applied context of the NIMBY (not in my back yard) phenomenon. (shrink)

Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach – forecast analysis – that would enable direct (...) and effective measure of the quality of risk/benefit estimation. We then consider some objections and limitations to the forecasting approach. (shrink)

Emerging technologies are, by definition, full of surprises: developments that we cannot fully anticipate and that might have some bad outcomes as well as good ones. This presents a challenge for anyone trying to make forward‐looking policy decisions, including those who apply benefit‐cost analysis. BCA is now widely known and used, but it is also widely misunderstood—by many of its advocates as well as its detractors. In this essay, I will begin by examining some of the strengths and weaknesses (...) of BCA as a normative science. Yes, “normative science” is an oxymoron, and the incongruity it speaks to is a source of much of the controversy; BCA is an imperfect answer, but often the best available answer, to the question of how a society should go about making collective but not unanimous choices.I also want to take a hard look at the question of what we are evaluating. BCA is designed to weigh government actions, to see whether they are in the public interest; it is not designed to evaluate private actions. But if the government action is to approve a private action that otherwise would be prohibited, then the BCA inevitably must evaluate the latter. From the perspective of a government regulator, it is very tempting to shift the burden of proof onto private innovators—to obligate them to seek permission to proceed, and to demonstrate that their proposed actions have acceptable risks and will produce a net social benefit. But such burden‐shifting is not merely an administrative convenience; it has serious economic consequences that need to be examined. (shrink)

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...) in research is required. Component analysis provides such a systematic approach. (shrink)

Mainstream risk analysis deviates in at least two important respects from the rationality ideal of mainstream economics. First, expected utility maximization is not applied in a consistent way. It is applied to endodoxastic uncertainty, i.e. the uncertainty (or risk) expressed in a risk assessment, but in many cases not to metadoxastic uncertainty, i.e. uncertainty about which of several competing assessments is correct. Instead, a common approach to metadoxastic uncertainty is to only take the most plausible assessment into account. This (...) will typically lead to risk-prone deviations from risk-neutrality. Secondly, risks and benefits for different persons are added to form a total value of risk. Such calculations are used to support the view that one should accept being exposed to a risk if it brings greater benefits for others. This is in stark contrast to modern Paretian welfare economics, that refrains from interindividual comparisons and does not require people to accept a disadvantage because it brings a larger advantage for others. (Published Online July 11 2006). (shrink)

Background: Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing (...) surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods: An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results: Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion: Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. (shrink)

Health care institutions have paid increasing attention to preventing nosocomial transmission of influenza through vaccination of health care personnel. While multifaceted voluntary interventions have increased vaccination rates, proponents of mandatory programs contend the rates remain unacceptably low. Conventional bioethical analyses of mandatory programs are inadequate; they fail to account for the obligations of nonprofessional personnel or to justify the weights assigned to different ethical principles. Using an ethics framework for public health permits a fuller analysis. The framework's focus on (...) fairness accentuates the potential differences between the risk of transmitting infection and employment status, and the need to equitably evaluate exemptions. The framework's emphasis on balancing benefits and burdens highlights the need to justify a specific goal and questions the need to exclude all nonmedical exemptions. While mandatory vaccination programs are justifiable, greater attention should be paid to their implementation. (shrink)

Health care institutions have paid increasing attention to preventing nosocomial transmission of influenza through vaccination of health care personnel. While multifaceted voluntary interventions have increased vaccination rates, proponents of mandatory programs contend the rates remain unacceptably low. Conventional bioethical analyses of mandatory programs are inadequate; they fail to account for the obligations of nonprofessional personnel or to justify the weights assigned to different ethical principles. Using an ethics framework for public health permits a fuller analysis. The framework's focus on (...) fairness accentuates the potential differences between the risk of transmitting infection and employment status, and the need to equitably evaluate exemptions. The framework's emphasis on balancing benefits and burdens highlights the need to justify a specific goal and questions the need to exclude all nonmedical exemptions. While mandatory vaccination programs are justifiable, greater attention should be paid to their implementation. (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)

Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review processes. (...) We collected every instance (N = 4,195) of feedback made on N = 197 ‘low-risk’ protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research. (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)