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)

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)

Some early phase clinical studies of candidate HIV cure and remission interventions appear to have adverse medical risk–benefit ratios for participants. Why, then, do people participate? And is it ethically permissible to allow them to participate? Recent work in decision theory sheds light on both of these questions, by casting doubt on the idea that rational individuals prefer choices that maximise expected utility, and therefore by casting doubt on the idea that researchers have an ethical obligation not to (...) enrol participants in studies with high risk–benefit ratios. This work supports the view that researchers should instead defer to the considered preferences of the participants themselves. This essay briefly explains this recent work, and then explores its application to these two questions in more detail. (shrink)

Existing ethical frameworks for public health provide insufficient guidance on how to evaluate the risks of public health programs that compromise the best clinical interests of present patients for the benefit of others. Given the relevant similarity of such programs to clinical research, we suggest that insights from the long‐standing debate about acceptable risk in clinical research can helpfully inform and guide the evaluation of risks posed by public health programs that compromise patients’ best clinical interests. We discuss (...) how lessons learned regarding the ethics of risk in one context can be fruitfully transferred to the other, using the example of a so‐called ‘rational antibiotic use’ guideline that limits antimicrobial prescribing in order to curb antimicrobial resistance. (shrink)

This research examined whether youth's forecasted risk taking is best predicted by a compensatory (namely, subjective expected utility) or non-compensatory (e.g., single-factor) model. Ninety youth assessed the importance of perceived benefits, importance of perceived drawbacks, subjective probability of benefits, and subjective probability of drawbacks for 16 risky behaviors clustered evenly into recreational and health/safety domains. In both domains, there was strong support for a noncompensatory model in which only the perceived importance of the benefits of engaging in a risky (...) behavior predicted youths' forecasted engagement in risky behavior. The study overcomes earlier methodological weaknesses by fully decomposing participants' assessments into importance and probability aspects for both benefits and drawbacks. As such, the findings provide clear evidence in support of a boundedrationality perspective on youth decision making regarding risk taking. (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)

Future-bias is the preference, all else being equal, for negatively valenced events be located in the past rather than the future, and positively valenced ones to be located in the future rather than the past. Strong risk aversion is the preference to pay some cost to mitigate the badness of the worst outcome. People who are both strongly risk averse and future-biased can face a series of choices that will guarantee them more pain, for no compensating benefit: (...) they will be pain pumped. Thus, combining these preferences is rationally impermissible. Dougherty (2011) argues that this gives us reason to think that future-bias is rationally impermissible. This argument, and a similar one presented by Greene and Sullivan (2015), relies on the idea that if several preferences are not rationally combinable, then in the absence of some explanation of why they are not combinable, we should conclude that (at least) one of them is rationally impermissible. We take up this question by, inter alia, reflecting on the empirical results of a study we ran that probes people’s risk averse and future-biased preferences. We argue that the data, in conjunction with other considerations, suggests that we should not infer from the irrationality of the combination of these preferences to the irrationality of one of the preferences singly. We also argue that given the descriptive data about these preferences, there is no reason to think that, if one of them is rationally impermissible, then it is future-bias. (shrink)

A lively topic of debate in decision theory over recent years concerns our understanding of the different risk attitudes exhibited by decision makers. There is ample evidence that risk-averse and risk-seeking behaviours are widespread, and a growing consensus that such behaviour is rationally permissible. In the context of clinical medicine, this matter is complicated by the fact that healthcare professionals must often make choices for the benefit of their patients, but the norms of rational choice are (...) conventionally grounded in a decision maker’s own desires, beliefs and actions. The presence of both doctor and patient raises the question of whose risk attitude matters for the choice at hand and what to do when these diverge. Must doctors make risky choices when treating risk-seeking patients? Ought they to be risk averse in general when choosing on behalf of others? In this paper, I will argue that healthcare professionals ought to adopt a deferential approach, whereby it is the risk attitude of the patient that matters in medical decision making. I will show how familiar arguments for widely held anti-paternalistic views about medicine can be straightforwardly extended to include not only patients’ evaluations of possible health states, but also their attitudes to risk. However, I will also show that this deferential view needs further refinement: patients’ higher-order attitudes towards their risk attitudes must be considered in order to avoid some counterexamples and to accommodate different views about what sort of attitudes risk attitudes actually are. (shrink)

ABSTRACT Because of the nature of preventive vaccination programs, the viability of these public health interventions is particularly susceptible to public perceptions. This is because vaccination relies on a concept of ‘herd immunity’, achievement of which requires rational public behavior that can only be obtained through full and accurate communication about risks and benefits. This paper describes how irrational behavior that threatens the effectiveness of vaccination programs – both in crisis and non‐crisis situations – can be tied to public perceptions (...) created by media portrayals of health risks. I concentrate on childhood vaccination as an exemplar of ‘non‐crisis’ preventive vaccination, and on the recent flu vaccine shortage as a ‘crisis’ situation. The paper concludes with an examination of the steps necessary to resolve these threats through better public communication. (shrink)

When the costs of acquiring knowledge outweigh the benefits of possessing it, ignorance is rational. In this paper I clarify and explore a related but more neglected phenomenon: cases in which ignorance is motivated by the anticipated costs of possessing knowledge, not acquiring it. The paper has four aims. First, I describe the psychological and social factors underlying this phenomenon of motivated ignorance. Second, I describe those conditions in which it is instrumentally rational. Third, I draw on evidence from the (...) social sciences to argue that this phenomenon of rational motivated ignorance plays an important but often unappreciated role in one of the most socially harmful forms of ignorance today: voter ignorance of societal risks such as climate change. Finally, I consider how to address the high social costs associated with rational motivated ignorance. (shrink)

The basic question for risk assessment is not "What are the risks?" but "How safe is safe enough?" Its ambitious goal is to make risk management a scientific enterprise. In order to succeed, not only must risks be quantified but also the many kinds of costs and benefits associated with technology and its control must be quantified and we must find a common metric for comparing these different factors. The risks of risk assessment include the possibility of (...) distorting values in the quest for general comparability and also the problem of responding rationally to different kinds of uncertainty. The problems discussed include comparing novel events to statistically frequent events, comparing different distributions of risk, and quantifying the value of saving human lives. (shrink)

Is there such a thing as a “best scientific methodology” in regulatory science? By examining cases from varying regulatory processes, we argue that there is no best scientific method for generating decision-relevant data. In addition, in regulatory science, the most suitable methodologies often differ from what is considered best practice in knowledge-oriented science. In data generation for regulatory purposes, we are faced with a wide spectrum of preferred methodologies as well as controversy as to methodological choice. What goes by the (...) most adequate scientific method can and will—justifiably and rationally—vary significantly according to context and use. In order to make this argument, we analyze four case studies, two from risk assessment and two from benefit assessment. Our analysis shows that it is the noncognitive objectives of a particular regulatory process that determine what counts as the most appropriate scientific method. We use the concept of bounded rationality to indicate that those methodological choices, despite being context-dependent, can be interpreted as rational. (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)

In ‘Patients, doctors and risk attitudes,’ Makins argues for ‘straightforwardly’ (Makins1 p1) extending antipaternalistic views about medical decision-making to include deferential considerations of risk attitudes that a patient might endorse. Reflecting on Makins’ important contribution to higher order attitudes in decision theory, we seek to clarify the practical applicability of his argument to specific clinical settings, namely in mental health. We argue that considering low and higher order risk preferences are not only practically difficult, but also potentially (...) ethically fraught and especially so in the provision of mental healthcare. Deferring to risk attitudes potentially mutes a more robust curiosity of patients’ preferences and desires that can promote both autonomy and beneficence but are explicitly relationally grounded. We argue that a relational understanding of autonomy is a much more robust way of thinking about the value of risk attitudes among other patient preferences, attitudes and goals. Makins rightly expounds on the challenges faced by healthcare professionals who are often required to make determinative recommendations for their patients. Providers must explain uncertain benefits in relation to uncertain risks, therefore, exploring the risk attitudes of patients, appears, prima facie, a rational, patient-centred and autonomy-promoting choice. It invariably invites discussion of Perske’s 1972 dignity of …. (shrink)

Decision Making Competence (DMC) reflects individual differences in rational responding across several classic behavioral decision-making tasks. Although it has been associated with real-world risk behavior, less is known about the degree to which DMC contributes to specific components of risk attitudes. Utilizing a psychological risk-return framework, we examined the associations between risk attitudes and DMC. Italian community residents (n = 804) completed an online DMC measure, using a subset of the original Adult-DMC battery (A-DMC; Bruine de (...) Bruin, Parker, & Fischhoff, 2007). Participants also completed a self-reported risk attitude measure for three components of risk attitudes (risk-taking, risk perceptions, and expected benefits) across six risk domains. Overall, greater performance on the DMC component scales were inversely, albeit modestly, associated with risk-taking tendencies. Structural equation modeling results revealed that DMC was associated with lower perceived expected benefits for all domains. In contrast, its association with perceived risks was more domain-specific. These analyses also revealed stronger indirect effects for the DMC  expected benefits  risk-taking than the DMC  perceived risk  risk-taking path, especially for risk behaviors that may be considered more antisocial in nature. These results suggest that DMC performance differentially impacts specific components of risk attitudes, and may be more strongly related to the evaluation of expected value of the given behavior. (shrink)

Research on incompetent humans raises ethical challenges, especially when there is no direct benefit to these research subjects. Contemporary codes of research ethics typically require that such research must specifically serve to benefit the population to which the research subjects belong. The article critically examines this “same-population condition”, raising issues of both interpretation and moral justification. Of particular concern is the risk that the way in which the condition is articulated and rationalized in effect disguises or downplays (...) the instrumentalization of incompetent individuals. (shrink)

Antimicrobial therapy is a cornerstone of therapy in critically ill patients; however, the wide use of antibiotics has resulted in increased antimicrobial resistance and outbreaks of resistant disease. To counter this, many hospitals have instituted antimicrobial stewardship programmes as a way to reduce the inappropriate use of antibiotics. However, uptake of antimicrobial stewardship programmes has been variable, as many clinicians fear that they may put individual patients at risk of treatment failure. In this paper, I argue that antimicrobial stewardship (...) programmes are indeed a form of bedside rationing, and explore the risks and benefits of such programmes for individual patients in the intensive care unit, and the critically ill population in general. Using Norman Daniels’ Accountability for Reasonableness as a framework for evaluating resource allocation policies, I conclude that antimicrobial stewardship programmes are an ethically sound form of bedside rationing. (shrink)

The Oregon Health Plan gained national attention by changing the focus of health care from who is covered to what is covered. This change was facilitated by insurance reforms in the areas of small market, employer mandates, high risk pooling and Medicaid. Most controversial of the reforms is the use by the legislature of a prioritized list of health services to determine benefit levels for the insurance programs. Significant debate has occured over whether the use of such a (...) list is rationing or reasoning. The Oregon Health Plan represents a thoughtful and deliberate blending of fact with public value for the purpose of responsible health policy. It is that unique blending of public values developed through community participation with fact that focused the attention of the world on Oregon. Keywords: community participation, employer mandates, health care reform, prioritization, rationing, small market insurance reform CiteULike Connotea Del.icio.us What's this? (shrink)

Because of the nature of preventive vaccination programs, the viability of these public health interventions is particularly susceptible to public perceptions. This is because vaccination relies on a concept of ‘herd immunity’, achievement of which requires rational public behavior that can only be obtained through full and accurate communication about risks and benefits. This paper describes how irrational behavior that threatens the effectiveness of vaccination programs – both in crisis and non-crisis situations – can be tied to public perceptions created (...) by media portrayals of health risks. I concentrate on childhood vaccination as an exemplar of ‘non-crisis’ preventive vaccination, and on the recent flu vaccine shortage as a ‘crisis’ situation. The paper concludes with an examination of the steps necessary to resolve these threats through better public communication. (shrink)

This chapter provides a defense of a type of occupational pension, known as “collective defined contribution”, which is based on the idea that it is possible to limit the employer’s liability to nothing more than a set contribution while retaining many of the benefits of the collectivization of risks of a traditional defined benefit pension. CDC can be defended against a freedom-based objection from the right via an appeal to the following Hobbesian voluntarist justification: CDC constitutes a “Leviathan of (...) Leviathans” into which it is rational for workers to choose to associate in order to tame longevity and investment risks. CDC pensions that arise from and mirror existing income inequalities can also be defended against an egalitarian objection from the left, by demonstration that they can be grounded in Rawlsian principles of reciprocity and property-owning democracy. (shrink)

There is no doubt that a negative perception of financial risk and a lack of credit risk management adversely impact business growth and business owners’ wellbeing. Past studies suggest that most Nigerian traders have poor risk perceptions and manage risk poorly. A business coaching program within rational-emotive behavior therapy framework was evaluated in order to determine its effects on financial risk perception and credit risk management among Nigerian traders. This study used an open-label parallel (...) randomized control design. This 8-weeks coaching program had 60 traders in the REBT-based business coaching group and 59 traders in the control group. The mixed-model repeated measures ANOVA was utilized for analysis of the study data. Results show that relative to a control group, traders’ financial risk perception [F = 637.29, p < 0.001, ω2 = 0.69] and credit risk management [F = 795.51, p < 0.001, ω2 = 0.80] significantly improved after participating in REBT-based business coaching program. This study shows that REBT-based business coaching program is integral to increasing financial risk perception and credit risk management among Nigerian traders. This study contributes to the advancement of business coaching program within the rational-emotive behavior therapy framework for market traders, and its application in similar situations. The study considered the benefits of business coaching program for market traders from a developing country, which is a rarely studied group. It is highly recommended that professionals study the relationship between REBT-based business coaching and economic decision-making within various organizational contexts. (shrink)

Centralized, democratic rules are often asserted as a superior basis for rationing than individualized physician discretion. This article counters this prevailing wisdom by exploring the deficiencies of rule-based rationing. Rules are too imprecise to accurately reflect all the nuances of physical and mental impairment and the complexity of medical science, particularly considering the widely varying personal values that different patients attach to medical risk and benefit. Rule-based rationing also suffers from the biasing effects of interest group pressure on (...) political processes and the tendency to absolve physicians from any moral responsibility for the rationing decisions they implement. Internalizing cost constraints is a more socially and professionally acceptable means of rationing and, in any event, it is inevitable since even a preponderance of rule-based rationing will leave considerable areas of discretion for physician judgment in the implementation and interpretation of the rules. As a consequence, despite the flaws of bedside rationing, it is foolhardy to dispense with it entirely in favor of an exclusively rule-based system. Keywords: Bedside rationing, cost-constraints, rule-based rationing CiteULike Connotea Del.icio.us What's this? (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)

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case (...) of a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: clinical use may not have stronger evidence than research use; a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; treatment within the context of a clinical trial may be the standard of care; and research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation. (shrink)

Lara Buchak sets out a new account of rational decision-making in the face of risk. She argues that the orthodox view is too narrow, and suggests an alternative, more permissive theory: one that allows individuals to pay attention to the worst-case or best-case scenario, and vindicates the ordinary decision-maker.

Policies and position statements regarding decision-making for extremely premature babies exist in many countries and are often directive, focusing on parental choice and expected outcomes. These recommendations often state survival and handicap as reasons for optional intervention. The fact that such outcome statistics would not justify such approaches in other populations suggests that some other powerful factors are at work. The value of neonatal intensive care has been scrutinized far more than intensive care for older patients and suggests that neonatal (...) care is held to a higher standard of justification. The relative value placed on the life of newborns, in particular the preterm, is less than expected by any objective medical data or any prevailing moral frameworks about the value of individual lives. Why do we feel less obligated to treat the premature baby? Do we put newborns in a special and lesser moral category? We explore this question from a legal and ethical perspective and offer several hypotheses pertaining to personhood, reproductive choices, “precious children,” and probable evolutionary and anthropological factors. (shrink)

Almost 60,000 people in the United States with end stage renal disease are waiting for a kidney transplant. Because of the scarcity of organs from deceased donors live kidney donors have become a critical source of organs; in 2001, for the first time in recent decades, the number of live kidney donors exceeded the number of deceased donors. The paradigm used to justify putting live kidney donors at risk includes the low risk to the donor, the favorable (...) class='Hi'>risk-benefit ratio, the psychological benefits to the donor, altruism, and autonomy coupled with informed consent; because each of these arguments is flawed we need to lessen our dependence on live kidney donors and increase the number of organs retrieved from deceased donors. An "opting in" paradigm would reward people who agree to donate their kidneys after they die with allocation preference should they need a kidney while they are alive. An "opting in" program should increase the number of kidneys available for transplantation and eliminate the morally troubling problem of "organ takers" who would accept a kidney if they needed one but have made no provision to be an organ donor themselves. People who "opt in" would preferentially get an organ should they need one at the minimal cost of donating their kidneys when they have no use for them; it is a form of organ insurance a rational person should find extremely attractive. An "opting in" paradigm would simulate the reciprocal altruism observed in nature that sociobiologists believe enhances group survival. Although the allocation of organs based on factors other than need might be morally troubling, an "opting in" paradigm compares favorably with other methods of obtaining more organs and accepting the status quo of extreme organ scarcity. Although an "opting in" policy would be based on enlightened self-interest, by demonstrating the utilitarian value of mutual assistance, it would promote the attitude that self-interest sometimes requires the perception that we are all part of a common humanity. (shrink)

After giving a brief account of human rights, the paper investigates five contemporary attacks on them. All of the attacks come from two contemporary proponents of the cost-benefit state, attorney Cass Sunstein and philosopher Larry Laudan. These attacks may be called, respectively, the rationality, objectivity, permission, voluntariness, and comparativism claims. Laudan's and Sunstein's rationality claim (RC) ist that only policy decisions passing cost-benefit tests are rational. Their objectivity presupposition (OP) is that only acute, deterministic threats to life are (...) objective. Sunstein’s permission claim (PC) is that regulators are merely permitted, 3 not required, to take distributive and human rights concerns into account. Sunstein’s 3 voluntariness claim (VC) is that the consent of potential victims is not relevant to government regulations about risks and benefits. Laudan’s comparativism claim 3 (CC) is that there are no rules of thumb, no precomparative norms like human rights, for assessing theory choice in policy science. The paper analyzes each of these claims, shows how they undercut human rights, and argues that each of them errs. (shrink)

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

Antimicrobial resistance kills people. According to a recent estimate, ‘7 00 000 people die of resistant infections every year’, and ‘by 2050 10 million lives a year are at risk due to drug resistant infections, as are 100 trillion USD of economic output’.1 Today, ‘bacteria are resistant to nearly all antibiotics that were earlier active against them’.2 For all these reasons, antimicrobial resistance is considered a ‘slowly emerging disaster’3 and a ‘global health security issue’.4 The prospect we are facing (...) is that of a ‘post antibiotic era’,5 in which we risk losing the availability of effective antibiotics and, with them, of medical interventions that require effective antibiotics, such as chemotherapy, transplantation and major surgery. One of the causes of antimicrobial resistance is antimicrobial consumption. As put by the Centers for Disease Control and Prevention, ‘the use of antibiotics is the single most important factor leading to antibiotic resistance around the world: simply using antibiotics creates resistance’.6 According to the 2016 Review on Antimicrobial Resistance commissioned by the UK Government, ‘more consumption of antibiotics directly leads to more resistance’.1 This is because microbes that are not killed by antimicrobials are more likely to reproduce and proliferate and to pass their resistance genes on to other microbes. Thus, exactly like the consumption of many other finite resources, antibiotic and antimicrobial consumption gives rise to the collective action problem known as ‘tragedy of the commons’: consuming a certain resource, such as antimicrobials, is in an individual’s best short-term interest, but many instances of individual consumption erode the resource and therefore conflict with the collective interest in preserving the good. How to solve a tragedy of the commons? As is the case with the consumption of other finite resources, the answer is quite simple: by rationing the resource. Simon Oczkowski’s article …. (shrink)

Who is right? In Risk and Rationality, Kristin Shrader-Frechette argues that neither charges of irresponsible endangerment nor countercharges of scientific illiteracy frame the issues properly.

Almost 60,000 people in the United States with end stage renal disease are waiting for a kidney transplant. Because of the scarcity of organs from deceased donors live kidney donors have become a critical source of organs; in 2001, for the first time in recent decades, the number of live kidney donors exceeded the number of deceased donors. The paradigm used to justify putting live kidney donors at risk includes the low risk to the donor, the favorable (...) class='Hi'>risk-benefit ratio, the psychological benefits to the donor, altruism, and autonomy coupled with informed consent; because each of these arguments is flawed we need to lessen our dependence on live kidney donors and increase the number of organs retrieved from deceased donors. An “opting in” paradigm would reward people who agree to donate their kidneys after they die with allocation preference should they need a kidney while they are alive. An “opting in” program should increase the number of kidneys available for transplantation and eliminate the morally troubling problem of “organ takers” who would accept a kidney if they needed one but have made no provision to be an organ donor themselves. People who “opt in” would preferentially get an organ should they need one at the minimal cost of donating their kidneys when they have no use for them; it is a form of organ insurance a rational person should find extremely attractive. An “opting in” paradigm would simulate the reciprocal altruism observed in nature that sociobiologists believe enhances group survival. Although the allocation of organs based on factors other than need might be morally troubling, an “opting in” paradigm compares favorably with other methods of obtaining more organs and accepting the status quo of extreme organ scarcity. Although an “opting in” policy would be based on enlightened self-interest, by demonstrating the utilitarian value of mutual assistance, it would promote the attitude that self-interest sometimes requires the perception that we are all part of a common humanity. (shrink)

Digital health technologies are often advocated as a way of helping people monitor, promote and manage their health, care for others and reduce the burden on healthcare systems. Yet these technologies have also been subject to criticism for limiting human flourishing and exacerbating socioeconomic disadvantage. Bioethical appraisals of digital health technologies tend to take a conventional risk‐benefit approach, positioning the human subject as a rational, autonomous agent who is acted on by technologies. In this paper, I present a (...) case for adopting an alternative more‐than‐human perspective on bioethics. A more‐than‐human approach considers human‐technological assemblages and agencies as distributed, relational, situated and emergent. To illustrate the insights that this perspective can offer, I draw on the findings of four empirical projects I have conducted on people’s use of digital devices and platforms used for health‐related purposes, including social media groups and online forums, mobile apps and wearable devices. I conclude with the argument that a more‐than‐human approach to bioethics can begin to incorporate a new ‘zoë ethics’ that can acknowledge and address the deeper affective, multisensory and relational dimensions of humans’ encounters with and enactments of material things and nonhuman creatures. (shrink)

Only ten to twelve percent of Americans would voluntarily live within a mile of a nuclear plant or hazardous waste facility. But industry spokespersons claim that such risk aversion represents ignorance and paranoia, and they lament that citizen protests have delayed valuable projects and increased their costs. Who is right? In _Risk and Rationality_, Kristin Shrader-Frechette argues that neither charges of irresponsible endangerment nor countercharges of scientific illiteracy frame the issues properly. She examines the debate over methodological norms for (...) risk evaluation and finds analysts arrayed in a spectrum. Points of view extend from cultural relativists who believe that any risk can be justified to naive positivists who believe that risk evaluation can be objective, neutral, and value free. Both camps, she argues, are wrong, because risk evaluation as a social process is rational and objective, even though all risk-evaluation rules are value-laden. Shrader-Frechette defends a middle position called "scientific proceduralism." She shows why extremist views are unreliable, reveals misconceptions underlying current risk-evaluation methods and strategies, and sketches the reforms needed to set hazard assessment and risk evaluation on a publicly defensible foundation. These reforms involve mathematical, economic, ethical, and legal procedures. They constitute a new paradigm for assessment when acceptance of public hazards is rational, recognizing that laypersons are often more rational in their evaluation of societal risks than either experts or governments have acknowledged. Such reforms would provide citizens with more influence in risk decisions and focus on mediating ethical conflicts, rather than seeking to impose the will of experts. Science, she argues, need not preclude democracy. (shrink)

While humans have made enormous progress in the exploration and exploitation of Earth, exploration of outer space remains beyond current human capabilities. The principal challenges lie in current space technology and engineering which includes the protection of astronauts from the hazards of working and living in the space environment. These challenges may lead to a paradoxical situation where progress in space technology and the ability to ensure acceptable risk/benefit for human space exploration becomes dissociated and the rate of (...) scientific discovery declines. In this paper, we discuss the predominant challenges of the space environment for human health and argue that development and deployment of a human enhancement policy, initially confined to astronauts – for the purpose of future human space programmes is a rational solution to these challenges. (shrink)

Polskie przepisy prawne formułujące warunki dopuszczalności eksperymentu medycznego, a więc ipso facto wyznaczające jego granice, można różnorako interpretować, zwłaszcza w tym zakresie, w jakim określają wymagany dla przeprowadzenia eksperymentu bilans związanych z nim możliwych korzyści i szkód. W artykułach prawniczych komentujących te przepisy w zasadzie jednak brak prób systematycznego i (na tyle, na ile pozwala na to sam przedmiot analizy) ścisłego wyróżnienia tych interpretacji w języku tzw. teorii racjonalnego wyboru (rational choice theory), teorii szczególnie przydatnej w tym kontekście z uwagi (...) na jej rozbudowany aparat pojęciowy pozwalający badać różnorakie konfiguracje relacji między costs i benefits. Artykuł próbuje wypełnić tę lukę: wyróżnione w nim zostały różne interpretacje przepisów prawnych określających warunki dopuszczalności eksperymentu medycznego; interpretacje te zostały również poddane ocenie. (shrink)

The paper is a record of a debate which took place between a group of clinicians and the author concerning a clinical trial of a drug supposed to postpone the time when HIV-patients develop AIDS. A problem with the trial was that on available (inconclusive) evidence it appeared that one patient out of 500 was killed by the drug. The question raised was whether, in view of this evidence, it was morally defensible to go on with the trial. The discussion (...) came to involve general topics such as the appropriate role of the ideal of autonomy as well as more particular topics of quantitative and qualitative risk assessments. The main thrust of the argument is that different conceptions of rationality may provide rationales of conflicting clinical decisions. Philosophy matters to medicine. Keywords: autonomy, equipoise, hazards, the Helsinki Declaration, maximizing expected utility, potential benefits, rationality, risk assessment CiteULike Connotea Del.icio.us What's this? (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 lieu of an abstract, here is a brief excerpt of the content:Credibility, Persuasiveness, and EffectivenessPatricia A. King (bio)Since the early 1970s, complex ethical, social, legal, and scientific controversies generated by biomedicine have been referred to governmentally created commissions, committees, boards, and panels that are commonly referred to as “ethics” committees. The Advisory Committee on Human Radiation Experiments is the most recent example of such a group. Although it is too early to know the full impact of the Committee’s work, (...) it is important to reflect on aspects of its deliberations that shed light on the public policy role of ethics bodies. Specifically, I will reflect on matters that go to the credibility, persuasiveness, and effectiveness of these committees.The point should be made at the outset that these ethics committees are, first and foremost, public policy groups. Governmentally created bodies of all types, including ethics committees, are established to provide pragmatic advice to governments about specific problems and controversies or to complete specified tasks on behalf of governments. What distinguishes ethics committees from other advisory groups is that the issues assigned to them are presumed to be primarily ethical, as opposed to, say, economic, in nature. It is expected that ethical analyses and premises will play a significant, albeit not exclusive, role in the committee’s deliberations. 1 As with other advisory groups, the primary responsibility of ethics committees is to respond to the branches of government that were instrumental in their creation as well as to the public at large. Since political concerns undoubtedly play a role in the creation of these groups, it is understandable that political concerns have some impact on the committee’s work. Thus, ethics committees are generally cognizant of the need to ensure that their processes and substantive conclusions are credible, persuasive, and effective.In my experience, members of ethics commissions understand the need to offer principled arguments that are factually accurate to justify their recommendations and conclusions. They also appreciate the need for consensus and rightly worry about disagreement among members. I believe, however, that committee members are less attentive than they should be to the social and political contexts in which they operate. This is not surprising. Members of these committees, and often their staffs as well, are typically experts drawn from the academy. [End Page 313] Scholars traditionally offer advice or influence policy through articles and scholarly work undertaken individually or in cooperation with like-minded individuals who do not need to be persuaded about the merits of a specific position. Moreover, scholarly articles are often pitched at a level of abstraction that may be of limited utility in the context of concrete decision making.Scholarly efforts are important. Particularly in bioethics, these scholarly efforts often have furnished the conceptual frameworks that are critical to the efforts of those who grapple with complex matters, the appropriate resolution of which pose moral disagreement and genuine perplexity. Policy formulation by its very nature, however, requires more. Attention must be paid to competing moral and social frameworks. Logical, rational arguments and risk/benefit assessments are important, but emotion, passion and values grounded in experience also demand consideration. Policy formulation as a result can be a quite messy process.Members of the academy are often uncomfortable in this environment. Pursuing the messy details can be threatening and at times at odds with values that academics prize highly. I believe this discomfort was evident in the reluctance of several Advisory Committee members to obtain security clearances that were required in order to see classified material related to the Committee’s work. Secrecy may have seemed at odds with cherished values of openness. As a result the perusal of classified materials was left to those with clearances. Fortunately, the Committee was successful in having relevant information declassified so all committee members read and deliberated about the same information. Committees needing to see more contemporaneous classified information might not be so fortunate.Ethics commission members correctly worry about disagreement. The ability to reach consensus helps to give recommendations a compelling quality. Morris Abram, chairman of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, makes this point powerfully. He states that “a commission requires agreement that is as... (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)

ABSTRACT The 2006 Institute of Medicine (IOM) report, ‘Ethical Considerations for Research Involving Prisoners’, recommended five main changes to current US Common Rule regulations on prisoner research. Their third recommendation was to shift from a category‐based to a risk‐benefit approach to research review, similar to current guidelines on pediatric research. However, prisoners are not children, so risk‐benefit constraints on prisoner research must be justified in a different way from those on pediatric research. In this paper I (...) argue that additional risk‐benefit constraints on prisoner research are unnecessary: the current Common Rule regulations, omitting category‐based restrictions but conjoined with the IOM report's other four main recommendations, ensure that prisoner research is as ethical as non‐prisoner research is. I explain why four problems which which may be more prevalent in prisons and which risk‐benefit constraints may seem to address – coercion, undue inducements, exploitation, and protection from harm – are in fact not solved by adding further risk‐benefit constraints on prisoner research. (shrink)

AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...) pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (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)

“Moral hazard” is a term familiar in economics and business ethics that illuminates why rational parties sometimes choose decisions with bad moral outcomes without necessarily intending to behave selfishly or immorally. The term is not generally used in medical ethics. Decision makers such as parents and physicians generally do not use the concept or the word in evaluating ethical dilemmas. They may not even be aware of the precise nature of the moral hazard problem they are experiencing, beyond a general (...) concern for the patient's seemingly excessive burden. This article brings the language and logic of moral hazard to pediatrics. The concept reminds us that decision makers in this context are often not the primary party affected by their decisions. It appraises the full scope of risk at issue when decision makers decide on behalf of others and leads us to separate, respect, and prioritize the interests of affected parties. (shrink)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the (...) “risks to subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)

With the rising interest in the field of trauma research, many Institutional Review Boards, policymakers, parents, and others grapple with the impact of trauma-research participation on research participants' well-being. Do individuals who participate in trauma-focused research risk experiencing lasting negative effects from participation? What are the potential benefits that may be gleaned from participation in this work? How can trauma research studies be designed ethically, minimizing the risk to participants? The following review seeks to answer these questions. This (...) review indicates that most studies in this area have found that only a minority of participants experience distress when participating in trauma-focused research. Furthermore, these negative feelings tend to dissipate quickly over time, with the majority of participants self-appraising their participation as positive, rewarding, and beneficial to society. Design characteristics that may serve to minimize participants' risk of experiencing distress are discussed, as well as implications for public policy and future research. (shrink)

Rational choice and other accounts of trust base it in objective assessments of the risks and benefits of trusting. But rational subjects must choose in the light of what knowledge they have, and that knowledge determines their capacities for trust. This is an epistemological issue, but not at the usual level of the philosophy of knowledge. Rather, it is an issue of pragmatic rationality for a given actor. It is commonly argued that trust is inherently embedded in iterated, thick relationships. (...) But such relationships are merely one source of relevant knowledge in a street-level epistemological account. Early experience may heavily influence later capacity for trust. For example, bad experience may lead to lower levels of trust and therefore fewer opportunities for mutual gain. (shrink)