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)

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)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of (...) direct benefit; and third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

The purpose of this article is to show that animal rights are not necessarily at odds with the use of animals for research. If animals hold basic moral rights similar to those of humans, then we should consequently extend the ethical requirements guiding research with humans to research with animals. The article spells out how this can be done in practice by applying the seven requirements for ethical research with humans proposed by Ezekiel Emanuel, David Wendler and Christine Grady to (...) animal research. These requirements are i) social value, ii) scientific validity, iii) independent review, iv) fair subject selection, v) favorable risk-benefit ratio, vi) informed consent, and vii) respect for research subjects. In practice, this means that we must reform the practice of animal research to make it more similar to research with humans, rather than completely abolish the former. Indeed, if we banned animal research altogether, then we would also deprive animals of its potential benefits – which would be ethically problematic. (shrink)

Ethics committees like Institutional Review Boards and Research Ethics Committees are typically empowered to approve or reject proposed studies, typically conditional on certain conditions or revisions being met. While some have argued this power should be primarily a function of applying clear, codified requirements, most institutions and legal regimes allow discretion for IRBs to ethically evaluate studies, such as to ensure a favourable risk-benefit ratio, fair subject selection, adequate informed consent, and so forth. As a result, ethics (...) committees typically make moral demands on researchers: require them to act in a way the committee considers ethically right or appropriate. This paper argues that moral demands are legitimate only if publicly justifiable; and as a result, committee decisions are subject to a public justification requirement. Ethics committees can permissibly request for more information, changes to the research protocol or that the research is delayed or even stopped only if these demands are publicly justifiable. This latter claim is in turn justified on the basis that moral demands to φ are permissible only if we are in a position to know that the addressee ought to φ and that we are in a position to know a proposition only if it is publicly justifiable. This argument suggests that ethics committees must consciously and explicitly appeal to public reasons in their decision-making. In cases where public reasons cannot be offered, committees would not be permitted to reject a given study or make approval conditional on an amendment. (shrink)

Many ethicists maintain that medical research on human subjects that presents no prospect of direct medical benefit must have a prospect of social benefit to be ethical. Payment is not the sort of benefit that justifies exposing subjects to risk. Alan Wertheimer has raised a serious challenge to this view, pointing out that in industry, social value is not considered necessary to make dangerous jobs ethical. This article argues that Wertheimer was correct to think that the (...) ethics of hazard pay should be the same in medical research and in business. Nevertheless, a qualified social benefit requirement should apply in both fields. For a study or a job with significant net physical risk to be ethical, it must have social value beyond the satisfaction of ordinary preferences, including the preference for money. The requirement derives from a non-absolutist version of the doctrine of double effect. If a risky study or a dangerous job has no distinctive social value, and hazard pay is subjects' or workers’ only reason to undergo risks, the very fact that they undergo risk is intended as a means to a financial end. Inviting people to enrol in such a study or to take such a job wrongfully treats people as mere means. By contrast, if a study or a job has social value, people can participate with a primary end other than money, even if they accept compensation. Researchers or employers do not intend but merely foresee risks to subjects or workers. (shrink)

While several tests and strategies are recommended for colorectal cancer (CRC) screening, studies suggest that primary care providers often recommend colonoscopy without providing information about its risks or alternatives. These observations raise concerns about the quality of informed consent for screening colonoscopy.

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)

Why can testimony alone be enough for findings of liability? Why statistical evidence alone can’t? These questions underpin the “Proof Paradox” (Redmayne 2008, Enoch et al. 2012). Many epistemologists have attempted to explain this paradox from a purely epistemic perspective. I call it the “Epistemic Project”. In this paper, I take a step back from this recent trend. Stemming from considerations about the nature and role of standards of proof, I define three requirements that any successful account in line with (...) the Epistemic Project should meet. I then consider three recent epistemic accounts on which the standard is met when the evidence rules out modal risk (Pritchard 2018), normic risk (Ebert et al. 2020), or relevant alternatives (Gardiner 2019 2020). I argue that none of these accounts meets all the requirements. Finally, I offer reasons to be pessimistic about the prospects of having a successful epistemic explanation of the paradox. I suggest the discussion on the proof paradox would benefit from undergoing a ‘value-turn’. (shrink)

This Note offers a normative critique of cost-benefit analysis, one informed by deontological moral theory, in the context of the debate over whether tort litigation or a non-tort approach is the appropriate response to mass harm. The first Part argues that the difference between lay and expert intuitions about risk and harm often reflects a difference in normative judgments about the existing facts, rather than a difference in belief about what facts exist, which makes the lay intuitions more (...) defensible. The second Part considers how tort has dealt with this divergence between lay and expert perspectives. It also evaluates how tort's approach has differed from that of public law approaches to accident law, such as legislative compensation and risk regulation by administrative agencies. Ultimately, tort's ability to recognize the value of lay intuitions supports retaining the tort perspective as part of our societal arsenal of responses to risk and harm. This ability can also support a pro-tort perspective in two practical debates in the arena of tort law: that over preemption of tort law by administrative agency judgments, and that over access to tort recovery as part of a no-fault system. (shrink)

Currently, under the conditions of permanent financial risks that hamper the sustainable economic growth in the financial sector, the development of evaluation and risk management methods both regulated by Basel II and III and others seem to be of special importance. The reputation risk is one of significant risks affecting reliability and credibility of commercial banks. The importance of reputation risk management and the quality of their assessment remain relevant as the probability of decrease in or loss (...) of business reputation influences the financial results and the degree of customers’, partners’ and stakeholders’ confidence. By means of imitating modeling based on Bayesian Networks and the fuzzy data analysis, the article characterizes the mechanism of reputation risk assessment and possible losses evaluation in banks by plotting normal and lognormal distribution functions. Monte-Carlo simulation is used to calculate the probability of losses caused by reputation risks. The degree of standardized histogram similarity is determined on the basis of the fuzzy data analysis applying Hamming distance method. The tree-like hierarchy based on the OWA-operator is used to aggregate the data with Fishburne's coefficients as the convolution scales. The mechanism takes into account the impact of criteria, such as return on equity, goodwill value, the risk assets ratio, the share of the productive assets in net assets, the efficiency ratio of interest bearing liabilities, the risk ratio of credit operations, the funding ratio and reliability index on the business reputation of the bank. The suggested methods and recommendations might be applied to develop the decision-making mechanism targeted at the implementation of reputation risk management system in commercial banks as well as to optimize risk management technologies. (shrink)

The standard argument to the conclusion that artificial intelligence (AI) constitutes an existential risk for the human species uses two premises: (1) AI may reach superintelligent levels, at which point we humans lose control (the ‘singularity claim’); (2) Any level of intelligence can go along with any goal (the ‘orthogonality thesis’). We find that the singularity claim requires a notion of ‘general intelligence’, while the orthogonality thesis requires a notion of ‘instrumental intelligence’. If this interpretation is correct, they cannot (...) be joined as premises and the argument for the existential risk of AI turns out invalid. If the interpretation is incorrect and both premises use the same notion of intelligence, then at least one of the premises is false and the orthogonality thesis remains itself orthogonal to the argument to existential risk from AI. In either case, the standard argument for existential risk from AI is not sound.—Having said that, there remains a risk of instrumental AI to cause very significant damage if designed or used badly, though this is not due to superintelligence or a singularity. (shrink)

In this paper, we argue that our moral concern for future well-being should reduce over time due to important practical considerations about how humans interact with spacetime. After surveying several of these considerations (around equality, special duties, existential contingency, and overlapping moral concern) we develop a set of core principles that can both explain their moral significance and highlight why this is inherently bound up with our relationship with spacetime. These relate to the equitable distribution of (1) moral concern in (...) a universe that we can only causally affect in one temporal direction; (2) access to the benefits from using spacetime as a resource; and (3) the burdens of care given (1) and (2). We conclude by considering the practical implications of our argument and find that, while it is often assumed that a preference for present over future well-being weakens the case for existential risk mitigation, this likely is not the case. (shrink)

Benefit/cost analysis is a technique for evaluating programs, procedures, and actions; it is not a moral theory. There is significant controversy over the moral justification of benefit/cost analysis. When a procedure for evaluating social policy is challenged on moral grounds, defenders frequently seek a justification by construing the procedure as the practical embodiment of a correct moral theory. This has the apparent advantage of avoiding difficult empirical questions concerning such matters as the consequences of using the procedure. So, (...) for example, defenders of benefit/cost analysis (BCA) are frequently tempted to argue that this procedurejust isthe calculation of moral Tightness – perhaps that what itmeansfor an action to be morally right is just for it to have the best benefit-to-cost ratio given the accounts of “benefit” and “cost” that BCA employs. They suggest, in defense of BCA, that they have found the moral calculus – Bentham's “unabashed arithmetic of morals.” To defend BCA in this manner is to commit oneself to one member of a family of moral theories (let us call thembenefit/cost moral theoriesorB/C moral theories) and, also, to the view that if a procedure is (so to speak) the direct implementation of a correct moral theory, then it is a justified procedure. Neither of these commitments is desirable, and so the temptation to justify BCA by direct appeal to a B/C moral theory should be resisted; it constitutes an unwarranted short cut to moral foundations – in this case, an unsound foundation. Critics of BCA are quick to point out the flaws of B/C moral theories, and to conclude that these undermine the justification of BCA. But the failure to justify BCA by a direct appeal to B/C moral theory does not show that the technique is unjustified. There is hope for BCA, even if it does not lie with B/C moral theory. (shrink)

Natasha McKeever argues that prima facie, a friends-with-benefits relationship can be, at the same time, a good friendship. This is because sex is compatible with friendship in that it can complement and potentially even strengthen the three core characteristics of friendship: mutual liking, mutual caring, and mutual sharing. She acknowledges that, by generating uncertainty and having the potential to generate feelings of romantic love, sex does pose risks to friendship. However, she argues that while these risks are significant considerations, they (...) can be mitigated and managed and so do not provide strong reasons against friends-with-benefits relationships. (shrink)

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

Nelson et al.(2023) argue that the inclusion of personal experience in bioethical debates has significant benefits and liabilities, illustrating their claim with two examples: unproven medical treatments and disability bioethics. We believe that the benefits of including personal experience in disability bioethics far exceed its liabilities. The absence of participants with relevant experience impoverishes and biases bioethical debates, while the biases risked by their inclusion are hardly unique to personal experiences and are readily mitigated.

ABSTRACT We have previously argued that there are forms of greenhouse gas offsetting for which, when one emits and offsets, one imposes no risk. Orri Stefansson objects that our argument fails to distinguish properly between the people who stand to be harmed by one’s emissions and the people who stand to be benefited by one’s offsetting. We reply by emphasizing the difference between acting with a probability of making a difference to the distribution of harm and acting in a (...) way that worsen’s someone’s prospect. (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)

Regan appeals to the benefit of the doubt as a reason to include some animals within the scope of his arguments about the rights of animals. I think the informal appeal to the benefit of the doubt can be fleshed out and made more compelling. What I shall do differs from his project, however. It is narrower in scope, because I shall focus on a single issue, the dietary use of animals. On another dimension, though, I aim to (...) do more. Regan thinks that it is “not unreasonable” to extend the benefit of the doubt, and that it is better to do so. I shall be arguing that it is unreasonable not to do so. (shrink)

I argue that ductal carcinoma in situ (DCIS), the tumor most commonly diagnosed by breast mammography, cannot be confidently classified as cancer, that is, as pathological. This is because there may not be dysfunction present in DCIS—as I argue based on its high prevalence and the small amount of risk it conveys—and thus DCIS may not count as a disease by dysfunction-requiring approaches, such as Boorse’s biostatistical theory and Wakefield’s harmful dysfunction account. Patients should decide about treatment for DCIS (...) based on the risks it poses and the risks and benefits of treatment, not on its disease status. (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)

This article asks how the costs and benefits of operating a monetary union should be distributed amongst its more and less competitive members, taking as an example the operation of the European Monetary Union (EMU or Eurozone). Drawing on existing domestic and transnational justice debates, I resist both a purely procedural and a purely distributive view. The former assumes treaties against a fair background can make any distribution fair and disregards how individual citizens are likely to fare depending on how (...) a monetary union is organized. The latter requires justice amongst Eurozone co-citizens, neglecting the value of member states’ choices and attitudes towards risk. Instead, I defend a view of the EMU as an association of free self-determining states. I also argue that a variety of factors are relevant to this problem, including the need to protect less competitive states from ‘domination,’ or inappropriate forms of control by their co-members, and to protect citizens from various forms of deprivation even if their own governments are willing to expose them to the relevant risks. (shrink)

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

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical (...) benefits for the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

Imagine you fly home from vacation with your one-and-a-half-year-old son who is traveling for free as a “lap child.” In the airport parking lot, you put him into his forward-facing car seat, where he sits much more contentedly than he did in the rear-facing one that was mandatory until his first birthday. After he falls asleep on the way home, you transfer him to his crib without waking him, lowering the side rail so you can lift him in more easily. (...) -/- Many parts of this idyllic parenting picture are deemed unacceptably risky according to recent child safety proposals. While these proposals all aim to improve child safety, their possible impact is unclear because there has been little discussion of the absolute risk and risk reduction involved in each. And while precise figures are lacking, rough estimates indicate that the magnitudes are quite small. I will argue that this risk and benefit data raises important questions about the proposals, including whether parents might reasonably believe that the small absolute risk reduction offered by the proposed changes does not justify the attendant burdens. This possibility—termed the “prevention paradox” in other contexts—highlights ethical and theoretical challenges in this area of public health. (shrink)

The author has extensive law enforcement experience and the paper is intended to provoke thought on the use of technology as it pertains to information sharing between the police and the private sector. -/- As the world edges closer and closer to the convergence of man and machine, the human capacity to retrieve information is increasing by leaps and bounds. We are on the verge of knowing everything and anything there is to know, and literally in the blink of an (...) eye! -/- This means that police will have the capacity to learn everything about everyone with the only restriction being privacy legislation. But it also means that those involved in immoral, unlawful or illegal activity will have that same capacity and with no such restriction. ‘Bad Brother’ may be far more dangerous than ‘Big Brother!' -/- The global community requires a secure and credible system to retrieve and assess all of the information ‘generally available to the public.' A system that will strive to keep ‘Big Brother’ in check and ‘Bad Brother’ out, all the while providing a means of alerting citizens to genuine risks or to dangerous people. Such as system would help diffuse the systemic inaccurate and harmful profiling that is often based on rumours and innuendo. -/- There is an identified public-private partnership opportunity. A chance to work with privacy advocate groups and background checking private companies to define, design and deliver on something that will be of immense benefit to citizens around the globe. -/- We have an opportunity to create something that will work to ensure that only the best information gets used and in a moralistic, lawful and legal way! Technology continues to move forward at incomprehensible speeds – failure to act could have serious consequences. (shrink)

It is generally recognised that the potential positive and negative impacts of geoengineering will be distributed unevenly both geographically and temporally. The question of distributive justice in geoengineering thus is one of the major ethical issues associated with geoengineering. Currently, the question of distributive justice in geoengineering is framed in terms of who gets what (potential) benefits and harms from geoengineering, i.e. it is about the distribution of the outcomes of geoengineering. In this paper, I argue that the discussions on (...) distributive justice in geoengineering should not be outcome-based. Instead, it should be risk-based. I identify two problems for framing the question of distributive justice in geoengineering in terms of the distribution of its outcomes, i.e. the ‘if and then’ syndrome and the limited applicability of distributive principles in geoengineering policy, and suggest risk is a more proper object of distribution in the case of geoengineering. Following Hayenhjelm, I argue that the object of distribution in the case of fair distribution of risk should be (i) sources of risks and (ii) precautionary measures. I shall then demonstrate how it can be applied to the question of distributive justice in geoengineering. Finally, I end this paper by exploring the possible responses to the question of distributive justice in geoengineering by three major accounts of distributive justice, i.e. egalitarianism, prioritarianism, and sufficientarianism. (shrink)

In the beginning of the COVID pandemic, researchers and bioethicists called for human challenge trials to hasten the development of a vaccine for COVID. However, the fact that we lacked a specific, highly effective treatment for COVID led many to argue that a COVID challenge trial would be unethical and we ought to pursue traditional phase III testing instead. These ethical objections to challenge trials may have slowed the progress of a COVID vaccine, so it is important to evaluate their (...) merit. One common way of doing so is to make an analogy to other social practices that are relevantly similar and which we currently sanction. We submit that non-directed live organ donation (NDLOD) is a promising analogy. After arguing that the risks to volunteers for each activity appear similar, we explore potential disanalogies that would undermine the comparison. We note that there are differences in both the kind and certainty of benefit secured by NDLOD compared to challenge trials. We conclude these differences are insufficient to make NDLOD permissible and challenge trials impermissible. Ultimately, if we think the risks associated with NDLOD are ethically permissible, then we should think the same of the risks associated with COVID challenge trials. (shrink)

The co-shaping of technology and values is a topic of increasing interest among philosophers of technology. Part of this interest pertains to anticipating future value change, or what Danaher (2021) calls the investigation of “axiological futurism”. However, this investigation faces a challenge: “axiological possibility space” is vast, and we currently lack a clear account of how this space should be demarcated. It stands to reason that speculations about how values might change over time should exclude farfetched possibilities and be restricted (...) to possibilities that can be dubbed to be realistic instead. But what does this realism criterion entail? This paper introduces the notion of realistic possibilities as a key conceptual advancement to the study of axiological futurism and offers suggestions as to how realistic possibilities of future value change might be identified. Additionally, I propose two slight modifications to the approach of axiological futurism. First, I argue that axiological futurism can benefit from a thoroughly historicised understanding of moral change. Secondly, I argue that when employed in normative contexts, the axiological futurist should seek to identify realistic possibilities that come along with substantial normative risks. (shrink)

The rare but severe cerebral venous thrombosis occurring in some AstraZeneca vaccine recipients has prompted some governments to suspend part of their COVID-19 vaccination programmes. Such suspensions have faced various challenges from both scientific and ethical angles. Most of the criticisms against such suspensions follow a consequentialist approach, arguing that the suspension will lead to more harm than benefits. In this paper, I propose a rights-based argument against the suspension of the vaccine rollouts amid this highly time-sensitive combat of COVID-19. (...) I argue that by suspending a vaccine rollout, a government infringes people's right to take the risks they deem worth taking for their health. I also consider four potential objections to my argument and explain why none of them undermines my argument. (shrink)

Breastfeeding advocates have criticised the phrase ‘breast is best’ as mistakenly representing breastfeeding as a departure from the norm rather than the default for infant feeding. Breastfeeding mothers have an interest in representing breastfeeding as the default, for example, to counteract criticism of breastfeeding outside the home. This connects to an increasing trend to frame feeding babies formula as harmful, which can be seen in research papers, public policy and information presented to parents and prospective parents. Whether we frame infant-feeding (...) decisions in terms of harming or benefit, protection or risk matters because these distinctions are generally morally significant and thus holding that those who decide to use formula ‘harm’, ‘risk harm’ to their babies or describing formula feeding as ‘dangerous’ is likely to contribute to guilt associated with formula feeding and thus to undermine the well-being of vulnerable women. It may undermine attempts to improve breastfeeding rates by leading women to reject information about health outcomes surrounding infant-feeding decisions. However, these distinctions do not apply easily to infant-feeding decisions, in part because of difficulties in determining whether we should treat breastfeeding as the normative baseline for infant feeding. I show that neither the descriptive ‘facts of the matter’ nor moral or pragmatic considerations provide an easy answer before discussing how to respond to these considerations. (shrink)

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

The co-evolutionary concept of Three-modal stable evolutionary strategy of Homo sapiens is developed. The concept based on the principle of evolutionary complementarity of anthropogenesis: value of evolutionary risk and evolutionary path of human evolution are defined by descriptive (evolutionary efficiency) and creative-teleological (evolutionary correctly) parameters simultaneously, that cannot be instrumental reduced to others ones. Resulting volume of both parameters define the trends of biological, social, cultural and techno-rationalistic human evolution by two gear mechanism ˗ gene-cultural co-evolution and techno- humanitarian (...) balance. The resultant each of them can estimated by the ratio of socio-psychological predispositions of humanization/dehumanization in mentality. Explanatory model and methodology of evaluation of creatively teleological evolutionary risk component of NBIC technological complex is proposed. Integral part of the model is evolutionary semantics (time-varying semantic code, the compliance of the biological, socio-cultural and techno-rationalist adaptive modules of human stable evolutionary strategy). (shrink)

Objective: In this study, we aimed to identify patients at risk of chemotherapy-induced cardiotoxicity with a simple method like platelet-to-lymphocyte ratio (PLR) before starting therapy. Method: A total of 65 breast cancer patients who completed anthracycline or adjuvant trastuzumab treatment were evaluated retrospectively. Serial PLR calculations, echocardiographic examinations, and cardiac markers before treatment and after follow-up period were analyzed. Cardiotoxicity was determined according to Cardiac Review and Evaluation Committee Criteria. Results: Patients were divided into two groups according to (...) their baseline PLR levels as Group C—PLR < 119 and Group D—PLR 120. The median follow-up of the study was 22.23 (12-42) months. Concomitant disease and baseline characteristics were similar in both groups. Symptomatic cardiotoxicity was not observed in both groups. Cardiotoxicity was occurred in one patient (2.3%) in Group C and in four patients (9.5%) in Group D (P ¼ .005). Average mean left ventricular ejection fraction loss from baseline was 10.7 6 7.0% in Group D vs 2.3 6 6.4% in Group C (P ¼ .008). Interpretation of cardiac markers that were present in nearly half of the patients revealed that serum hs-c-reactive protein and pro-brain natriu¨ retic peptide levels were significantly higher in patients who developed cardiotoxicity compared to who did not develop cardiotoxicity. PLR 120 had 99% sensitivity and 85% specificity in predicting cardiotoxicity. Conclusion: This study’s results showed that high PLR levels were associated with chemotherapy-induced cardiotoxicity. To our best knowledge, this is the first study, examining the impact of whole blood test on chemotherapy-induced cardiotoxicity before starting the therapy and allowing doctors plot a route for these risky patients. (shrink)

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

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the (...) REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

Drug regulation is fraught with inductive risk. Regulators must make a prediction about whether or not an experimental pharmaceutical will be effective and relatively safe when used by typical patients, and such predictions are based on a complex, indeterminate, and incomplete evidential basis. Such inductive risk has important practical consequences. If regulators reject an experimental drug when it in fact has a favourable benefit/harm profile, then a valuable intervention is denied to the public and a company’s material (...) interests are needlessly thwarted. Conversely, if regulators approve an experimental drug when it in fact has an unfavourable benefit/harm profile, then resources are wasted, people are needlessly harmed, and other potentially more effective treatments are underutilized. Given that such regulatory decisions have these practical consequences, non-epistemic values about the relative importance of these consequences impact the way such regulatory decisions are made (similar to the analysis of laboratory studies on the toxic effects of dioxins presented in Douglas [2000]). To balance the competing demands of the pertinent non-epistemic values, regulators must perform what I call an “inductive risk calculus.” At least in the American context this inductive risk calculus is not well-managed. (shrink)

Humans and artificial intelligences (AI) will increasingly participate digitally and physically in conflicts yet there is a lack of trusted communications across agents and platforms. For example, humans in disasters and conflict already use messaging and social media to share information, however, international humanitarian relief organisations treat this information as unverifiable and untrustworthy. AI may reduce the ‘fog-of-war’ and improve outcomes, however current AI implementations are often brittle, have a narrow scope of application and wide ethical risks. Meanwhile, human error (...) causes significant civilian harms even by combatants committed to complying with international humanitarian law. AI offers an opportunity to help reduce the tragedy of war and better deliver humanitarian aid to those who need it. However, to be successful, these systems must be trusted by humans and their information systems, overcoming flawed information flows in conflict and disaster zones that continue to be marked by intermittent communications, poor situation awareness, mistrust and human errors. In this paper, we consider the integration of a communications protocol (the ‘Whiteflag protocol’), distributed ledger technology, and information fusion with artificial intelligence (AI), to improve conflict communications called “Protected Assurance Understanding Situation & Entities” PAUSE. Such a trusted human-AI communication network could provide accountable information exchange regarding protected entities, critical infrastructure; humanitarian signals and status updates for humans and machines in conflicts. Trust-based information fusion provides resource-efficient use of diverse data sources to increase the reliability of reports. AI can be used to catch human mistakes and complement human decision making, while human judgment can direct and override AI recommendations. We examine several case studies for the integration of these technologies into a trusted human-AI network for humanitarian benefit including mapping a conflict zone with civilians and combatants in real time, preparation to avoid incidents and using the network to manage misinformation. (shrink)

Introduction National statistics suggest that up to 40% of new teachers will leave their school or the teaching profession within their first five years of teaching. Much of this attrition is associated with work-related burnout, some of which may be preventable with targeted worksite health interventions. Previous research suggests that mindfulness skills may be protective from burnout, ultimately reducing the likelihood of attrition from the profession. Methods This study compared the self-reported levels of burnout and secondary traumatic stress with participants’ (...) levels of interpersonal and intrapersonal mindfulness. Participants completed the Professional Quality of Life Inventory and the Mindfulness in Teaching Inventory. Odds Ratios and Relative Risks were calculated using Epi Info. Pearson correlations, linear regression, and ANOVA analyses were completed using SPSS. Chronbach’s alpha values were also calculated to evaluate score reliability of the five constructs. Results Relative Risks and Odds Ratios of having secondary traumatic stress scores of “average/high” were significantly lower for those with high intrapersonal mindfulness scores. Those who reported high intrapersonal mindfulness scores were up to 11 times more likely to report “low” burnout than those who reported low intrapersonal mindfulness scores. Burnout negatively correlated with both intrapersonal mindfulness suggesting that as intrapersonal mindfulness level decreases, burnout increases. ANOVA testing identified significant differences in burnout based on intrapersonal mindfulness level. Conclusion Those who reported high levels of intrapersonal mindfulness had significantly reduced risk of burnout. These results will inform further research in the region regarding mindfulness practice and the experience of burnout among teachers in the region. Thus, mindfulness may be protective from occupation-related burnout for this population. Interventions informed by additional research could reduce the burden of occupation-related burnout and may ultimately contribute toward reduced attrition in the teaching profession. (shrink)

Mehlman and Li offer a framework for approaching the bioethical issues raised by the military use of genomics that is compellingly grounded in both the contemporary civilian and military ethics of medical research, arguing that military commanders must be bound by the two principles of paternal- ism and proportionality. I agree fully. But I argue here that this is a much higher bar than we may fully realize. Just as the principle of proportionality relies upon a thorough assessment of harms (...) caused and military advantage gained, the use of genomic research, on Mehlman and Li’s view, will require an accurate understanding of the connection between genotypes and phenotypes – accurate enough to ameliorate the risk undertaken by our armed forces in being subject to such research. Recent conceptual work in evolutionary theory and the philosophy of biology, however, renders it doubtful that such knowledge is forthcoming. The complexity of the relationship between genotypic factors and realized traits (the so-called ‘G→P map’) makes the estimation of potential military advantage, as well as potential harm to our troops, incredibly challenging. Such fundamental conceptual challenges call into question our ability to ever satisfactorily satisfy the demands of a sufficiently rigorous ethical standard. (shrink)

Abstract: Background: Coronary artery disease remains the leading cause of morbidity and mortality Worldwide. Previous reviews pointed that nursing interventions are beneficial for coronary artery patients. However, most interventions focused on education and counselling, but not consistent with the outcome set; still did not consider patient’s coronary artery disease risky characteristics. Related studies in China also difficult to find. Therefore this study was conducted to investigate kinds of nursing interventions delivered to coronary artery patients and match them with patient’s (...) class='Hi'>risk factors of coronary artery disease. Results of this study were expected to add new knowledge that will alert nurses to consider coronary artery risk factors which in turn might enable the development of appropriate approaches to improve patient’s wellbeing hence reduce frequent coronary artery morbidity and mortality. Methods: A descriptive, cross-sectional, retrospective design using clinical case notes was employed. Study was undertaken in coronary care wards at the teaching hospital in China from November 2017 to September 2018. Structured-literature supported self-designed questionnaire was utilized for data collection. Chi square (χ2) test and multivariate logistic regression for adjusted odds ratio with 95% confidence interval were used to compare the relationship among independent (patient’s risk coronary artery disease factors) and dependent (nursing interventions) categorical variables. Ethical permission was granted accordingly. Results: A total of 300 coronary artery patients’ case notes were audited with mean age 63±11.2 years. Of these 175 (58.3%) were males. 126(42%) were smoking and 224(74.7%) were hypertensive. More evidence based nursing interventions than education and counselling were found to be delivered to these patients. “Administer coronary artery disease medication and their instructions” was mostly delivered to many patients 291(97%) while “counsel to cope with stress” was the least one 60 (20.0%). Three of eight nursing interventions delivered significantly matched with three or all of these patient’s coronary artery risk variables (age, smoking, hypertension and diabetes) (p < 0.05 and/or < 0.01) with Adjusted odds ratio (95% CI) within their significant ranges. Conclusion: This study delivers valuable insight that, nurses in the studied teaching hospital delivered beneficial evidence based nursing interventions to patients with coronary artery disease which significantly matched with their risk factors of coronary artery illness. However, care for stress was low hence needs improvement. Furthermore, research is needed to get consistency of nursing interventions with patient’s end point clinical outcomes for further appraisal of nursing efforts in caring CAD patients . (shrink)

Longtermists have argued that humanity should significantly increase its efforts to prevent catastrophes like nuclear wars, pandemics, and AI disasters. But one prominent longtermist argument overshoots this conclusion: the argument also implies that humanity should reduce the risk of existential catastrophe even at extreme cost to the present generation. This overshoot means that democratic governments cannot use the longtermist argument to guide their catastrophe policy. In this paper, we show that the case for preventing catastrophe does not depend on (...) longtermism. Standard cost-benefit analysis implies that governments should spend much more on reducing catastrophic risk. We argue that a government catastrophe policy guided by cost-benefit analysis should be the goal of longtermists in the political sphere. This policy would be democratically acceptable, and it would reduce existential risk by almost as much as a strong longtermist policy. (shrink)

It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's consent to research (...) participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan's argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (shrink)

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

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

Abstract: Under traditional Jewish Law (halacha), assessment of human reproductive cloning (HRC) has been formulated along four lines of inquiry, which I discussed in Part I of this paper. Therein I also analyze five relevant doctrines of Talmudic Law, concluding that under with a risk-benefit analysis HRC fails to fulfill the obligation ‘to be fruitful and multiply’ and should be strictly prohibited. Here, I review of the topic from an exigetical Biblical and Kabbalistic perspective, beginning with exploring comments (...) of the Ramban (Nachmanides) which suggest Kabbalistic insights very much in keeping with current biology. In this Part II of the paper, I expand and annotate statements of the Ramban on the interrelationship of the reproductive faculties of an organism and its soul by examining the development of the spiritual states of plant, animal and human and noting the commensurate evolution with its reproductive facilities. Speculating that the reproductive mechanism of each species is indelibly related to its soul-state, I suggest that interfering with human sexual reproduction by HRC has the same effect the Ramban argues is the result of Kilayim (interbreeding), i.e., wrecking havoc with the Universe. In Part III, I postulate a biologic explanation for warnings found in the Golemic Literature and suggest that these allude to the importance of maintaining human genetic diversity through sexual reproduction. The conclusions I reached after evaluating the propriety of HRC under a Kabbalistic/metaphysical index comports with those I reached using a traditional legal /halachic inquiry in Part I. Thus, both systems arrive at the conclusion that HRC is in violation of the divine and natural order and constitute a distinct biological threat to the survival of the human species, a conclusions in accord with current scientific thinking. (shrink)

Relational aspects, such as involvement of donor’s relatives or friends in the decision-making on participation in a research biobank, providing relatives’ health data to researchers, or sharing research findings with relatives should be considered when reflecting on ethical aspects of research biobanks. The aim of this paper is to explore what the role of donor’s relatives and friends is in the process of becoming and being a biobank donor and which ethical issues arise in this context. We performed qualitative analysis (...) of 40 qualitative semi-structured interviews with biobank donors and researchers. The results show that relatedness to relatives or other types of close relationships played a significant role in the donors’ motivation to be involved in a biobank, risk-benefit assessment, and decisions on sharing information on research and its results. Interviewees mentioned ethical issues in the context of sharing relatives’ health-related data for research purposes and returning research findings that may affect their relatives. We conclude that the question of what information on family members may be shared with a biobank by research participants without informed consent of those relatives, and when family members become research subjects, lacks a clear answer and detailed guidelines, especially in the context of the introduction of the European Union’s (EU) General Data Protection Regulation. Researchers in Latvia and EU face ethical questions and dilemmas about returning research results and incidental findings to donors’ relatives, and donors need more information on sharing research results with relatives in the informed consent process. (shrink)

We begin by showing that every theory of the value of uncertain prospects must have one of three unpalatable properties. _Reckless_ theories recommend giving up a sure thing, no matter how good, for an arbitrarily tiny chance of enormous gain; _timid_ theories permit passing up an arbitrarily large potential gain to prevent a tiny increase in risk; _non-transitive_ theories deny the principle that, if A is better than B and B is better than C, then A must be better (...) than C. Having set up this trilemma, we study its horns. Non-transitivity has been much discussed; we focus on drawing out the costs and benefits of recklessness and timidity when it comes to axiology, decision theory, and normative uncertainty. (shrink)