Work on the therapeutic misconception suggests that investigators should ensure that potential research subjects understand the fundamental differences between clinical research and clinical care. Yet, what potential research subjects should understand depends on their circumstances and the study in question. This analysis implies that researchers and review committees should stop attempting to define, measure, and dispel the therapeutic misconception, and instead should focus on what potential subjects should understand to participate in individual studies.

In a previous article, I attempted to assess the likely impact of the most prominent versions of the therapeutic misconception (TM) on research subjects’ informed consent. I concluded that the TM is not nearly as significant a concern as is commonly thought, and that focusing on it is more likely to undermine than promote research subjects’ informed consent.A recent commentary rejects these conclusions, as least as they pertain to the “consensus” definition of the TM. The authors of the commentary argue (...) that work on the TM remains central to ensuring the appropriateness of research subjects’ consent and, by implication, the ethical acceptability of clinical research.The present work evaluates the arguments offered in support of these claims. This analysis reveals that the authors offer few substantive responses to my arguments, and the responses they do offer fail to undermine my prior conclusions. Furthermore, consideration of an additional issue—the emergence of learning healthcare systems—suggests that the TM is likely to be even less significant in the future, hence, focusing on it may be even more problematic than I argued previously. (shrink)

Discussion of the ethics of clinical trials in lower income countries has been dominated by concern over double standards. Most prominently, clinical trials of interventions that are less effective than the worldwide best treatment methods typically are not permitted in higher income countries. Commentators conclude that permitting such trials in lower income countries involves an ethical double standard. Despite significant attention to this concern, and its influence over prominent guidelines for research in lower income countries, there has been little analysis (...) of what constitutes an ethical double standard in clinical research. The present article attempts to address this gap in the literature. This analysis finds that ethical double standards involve a kind of disrespect, and yields a three-step decision procedure for evaluating when trials of less than the worldwide best methods raise this concern. Application of this procedure reveals that permitting these trials in lower income countries rarely involves an ethical double standard. Instead, the real challenge is determining when clinical trials of interventions that are less effective than the worldwide best represent a permissible and effective response to differences in access to healthcare between higher income and lower income countries. To protect research subjects, without blocking clinical trials that have the potential to improve health in lower income countries, research review committees and other stakeholders should focus on this issue, not on ethical double standards. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

abstractBackground: Evidence shows both a tendency for research participants to conflate research and clinical care and a limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite this evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. Methods: As part of a longer semistructured interview evaluating assent and parental permission for research, (...) adolescent research participants (n = 177), including adolescents with illnesses and healthy volunteers, and their parents (n = 177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes were identified through an iterative process. Results: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and differences in logistics. Conclusions: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceive a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience. (shrink)

In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective interpretation). (...) The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

It has recently been proposed to incorporate the use of a “Patient Preference Predictor” (PPP) into the process of making treatment decisions for incapacitated patients. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Including a PPP in the shared decision-making process between clinicians and surrogates has the potential to better realize important ethical goals for making treatment decisions (...) for incapacitated patients. However, developing and implementing a PPP poses significant practical challenges. The present paper discusses these practical challenges and considers ways to address them. (shrink)

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern (...) by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (shrink)

: In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective (...) interpretation). The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data that (...) many research participants do not understand randomization, implies that randomized clinical trials often fail to obtain adequately informed consent. Before accepting this conclusion, and before initiating extensive efforts to improve research participants' understanding of randomization, we should assess the plausible, but rarely analyzed assumption that participants need to understand randomization to give valid informed consent for randomized clinical trials. (shrink)

The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This “subjects' condition” requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should (...) be understood. (shrink)

When a patient lacks decision-making capacity and has not left a clear advance directive, there is now widespread agreement that patient-designated and next-of-kin surrogates should implement substituted judgment within a process of shared decision-making. Specifically, after discussing the “best scientific evidence available, as well as the patient's values, goals, and preferences” with the patient's clinicians, the patient-designated or next-of-kin surrogate should attempt to determine what decision the patient would have made in the circumstances. To the extent that this approach works, (...) it seems to provide about as much respect for the autonomy of incapacitated patients as we could ask for. But, as articles in this issue of the Report by Jeffrey Berger and by Ellen Robinson and colleagues emphasize, reality presents challenges. (shrink)

There is much philosophical literature on the duty to rescue. Individuals who encounter and could save, at relatively little cost to themselves, a person at risk of losing life or limb are morally obligated to do so. Yet little has been said about the other side of the issue. There are cases in which the need for rescue could have been reasonably avoided by the rescuee. We argue for a duty to take rescue precautions, providing an account of the circumstances (...) in which it arises. This novel duty has important implications for public policy. We apply it to the situation of some of the uninsured in the United States. Given the US clinician's duty to provide emergency care to all people regardless of ability to pay, some of the uninsured have a moral duty to purchase health insurance. We defend the duty against objections, including the possibility that a right to rescue can be waived, thus undermining a duty to take rescue precautions, that the duty of many professionals is voluntarily incurred, and that a distinction between actively assumed and passively assumed risks matters morally. (shrink)

Although many of the issues surrounding innateness have received a good deal of attention lately, the basic concept of token innateness has been largely ignored. In the present paper, I try to correct this imbalance by offering an account of the innateness of token traits. I begin by explaining Stephen Stich's account of token innateness and offering a counterexample to that account. I then clarify why the contemporary biological approaches to innateness will not be able to resolve the problems that (...) beset Stich's account. From there, I develop an alternative understanding of the innateness of token traits, what I call a causal/explanatory account. The argument to be made is that token innateness is both a causal, and an explanatory, concept. After clarifying this understanding of innateness, and showing how it handles several counterexamples to other accounts, I end with some comments on what the causal/explanatory account suggests for our understanding of innateness in general. (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

In this issue of the Hastings Center Report, Danielle Wenner looks at a few prominent analyses of the social value requirement for clinical research, claiming that they are all based on what she calls a transactional model of research ethics. She argues that the transactional model fails to provide a secure foundation for the social value requirement, and then, appealing to John Rawls, she argues that a more secure foundation lies in the principles of social justice. Wenner's attempt to locate (...) the source of the social value requirement raises important questions regarding its scope and strength. To determine what the social value requirement requires, we need to know why it's a requirement. Does the social value requirement apply to all trials or only to a subset? Is it a necessary condition on ethical research or an important consideration that can conflict with, and sometimes be defeated by, other considerations? Wenner's attempt to answer these questions is obscured by the fact that she mistakenly regards a minority view of research ethics as the mainstream view. Once we correct for that, her analysis of the foundation of the social value requirement provides a valuable opportunity to consider how the ethics of research as an institution might supplement or alter the ethics of individual clinical trials. (shrink)

Many research projects rely on human biological materials and some of these projects generate revenue. Recently, it has been argued that investigators have a moral claim to share in the revenue generated by these projects, whereas persons who provide the biological material have no such claim (Truog, Kesselheim, and Joffe 2012). In this paper, we critically analyze this view and offer a positive proposal for why tissue providers have a moral claim to benefit. Focusing on payment as a form of (...) benefit, we argue that research is a joint project and propose a contribution principle for paying participants in those joint projects. We distinguish between contributions that shape a project’s revenue generating properties, grounding a claim to payment, and contributions that fail to ground such a claim. We conclude, contrary to existing arguments and practices, that some tissue providers have a moral claim to payment beyond compensation for risk and burden. This conclusion suggests that investigators, institutions, and sponsors should reconsider the fairness of their current practices. (shrink)

Many people believe that animals possess moral status, but human beings possess higher moral status than animals. To try to identify a theoretical basis for this view, Robert Nozick proposed Utilitarianism for Animals, Kantianism for People. The present manuscript evaluates Nozick’s proposal by identifying the tradeoffs in welfare that it permits in medical research with animals and assessing whether those tradeoffs are indeed permissible. This analysis suggests that at least some deontological side constraints apply to the treatment of sentient animals, (...) hence, Utilitarianism for Animals, Kantianism for People is mistaken. Because Nozick’s proposal represents a prominent attempt to provide a theoretical basis for the common belief that human beings possess higher moral status than animals, this conclusion is noteworthy in its own right. Moreover, by granting equal moral weight to the interests of animals, but reserving deontological side constraints for human beings, Utilitarianism for Animals, Kantianism for People offers one of the more plausible bases for the claim that there are degrees of moral status among those who matter morally. The manuscript thus ends by considering the implications of the present analysis for the possibility that moral status comes in degrees. (shrink)

Those involved in research with humans confront a host of ethical issues and a maze of regulations. James M. DuBois’s Ethics in Mental Health Research: Principles, Guidance, and Cases is here to help. The book covers a broad range of issues in research ethics, including informed consent, risks and benefits, privacy and confidentiality, and conflicts of interest. Thus, while the title focuses on mental health research, the book should also be of interest to individuals involved in other types of research (...) with humans. (shrink)

Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow institutional review boards to approve pediatric research that does not offer a prospect of direct benefit when the risks are no greater than a minor increase over minimal risk. To approve research (...) in this category, IRBs must find that two additional conditions obtain:1). The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and 2). The intervention or procedure is likely to yield generalizable knowledge about the subjects disorder or condition which is of vital importance for the understanding or amelioration of the subjects disorder or condition. (shrink)

Individuals do not have a right to participate in clinical trials. But, they do have a right against being denied participation for inappropriate reasons. Despite the widespread endorsement of these two claims, there has been little discussion regarding which conditions for participation in clinical trials are appropriate and which are inappropriate. The present manuscript attempts to address this gap in the literature. We first describe and then argue against the claim that conditions on enrollment or continued participation are appropriate only (...) when they are needed to answer the scientific question(s) posed by the trial. We then offer an alternative view according to which the appropriateness of conditions depends on whether they help to satisfy the ethical requirements of clinical research. Because these requirements include social value, the present view implies that promoting social value is an acceptable reason to impose conditions on research participation. With this in mind, we explain why it is not coercive to require potential participants to accept conditions on enrollment that promote a trial's social value, even when the participants find those conditions unwelcome. We conclude by evaluating the present proposal's implications for the common practice of requiring participants to agree to the possible use of their leftover biospecimens in a broad range of future research. We argue, contra current regulatory policy, that this practice can be acceptable even when the present trial offers participants the prospect of clinical benefit and the samples are being reserved for future research that is unrelated to the present trial. (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)

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

When making substituted judgments for incapacitated patients, surrogates often struggle to guess what the patient would want if they had capacity. Surrogates may also agonize over having the (sole) responsibility of making such a determination. To address such concerns, a Patient Preference Predictor (PPP) has been proposed that would use an algorithm to infer the treatment preferences of individual patients from population-level data about the known preferences of people with similar demographic characteristics. However, critics have suggested that even if such (...) a PPP were more accurate, on average, than human surrogates in identifying patient preferences, the proposed algorithm would nevertheless fail to respect the patient’s (former) autonomy since it draws on the ‘wrong’ kind of data: namely, data that are not specific to the individual patient and which therefore may not reflect their actual values, or their reasons for having the preferences they do. Taking such criticisms on board, we here propose a new approach: the Personalized Patient Preference Predictor (P4). The P4 is based on recent advances in machine learning, which allow technologies including large language models to be more cheaply and efficiently ‘fine-tuned’ on person-specific data. The P4, unlike the PPP, would be able to infer an individual patient’s preferences from material (e.g., prior treatment decisions) that is in fact specific to them. Thus, we argue, in addition to being potentially more accurate at the individual level than the previously proposed PPP, the predictions of a P4 would also more directly reflect each patient’s own reasons and values. In this article, we review recent discoveries in artificial intelligence research that suggest a P4 is technically feasible, and argue that, if it is developed and appropriately deployed, it should assuage some of the main autonomy-based concerns of critics of the original PPP. We then consider various objections to our proposal and offer some tentative replies. (shrink)

Background Sickle cell anemia is a major genetic disease with the greatest burden in sub-Saharan Africa. To try to help reduce this burden, some churches in Nigeria conduct premarital sickle cell hemoglobin screening and refuse to conduct weddings when both individuals are identified as carriers of sickle cell trait. Main body This paper explores the ethical challenges involved in such denials. We assess whether churches have the right to decline to marry adults who understand the risks and still prefer to (...) get married, and whether couples should be denied church weddings based on the risk that their child may suffer from sickle cell anemia. We examine the moral and ethical dimensions of such denials and explore the underlying socio-cultural context involving the purpose of marriage and the meaning of the wedding ceremony in societies where premarital screening is one of the few tools available to reduce the risk of having children with SCA. The potential role of the church is also examined against the background of church beliefs, the duty of the church to its members and its role in reducing the suffering of its members and /or their children. Conclusion We argue that the church should impose these burdens on couples only if doing so promotes a sufficiently compelling goal and there is no less burdensome way to achieve it. We then argue that the goal of reducing the number of individuals in Nigeria who have SCA is compelling. However, testing earlier in life offers a less burdensome and potentially even more effective means of achieving this goal. This suggests that, advocating for earlier screening and helping to support these programs, would likely better promote the church’s own goals of helping its parishioners, increasing the number of church weddings, and reducing the burden of SCA in Nigeria. (shrink)

Sickle cell anemia is a major genetic disease with the greatest burden in sub-Saharan Africa. To try to help reduce this burden, some churches in Nigeria conduct premarital sickle cell hemoglobin screening and refuse to conduct weddings when both individuals are identified as carriers of sickle cell trait. This paper explores the ethical challenges involved in such denials. We assess whether churches have the right to decline to marry adults who understand the risks and still prefer to get married, and (...) whether couples should be denied church weddings based on the risk that their child may suffer from sickle cell anemia. We examine the moral and ethical dimensions of such denials and explore the underlying socio-cultural context involving the purpose of marriage and the meaning of the wedding ceremony in societies where premarital screening is one of the few tools available to reduce the risk of having children with SCA. The potential role of the church is also examined against the background of church beliefs, the duty of the church to its members and its role in reducing the suffering of its members and /or their children. We argue that the church should impose these burdens on couples only if doing so promotes a sufficiently compelling goal and there is no less burdensome way to achieve it. We then argue that the goal of reducing the number of individuals in Nigeria who have SCA is compelling. However, testing earlier in life offers a less burdensome and potentially even more effective means of achieving this goal. This suggests that, advocating for earlier screening and helping to support these programs, would likely better promote the church’s own goals of helping its parishioners, increasing the number of church weddings, and reducing the burden of SCA in Nigeria. (shrink)

Controversy persists over the ethics of compensating research participants and providing posttrial benefits to communities in developing countries. Little is known about residents' views on these subjects. In this study, interviews about compensation and posttrial benefits from a hypothetical HIV vaccine trial were conducted in Uganda’s Rakai District. Most respondents said researchers owed the community posttrial benefits and research compensation, but opinions differed as to what these should be. Debates about posttrial benefits and compensation rarely include residents' views like these, (...) but future ones should. (shrink)

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

We propose a formal framework for interpretable machine learning. Combining elements from statistical learning, causal interventionism, and decision theory, we design an idealised explanation game in which players collaborate to find the best explanation for a given algorithmic prediction. Through an iterative procedure of questions and answers, the players establish a three-dimensional Pareto frontier that describes the optimal trade-offs between explanatory accuracy, simplicity, and relevance. Multiple rounds are played at different levels of abstraction, allowing the players to explore overlapping causal (...) patterns of variable granularity and scope. We characterise the conditions under which such a game is almost surely guaranteed to converge on a optimal explanation surface in polynomial time, and highlight obstacles that will tend to prevent the players from advancing beyond certain explanatory thresholds. The game serves a descriptive and a normative function, establishing a conceptual space in which to analyse and compare existing proposals, as well as design new and improved solutions. (shrink)

Many scholars have argued that the Protestant Reformation generally departed from virtue ethics, and this claim is often accepted by Protestant ethicists. This essay argues against such discontinuity by demonstrating John Calvin’s reception of ethical concepts from Augustine and Aristotle. Calvin drew on Augustine’s concept of eudaimonia and many aspects of Aristotle’s Nicomachean Ethics , including concepts of choice, habit, virtue as a mean, and the specific virtues of justice and prudence. Calvin also evaluated the problem of pagan virtue in (...) light of traditional Augustinian texts discussed in the medieval period. He interpreted the Decalogue as teaching virtue, including the cardinal virtues of justice and temperance. Calvin was not the harbinger of an entirely new ethical paradigm, but rather a participant in the mainstream of Christian thinkers who maintained a dual interest in Aristotelian and Augustinian eudaimonist virtue ethics. (shrink)

This is a series of essays critical of the utilitarian bioethics now dominating contemporary discussion. Analysing questions of moral theory as well as applied ethics this book aims to supply essays on matters as diverse as beginning and end-of-life issues as well as animal rights, the act-omission distinction and the principle of double effect in caring in medical ethics.

This paper describes differences in two perspectives on the idea of virtue as a theoretical foundation for positive organizational ethics (POE). The virtue ethics perspective is grounded in the philosophical tradition, has classical roots, and focuses attention on virtue as a property of character. The positive social science perspective is a recent movement (e.g., positive psychology and positive organizational scholarship) that has implications for POE. The positive social science movement operationalizes virtue through an empirical lens that emphasizes virtuous behaviors. From (...) a virtue ethics perspective, a behaviorally based account of virtue is a weak theory of virtue. Observations are suggested for integrating the two perspectives. First, virtue should always be understood as an excellence and is often an optimal point between extreme dysfunctions on continuum of potential states. Second, an empirical exploration of virtue needs to account for character and context. Finally, the properties of organization-level virtue need to be further specified and explored. Implications and directions for future research are discussed. (shrink)

_Real Essentialism_ presents a comprehensive defence of neo-Aristotelian essentialism. Do objects have essences? Must they be the kinds of things they are in spite of the changes they undergo? Can we know what things are really like – can we define and classify reality? Many, if not most, philosophers doubt this, influenced by centuries of empiricism, and by the anti-essentialism of Wittgenstein, Quine, Popper, and other thinkers. _Real Essentialism_ reinvigorates the tradition of realist, essentialist metaphysics, defending the reality and knowability (...) of essence, the possibility of objective, immutable definition, and its relevance to contemporary scientific and metaphysical issues such as whether essence transcends physics and chemistry, the essence of life, the nature of biological species, and the nature of the person. (shrink)

Virtuousness refers to the pursuit of the highest aspirations in the human condition. It is characterized by human impact, moral goodness, and unconditional societal betterment. Several writers have recently argued that corporations, in addition to being concerned with ethics, should also emphasize an ethos of virtuousness in corporate action. Virtuousness emphasizes actions that go beyond the “do no harm” assumption embedded in most ethical codes of conduct. Instead, it emphasizes the highest and best of the human condition. This research empirically (...) examines the buffering and amplifying effects of virtuousness in organizations. The study hypothesizes that virtuousness has a positive effect on organizations because amplifying dynamics make subsequent virtuous action more likely, and buffering dynamics reduce the harmful effects of downsizing. The study reveals that two types of virtuousness – tonic and phasic – are associated with these effects. (shrink)

BackgroundAs suggested by Shook and Giordano, understanding and therefore addressing the urgent international governance issues around globalizing bio-medical/technology research and applications is limited by the perception of the underlying science.MethodsA philosophical methodology is used, based on novel and classical philosophical reflection upon existent literature, clinical wisdoms and narrative theory to discover a meta-science and telos of humankind for the development of a relevant and defendable global biomedical bioethics.ResultsIn this article, through pondering an integrative systems approach, I propose a biomedical model (...) that may provide Western biomedicine with leadership and interesting insight into the unity beyond the artificial boundaries of its traditional divisions and the limit between physiological and pathological situations. A unified biomedicine, as scientific foundation, might then provide the basis for dissolution of similar reflected boundaries within bioethics. A principled and communitarian cosmopolitan bioethics may then be synonymous with a recently proposed principled and communitarian cosmopolitan neuroethics based on a novel objective meta-ethics. In an attempt to help facilitate equal and inclusive participation in inter-, multi-, and transdisciplinary intercultural discourse regarding the aforementioned international governance issues, I offer: a meta-science derived through considering the general behaviour of activity, plasticity and balance in biology and; a novel thought framework to encourage and enhance the ability for self-evaluation, self-criticism, and self-revision aimed at broadening perspective, as well as acknowledging and responding to the strengths and limitations of extant knowledge.ConclusionsThrough classical philosophical reflection, I evolve a theory of medicine to discover a telos of humankind which in turn provides an ‘internal’ moral grounding for a proposed global biomedical bioethics. (shrink)

We propose a formal framework for interpretable machine learning. Combining elements from statistical learning, causal interventionism, and decision theory, we design an idealised explanation game in which players collaborate to find the best explanation for a given algorithmic prediction. Through an iterative procedure of questions and answers, the players establish a three-dimensional Pareto frontier that describes the optimal trade-offs between explanatory accuracy, simplicity, and relevance. Multiple rounds are played at different levels of abstraction, allowing the players to explore overlapping causal (...) patterns of variable granularity and scope. We characterise the conditions under which such a game is almost surely guaranteed to converge on a optimal explanation surface in polynomial time, and highlight obstacles that will tend to prevent the players from advancing beyond certain explanatory thresholds. The game serves a descriptive and a normative function, establishing a conceptual space in which to analyse and compare existing proposals, as well as design new and improved solutions. (shrink)