Whether intended or not, conceptions of informed consent are often rooted in archetypal notions of the researcher and prospective study participant. The former is assumed problematically to be a disinterested yet humanitarian individual who is well trained to conduct robust science. The latter is often characterized as being motivated by some altruistic notions about the contribution to science and society they are making even as they seek some personal benefit from the research. Cast in a dyad, the researcher has the (...) responsibility to inform the participant thoroughly about the purpose of the research, the risks and benefits of participation, and any alternatives to research available, as well as the .. (shrink)

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in (...) the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. (shrink)

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

This paper considers three package deals combining views in philosophy of mind, meta-philosophy, and experimental philosophy. The most familiar of these packages gives center-stage to pumping intuitions about fanciful cases, but that package involves problematic commitments both to a controversial descriptivist theory of reference and to intuitions that “negative” experimental philosophers have shown to be suspiciously variable and context-sensitive. In light of these difficulties, it would be good for future-minded experimental philosophers to align themselves with a different package deal. This (...) paper suggests two alternatives. Experimentalists might help fans of “naturalized” approaches discover what natural kinds have been playing an appropriate role in causing us to use concepts as we do. Or, better still, experimentalists might instead help pragmatists and teleo-semanticists discover how our concept usage regularly yields beneficial outcomes, so that we can then craft philosophical analyses that will.. (shrink)

A number of authors have suggested that a conditional analysis of dispositions must take roughly the following form: Thing X is disposed to produce response R to stimulus S just in case, if X were exposed to S and surrounding circumstances were auspicious, then X would produce R. The great challenge is cashing out the relevant notion of ‘auspicious circumstances’. I give a general argument which entails that all existing conditional analyses fail, and that there is no satisfactory way to (...) define ‘auspicious circumstances’ just in terms of S, R, and X. Instead, I argue that the auspicious circumstances C for the manifestation of a disposition constitute a third irreducible element of that disposition, and that to pick out (or to ‘individuate’) that disposition one must specify C along with S and R. This enables a new conditional analysis of dispositions that gives intuitively satisfying answers in cases that pose problems for other approaches. (shrink)

This paper contributes to an ongoing debate regarding the cognitive processes involved when one person predicts a target person's behavior and/or attributes a mental state to that target person. According to simulation theory, a person typically performs these tasks by employing some part of her brain as a simulation of what is going on in a corresponding part of the brain of the target person. I propose a general intuitive analysis of what 'simulation' means. Simulation is a particular way of (...) using one process to acquire knowledge about another process. What distinguishes simulation from other ways of acquiring knowledge is that simulation requires, for its non-accidental success, that the simulating process reflect significant aspects of the simulated process. This conceptual work is of independent philosophical interest, but it also enables me to argue for two conclusions that are of great significance to the debate about mental simulation theory. First, I argue that, in order to stake a non-trivial claim, simulation theory must hold that mental simulation involves what I call concretely similar processes. Second, I argue for the surprising conclusion that a significant class of cases that simulation theorists have claimed as intuitive cases of simulation do not actually involve simulation, after all. I close by sketching an alternative account that might handle these problematic cases. (shrink)

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles in (...) reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society. (shrink)

The first years of life mark a time of rapid development and dietary change, as children transition from an exclusive milk diet to a modified adult diet. During these early years, children's learning about food and eating plays a central role in shaping subsequent food choices, diet quality, and weight status. Parents play a powerful role in children's eating behavior, providing both genes and environment for children. For example, they influence children's developing preferences and eating behaviors by making some foods (...) available rather than others, and by acting as models of eating behavior. In addition, parents use feeding practices, which have evolved over thousands of years, to promote patterns of food intake necessary for children's growth and health. However in current eating environments, characterized by too much inexpensive palatable, energy dense food, these traditional feeding practices can promote overeating and weight gain. To meet the challenge of promoting healthy weight in children in the current eating environment, parents need guidance regarding alternatives to traditional feeding practices. (shrink)

There has been considerable interest in the literature about how professions operate in both the private and public interest. This paper examines this issue in the context of the enforcement of the professional code of conduct of a particular professional accounting association. The paper explores whether certain enforcement actions of the association suggest behaviour motivated at least partially by private interest. It then considers whether the consequences of such behaviour or practices are troubling.

Volume 19, Issue 9, September 2019, Page 35-36.

Three widely accepted principles – autonomy, beneficence and justice – provide a useful analytic framework for considering controversies and conflicts in bioethics. Since these principles capture key concepts found in diverse normative theories they provide a starting point from which consistent ethical analysis and comparison can begin. While justice is commonly discussed in the business ethics literature, the other two principles are not widely discussed. This paper investigates whether the principles of autonomy and beneficence provide a framework that is equally (...) useful for framing issues in business ethics. It is argued that they do. First, the principle of autonomy, with its associated notions of informed consent, privacy, confidentiality, voluntariness, self-mastery, and so on, provides a consistent approach to the analysis of diverse issues that arise in business ethics from market research to recruitment practices. Second, it is argued that the relationships between a business and its stakeholders ground duties of beneficence. The principle of beneficence provides a framework for considering the issues that arise in these relationships. (shrink)

Eating behaviors evolve during the first years of life as biological and behavioral processes directed towards meeting requirements for health and growth. For the vast majority of human history, food scarcity has constituted a major threat to survival, and human eating behavior and child feeding practices have evolved in response to this threat. Because infants are born into a wide variety of cultures and cuisines, they come equipped as young omnivores with a set of behavioral predispositions that allow them to (...) learn to accept the foods made available to them. During historical conditions of scarcity, family life and resources were devoted to the procurement and preparation of foods, which are often low in energy, nutrients, and palatability. In sharp contrast, today in non-Third World countries children's eating habits develop under unprecedented conditions of dietary abundance, where palatable, inexpensive, ready-to-eat foods are readily available. (shrink)

: This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function (...) as root causes of therapeutic misconceptions. (shrink)

Mental internalists hold that an individuals mental features at a given time supervene upon what is in that individuals head at that time. While many people reject mental internalism about content and justification, mental internalism is commonly accepted regarding such other mental features as rationality, emotion-types, propositional-attitude-types, moral character, and phenomenology. I construct a counter-example to mental internalism regarding all these features. My counter-example involves two creatures: a human and an alien from Pulse World. These creatures environments, behavioral dispositions and (...) histories are such that it is intuitively clear that they are mentally quite different, even while they are, for a moment, exactly alike with respect to whats in their heads. I offer positive reasons for thinking that the case I describe is indeed possible. I then consider ways in which mental internalists might attempt to account for this case, but conclude that the only plausible option is to reject mental internalism and to adopt a particular externalist alternative a history-oriented version of teleo-functionalism. (shrink)

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

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...) the adverse events they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. (shrink)

While Aristotle is often lauded, especially by virtue ethicists, for his focus on and insight into virtue, a central aspect of his conception of virtue—the doctrine of the mean—is often derided as false if not indeed absurd. The reason for this disparity in reaction to Aristotle is that the doctrine of the mean has been severely misinterpreted as stating that there are a variety of parameters in which one must achieve a mean. Such a doctrine is false, but it is (...) not Aristotle’s. In this paper, the author gives a more accurate account of the doctrine of the mean than has heretofore been given. According to this account, the doctrine simply states that virtue disposes one to feel one’s passions with an appropriate intensity. The author closes by considering Hursthouse’s famous criticisms of the doctrine of the mean, and he shows that they fail to be reasons for rejecting the doctrine. (shrink)

This paper explores what Epictetus thinks we need to learn in order to acquire the art of living, and, in doing so, illuminates the central tenets of Epictetus’ epistemology. It argues that we need to have cognition of preconceptions–innate, self-evident, general, ethical truths–and we need to know how to apply them. We acquire this “know-how” through habituation and, with it, are able to have cognition of correct applications.

It is difficult to place jazz within a philosophy of music dominated by the concepts and practices of classical music. One key puzzle concerns the nature and role, if any, of musical works in jazz. I briefly describe the debate between those who deny that there are musical works in jazz (Kania) and those who affirm that there are such (Dodd and others). I argue that musical works are performed in jazz but that jazz performance of works is very different (...) from performance of classical music works. The first step toward resolving the puzzle is to embrace the descriptive concept of a musical work and reject inappropriate normative concepts of a musical work. In particular, I argue against the accounts of musical works by Kania and Goehr, each of which implies a no-works thesis for jazz performance. I contrast the norms governing work performance in classical music with the practices governing performances of works in jazz, which I call realization or staging. Finally, I propose a model of jazz appreciation that incorporates a role for jazz works and that differs from the appreciation of classical music. (shrink)

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians (...) and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. (shrink)

The author believes that plato's view of the nature of philosophical activity can be seen in plato's paradoxical attitude toward the relationship between the written and spoken word. The "phaedrus" is examined from this perspective, And the author concludes that the varied wing symbols used by plato here indicate that although written words "have no wings," the words of philosophy do. Written words have some effectiveness for persuasion, But a philosopher needs more spirited interaction than this; only the spoken word (...) can supply this. (staff). (shrink)

While there is increasing pressure on scarce health care resources, advances in medical science have blurred the boundary between life and death. Individuals can survive for decades without consciousness and individuals whose whole brains are dead can be supported for extended periods. One suggested response is to redefine death, justifying a higher brain criterion for death. This argument fails because it conflates two distinct notions about the demise of human beings--the one, biological and the other, ontological. Death is a biological (...) phenomenon. This view entails the rejection of a higher brain criterion of death. Moreover, I claim that the justification of the whole brain (or brain stem) criterion of death is also cast into doubt by these advances in medical science. I proceed to argue that there is no need to redefine death in order to identify which treatments ought to be provided for the permanently and irreversibly unconscious. There are already clear treatment guidelines. (shrink)

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures. In exchange, they are paid. Healthy volunteers are, in a very direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. In his ethnographic study of socalled professional guinea pigs, Roberto Abadie writes, "Paid volunteers are well aware of the demand for an idealized, perfectly healthy volunteer. They also realize that their (...) body is a valued commodity in clinical trials research". It is perhaps surprising, then, that commodification is little discussed in the bioethics literature on phase I... (shrink)

In this paper I argue that, according to Plato’s Statesman, true statesmen directly control, administer, or govern none of the affairs of the city. Rather, administration and governance belong entirely to the citizens. Instead of governing the city, the task of the statesman is to facilitate the citizens’ successful self-governance or self-rule. And true statesmen do this through legislation, by means of which they inculcate in the citizens true opinions about the just, the good, the fine, and the opposites of (...) these. (shrink)

considers what I call free-floating chances—objective chances that obtain at a given time despite the fact that their values are not determined by the laws of nature together with the full history of non-chancy facts up to that time. I offer an intuitive example of this phenomenon, and use it to argue that free-floating chances are indeed possible. Their possibility violates three quite widely held principles about chances: the lawful magnitude principle, the principle that chances evolve by conditionalization and a (...) version of David Lewis' principal principle. I argue that we should reject common formulations of each of these principles, though I offer revised understandings of each which retain much of the intuitive attractiveness of the originals and are consistent with the possibility of free-floating chances. I conclude by arguing that, while considerations of free-floating chances are important, they will not sustain the extravagant conclusions Lange attempts to draw from them. Introduction First- and Higher-Order Chances Free-Floating Chances Support for the Intuitive Assessment Three Principles Violated What to do? COND as a Default Hypothesis A More Principled Principal Principle Conclusion. (shrink)

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed (...) specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. (shrink)

The question ‘Is it worth it?’, as originally applied to artworks by Tolstoy and here reintroduced by Sheila Lintott, opens a fruitful avenue for understanding land art. It is, however, a question...

Clinical trials on healthy volunteers generate unique ethical challenges both because participants accept potential physical risks without the possibility of direct medical benefit and because participants’ financial motivations to enroll in trials could lead to their exploitation. Despite the large volume of published empirical studies and ethical analyses of healthy volunteer research, there has been little concerted effort to change how healthy‐volunteer research is overseen or regulated. A new collaborative effort to do so is the VolREthics (Volunteers in Research and (...) Ethics) Initiative. Launched in 2022, this initiative brings together an international community to engage questions about how healthy volunteers could best be protected from the risks of harm and exploitation while the validity of clinical trials is optimized. (shrink)