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Thirty-five current therapy clients, 47 former clients, and 42 college students with no therapy experience rated 27 items in terms of importance for inclusion in informed consent discussions. The current and former client samples rated information about inappropriate therapeutic techniques, confidentiality, and the risks of alternative treatments as most important, and information about the personal characteristics of the therapist and the therapist's degree as least important. The results of this study provide evidence for differential informed consent disclosure practices. |
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Criminal offenders may be offered to participate in voluntary rehabilitation programs aiming at correcting undesirable behaviour, as a condition of early release. Behavioural treatment may include direct intervention into the central nervous system (CNS). This article discusses under which circumstances voluntary rehabilitation by CNS intervention is justified. It is argued that although the context of voluntary rehabilitation is a coercive circumstance, consent may still be effective, in the sense that it can meet formal criteria for informed consent. Further, for a (...) |
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Who should decide about organ donation after death, the individual or the family? This paper examines why this practical question can be difficult to resolve. A comparison is made between standard decision‐making in medicine and decision‐making about organ donation. The questions are raised of the connection of the dead body to the person, and of who properly has autonomous control over the dead body. To understand the issues, an exploration of autonomy is needed, but at the same time this shows (...) |
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Policymakers, employers, insurance companies, researchers, and health care providers have developed an increasing interest in using principles from behavioral economics and psychology to persuade people to change their health-related behaviors, lifestyles, and habits. In this article, we examine how principles from behavioral economics and psychology are being used to nudge people (the public, patients, or health care providers) toward particular decisions or behaviors related to health or health care, and we identify the ethically relevant dimensions that should be considered for (...) |
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Bioethicists often draw sharp distinctions between hope and states like denial, self-deception, and unrealistic optimism. But what, exactly, is the difference between hope and its more suspect cousins? One common way of drawing the distinction focuses on accuracy of belief about the desired outcome: Hope, though perhaps sometimes misplaced, does not involve inaccuracy in the way that these other states do. Because inaccurate beliefs are thought to compromise informed decision making, bioethicists have considered these states to be ones where intervention (...) |
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Cognitive scientists have identified a wide range of biases and heuristics in human decision making over the past few decades. Only recently have bioethicists begun to think seriously about the implications of these findings for topics such as agency, autonomy, and consent. This article aims to provide an overview of biases and heuristics that have been identified and a framework in which to think comprehensively about the impact of them on the exercise of autonomous decision making. I analyze the impact (...) |
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The paper focuses on the nature and moral status of manipulation. I analyse a popular account of manipulation by Robert Noggle and assess a challenge that has been posed by Moti Gorin. I argue that Noggle’s theory can fend off the challenge. The analysis is instructive in that it enables one to look more closely at the nature of manipulation. I argue, contrary to some proposed accounts, that manipulation essentially involves deception about the manipulator’s intentions. Secondly, since manipulation contains an (...) |
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Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to (...) |
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OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with (...) |
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One moot point in bioethical debates about genetic testing concerns the conditions that have to be fulfilled to make individual genetic testing or individual participation in genetic screening programs truly voluntary. Though there is a relatively broad consensus about the non-viability of views on the extremes of the spectrum of opinions, there is considerable disagreement in the middle. This mirrors the difficulties in defining satisfactory demarcation lines between autonomous choice, pressured choice and coercion in cases in which the decision to (...) |
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Free and informed consent is generally acknowledged as the legal andethical basis for living organ donation, but assessments of livingdonors are not always an easy matter. Sometimes it is necessary toinvolve psychosomatics or ethics consultation to evaluate a prospectivedonor to make certain that the requirements for a voluntary andautonomous decision are met. The paper focuses on the conceptualquestions underlying this evaluation process. In order to illustrate howdifferent views of autonomy influence the decision if a donor's offer isethically acceptable, three cases (...) |
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Advertisements for pharmaceuticals may promote placebo responses by generating an expectation of therapeutic success. Some cite this as reason to favour Direct to Consumer Advertising of Prescription Pharmaceuticals (DTCA). Against this, I show placebo responses to emanate from beliefs rendered unjustified by the influence of a conditioning process. I argue that drug safety and efficacy are material properties and that unjustified beliefs in these domains entail costs to autonomy that outweigh any prudential gains attending a placebo response. I conclude that (...) |
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A central goal in regulating direct-to-consumer advertising of prescription pharmaceuticals is to ensure that explicit drug claims are truthful. Yet imagery can also alter viewer attitudes, and the degree to which this occurs in DTCA is uncertain. Addressing this data gap, we provide evidence that positive feelings produced by images can promote favourable beliefs about pharmaceuticals. We had participants view a fictitious anti-influenza drug paired with unrelated images that elicited either positive, neutral or negative feelings. Participants who viewed positive images (...) |
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The risk that direct-to-consumer advertising of prescription pharmaceuticals (DTCA) may increase inappropriate medicine use is well recognized. The U.S. Food and Drug Administration addresses this concern by subjecting DTCA content to strict scrutiny. Its strictures are, however, heavily focused on the explicit claims made in commercials, what we term their “propositional content.” Yet research in social psychology suggests advertising employs techniques to influence viewers via nonpropositional content, for example, images and music. We argue that one such technique, evaluative conditioning, is (...) |
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There has been a significant increase in the use of radiological services in the past 30 years. There are many reasons for this, but one has received little attention: the increased role of patient autonomy in healthcare. Patients demand x rays, CT scans, MRI, and positron emission tomography scans. The key question in this article is how a moral principle, such as respect for patient autonomy, can influence the extension of radiological services. A literature review reveals how patient autonomy is (...) |
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Hip fractures are common and serious injuries in the geriatric population. Obtaining informed consent for surgery in geriatric patients can be difficult due to the high prevalence of comorbid cognitive impairment. Given that virtually all patients with hip fractures eventually undergo surgery, and given that delays in surgery are associated with increased mortality, we argue that there are select instances in which it may be ethically permissible, and indeed clinically preferable, to initiate surgical treatment in cognitively impaired patients under the (...) |
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The ‘best interests’ decision making standard is used in clinical care to make necessary health decisions for non-capacitated individuals for whom neither explicit nor inferred wishes are known. It has been also widely acknowledged as a basis for enrolling some non-capacitated adults into clinical research such as emergency, critical care, and dementia research. However, the best interests standard requires that choices provide the highest net benefit of available options, and clinical research rarely meets this criterion. In the context of modern (...) |
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Editorial introduction to series of papers resulting from a European Commission Project on mental capacity. |
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Literature on the mental capacities and cognitive mechanisms of the great apes has been silent about whether they can act autonomously. This paper provides a philosophical theory of autonomy supported by psychological studies of the cognitive mechanisms that underlie chimpanzee behavior to argue that chimpanzees can act autonomously even though their psychological mechanisms differ from those of humans. Chimpanzees satisfy the two basic conditions of autonomy: (1) liberty (the absence of controlling influences) and (2) agency (self-initiated intentional action), each of (...) |
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Definition of the problemThe Shared Decision Making model is becoming increasingly popular also in the German-speaking context, but it only considers values of patients to be relevant for medical decisions. Nevertheless, studies show that the values of physicians are also influential in medical decisions. Moreover, physicians are often unaware of this influence, which makes it impossible to control it.ArgumentsThe influence of both patients’ and physicians’ values is examined from an empirical and normative perspective. The review about the empirical data provides (...) |
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Following Alder Hey and the earlier and much more extreme practices at Nuremberg, legislation has been developed governing the practice of medical ethics and research involving human participants more generally. In the medical context, relevant legislation includes GMC guidance, which states that disclosure of identifiable patient information without consent, for research purposes, is not acceptable unless it is justified in the public interest. There is a presumption, in other words, in favour of the view that patient consent ought to be (...) |
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A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in (...) |
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In recent years, several studies have advocated the need to expand the concept of patient autonomy beyond the capacity to deliberate and make decisions regarding a specific medical intervention or treatment (decision-making or decisional autonomy). Arguing along the same lines, this paper proposes a multidimensional concept of patient autonomy (decisional, executive, functional, informative and narrative) and argues that determining the specific aspect of autonomy affected is the first step towards protecting or promoting (and respecting) patient autonomy. These different manifestations of (...) |
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In der gegenwärtigen Diskussion um Patientenverfügungen dominieren die Fragen nach deren Reichweite und Verbindlichkeit. Diese bilden, ebenso wie die Kontroverse um diese beiden Themen, die professionsspezifische Sichtweise von Ärzten und Juristen ab. Aus Patientenperspektive jedoch, so die Ergebnisse einer Studie mit 272 Tumorpatienten, stellt sich die Situation anders dar: Hier fungieren Patientenverfügungen vielmehr als Türöffner für eine intensivere Kommunikation mit Ärzten, aber auch mit Angehörigen und mit sich selbst. Die Frage nach der Verbindlichkeit spielt demgegenüber nur eine nachgeordnete Rolle. |
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ZusammenfassungIn der gegenwärtigen Diskussion um Patientenverfügungen dominieren die Fragen nach deren Reichweite und Verbindlichkeit. Diese bilden, ebenso wie die Kontroverse um diese beiden Themen, die professionsspezifische Sichtweise von Ärzten und Juristen ab. Aus Patientenperspektive jedoch, so die Ergebnisse einer Studie mit 272 Tumorpatienten, stellt sich die Situation anders dar: Hier fungieren Patientenverfügungen vielmehr als Türöffner für eine intensivere Kommunikation mit Ärzten, aber auch mit Angehörigen und mit sich selbst. Die Frage nach der Verbindlichkeit spielt demgegenüber nur eine nachgeordnete Rolle. |
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ZusammenfassungIn der gegenwärtigen Diskussion um Patientenverfügungen dominieren die Fragen nach deren Reichweite und Verbindlichkeit. Diese bilden, ebenso wie die Kontroverse um diese beiden Themen, die professionsspezifische Sichtweise von Ärzten und Juristen ab. Aus Patientenperspektive jedoch, so die Ergebnisse einer Studie mit 272 Tumorpatienten, stellt sich die Situation anders dar: Hier fungieren Patientenverfügungen vielmehr als Türöffner für eine intensivere Kommunikation mit Ärzten, aber auch mit Angehörigen und mit sich selbst. Die Frage nach der Verbindlichkeit spielt demgegenüber nur eine nachgeordnete Rolle. |
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Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...) |
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The use of tanning beds has been identified as being among the most significant causes of melanoma and non-melanoma skin cancer. Accordingly, the activity is properly seen as one that involves profound harm to self. The article examines paternalistic reasons for restricting sunbed usage. We argue that both so-called soft and hard paternalistic arguments support prohibiting the use of sunbeds. We make the following three arguments: an argument from oppressive patterns of socialization suggesting that the autonomous nature of the conduct (...) |
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Large-scale whole genome sequencing (WGS) studies promise to revolutionize cancer research by identifying targets for therapy and by discovering molecular biomarkers to aid early diagnosis, to better determine prognosis and to improve treatment response prediction. Such projects raise a number of ethical, legal, and social (ELS) issues that should be considered. In this study, we set out to discover how these issues are being handled across different jurisdictions. |
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The spectacular progress in assisted reproduction technology that has been witnessed for the past thirty years resulted in emerging new ethical dilemmas as well as the revision of some perennial ones. The paper aims at a feminist approach to oocyte and spare embryo donation for research. First, referring to different concepts of autonomy and informed consent, we discuss whether the decision to donate oocyte/embryo can truly be an autonomous choice of a female patient. Secondly, we argue the commonly adopted language (...) |
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Background: Informed consent involves patients being informed, in detail, of information relating to diagnosis, treatment, care and prognosis that relates to him or her. It also involves the patient explicitly demonstrating an understanding of the information and a decision to accept or decline the intervention. Nurses in particular experience problems regarding informed consent. Research question and design: This descriptive study was designed to determine nurse knowledge and practices regarding their roles and responsibilities for informed consent in Turkey. The research was (...) |
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It is sometimes argued that autonomous decision-making requires that the decision-maker’s desires are authentic, i.e., “genuine,” “truly her own,” “not out of character,” or similar. In this article, it is argued that a method to reliably determine the authenticity (or inauthenticity) of a desire cannot be developed. A taxonomy of characteristics displayed by different theories of authenticity is introduced and applied to evaluate such theories categorically, in contrast to the prior approach of treating them individually. The conclusion is drawn that, (...) |
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The Japanese Ministry of Health and Welfare has implemented a policy of paying physicians to explain the nature of the patient's medical condition and the treatment plan. We describe the precepts of this policy and examine ethical dimensions of this development. We question whether this policy will be sufficient to ensure patients will have the opportunity to become informed participants in medical decision making. The policy also raises a broader philosophical question as to whether informed consent is a fundamental ethical (...) |
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The aim of this article is to examine whether informational manipulation, used intentionally by the researcher to increase recruitment in the research study, can be morally acceptable. We argue that this question is better answered by following a non-normative account, according to which the ethical justifiability of informational manipulation should not be relevant to its definition. The most appropriate criterion by which informational manipulation should be considered as morally acceptable or not is the researcher’s special moral duties towards their subjects. (...) |
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Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the (...) |
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Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) |
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Obtaining informed consent from patients is a moral and legal duty and, thus, a key legitimation for medical treatment. The pivotal prerequisite for valid informed consent is decision-making capacity of the patient. Related to the question of whether and when consent should be morally and legally valid, there has been a long-lasting philosophical debate about freedom of will and the connection of freedom and responsibility. The scholarly discussion on decision-making capacity and its clinical evaluation does not sufficiently take into account (...) |
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In a recent paper, Levy, Gadd, Kerridge, and Komesaroff attempt to defend the ethicality of homeopathy by attacking the utilitarian ethical framework as a basis for medical ethics and by introducing a distinction between evidence-based medicine and modern science. This paper demonstrates that their argumentation is not only insufficient to achieve that goal but also incorrect. Utilitarianism is not required to show that homeopathic practice is unethical; indeed, any normative basis of medical ethics will make it unethical, as a defence (...) |
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Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal (...) |
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