Many ICT services require that users explicitly consent to conditions of use and policies for the protection of personal information. This consent may become ‘routinised’. We define the concept of routinisation and investigate to what extent routinisation occurs as well as the factors influencing routinisation in a survey study of internet use. We show that routinisation is common and that it is influenced by factors including gender, age, educational level and average daily internet use. We further explore the reasons users (...) provide for not reading conditions and policies and show that they can be grouped in meaningful ways that may delineate different types of routinsation. (shrink)

Through the continuous investigation of humans in organizations, we have learned much about motivation, attitudes, and performance. For example, Yukl and others have helped increase our understanding of influence tactics and the effect they have on the performance of subordinates, supervisors, and peers. Some tactics (and combinations of tactics) lead to resistance, some lead to compliance, and some lead to commitment. In this study, we raise the question of whether or not we incorporate our knowledge of these research findings into (...) the design, implementation, and interpretation of our own research studies that require the participation of human subjects. In a survey of 134 subjects from a previous social science study, we found that performance varied across the sample, consistent with the concepts of resistance, compliance, and commitment. In addition, the variance in performance could be explained, in part, by task interest and perceived task demands. Implications are discussed. (shrink)

The least infringement principle has been widely endorsed by public health scholars. According to this principle, public health policies may infringe upon “general moral considerations” in order to achieve a public health goal, but if two policies provide the same public health benefit, then policymakers should choose the one that infringes least upon “general moral considerations.” General moral considerations can encompass a wide variety of goals, including fair distribution of burdens and benefits, protection of privacy and confidentiality, and respect for (...) autonomy.In this article, we argue that the Center for Disease Control and Prevention's 2006 HIV screening recommendations may violate the least infringement principle. This is a concern because, although not legally binding, the Recommendations appear to have already influenced state laws and will likely continue to do so as legislative proposals continue to be passed. At a minimum, therefore, the Recommendations have important implications for HIV screening within the United States. (shrink)

There is a common problem in artificial intelligence (AI) and information security. In AI, an expert system needs to be able to justify and explain a decision to the user. In information security, experts need to be able to explain to the public why a system is secure. In both cases, an important goal of explanation is to acquire or maintain the users’ trust. In this paper, I investigate the relation between explanation and trust in the context of computing science. (...) This analysis draws on literature study and concept analysis, using elements from system theory as well as actor-network theory. I apply the conceptual framework to both AI and information security, and show the benefit of the framework for both fields by means of examples. The main focus is on expert systems (AI) and electronic voting systems (security). Finally, I discuss consequences of the analysis for ethics in terms of (un)informed consent and dissent, and the associated division of responsibilities. (shrink)

In this article, I present an argument that suggests neuroscience should inform judgments of decision-making capacity. First, I review key behavioral and neurocognitive data to demonstrate that neuroscientific tests might be predictive of decision-making capacity, and that these tests might inform clinical judgments of capacity. Second, I argue that, consistent with the principles of autonomy and justice, such data should inform judgements of decision-making capacity. While the neuroscience of decision-making capacity still requires time to mature, there is strong reason to (...) believe that neuroscience might assist clinicians in adjudicating difficult cases in the future. This article focuses on the assessment of capacity in brain injury patients who have profound communication impairments, however, the overarching aim of the article is to highlight the potential use of neuroscience to improve our understanding of the relationship between cognition and decision-making capacity. (shrink)

What should we do if climate change or global injustice require radical policy changes not supported by the majority of citizens? And what if science shows that the lacking support is largely due to shortcomings in citizens’ individual psychology such as cognitive biases that lead to temporal and geographical parochialism? Could then a plausible case for enhancing the morality of the electorate—even against their will –be made? But can a democratic government manipulate the will of the people without losing democratic (...) legitimacy? This paper explores the problems that governmental manipulation of voters pose for democratic legitimacy and the tensions between non-manipulated input and morally acceptable output. These venerable issues of political theory resurface in light of recent suggestions to tackle today’s global mega-problems by Ingmar Persson and Julian Savulescu. They suggest that to avert the looming catastrophe, governments should alter psychological traits of the citizenry through biomedical means, from pharmaceuticals to genetics. However, we argue that a government cannot rule with democratic legitimacy if elected by a will of the people it manipulated before. Normatively, conferring power from the governed onto governors is a one-directional relation that is incompatible with manipulation. But while it is tempting to rebut suggestions to morally enhance the people as antithetical to essential ideas of democracy, swift rebuttals tend to overlook the deeper challenge: Majoritarian decision-making may lead to inacceptable outcomes. The dilemma between input and output runs through major works in political theory. Rather than wishfully ignoring the dangers of democracy, democratic theory has to provide answers. (shrink)

Depression is often diagnosed in patients nearing the end of their lives and medication or psychotherapy is prescribed. In many cases this is appropriate. However, it is widely agreed that a health care professional should treat sick persons so as to improve their condition as they define improvement. This raises questions about the contexts in which treatment of depression in late life is appropriate. This article reviews a problematic case concerning the appropriateness of treatment in light of the literature in (...) bioethics. Specific attention is paid to the concept of authenticity and the role of suffering. Suffering is often the result of a situation in which one's self is damaged. In some circumstances, this suffering should not be seen as a symptom of illness but as a reflection, in a difficult life context, of the individual's authentic nature. Assessment of depression in the elderly must go beyond a symptom list and must consider both the context of the individual's situation and his or her authentic self. When the symptoms reflect the individual's assessment of the situation in the context of the authentic self, they may be "appropriate." However, even when the symptoms are appropriate, if they interfere with life assessment and adjustment, treatment should be considered. (shrink)

Candidate evaluation for breast implantation presents a more important obstacle to the fulfillment of the normative requirements of informed consent than do the social roles of women or cultural norms governing female beauty. I argue that women's decisions to receive breast implants may indeed be informed, competently made, and substantially voluntary, but that the cultural construction of beauty may undermine women's autonomy by influencing the evaluation of surgical candidates and risk disclosure during informed consent.

The starting point of this article is that employees’ chances of securing reasonable expectations of privacy at work must be better protected. A dependency asymmetry between employer and job-applicant implies that prospective employees are in a disadvantaged position vis à vis the employer regarding the chances of defending their reasonable interests. Since an increased usage of work related surveillance will, to a larger extent, require of job-applicants that they negotiate their privacy interests in employment contracting, it is important to consider (...) means of strengthening employees’ negotiating power. This article emphasizes the importance of contextualizing consent for contractual agreements to be ethically acceptable. (shrink)

The paper examines how technology challenges conventional borders of national legal systems, as shown by cases that scholars address as a part of their everyday work in the fields of information technology (IT)-Law, i.e., computer crimes, data protection, digital copyright, and so forth. Information on the internet has in fact a ubiquitous nature that transcends political borders and questions the notion of the law as made of commands enforced through physical sanctions. Whereas many of today’s impasses on jurisdiction, international conflicts (...) of law and diverging interpretations of statutes can be addressed by embedding legal safeguards in ICT and other kinds of technology, to overcome the ineffectiveness of state action by design entails its own risks, e.g., threats of paternalism hinging on the regulatory tools of technology. Rather than modelling people’s behaviour by design, the article suggests that design policies should respect individual and collective autonomy by decreasing the impact of harm-generating behaviour (e.g., security measures and default settings for data protection), or by widening the range of people’s choices (e.g., user friendly interfaces). (shrink)

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific (...) consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given. (shrink)

A normatively adequate public health ethics needs to be anchored in political philosophy rather than in ethics. Its central ethical concerns are likely to include trust and justice, rather than autonomy and informed consent.

BackgroundThis case report discusses an ethical communication dilemma in prehospital patient interaction, involving a patient who was about to board a plane at a busy airport. The article argues that the situation raised dilemmas about communication, patient autonomy and paternalism. Paramedics should be able to find good solutions to these dilemmas, but they have not received much attention in the literature on prehospital ambulance work.Case presentationThe patient had chest pains that were consistent with serious heart disease, but she wanted to (...) catch her plane and was unwilling to let paramedics assess her heart activity by means of an electrocardiogram (ECG). The paramedics had to decide, there and then, whether the patient’s refusal to submit to an ECG should be respected, or whether they should set the patient’s expressed wishes aside by exercising verbal power and persuasive communication techniques. The paramedics chose to do the latter. It later turned out that the patient was grateful that the paramedics had been very direct, almost brutal, in their communication. When the patient regained her autonomy, she saw clearly that taking time to obtain and monitor an ECG was the best option for her.ConclusionLooking forward in time might be a good professional strategy for deciding whether ethical paternalism in communication is justified. If there is good reason to believe that patients who later regain their autonomy will agree that paternalistic verbal actions were in their best interests, and if acting in accordance with patients’ preferences can have severe negative health consequences for them, then paramedics have good reason to believe that ethical paternalism is justified. (shrink)

In this article, we use the principlist approach to identify, analyse and attempt to solve the ethical problem raised by a pregnant woman's request for cesarean delivery in absence of medical indications.We use two different types of premises: factual (facts about cesarean delivery and specifically attitudes of obstetricians as derived from the EUROBS European study) and value premises (principles of beneficence and non-maleficence, respect for autonomy and justice).Beneficence/non-maleficence entails physicians' responsibility to minimise harms and maximise benefits. Avoiding its inherent risks (...) makes a prima facie case against cesarean section without medical indication. However, as vaginal delivery can have unintended consequences, there is a need to balance the somewhat dissimilar risks and benefits. The principle of autonomy poses a challenge in case of disagreement between the pregnant woman and the physician. Improved communication aimed to enable better informed choice may overcome some instances of disagreement. The principle of justice prohibits unfair discrimination, and broadly favours optimising resource utilisation.Available evidence supports vaginal birth in uncomplicated term pregnancies as the standard of care. The principlist approach offered a useful framework for ethical analysis of cesarean delivery on maternal request, identified the rights and duties of those involved, and helped reach a conclusion, although conflict at the individual level may remain challenging. (shrink)

The debate on the ‘right to know’ has simmered on for over 30 years. New examples where a right to be informed is contrasted to a right to be kept in ignorance occasionally surface and spark disagreement on the extent to which patients and research subjects have a right to be self-determining concerning the health related information they receive. Up until now, however, this debate has been unsatisfactory with regard to the question what type of rights—if any—are in play here (...) and to what extent they can provide a normative basis for informed consent. This paper provides an analysis of informed consent in the context of ‘epistemic interventions’: interventions which involve the communication of information. First, I offer an analysis of the concept of a ‘right not to know’ in the context of consent to epistemic interventions. I argue that the scope of the consent is determined by the extent to which this intervention can be seen as an infringement of the private sphere. After that I show how this analysis affects the scope and standards of informed consent. (shrink)

Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents, healthcare professionals and policy decision makers in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, decision-making and information (...) attainment. Decision-making comprised: parent decision authority; voluntariness; parent engagement with decision-making; and the process of enacting choice. Information ascertainment comprised: professional responsibilities ; parent responsibilities; and the need for discussion and understanding prior to a decision. Our findings indicate that consent-related terms are variously understood, with substantive implications for practice. We suggest that consent procedures should be explained descriptively, regardless of approach, so there are clear indications of what is expected of parents and healthcare professionals. Support systems are required both to meet the educational needs of parents and families and to support healthcare professionals in delivering information in a manner in keeping with parent needs. (shrink)

The frequency of the use of deception in American psychological research was studied by reviewing articles from journals in personality and social psychology from 1921 to 1994. Deception was used rarely during the developmental years of social psychology into the 1930s, then grew gradually and irregularly until the 1950s. Between the 1950s and 1970s the use of deception increased significantly. This increase is attributed to changes in experimental methods, the popularity of realistic impact experiments, and the influence of cognitive dissonance (...) theory. Since 1980 there appears to have been a decrease in the use of deception as compared to previous decades which is related to changes in theory, methods, ethical standards, and federal regulation of research. (shrink)

Newborn screening is the programme through which newborn babies are screened for a variety of conditions shortly after birth. Programmes such as this are individually oriented but resemble traditional public health programmes because they are targeted at large groups of the population and they are offered as preventive interventions to a population considered healthy. As such, an ethical tension exists between the goals of promoting the high uptake of supposedly ‘effective’ population-oriented programmes and the goal of promoting genuinely informed decision-making. (...) There is, however, a lack of understanding with regard to how parents experience the tension between promoting uptake and facilitating informed choice. This paper addresses this issue, and data are presented to show how aspects of the timing, presentation of information and procedural routinisation of newborn screening serves to impact on the decisions made by parents. (shrink)

In this paper, I examine the ethics of e - trust and e - trustworthiness in the context of health care, looking at direct computer-patient interfaces (DCPIs), information systems that provide medical information, diagnosis, advice, consenting and/or treatment directly to patients without clinicians as intermediaries. Designers, manufacturers and deployers of such systems have an ethical obligation to provide evidence of their trustworthiness to users. My argument for this claim is based on evidentialism about trust and trustworthiness: the idea that trust (...) should be based on sound evidence of trustworthiness. Evidence of trustworthiness is a broader notion than one might suppose, including not just information about the risks and performance of the system, but also interactional and context-based information. I suggest some sources of evidence in this broader sense that make it plausible that designers, manufacturers and deployers of DCPIs can provide evidence to users that is cognitively simple, easy to communicate, yet rationally connected with actual trustworthiness. (shrink)

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. (...) Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page W1-W3, August 2011.

Techniques from behavioral economics—nudges—may help physicians increase pediatric vaccine compliance, but critics have objected that nudges can undermine autonomy. Since autonomy is a centrally important value in healthcare decision-making contexts, it counts against pediatric vaccination nudges if they undermine parental autonomy. Advocates for healthcare nudges have resisted the charge that nudges undermine autonomy, and the recent bioethics literature illustrates the current intractability of this debate. This article rejects a principle to which parties on both sides of this debate sometimes seem (...) committed: that nudges are morally permissible only if they are consistent with autonomy. Instead, I argue that, at least in the case of pediatric vaccination, some autonomy-undermining nudges may be morally justified. This is because parental autonomy in pediatric decision-making is not as morally valuable as the autonomy of adult patients, and because the interests of both the vaccinated child and other members of the community can sometimes be weighty enough to justify autonomy-infringing pediatric vaccination nudges. This article concludes with a set of worries about the effect of pediatric vaccination nudges on parent-physician relationships, and it calls on the American Academy of Pediatrics to draw on scientific and bioethics research to develop guidelines for the use of nudges in pediatric practice and, in particular, for the use of pediatric vaccination nudges. (shrink)

Children’s preferences about medical treatment—like the preferences of other patients—hold moral weight in decision-making that is independent of considerations of autonomy or best interests. In light of this understanding of the moral value of patient preferences, the American Academy of Pediatrics could strengthen the ethical foundation for its formal guidance on pediatric assent.

The clinical application of the concept of patient autonomy has centered on the ability to deliberate and make treatment decisions (decisional autonomy) to the virtual exclusion of the capacity to execute the treatment plan (executive autonomy). However, the one-component concept of autonomy is problematic in the context of multiple chronic conditions. Adherence to complex treatments commonly breaks down when patients have functional, educational, and cognitive barriers that impair their capacity to plan, sequence, and carry out tasks associated with chronic care. (...) The purpose of this article is to call for a two-component re-conceptualization of autonomy and to argue that the clinical assessment of capacity for patients with chronic conditions should be expanded to include both autonomous decision-making and autonomous execution of the agreed-upon treatment plan. We explain how the concept of autonomy should be expanded to include both decisional and executive autonomy, describe the biopsychosocial correlates of the two-component concept of autonomy, and recommend diagnostic and treatment strategies to support patients with deficits in executive autonomy. (shrink)

Clinical evidence suggests that many patients undergo surgery that they would decline if fully informed. Failure to communicate the relevant risks, benefits, and alternatives of a procedure violates medical ethics and wastes medical resources. Integrating shared decision-making, a method of communication between provider and patient, into medical decisions can satisfy physicians' ethical obligations and reduce unwanted procedures. This article proposes a three-step process for implementing a nationwide practice of shared decision-making: create model integration programs; provide legal incentives to ease the (...) transition; and incorporate shared decision-making into medical necessity determinations. (shrink)

Medical practice should evolve alongside medical ethics. As our understanding of the ethical implications of physician-patient interactions becomes more nuanced, physicians should integrate those lessons into practice. As early as the 1930s, epidemiological studies began to identify that the rates of medical procedures varied significantly along geographic and socioeconomic lines. Dr. J. Alison Glover recognized that tonsillectomy rates in school children in certain school districts in England and Wales were in some cases eight times the rates of children in other (...) districts, with the only significant predictive factors being the current chief medical officer in the area and the socioeconomic well-being of the child's parents. Unfortunately, Dr. Glover's work revealed that the increase in tonsillectomies did not improve the health of adolescent patients and appeared to be performed “as a routine prophylactic ritual for no particular reason and with no particular result.”. (shrink)

In response to Korn, Huelsman, and Reed's (1992)question, "Who defines those interests, and how serious must the setback be?" (p. 126), we argue that a wrongful (unjust) harm (a setback of interest) is not equivalent to a hurt (a temporary distressing mental state) and that the interests of importance are welfare interests (general means to our ulterior aims), not just a desire to avoid unpleasant mental states (hurts). To set back a welfare interest is to reverse its course or to (...) impede, thwart, defeat, or doom it. It is the primary responsibility of the investigator to define both welfare interests and the risk of harm. An informed consent - one with substantial understanding, in substantial absence of control by others, and given intentionally - allows participants to autonomously authorize participation in research, including their toleration of acts of mental discomfort or distress during an experiment. Not only were our participants not wrongfully harmed, they benefited and were willing to volunteer for future research. No strong evidence has been advanced or linked to guided imagery in a way that would justify its restraint; to so claim evokes a standard of legal paternalism that fails to respect participants' competence and autonomy to choose to participate in research on rape using guided imagery. (shrink)

This paper investigates the ethical implications of research at the interface between biodiversity and both human and animal health. Health and sanitary crises often lead to ethical debates, especially when it comes to disruptive interventions such as forced vaccinations, quarantine, or mass culling of domestic or wild animals. In such debates, the emergence of a “Planetary health ethics” can be highlighted. Ethics and accountability principles apply to all aspects of scientific research including its technological and engineering applications, regardless of whether (...) they are considered “hard sciences”, such as state-of-the-art technology in the fields of medicine, veterinary medicine, agronomy, or environment, or “soft”, such as local or global governance, health, socio-ecosystems, and the environment. Ethical reflection in the interdisciplinary field of biodiversity and health requires the examination of relevant scientific domains, such as biology, ecology, evolution, human medicine, animal medicine, anthropology, and law, and their epistemology and representation as well as scientific pluralism, which is crucial to establish genuine interdisciplinarity. Navigating the ethics-scape necessitates going beyond the hierarchy of science by recognising that scientific knowledge has implications for both scientific and non-scientific perspectives on the study of nature. The example of a Nipah virus outbreak is used to illustrate how the so-called “modern epidemiological” approach often focuses on risk factors associated with individual behavioural characteristics or collective practices, whereas the so-called “eco-social” approach focuses on global, socio-economic, and environmental factors that are the contextual causes of the health problem affecting the community. “Modern epidemiologists” aim to “correct” individual or practice factors using a “minimal set” of ethics, whereas “eco-social” scientists have to act systemically, which requires integrated research that acknowledges scientific pluralism, avoids the hierarchy of sciences, but accepts the pluralism of ethics and values. (shrink)

In this article we explore some of the ethical dimensions of using social media to increase the number of living kidney donors. Social media provides a platform for changing non-identifiable ‘statistical victims’ into ‘real people’ with whom we can identify and feel empathy: the so-called ‘identifiable victim effect’, which prompts charitable action. We examine three approaches to promoting kidney donation using social media which could take advantages of the identifiable victim effect: institutionally organized campaigns based on historical cases aimed at (...) promoting non-directed altruistic donation; personal case-based campaigns organized by individuals aimed at promoting themselves/or someone with whom they are in a relationship as a recipient of directed donation; institutionally organized personal case-based campaigns aimed at promoting specific recipients for directed donation. We will highlight the key ethical issues raised by these approaches, and will argue that the third option, despite raising ethical concerns, is preferable to the other two. (shrink)

In this article, we use the principlist approach to identify, analyse and attempt to solve the ethical problem raised by a pregnant woman's request for cesarean delivery in absence of medical indications. We use two different types of premises: factual and value premises. Beneficence/non-maleficence entails physicians' responsibility to minimise harms and maximise benefits. Avoiding its inherent risks makes a prima facie case against cesarean section without medical indication. However, as vaginal delivery can have unintended consequences, there is a need to (...) balance the somewhat dissimilar risks and benefits. The principle of autonomy poses a challenge in case of disagreement between the pregnant woman and the physician. Improved communication aimed to enable better informed choice may overcome some instances of disagreement. The principle of justice prohibits unfair discrimination, and broadly favours optimising resource utilisation. Available evidence supports vaginal birth in uncomplicated term pregnancies as the standard of care. The principlist approach offered a useful framework for ethical analysis of cesarean delivery on maternal request, identified the rights and duties of those involved, and helped reach a conclusion, although conflict at the individual level may remain challenging. (shrink)

The realm of non-rational influence, which includes nudging, is home to many other morally interesting phenomena. In this paper, I introduce the term bumping, to discuss the category of unintentional non-rational influence. Bumping happens constantly, wherever people make choices in environments where they are affected by other people. For instance, doctors will often bump their patients as patients make choices about what treatments to pursue. In some cases, these bumps will systematically tend to make patients’ decisions worse. Put another way: (...) doctors will sometimes harm their patients by bumping them in systematic ways. I use the case of medical overuse, the provision of medical services where the likely harm outweighs the likely benefit to the patient, as a touchstone for arguing that doctors who systematically bump their patients towards harm can be blameworthy for their unwitting influence. (shrink)

Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, carefully talks through (...) the most important points, and gives him time to ask questions. Though it is a Phase 1 study and the chance that he will benefit is very low, Miguel happily agrees to take part. A week later, after the first experimental injection, she asks him if he is worried about the risks. “Risks?” he asks. “I’m sure this is safe—you’re a doctor, after all!”. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit assessment (...) and informed consent. (shrink)

Coercion by the recipient of consent renders that consent invalid. But what about when the coercive force comes from a third party, not from the person to whom consent would be proffered? In this paper I analyze how threats from a third party affect consent. I argue that, as with other cases of coercion, we should distinguish threats that render consent invalid from threats whose force is too weak to invalidate consent and threats that are legitimate. Illegitimate controlling third party (...) threats render consent invalid just as they do in two party cases. However, knowing that the consent is invalid is not sufficient to tell the recipient of consent what she may or should do. I argue that when presented with a token of consent from someone whom she thinks is experiencing an illegitimate controlling threat, the recipient may act on that token if and only if doing so represents a reasonable joint decision for her and the victim of coercion. The appropriate action for someone faced with third party coercion therefore depends on the other options open to her and those open to the victim of coercion. (shrink)

Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE (...) study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. (shrink)

Since the late 1960s, the legal doctrine of consent has occasionally been subject to severe criticism from within the bioethical discourse. The criticism was often based on observations indicating that consents and refusals, which had been considered valid from legal or institutional points of view, had frequently failed to reflect genuinely autonomous decision making, hence genuinely autonomous choices.This has led several critics to conclude that informed consent is a legal fiction. To clarify the concept, a legal fiction is a supposition (...) of fact taken to be true by the courts of law, irrespective of whether it is true or not, and even though it might not be true .1 What these critics probably meant to say was that the law deems any person who has given a legally valid consent to be genuinely task specifically autonomous, regardless of whether this is true or not and even though it might not be true. In other words, informed consent is a legal fiction, since it presupposes—that is, claims to reflect—genuine task specific autonomy, however baselessly.It was precisely this potentially embarrassing conclusion that prompted Faden and Beauchamp to develop a brilliant and remarkably effective argument in defence of the legal doctrine of consent. In their seminal work, AHistory and Theory of Informed Consent, they indeed acknowledged that effective consent often fails to be compatible with autonomous authorisation . Indeed, they recognised that effective consent does not necessarily entail autonomous authorisation. They argued, however, that the former is not a legal fiction, since it does not presuppose the …. (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)

We describe the growth of interest in the ethics of research with human participants based on articles abstracted in Psychological Abstracts and PsycLZT. Interest was low and variable until 1974, after which there was a marked increase in the number of articles published. We explain this emergence of ethical interest in terms of the social climate of concern for human rights in the 1960s and 1970s, the 1973 revision of the American Psychological Association's ethical principles, and the development of federal (...) regulation of research with human participants. (shrink)

Taking the critical turn is one of the main tools of the humanities and inculcates an intellectual discipline that prevents ossification of thinking about issues and of organizational policies in clinical ethics. The articles in this "Clinical Ethics" number of the Journal take the critical turn with respect to cherished ways of thinking in Western clinical ethics, life extension, the clinical determination of death, physicians' duty to treat even at personal risk, clinical ethics at the interface of research ethics, and (...) the pertinence of the Hippocratic Oath to clinical ethics. These articles challenge clinical ethicists to inculcate the intellectual discipline of the critical turn into everyday practice and continuous quality enhancement of clinical ethics. (shrink)