In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses a major problem to informed consent. (...) The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

Physicians place significant weight on the distinction between acts and omissions. Most believe that autonomous refusals for procedures, such as blood transfusions and resuscitation, ought to be respected, but they feel no similar obligation to accede to requests for treatment that will, in the physician’s opinion, harm the patient (e.g., assisted death). Thus, there is an asymmetry. In this paper, we challenge the strength of this distinction by arguing that the ordering of values should be the same in both cases. (...) The reason for respecting refusals is that, in such cases, autonomy outweighs well-being. We argue that the same should be true in request cases, which means that requests should not be denied only due to the treatment being too harmful in the physician’s opinion. Our strategy is to consider and reject a number of arguments for the asymmetrical view, including an appeal to the doing–allowing distinction and positive and negative rights. The duty to respect refusals is still greater than the duty to grant requests on our view, but, by arguing that the ordering of values is the same in both cases, we show that there is less of a distinction in healthcare between requests and refusals than many currently believe. (shrink)

Personal autonomy is often lauded as a key value in contemporary Western bioethics. Though the claim that there is an important relationship between autonomy and rationality is often treated as uncontroversial in this sphere, there is also considerable disagreement about how we should cash out the relationship. In particular, it is unclear whether a rationalist view of autonomy can be compatible with legal judgments that enshrine a patient's right to refuse medical treatment, regardless of whether the reasons underpinning the choice (...) are known and rational, or indeed whether they even exist. Jonathan Pugh brings recent philosophical work on the nature of rationality to bear on the question of how we should understand personal autonomy in contemporary bioethics. In doing so, he develops a new framework for thinking about the concept of autonomy, one that is grounded in an understanding of the different roles that rational beliefs and rational desires have to play in it. Pugh's account allows for a deeper understanding of d the relationship between our freedom to act and our capacity to decide autonomously. His rationalist perspective is contrasted with other prominent accounts of autonomy in bioethics, and the revisionary implications it has for practical questions in biomedicine are also outlined. (shrink)

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 (...) this fundamental debate. It is contended that the notion of free will must be reflected when evaluating decision-making capacity. Namely, it should be included as a part of the appreciation-criterion for decision-making capacity. The argumentation is mainly drawn on the compatibilism of Harry Frankfurt. A solution is proposed which at the same time takes the notion of free will seriously and enriches the traditional understanding of decision-making capacity, strengthening its justificatory force while remaining clinically applicable. (shrink)

Background While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients.Methods We conducted semi-structured interviews with 31 GHPs across Europe, Australia (...) and Canada to identify some of these challenges.Results Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients – many of whom may be focused on ending their ‘diagnostic odyssey’ – in the informed consent process in a meaningful way. Thus, some questioned how ‘informed’ patients actually are when they agree to undergo clinical genomic sequencing.Conclusions These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from ‘fully informed consent’ toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote. (shrink)

Background While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients.Methods We conducted semi-structured interviews with 31 GHPs across Europe, Australia (...) and Canada to identify some of these challenges.Results Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients – many of whom may be focused on ending their ‘diagnostic odyssey’ – in the informed consent process in a meaningful way. Thus, some questioned how ‘informed’ patients actually are when they agree to undergo clinical genomic sequencing.Conclusions These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from ‘fully informed consent’ toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote. (shrink)

Objective: To gain insight into the standards of rationality that physicians use when evaluating patients’ treatment refusals.Design of the study: Qualitative design with indepth interviews.Participants: The study sample included 30 patients with cancer and 16 physicians . All patients had refused a recommended oncological treatment.Results: Patients base their treatment refusals mainly on personal values and/or experience. Physicians mainly emphasise the medical perspective when evaluating patients’ treatment refusals. From a medical perspective, a patient’s treatment refusal based on personal values and experience (...) is generally evaluated as irrational and difficult to accept, especially when it concerns a curative treatment. Physicians have a different attitude towards non-curative treatments and have less difficulty accepting a patient’s refusal of these treatments. Thus, an important factor in the physician’s evaluation of a treatment refusal is whether the treatment refused is curative or non-curative.Conclusion: Physicians mainly use goal oriented and patients mainly value oriented rationality, but in the case of non-curative treatment refusal, physicians give more emphasis to value oriented rationality. A consensus between the value oriented approaches of patient and physician may then emerge, leading to the patient’s decision being understood and accepted by the physician. The physician’s acceptance is crucial to his or her attitude towards the patient. It contributes to the patient’s feeling free to decide, and being understood and respected, and thus to a better physician–patient relationship. (shrink)

Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of (...) these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach. (shrink)

The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.

The prelims comprise: Introduction Controversial Choices Kinds of Normative Reasons for Action Limits on Respect for Autonomy Children and Controversial Choice Controversial Choices and the Duty to Strive Toward Perfection and Full Autonomy Acknowledgments Notes References.

In patient centred care, shared decision making is a central feature and widely referred to as a norm for patient centred medical consultation. However, it is far from clear how to distinguish SDM from standard models and ideals for medical decision making, such as paternalism and patient choice, and e.g., whether paternalism and patient choice can involve a greater degree of the sort of sharing involved in SDM and still retain their essential features. In the article, different versions of SDM (...) are explored, versions compatible with paternalism and patient choice as well as versions that go beyond these traditional decision making models. Whenever SDM is discussed or introduced it is of importance to be clear over which of these different versions are being pursued, since they connect to basic values and ideals of health care in different ways. It is further argued that we have reason to pursue versions of SDM involving, what is called, a high level dynamics in medical decision-making. This leaves four alternative models to choose between depending on how we balance between the values of patient best interest, patient autonomy, and an effective decision in terms of patient compliance or adherence: Shared Rational Deliberative Patient Choice, Shared Rational Deliberative Paternalism, Shared Rational Deliberative Joint Decision, and Professionally Driven Best Interest Compromise. In relation to these models it is argued that we ideally should use the Shared Rational Deliberative Joint Decision model. However, when the patient and professional fail to reach consensus we will have reason to pursue the Professionally Driven Best Interest Compromise model since this will best harmonise between the different values at stake: patient best interest, patient autonomy, patient adherence and a continued care relationship. (shrink)

In light of the variety of uses of the term autonomy in recent bioethics literature, in this paper, I suggest that competence, not being as contested, is better placed to play the anti-paternalistic role currently assigned to autonomy. The demonstration of competence, I will argue, can provide individuals with robust spheres of non-interference in which they can pursue their lives in accordance with their own values. This protection from paternalism is achieved by granting individuals rights to non-interference upon demonstration of (...) competence. In this paper, I present a risk-sensitive account of competence as a means of grounding rights to non-interference. On a risk-sensitive account of competence individuals demonstrate their competence by exercising three capacities to the extent necessary to meet a threshold determined by the riskiness of the decision. These three capacities are the capacity to acquire knowledge, use instrumental rationality, and form and revise a life plan. (shrink)

Most physicians dealing with Jehovah's Witnesses (JWs) who refuse blood-based treatment are uncertain as to any obligation to educate patients where it concerns the JW blood doctrine itself. They often feel they must unquestioningly comply when demands are framed as religiously based. Recent discussion by dissidents and reformers of morally questionable policies by the JW organisation raise ethical dilemmas about "passive" support of this doctrine by some concerned physicians. In this paper, Part 2, I propose that physicians discuss the misinformation (...) and irrationality behind the blood doctrine with the JW patient by raising questions that provide new perspectives. A meeting should be held non-coercively and in strict confidence, and the patient's decision after the meeting should be fully honoured (non-interventional). A rational deliberation based on new information and a new perspective would enable a certain segment of JW patients to make truly informed, autonomous and rational decisions. (shrink)

In their recent article, Erbay et al considered whether a seriously injured patient should be able to refuse treatment if the refusal was based on a (mis)interpretation of religious doctrine. They argued that in such a case ‘what is important…is whether the teaching or philosophy used as a reference point has been in fact correctly perceived’ (p 653). If it has not been, they asserted that this eroded the patient's capacity to make an autonomous decision and that therefore, in such (...) cases, it is the role of the healthcare professional (HCP) to ‘assist patients to think more clearly and rationally’ (p 653). There are, however, a number of problems with the reasons why Erbay et al suggest we should help patients to rationalise their decisions and how HCPs should go about this. In this article, the author explores some of their main arguments regarding consent and rationality (particularly in relation to religious beliefs), as well as Erbay et al's normative claim that HCPs have an obligation to promote autonomy by helping patients to come to a ‘rational’ decision. Ultimately, the author agrees that the (temporary) solution to the dilemma presented in this scenario (which was to insert an intravenous cannula into the patient in order to allow an infusion of fluids in the event that he changed his mind) seemed both pragmatic and ethically permissible. However, it is suggested that the arguments which underpin this conclusion in Erbay et al's article are largely unsound. (shrink)

There is preliminary evidence, from case reports and investigational studies, to suggest that Deep Brain Stimulation could be used to treat some patients with Anorexia Nervosa. Although this research is at an early stage, the invasive nature of the intervention and the vulnerability of the potential patients are such that anticipatory ethical analysis is warranted. In this paper, we first show how different treatment mechanisms raise different philosophical and ethical questions. We distinguish three potential mechanisms alluded to in the neuroscientific (...) literature, relating to desire, control, and emotion, respectively. We explain why the precise nature of the mechanism has important implications for the patient’s autonomy and personal identity. In the second part of the paper, we consider practical dimensions of offering DBS to patients with AN in certain cases. We first discuss some limited circumstances where the mere offering of the intervention might be perceived as exerting a degree of coercive pressure that could serve to undermine the validity of the patient’s consent. Finally, we consider the implications of potential effects of DBS for the authenticity of the patient’s choice to continue using stimulation to ameliorate their condition. (shrink)

According to the High Court in England and Wales, the primary purpose of legal interventions into the lives of vulnerable adults with mental capacity should be to allow the individuals concerned to regain their autonomy of decision making. However, recent cases of clinical decision making involving capacitous vulnerable adults have shown that, when it comes to medical law, medical ethics and clinical practice, vulnerability is typically conceived as opposed to autonomy. The first aim of this paper is to detail the (...) problems that arise when the courts and health care practitioners respond to the vulnerability of capacitous adults on the basis of such an opposition. It will be shown that not only does the common law approach to vulnerability fail to adequately capture the autonomy of capacitous vulnerable adults, the conception of vulnerability and autonomy in oppositional terms leads to objectionably paternalistic health care responses that undermine the autonomy of vulnerable patients as well as clinical and legal interventions that violate their autonomy. In response, the second aim of this paper is to show that the concepts of autonomy and vulnerability are necessarily entwined and, on that basis, the focus should be on promoting the autonomy of capacitous vulnerable adults where possible. In order to make this case, the paper explains the limitations of standard approaches to the autonomy of vulnerable adults and, in their place, offers a conception of legitimate, self-authorised autonomy that is fundamentally dependent on intersubjective practices of recognition. (shrink)

In the debates regarding the ethics of human enhancement, proponents have found it difficult to refute the concern, voiced by certain bioconservatives, that cognitive enhancement violates the autonomy of the enhanced. However, G. Owen Schaefer, Guy Kahane and Julian Savulescu have attempted not only to avoid autonomy-based bioconservative objections, but to argue that cognition-enhancing biomedical interventions can actually enhance autonomy. In response, this paper has two aims: firstly, to explore the limits of their argument; secondly, and more importantly, to develop (...) a more complete understanding of autonomy and its relation to cognitive enhancement. By drawing a distinction between the capacity for autonomy and the exercise and achievement of autonomy and by exploring the possible effects of cognitive enhancement on both competence and authenticity conditions for autonomy, the paper identifies and explains which dimensions of autonomy can and cannot, in principle, be enhanced via direct cognitive interventions. This allows us to draw conclusions regarding the limits of cognitive enhancement as a means for enhancing autonomy. (shrink)

Most agree that, if all else is equal, patients should be provided with enough information about proposed medical therapies to allow them to make an informed decision about what, if anything, they wish to receive. This is the principle of informed choice; it is closely related to the notion of informed consent. Contemporary clinical trials are analysed according to classical statistics. This paper puts forward the argument that classical statistics does not provide the right sort of information for informing choice. (...) The notion of probability used by classical statistics is complex and difficult to communicate. Therapeutic decisions are best informed by statistical approaches that assign probabilities to hypotheses about the benefits and harms of therapies. Bayesian approaches to statistical inference provide such probabilities. (shrink)

The majority of current attention on the question of autonomy has focused on the internal reflection of the agent. The quality of an agent’s reflection on her potential action (or motivating desire or value) is taken to determine whether or not that action is autonomous. In this paper, I argue that there is something missing in most of these contemporary accounts of autonomy. By focusing overwhelmingly on the way in which the agent reflects, such accounts overlook the importance of what (...) the agent is reflecting upon. Whichever of these current formulations of autonomy we accept, reflection could be undertaken in full accordance with the conditions set, and yet the action fail to be autonomous. This will occur, I argue, if the agent is mistaken about the object of her reflection. More precisely, if she has a particular kind of false belief about the action she is contemplating undertaking, then no amount of reflection can render that action autonomous. This suggests the need for externalist conditions to be incorporated into an account of autonomy. (shrink)

In this paper I argue that selective abortion for disability often involves inadequate counselling on the part of reproductive medicine professionals who advise prospective parents. I claim that prenatal disability clinicians often fail in intellectual duty—they are culpably ignorant about intellectual disability. First, I explain why a standard motivation for selective abortion is flawed. Second, I summarize recent research on parent experience with prenatal professionals. Third, I outline the notions of epistemic excellence and deficiency. Fourth, I defend culpable ignorance as (...) the best explanation of inadequate disability counselling. Fifth, I rebut alternative explanations. My focus is pregnancies diagnosed with mild or moderate intellectual disability. (shrink)

This paper explores how transformative experience generates decision-making problems of particular seriousness in medical settings. Potentially transformative experiences are especially likely to be encountered in medicine, and the associated decisions are confronted jointly by patients and clinicians in the context of an imbalance of power and expertise. However in such scenarios the principle of informed consent, which plays a central role in guiding clinicians, is unequal to the task. We detail how the principle’s assumptions about autonomy, rationality and information handle (...) transformative experiences poorly, appealing to several difficult cases for medical decision-making to illustrate the resulting problem, and we consider how the existing literature on complications with consent fails to offer a resolution. We argue that recognition of the problem has a role to play in achieving a more effective response to transformative decisions. In Sect. 1 we introduce several representative cases of challenging patient decision-making that clinicians might face. In Sect. 2 we detail how transformative experience has been analysed in the recent literature, before outlining in Sect. 3 the theoretical basis of the principle of informed consent, which plays a central role in how clinicians are expected to support decision-making. In Sect. 4, having laid the groundwork for a clear description, we return to the cases given in Sect. 1 to confirm how their transformative nature presents a problem: either clinicians treat the decisions faced by these patients as ‘normal’, encouraging them to focus on information provision that patients may be unable to act on, or they treat them as transformative, in which case they lack the resources to recognise whether they are helping patients make (subjectively) good decisions. In Sect. 5 we argue that the existing literature does not offer any escape from this problem. We close in Sect. 6 by noting the significant impact that appreciating the problem of transformative experience could have on supporting transformative decisions in medicine and briefly suggesting how we might aim to develop new approaches to dealing with these. (shrink)

Pickering et al. argue that patients who refuse doctor-recommended treatments should in some cases be deemed incompetent to decide about their own medical care—in part because of their decis...

Consent governs innumerable everyday social interactions, including sex, medical exams, the use of property, and economic transactions. Yet little is known about how ordinary people reason about the validity of consent. Across the domains of sex, medicine, and police entry, Study 1 showed that when agents lack autonomous decision-making capacities, participants are less likely to view their consent as valid; however, failing to exercise this capacity and deciding in a nonautonomous way did not reduce consent judgments. Study 2 found that (...) specific and concrete incapacities reduced judgments of valid consent, but failing to exercise these specific capacities did not, even when the consenter makes an irrational and inauthentic decision. Finally, Study 3 showed that the effect of autonomy on judgments of valid consent carries important downstream consequences for moral reasoning about the rights and obligations of third parties, even when the consented-to action is morally wrong. Overall, these findings suggest that laypeople embrace a normative, domain-general concept of valid consent that depends consistently on the possession of autonomous capacities, but not on the exercise of these capacities. Autonomous decisions and autonomous capacities thus play divergent roles in moral reasoning about consent interactions: while the former appears relevant for assessing the wrongfulness of consented-to acts, the latter plays a role in whether consent is regarded as authoritative and therefore as transforming moral rights. (shrink)

Some healthcare systems are said to be grounded in solidarity because healthcare is funded as a form of mutual support. This article argues that health care systems that are grounded in solidarity have the right to penalise some users who are responsible for their poor health. This derives from the fact that solidary systems involve both rights and obligations and, in some cases, those who avoidably incur health burdens violate obligations of solidarity. Penalties warranted include direct patient contribution to costs, (...) and lower priority treatment, but not typically full exclusion from the healthcare system. We also note two important restrictions on this argument. First, failures of solidary obligations can only be assumed under conditions that are conducive to sufficiently autonomous choice, which occur when patients are given ‘Golden Opportunities’ to improve their health. Second, because poor health does not occur in a social vacuum, an insistence on solidarity as part of healthcare is legitimate only if all members of society are held to similar standards of solidarity. We cannot insist upon, and penalise failures of, solidarity only for those who are unwell, and who cannot afford to evade the terms of public health. (shrink)

This article discusses the view that bioethics should become ‘‘culturally sensitive’’ and give more weight to various cultural traditions and their respective moral beliefs. It is argued that this view is implausible for the following three reasons: it renders the disciplinary boundaries of bioethics too flexible and inconsistent with metaphysical commitments of Western biomedical sciences, it is normatively useless because it approaches cultural phenomena in a predominantly descriptive and selective way, and it tends to justify certain types of discrimination.

This paper explores the value of respect for personal autonomy in relation to clearly immoral and irrational acts committed freely and intentionally by competent people. Following Berlin's distinction between two kinds of liberty and Darwall's two kinds of respect, it is argued that coercive suppression of nonautonomous, irrational, and self-harming acts of competent persons is offensive to their human dignity, but not disrespectful of personal autonomy. Irrational and immoral choices made by competent people may claim only the negative liberty to (...) be left alone. Lives disposed to autonomy are worthy of solidarity and active support in addition to the right of free choice and action. Autonomous premeditated desires (distinguished from mere consent) may embody transcendental choices, which transcend consideration of physical and psychological well-being. Choices made by incompetent persons (e.g., children and the mentally disabled) are not related to autonomy, but to self-directedness. The value of human dignity confers protection to self-directedness, but not at the expense of other vital interests. (shrink)