Informed consent to therapy is the legal doctrine which imposes on a physician the duty to explain the nature and risks of a proposed treatment so the patient can make an informed decision whether to undergo the treatment. The doctrine has spawned tremendous controversy in the legal and medical professions.In this paper I examine the doctrine of informed consent as developed by the courts. The thrust of my criticism is that as the doctrine has (...) been developed, it significantly undercuts individual autonomy. Several modifications are suggested which would provide more support for autonomy interests. (shrink)

Although Chinese law imposes informed consent for medical treatments, the Chinese understanding of this requirement is very different from the European one, mostly due to the influence of Confucianism. Chinese doctors and relatives are primarily interested in protecting the patient, even from the truth; thus, patients are commonly uninformed of their medical conditions, often at the family’s request. The family plays an important role in health care decisions, even substituting their decisions for the patient’s. Accordingly, instead (...) of personal informed consent, what actually exists is ‘family informed consent’. From a Western perspective, these features of Chinese law and Chinese culture might seem strange, contradicting our understanding of doctor-patient relationship and even the very essence of self-determination and fundamental rights. However, we cannot forget the huge influence of cultural factors in these domains, and that ‘Western’ informed consent is grounded on the individualistic nature of Western culture. This article will underline the differences between the Western and the Chinese perspectives, clarifying how each of them must be understood in its own cultural environment. But, while still respecting Chinese particularities, this paper advocates that China adopt patient individual informed consent because this is the only solution compatible with human dignity and human rights. (shrink)

In the "big data age", providing informed consent online has never been more challenging. Countless companies collect and share our personal data through devices, apps, and websites, fuelling a growing data economy and the emergence of surveillance capitalism. Few of us have the time to read the associated privacy policies and terms and conditions, and thus are often unaware of how our personal data are being used. This is a problem, as in the last few years, large tech (...) companies have abused our personal data. As privacy self-management, through the mechanism of providing online consent, has become increasingly difficult, some have argued that surveillance capitalism, and the data economy more broadly, need to be overthrown. This book presents a different perspective. It departs from the concept of revolutionary change to focus on pragmatic, incremental solutions tailored to everyday contexts. It scrutinizes how consent is currently sought and provided online and offers suggestions about how online consent practices can be improved upon. These include: the possibility of subjecting consent-gathering practices to ethics committees for review; the creation of visual-based consent agreements and privacy policies, to help with transparency and engagement; the development of software to protect privacy; and the idea of automated consent functionalities that allow users to bypass the task of reading vast amounts of online consent agreements. The author suggests that these "small-scale" changes to online consent-obtaining procedures, could, if successfully implemented, provide us with a way of self-managing our privacy in a way that avoids a revolutionary dismantling of the data economy. In the process, readers are encouraged to rethink the very purpose of providing inform consent online. Rethinking Informed Consent in the Big Data Age will appeal to researchers in normative ethics, applied ethics, philosophy of law, and the philosophy of AI. It will also be of interest to business scholars, communication researchers, students, and those in industry. (shrink)

The carbon emissions of global health care activities make up 4–5% of total world emissions, placing it on par with the food sector. Carbon emissions are particularly relevant for health care because of climate change health hazards. Doctors and health care professionals must connect their health care delivery with carbon emissions and minimize resource use when possible as a part of their obligation to do no harm. Given that reducing carbon is a global ethical priority, the informed consent (...) process in health care delivery must change. I argue that the expanded role of bioethicists in this climate crisis is to promote and support “green informed consent:” the sharing of climate information with patients, offering options for lower-carbon health care, and accepting the patient’s right to decline treatments which are deemed too carbon intensive for their values. (shrink)

Informed consent (IC) is a key patients’ right. It gives patients the opportunity to access relevant information/knowledge and to support their decision-making role in partnership with clinicians. Despite this promising account of IC, the relationship between ‘knowledge’, as derived from IC, and the role of clinicians is often misunderstood. I offer two examples of this: (1) the prenatal testing and screening for disabilities; (2) the consent process in the abortion context. In the first example, IC is often (...) over-medicalized, that is to say the disclosure of information appears to be strongly in the clinicians’ hands. In this context, knowledge has often been a curse on prospective parents. Framing information in a doctor-centred and often negative way has hindered upon prospective parents’ decision-making role and also portrayed wrong assumptions upon disabled people more widely. In the second context, information is more often than not dismissed and, in a de-medicalized scenario, medical contribution often underplayed. The latter leads to an understanding of the dialogue with clinicians as a mere hinderance to the timely access to an abortion. Ultimately, I claim that it is important that knowledge, as derived from IC, is neither altogether dismissed via a process of de-medicalization, nor used as a curse on patients via a process of over-medicalization. None of the two gives justice to IC. Only when a better balance between medical and patients’ contribution is sought, knowledge can aspire to be a blessing (i.e. an opportunity for them), not a curse on patients in the IC context. (shrink)

The law of informed consent to medical treatment has recently been extensively overhauled in England. The 2015 Montgomery judgment has done away with the long-held position that the information to be disclosed by doctors when obtaining valid consent from patients should be determined on the basis of what a reasonable body of medical opinion agree ought to be disclosed in the circumstances. The UK Supreme Court concluded that the information that is material to a patient’s (...) decision should instead be judged by reference to a new two-limbed test founded on the notions of the ‘reasonable person’ and the ‘particular patient’. The rationale outlined in Montgomery for this new test of materiality, and academic comment on the ruling’s significance, has focused on the central ethical importance that the law now accords to respect for patient autonomy in the process of obtaining consent from patients. In this paper, we dispute the claim that the new test of materiality articulated in Montgomery equates with respect for autonomy being given primacy in re-shaping the development of the law in this area. We also defend this position, arguing that our revised interpretation of Montgomery’s significance does not equate with a failure by the courts to give due legal consideration to what is owed to patients as autonomous decision-makers in the consent process. Instead, Montgomery correctly implies that doctors are ethically obliged to attend to a number of relevant ethical considerations in framing decisions about consent to treatment, which include subtle interpretations of the values of autonomy and well-being. Doctors should give appropriate consideration to how these values are fleshed out and balanced in context in order to specify precisely what information ought to be disclosed to a patient as a requirement of obtaining consent, and as a core component of shared decision-making within medical encounters more generally. (shrink)

This paper discusses the importance of informed medical consent through a case study examines the implications this case had for the medical rights of EU citizens. I start by describing a case of a Slovakian national of Roma origin against the Government of Slovakia, which appeared at the European Court of Human Rights in 2007-2012. The twenty-year old woman, who had been sterilized at a Slovakian hospital during the birth of her second child, claimed that the (...) procedure took place without her full and informed consent, and argued that the doctors’ decision was connected to the society’s long-standing negative attitude towards Roma people. After presenting the background of the case and the legal proceedings, I discuss the relevant national and European law in order to explain the positions of both sides and the rulings of the courts. I conclude by putting the case in a wider context of racial discrimination in the EU and providing a policy analysis regarding both the Slovakian and the European policies toward the Roma minority. (shrink)

The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of (...) the roots of Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as “qualified relatives” who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families. (shrink)

Requiring that a woman who is seeking an abortion be given the opportunity to view an ultrasound of her fetus has spread from anti-abortion “pregnancy resource centers” to state laws. Proponents of these laws claim that having access to the ultrasound image is necessary for a woman to make a medically informed decision. In this paper, we argue that ultrasound examinations frame fetuses visually and linguistically as persons and interpellate pregnant women as mothers, with all of the cultural meaning (...) invested in those two normative concepts. Presenting these judgments as medical information is misleading. Because women are being subjected to these cultural expectations unknowingly, mandatory ultrasound laws in fact undermine women’s autonomy. Fully informed consent would include a critical engagement with social norms around femininity and a recognition that such laws are meant to advance the state’s interest in preserving potential life. (shrink)

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of (...) informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism. (shrink)

From Hippocrates to paternalism to autonomy : the new hegemony -- From autonomy to consent -- Consent, autonomy, and the law -- Autonomy at the end of life -- Autonomy and pregnancy -- Autonomy and genetic information -- Autonomy and organ transplantation -- Autonomy, consent, and the law.

This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data (...) can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data. (shrink)

This timely book analyses and evaluates ethical and social implications of recent developments in reporting surgeon performance. It contains chapters by leading international specialists in philosophy, bioethics, epidemiology, medical administration, surgery, and law, demonstrating the diversity and complexity of debates about this topic, raising considerations of patient autonomy, accountability, justice, and the quality and safety of medical services. Performance information on individual cardiac surgeons has been publicly available in parts of the US for over a decade. Survival rates (...) for individual cardiac surgeons in the UK have recently been released to the public. This trend is being driven by various factors, including concerns about accountability, patients' rights, quality and safety of medical care, and the need to avoid scandals in medical care. This trend is likely to extend to other countries, to other clinicians, and to professions beyond health care, making this text an essential addition to the literature available. (shrink)

Background On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person’s autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives. Few years after the approval of the law, we (...) conducted a survey among physicians working in four health care facilities specific for the care of people suffering from psychiatric disorders, cognitive disorders and dementia located in the North of Italy aiming to investigate their perceived knowledge and training need, attitudes regarding law n. 219/2017 provisions, and practices of implementation of the law. Methods A semi-structured questionnaire was developed on an online platform. The invitation to participate in the survey was sent by email to the potential participants. Information was collected by means of the online platform (Google Forms) which allows to export data in a spreadsheet (Windows Excel) to perform basic statistical analysis (frequency distributions, bar chart representation). Results Twenty-five out of sixty physicians participated in the survey. None of the respondents value their knowledge of the law as very good, 10 good, 13 neither poor nor good, 1 poor and 1 very poor. All the respondents want to learn more about the law (21 yes and 4 absolutely yes). The majority of respondents agrees with the content of the law as a whole (3 absolutely agree, 13 agree), and on each provision. The question on the clarity of the concept of capacity in the law received mixed answers and this impacted on the physicians’ opinion regarding the legitimacy in principle for our groups of patients to realize shared care planning and write advance directives. Thirteen physicians neither introduced the theme of shared care planning nor arranged for shared care planning and the main reason for this was that no patient was in a clinical situation to require it. When shared care planning is realized, a variability in terms of type and number of meetings, mode of tracking and communication is registered. Conclusions Our survey results indicate a need for more clarity regarding the interpretation and implementation of the law in the patient groups under study. There are in particular two related areas that deserve further discussion: (1) the question of whether these patient groups are in principle legitimized by the law to realize shared care planning or write advance directives; (2) the notion of capacity required by the law and how this notion can be declined in real-life situations. (shrink)

In this article we explore the underpinnings of what we view as a recent "backlash" in English law, a judicial reaction against considering children's and young people's expressions of their own feelings about treatment as their "true" wishes. We use this case law as a springboard to conceptual discussion, rooted in (a) empirical psychological work on child development and (b) three key philosophical ideas: rationality, autonomy and identity. Using these three concepts, we explore different understandings of our central theme, true (...) wishes. These different conceptual interpretations, we argue, help to elucidate important clinical questions in the area of children's informed consent to treatment. For example, how much should a child's own wishes count in making medical decisions? Does it make a difference if the child or young person is undergoing psychiatric treatment?—if in some sense her wishes are abnormal, not "true" expressions of what she really wants? If the child's wishes do not count, why not? If they do matter but count for less, how much less? We conclude by advocating functional tests of a young person's true wishes, applicable on a case-by-case basis, rather than a black-and-white distinction between "incompetent" children and "competent" adults. (shrink)

This paper deals with ethical issues of particular relevance to longitudinal research involving children. First some general problems concerning information and lack of understanding are discussed. Thereafter focus is shifted to issues concerning information and consent procedures in studies that include young children growing up to become autonomous persons while the project still runs. Some of the questions raised are: When is it right to include children in longitudinal studies? Is an approval from the child needed? How should information (...) to children be handled? A general point stressed is that autonomy considerations underline the importance of adjusting the information given to meet demands. A “presumption of competence” may be needed in research involving children, in order to pay their views sufficient attention. (shrink)

Voluntariness is a necessary condition of valid consent. But determining whether a person consented voluntarily can be difficult, especially when people are subjected to coercion or manipulation, placed in a situation with no acceptable alternative other than to consent to something, or find themselves in an abusive relationship. This book presents a novel view on the voluntariness of consent, especially medical consent, which the author calls Interpersonal Consenter-Consentee Justification (ICCJ). According to this view, consent (...) is voluntary if and only if the process by which it has been obtained aligns with principles of interpersonal justification. ICCJ is distinctive because it explains voluntary consent neither as a 'psychological' concept indicative of the inner states of a person's mind (e.g. willingness or reluctance) nor as a 'circumstantial' concept indicative of a person's set of options. Rather, ICCJ explains the voluntariness of consent as an 'interpersonal' concept requiring the absence of illegitimate control within the interaction between the person giving consent and the person receiving it. In so doing, ICCJ further develops the notion of interpersonal justification, known from contractualist theories in moral philosophy, and introduces it to the debate on consent. The author employs a top-down approach, defending ICCJ's key characteristics on the basis of general theoretical arguments, as well as a bottom-up approach, supporting ICCJ in its application to clinical challenges such as nudging and manipulation, living organ donation, and clinical trials. Voluntary Consent will appeal to researchers and advanced students in normative ethics, bioethics, philosophy of law, behavioural psychology, and medicine. (shrink)

In some criminal cases a forensic psychiatrist is asked to make an assessment of the state of mind of the defendant at the time of the legally relevant act. A considerable number of people seem to hold that the basis for this assessment is that free will is required for legal responsibility, and that mental disorders can compromise free will. In fact, because of the alleged relationship between the forensic assessment and free will, researchers in forensic psychiatry also consider the (...) complicated metaphysical discussions on free will relevant to the assessment. At the same time, there is concern about the lack of advancement with respect to clarifying the nature of the forensic assessment. In this paper I argue that, even if free will is considered relevant, there may be no need for forensic researchers to engage into metaphysical discussions on free will in order to make significant progress. I will do so, drawing a parallel between the assessment of criminal responsibility on the one hand, and the medical practice of obtaining informed consent on the other. I argue that also with respect to informed consent, free will is considered relevant, or even crucial. This is the parallel. Yet, researchers on informed consent have not entered into metaphysical debates on free will. Meanwhile, research on informed consent has made significant progress. Based on the parallel with respect to free will, and the differences with respect to research, I conclude that researchers on forensic assessment may not have to engage into metaphysical discussions on free will in order to advance our understanding of this psychiatric practice. (shrink)

Many believe that the ethical problems of donation after cardiocirculatory death (DCD) have been "worked out" and that it is unclear why DCD should be resisted. In this paper we will argue that DCD donors may not yet be dead, and therefore that organ donation during DCD may violate the dead donor rule. We first present a description of the process of DCD and the standard ethical rationale for the practice. We then present our concerns with DCD, including the following: (...) irreversibility of absent circulation has not occurred and the many attempts to claim it has have all failed; conflicts of interest at all steps in the DCD process, including the decision to withdraw life support before DCD, are simply unavoidable; potentially harmful premortem interventions to preserve organ utility are not justifiable, even with the help of the principle of double effect; claims that DCD conforms with the intent of the law and current accepted medical standards are misleading and inaccurate; and consensus statements by respected medical groups do not change these arguments due to their low quality including being plagued by conflict of interest. Moreover, some arguments in favor of DCD, while likely true, are "straw-man arguments," such as the great benefit of organ donation. The truth is that honesty and trustworthiness require that we face these problems instead of avoiding them. We believe that DCD is not ethically allowable because it abandons the dead donor rule, has unavoidable conflicts of interests, and implements premortem interventions which can hasten death. These important points have not been, but need to be fully disclosed to the public and incorporated into fully informed consent. These are tall orders, and require open public debate. Until this debate occurs, we call for a moratorium on the practice of DCD. (shrink)

Is it ever permissible to publish a patient’s confidences without permission? I investigate this question for the field of psychoanalysis. Whereas most medical fields adopted a 1995 recommendation for consent requirements, psychoanalysis continues to defend the traditional practice of nonconsensual publication. Both the hermeneutic and the scientific branches of the field justify the practice, arguing that it provides data needed to help future patients, and both branches advance generalizations and causal claims. However the hermeneutic branch embraces methods tending (...) to undermine the reliability of such claims, while the scientific branch aims to improve the field’s empirical base – in their words, to advance psychoanalysis as a science. The scientific branch therefore has the stronger claim to the traditional practice, and it their claim that I consider. An immediate concern arises. We seem unable to answer the applied ethical question without first determining which ethical theory is correct; for defenders of the practice appeal variously to therapeutic privilege, principlism, and utilitarianism, while opponents wage autonomy-based arguments. The concern turns out to be unfounded, however, because all of these ethical approaches fail to justify the traditional practice. The more promising defenses fail partly because even the scientific branch of the field lacks empirically sound methods for establishing its causal claims and generalizations, often appealing to authority instead. I conclude that it is currently unethical for analysts to continue publishing their patients’ confidences without permission, and I suggest that the field help future patients by attending to its methodological problems. (shrink)

The General Medical Council (GMC) instructs doctors to act ‘reasonably’ in obtaining consent from patients. However, the GMC does not explain what it means to be reasonable: it is left to doctors to figure out the substance of this instruction. The GMC relies on the Supreme Court’s judgment in Montgomery v Lanarkshire Health Board; and it can be assumed that the judges’ idea of reasonability is adopted. The aim of this paper is to flesh out this idea of (...) reasonability. This idea is commonly personified as the audience that has to be satisfied by the doctor’s justification for offering, or withholding, certain treatments and related information. In case law, this audience shifted from a reasonable doctor to a ‘reasonable person in the patient’s position’; and Montgomery expands the audience to include ‘particular’ patients, too. Senior judges have clarified that the reasonable person is a normative ideal, and not a sociological construct; but they do not set out the characteristics of this ideal. John Rawls has conceived the reasonable person-ideal as one that pursues fair terms of co-operation with other members of society. An alternative ideal can be inferred from the feminist ethic of care. However, the reasonable patient from Montgomery does not align with either theoretical ideal; but, instead, is an entirely rational being. Such a conception conflicts with both real-life constraints on rationality and the doctor’s duty to care for the patient, and it challenges the practice of medicine. (shrink)

The right of adults with sound mind to consent to treatment or risk their own health for the benefit of the community in a clinical trial is unequivocally recognised by the law. But what about those vulnerable by virtue of their age, nature or position in society? Experts from the fields of medicine, philosophy, theology and law, explore the ethical and legal principles which seek to reconcile the individual's right to autonomy with the need to protect vulnerable groups. Discussions (...) refer both to specific groups and specific issues. (shrink)

Background On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of-life choices. The law does not contain an explicit reference to Ethics Committees (ECs), but they could still play a role in implementing the law. Methods A questionnaire-based survey was performed among the ECs of the Italian Institute for Research and Care belonging to the Network of neuroscience and neurorehabilitation, (...) with the aim of (1) knowing whether the ECs participated and, if so, how in the process of implementation of law n. 219/2017 in the referring institutes; (2) investigating the point of view of the ECs regarding their possible involvement in the process; (3) exploring the contribution ECs can provide to give effective implementation to the law principles and provisions. Results Seventeen ECs out of thirty took part in the survey; the characteristics of the responding and non-responding committees are similar, so the responding ECs can be regarded as representative of all ECs in the Network. Nine ECs did not discuss the law in anyway: the main reason for this is that the referring institutions (6) and the health care professionals (3) did not ask for an EC intervention. Nevertheless, the large majority of the ECs believe that their involvement in the implementation of the law as a whole is appropriate (8) or absolutely appropriate (6), while 3 of them are neutral. No EC believes that the involvement is inappropriate. The aspect of the law on which the 14 ECs converge in considering the EC involvement appropriate/absolutely appropriate is the one related to the health facilities obligation to guarantee the full and proper implementation of the principles of the law. Conclusions Our survey confirms that ECs believe they can play a role in the implementation of law n. 219/2017, although this does not entirely correspond to what the committees have actually done in reality. This role could be better exercised by ECs specifically established for clinical practice, which would have a composition, functioning and a mandate better suited to the purpose. This supports the call for a national regulation of ECs for clinical practice. (shrink)

Ethical and legal discourse pertaining to the ability to consent to treatment and research in England operates within a dualist framework of “competence” and “capacity”. This is confusing, as while there exists in England two possible senses of legal capacity – “first person” legal capacity and “delegable” legal capacity, currently neither is formulated to bear a necessary relationship with decision-making competence. Notwithstanding this, judges and academic commentators frequently invoke competence to consent in discussions involving the validity of offering (...) or withholding consent as a synonym for legal capacity to consent. I argue that this gives rise to a conflation, jeopardising clarity and consistency in law. This is somewhat less problematic in instances of “first-person” legal capacity that are heavily informed by criteria for decision-making competence than in the second sense of legal capacity, which is qualitatively different from decision-making competence, or with first-person legal capacity when defined in different terms from competence. The paper concludes by proposing that the soundest resolution to this problem is by making decision-making competence a necessary and sufficient condition of first-person legal capacity, affording a more scrupulous distinction between the two different forms of legal capacity that exist. (shrink)

Autonomy is a vital principle in medical law and ethics. It occupies a prominent place in all medico-legal and ethical debate. But there is a dangerous presumption that it should have the only vote, or at least the casting vote. This book is an assault on that presumption, and an audit of autonomy's extraordinary status. This book surveys the main issues in medical law, noting in relation to each issue the power wielded by autonomy, asking whether that power (...) can be justified, and suggesting how other principles can and should contribute to the law. It concludes that autonomy's status cannot be intellectually or ethically justified, and that positive discrimination in favour of the other balancing principles is urgently needed in order to avoid some sinister results. 'This book is a sustained attack on the hegemony of the idea of autonomy in medical ethics and law. Charles Foster is no respecter of authority, whether of university professors or of law Lords. He grabs his readers by their lapels and shakes sense into them through a combination of no-nonsense rhetoric and subtle argument that is difficult to resist.' Tony Hope, Professor of Medical Ethics, Oxford University 'This book is unlikely to be in pristine state by the time you have finished reading it. Whether that is because you have thrown it in the air in celebration or thrown it across the room in frustration will depend on your perspective. But this book cannot leave you cold. It is a powerful polemic on the dominance of autonomy in medical law, which demands a reaction. Charles Foster sets out a powerful case that academic medical lawyers have elevated autonomy to a status it does not deserve in either ethical or legal terms. In a highly engaging, accessible account, he challenges many of the views which have become orthodox within the academic community. This will be a book which demands and will attract considerable debate.' Jonathan Herring, Exeter College, Oxford University 'This is a learned, lively and thought-provoking discussion of problems central to the courts' approach to ethical issues in medical law. What principles are involved? More significantly, which really underlie and inform the process of seeking justice in difficult cases? Charles Foster persuasively argues, and demonstrates, that respect for autonomy is but one of a number of ethical principles which interact and may conflict. He also addresses the sensitive issue of the extent to which thoughts and factors which go to influence legal decisions may not appear in the judgments.' Adrian Whitfield QC. 'Introducing the Jake La Motta of medical ethics. Foster is an academic street-fighter who has bloodied his hands in the court room. He provides a stinging, relentless, ground attack on the Goliath of medical ethics: the central place of autonomy in liberal medical ethics. This is now the first port of call for those who feel that medical ethics has become autonomized.' Julian Savulescu, Uehiro Chair in Practical Ethics, University of Oxford. "This important book offers a robust challenge to anyone, whether lawyer or 'ethicist', who sees respect for autonomy as the only game in town. It argues eloquently and effectively that, on the one hand, despite the reverence paid to it by judges, in practice the law, even in the context of consent, weaves together a number of moral threads of which autonomy is merely one, in the pursuit of a good decision. It argues on the other hand, that were the day-to-day practice of law to be guided primarily by respect for autonomy, this would be wrong. Foster concludes that whilst, 'any society that does not have laws robustly protecting autonomy is an unsafe and unhappy one', so too would be a society in which too much emphasis was placed on respect for autonomy at the expense of other important moral principles. This is essential reading for anyone interested in the role of autonomy and indeed of medical ethics, in the law." Michael Parker, Professor of Bioethics, University of Oxford. (shrink)

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective (...) as well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss. (shrink)

Patients in Quebec can legally obtain medical assistance in dying (MAID) if they are able to give informed consent, have a serious and incurable illness, are at the end of their lives and are in a situation of unbearable suffering. Since the Supreme Court of Canada’s 2015 Carter decision, access to MAID, under certain conditions, has become a constitutional right. Quebec physicians are now likely to receive requests for MAID from their patients. The Quebec and Canadian laws (...) recognize a physician’s right to conscientious objection, but this right is contested both in the medical ethics literature and in the public sphere. This paper presents the results of a qualitative study conducted with twenty Quebec physicians who did not integrate MAID into their medical practice, either because they were opposed to or deeply ambivalent about MAID. The interviews aimed to explore the reasons – religious and secular – for opposition to or ambivalence towards MAID. The secular reasons given by participants were grouped into four main categories: 1) the ends of medicine and professional identity, 2) the philosophy of palliative medicine and resource allocation in palliative care, 3) benevolent paternalism, the “good death”, and the interests of future selves, 4) the risk of a slippery slope and the protection of vulnerable people. (shrink)

In _Pharmaceutical Freedom_ Professor Flanigan argues we ought to grant people self-medication rights for the same reasons we respect people’s right to give (or refuse to give) informed consent to treatment. Despite being the most comprehensive argument in favour of self-medication written to date, Flanigan’s _Pharmaceutical Freedom_ leaves a number of questions unanswered, making it unclear how the safe-guards Flanigan incorporates to protect people from harming themselves would work in practice. In this paper, I extend Professor Flanigan’s account (...) by discussing a hypothetical case to illustrate how these safe-guards could work together to protect people from harms caused by their own ignorance or incompetence. (shrink)

While the importance of Consent has been discussed widely over the last few decades, interest in its study has received renewed attention in recent years, particularly regarding medical treatment, clinical research and sexual acts. The Routledge Handbook of the Ethics of Consent is an outstanding reference source to this exciting subject and the first collection of its kind. Comprising over thirty chapters by a team of international contributors the Handbook is divided into five main parts: General Questions (...) Normative Ethics Legal Theory Medical Ethics Political Philosophy ¿ Within these sections central issues, debates and problems are examined, including: the nature and normative importance of consent, paternalism, exploitation and coercion, privacy, sexual consent, consent and criminal law, informed consent, organ donation, clinical research, and consent theory of political obligation and authority. ¿ The Routledge Handbook of the Ethics of Consent is essential reading for students and researchers in moral theory, applied ethics, medical ethics, philosophy of law and political philosophy. This volume will also be very useful for those in related fields, such as political science, law, medicine and social science. (shrink)

PHOTO ID 121339257© Designer491| Dreamstime.com ABSTRACT When physicians use their clinical knowledge and skills to advance the well-being of their patients, there may be apparent conflict between patient autonomy and physician beneficence. We are skeptical that today’s medical ethics education adequately fosters future physicians’ commitment to beneficence, which is both rationally defensible and fundamentally consistent with patient autonomy. We use an ethical dilemma that was presented to a group of third-year medical students to examine how ethics education might (...) be causing them to give undue deference to autonomy, thereby undermining their commitment to beneficence. INTRODUCTION The right of patients to choose which treatments they prefer is rooted in today’s social mores and taught as a principle of medical ethics as respect for autonomy. Yet, when physicians use their clinical knowledge and skills to advance the well-being of their patients, there may be a conflict between patient autonomy and physician beneficence. We are skeptical that today’s medical ethics education adequately fosters a commitment to beneficence, which is both rationally defensible and fundamentally consistent with patient autonomy. I. An Ethical Dilemma The impetus for this paper arose when students who were completing their third clinical year discussed a real-life ethical dilemma. A middle-aged man developed a pulmonary hemorrhage while on blood thinners for a recently placed coronary stent. The bleeding was felt to be reversible, but the patient needed immediate intubation or he would die. The cardiologist was told that the patient previously expressed to other physicians that he never wanted to be intubated. However, the cardiologist made the decision to intubate the patient anyway, and the patient eventually recovered.[1] Students were asked if they believed that the cardiologist had acted ethically. Their overwhelming response was, “No, the patient should have been allowed to die.” We looked into how students applied ethical reasoning to conclude that this outcome was ethically preferred. To explore how the third-year clinical experience might have formed the students’ judgment, we presented the same case to students who were just beginning their third year. Their responses were essentially uniform in recommending intubation. While there is likely more than one reasonable view in this case, we agree with the physician and the younger medical students that intubation was the ethically appropriate decision and will present an argument for it. But first, we explain the reasoning behind the more advanced medical students’ decision to choose patient autonomy at the expense of beneficence. II. Medical Ethics Education and the Priority of Autonomy Beauchamp and Childress’s Principles of Biomedical Ethics, first published in 1979 and now in its 8th edition, is a significant part of the formal ethics education in medical school.[2] Students learn an ethical decision-making approach based on respect for four ethical principles: autonomy, beneficence, nonmaleficence, and justice. While Beauchamp and Childress officially afford no prima facie superiority to any principle, the importance of respect for patient autonomy has increased through the editions of their book. For example, early editions of their book opposed the legalization of physician-assisted death compared to recent editions that defended it.[3] As another example, Beauchamp and Childress make paternalism harder to justify by adding an autonomy-protecting condition to the list of conditions for acceptable paternalism.[4] Authority, they contend, need not conflict with autonomy—provided the authority is autonomously chosen.[5] “The main requirement,” they write, “is to respect a particular patient’s or subject’s autonomous choices, whatever they may be.[6] In the principlism of Beauchamp and Childress, autonomy now seems to have a kind of default priority.[7] However, the bioethics discourse has strong counternarratives, noting some movement to elevate the role of beneficence and to respect the input of stakeholders, including the family and the healthcare team. Ethics education achieves particular relevance in the third clinical year when students become embedded in the care of patients and learn from what has been called the informal curriculum. They observe how attending physicians approach day-to-day ethical problems at the patient’s bedside. In this context, students observe the importance of informed consent for serious treatments or invasive procedures, a practice that highlights the principle of patient autonomy. In both the formal and informal curriculum, medical students observe how, in the words of Paul Wolpe, “patient autonomy has become the central and most powerful principle in ethical decision-making in American medicine.”[8] In short, students appear to learn a deference for patient autonomy. This curricular shift in favor of autonomy coincides with legal developments that protect patients’ rights and decision-making with respect to their healthcare choices. The priority of autonomy in medicine benefits patients by reflecting their choices and, in some cases, their fundamental liberty. III. The Practice of Medicine and the Commitment to Beneficence There are many critiques of the dominant place that autonomy has in biomedical ethics,[9] especially considering that autonomy seems to be biased toward individualistic, Western, and somewhat American culture-driven values.[10] In addition, many bioethical dilemmas are cast as a conflict between autonomy and beneficence. Our point is that medical students bring to their study of medicine a commitment to beneficence that seems to be suppressed by practical ethics education. We think this commitment is rationally defensible and should be nurtured. It is striking that young medical students have a pre-reflective commitment to beneficence at all. For, as we mentioned, it is not just medicine but Western culture generally that prioritizes autonomy in settling ethical dilemmas. In wanting to act for the good of others (rather than simply agreeing to what others want), physicians are already swimming somewhat against the cultural tide.[11] However, doing so makes sense, given the nature of medicine and the profession of healing. When prospective medical students are asked why they wish to become physicians, the usual answer is some variation on caring for the sick and preventing disease. It is unlikely that a reason to become a physician is to respect a patient’s autonomy. It would be easy to dismiss medical students’ commitment to beneficence as a mere intuition and contrary to a more reasoned and deliberative approach. Beauchamp and Childress seem to minimize the value of physician intuition, stating that justifications for certain procedures are “…supported by good reasons. They need not rest merely in intuition or feeling.”[12] Henry Richardson writes that “situational or perceptive intuition…leaves the reasons for decision unarticulated.”[13] We think this is a crude and rather thin way of understanding intuition. Some bioethicists have defended intuition as essential to the practice of medicine and not something opposed to reason.[14] In the case we describe, we believe the ethical justifications s for the patient’s intubation are fundamentally sound: the patient did not have a “do not intubate” order written in the chart, the emergency intubation had not been foreseen, so the patient did not have the opportunity to consent to or reject intubation; the patient had consented to the treatment for his cardiac disease so his consent for intubation could have been assumed;[15] and the consequences of respecting his autonomy did not justify allowing him to die.[16] While it is possible to have more than one reasonable view on this case, we think the case for beneficence is strong and certainly should not be dismissed out of hand. We do not deny that if a patient makes a clearly documented, well-informed decision to forgo intubation that this decision ought to be respected by the physician (even if the physician disagrees with the patient’s decision). But, in this situation, as in many others in the practice of medicine, the patient’s real wishes and preferences are not well-articulated in advance. There are many cases where a physician acts based on what she believes the patient, or the surrogate, would want, sometimes in situations that do not allow much time for reflection. An example might be resuscitation of a newborn at the borderline of viability. In their ethics education, beneficence would mean acting first to save a life. If the patient or surrogate makes an informed decision to the contrary, a beneficent physician respects that autonomous decision. In the case presented, the patient expressed gratitude to the cardiologist when extubated. But what if he had expressed anger at the physician for violating his autonomy? There are those who could argue that not only was intubation ethically wrong but that the cardiologist put himself in legal jeopardy by his actions (especially if there had been a written refusal applicable to the specific situation). In the example we use, we point out that the cardiologist may not have escaped a lawsuit if the patient had died without intubation. His family, when hearing the circumstances, may have sued for failure to act and dereliction of the cardiologist’s duty to save him. Beyond a potential legal challenge for either action or inaction, there is an overriding ethical question the cardiologist had to address: what course would be most satisfying to his conscience? Would he rather allow a patient to die for fear of recrimination, or act to save his life, regardless of the personal consequences? In the absence of real knowledge about the patient’s considered wishes, it is most reasonable to err on the side of promoting patient well-being. A physician’s commitment to beneficence is not necessarily a way of undermining a patient’s autonomy. In acting for the patient's good, physicians are also acting on what it is reasonable to believe a patient (or most patients, perhaps) would want, which is obviously connected to what a patient does want. Pellegrino and Thomasma argue that beneficence includes respect for a patient’s autonomy since “the best interests of the patient are intimately linked with their preferences.”[17] Instead of conceptualizing ethical dilemmas in medicine as conflicts between autonomy and beneficence, it is possible that medical schools could teach students that truly practicing beneficence is a way of valuing patient autonomy, especially when the patient’s wishes are not specific to the situation and are not clearly expressed. CONCLUSION It is important for students and practicing physicians to understand the principle of respect for patient autonomy in a pluralistic society that demands personal self-determination. However, the role of the physician as a beneficent healer should not be diminished by this respect for autonomy. Respecting a patient’s autonomy is grounded in and manifested by physician beneficence.[18] That is, seeking what is good for the patient can only be good if it respects their personhood and dignity. We propose that a commitment to beneficence, incipient in young medical students, should be developed over time with their other clinical reasoning skills. Such a commitment need not be sacrificed on the altar of patient autonomy. Beneficence needs greater relative moral weight with students as they proceed in their ethics education. - [1] S. Jauhar, “When Doctors Need to Lie,” New York Times, February 22, 2014, https://www.nytimes.com/2014/02/23/opinion/sunday/when-doctors-need-to-lie.html. [2] T. L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 8th ed. (New York, NY: Oxford University Press, 2019). [3] Louise A. Mitchell, “Major Changes in Principles of Biomedical Ethics,” The National Catholic Bioethics Quarterly 14, no. 3 (2014): 459–75, https://doi.org/10.5840/ncbq20141438. [4] Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 8th ed. (New York, NY: Oxford University Press, 2019), 238. [5] Beauchamp and Childress, 103. [6] Beauchamp and Childress, p. 108. [7] For other accounts that prioritize autonomy, see e.g. Allen E. Buchanan and Dan W. Brock, Deciding for Others: The Ethics of Surrogate Decision Making (Cambridge University Press, 1989), 38–39; R Gillon, “Ethics Needs Principles—Four Can Encompass the Rest—and Respect for Autonomy Should Be ‘First among Equals,’” Journal of Medical Ethics 29, no. 5 (October 2003): 307–12, https://doi.org/10.1136/jme.29.5.307. For examples of critiques of these accounts, see footnote 9. [8] P. R. Wolpe, “The Triumph of Autonomy in American Bioethics: A Sociological View,” in Bioethics and Society: Constructing the Ethical Enterprise, p. 43. [9] V. A. Entwistle et al., “Supporting Patient Autonomy: The Importance of Clinician-Patient Relationships,” Journal of General Internal Medicine 25, no. 7 (July 2010): 741–45; C. Foster, Choosing Life, Choosing Death: The Tyranny of Autonomy in Medical Ethics and Law, 1st ed. (Oxford ; Hart Publishing, 2009); O. O’Neill, Autonomy and Trust in Bioethics, The Gifford Lectures, University of Edinburgh 2001 (Cambridge, UK: Cambridge University Press, 2002). [10] P. Marshall and B. Koenig, “Accounting for Culture in a Globalized Bioethics,” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 32, no. 2 (2004): 252–66; R. Fan, “Self-Determination vs. Family-Determination: Two Incommensurable Principles of Autonomy,” Bioethics 11, no. 3–4 (1997): 309–22. [11] Arguments stressing the importance of beneficence, as ours does here, certainly approach paternalistic arguments. We set aside the complex issue of paternalism for purposes of this paper and simply note that the principle of beneficence as such does not say anything specifically about acting against the patient’s will. In the case study that focuses this paper, we do not believe the patient’s will or wishes were clearly indicated. [12] Beauchamp and Childress, Principles of Biomedical Ethics, p. 20, see note 2 above. [13] H. S. Richardson, “Specifying, Balancing, and Interpreting Bioethical Principles,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 25, no. 3 (January 1, 2000): 285–307, p. 287. [14] H. D. Braude, Intuition in Medicine a Philosophical Defense of Clinical Reasoning (Chicago ; University of Chicago Press, 2012). [15] R. Kukla, “Conscientious Autonomy: Displacing Decisions in Health Care,” The Hastings Center Report 35, no. 2 (2005): 34–44. [16] M. Schermer, The Different Faces of Autonomy: Patient Autonomy in Ethical Theory and Hospital Practice, vol. 13, Library of Ethics and Applied Philosophy (Dordrecht: Springer Netherlands, 2002). [17] E. D. Pellegrino and D. C. Thomasma, For the Patient’s Good - the Restoration of Beneficence in Health Care (New York, NY: Oxford University Press, 1988), p. 29. [18] Pellegrino and Thomasma, For the Patient’s Good. 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Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that (...) an informed consent approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large. (shrink)

COVID-19 has turned many ethical principles and presuppositions upside down. More precisely, the principle of respect for autonomy has been shown to be ill suited to face the ethical challenges posed by the current health crisis. Individual wishes and choices have been subordinated to public interests. Patients have received trial therapies under extraordinary procedures of informed consent. The principle of respect for autonomy, at least in its mainstream interpretation, has been particularly questioned during this pandemic. Further reflection on (...) the nature and value of autonomy is urgently needed. Relational autonomy has been proposed as an alternative account of autonomy that can more adequately respond to contemporary ethical issues in general and to a pandemic such as the one we are currently facing in particular. As relational autonomy is an emerging notion in current bioethics, it requires further consideration and development to be properly operationalized. This paper aims to show how six different philosophical branches––namely, philosophy of nature, philosophical anthropology, existential phenomenology, discourse ethics, hermeneutics, and cultural anthropology––have incorporated the category of relation throughout the twentieth century. We first delve into primary philosophical sources and then apply their insights to the specific field of medical ethics. Learning from the historical developments of other philosophical fields may provide illumination that will enable bioethics to experience a successful “relational turn”, which has been partially initiated in contemporary bioethics but not yet achieved. (shrink)

There are a variety of ethical and legal issues that arise with the growing use of health information technology in clinical settings. While privacy and confidentiality of information is an important consideration in any electronic system, some of the issues related to using these systems to improve patient safety include changes to the standard of care in regard to using electronic rather than paper medical records, user training, and assuring accurate information is in the medical record and provided (...) to users. There are other unique issues involved with the use of clinical decision support tools, exchange of health information across institutions, and the incorporation of genomic information into the clinical record. Informed consent for exchange of information as well as for the use of specialized tools will also be important to address. Health care information technology is rapidly improving and momentum is building for its expanded implementation. Strategies need to be developed to maximize the benefits of health information technology while minimizing the risks of harm associated with its implementation. The ethical issues raised in this article need to be addressed if the enormous potential of these systems to improve patient safety and quality of care is to be realized. Springer 2008. (shrink)

A history of injustices to diverse groups of human subjects in medical research has resulted in concerted efforts by U.S. policymakers in the second half of the twentieth century to provide greater protection for future subjects. However, in the context of patient populations demanding better therapies, potential medical advances, and greater attention to issues of social justice, Kahn, Mastroianni, and Sugarman set out to reconceptualize the principle of justice in human subjects research to address these urgent concerns. In (...) BeyondConsent, Kahn and colleagues advance a framework of justice in terms of access to participation in research, instead of protection. Their worthy cause, developed out of collaboration on the White House Advisory Committee on Human Radiation Experiments, aims to demonstrate how previously unaddressed notions of justice now require greater consideration in research. Specifically, they emphasize how fairness requires a greater distribution of risks and benefits, and that The volume does not report new research findings but rather draws on multidisciplinary approaches, including law, medicine, philosophy, history, and health policy, to argue that justice must go beyond informed consent. The editors posit that this challenge to protectionism is necessary given the heightened urgency for patients to benefit from investigational therapies although they incur increased risks. (shrink)

The High Court continues to exercise its inherent jurisdiction to make declarations about interventions into the lives of situationally vulnerable adults with mental capacity. In light of protective responses of health care providers and the courts to decision-making situations involving capacitous vulnerable adults, this paper has two aims. The first is diagnostic. The second is normative. The first aim is to identify the harms to a capacitous vulnerable adult’s autonomy that arise on the basis of the characterisation of situational vulnerability (...) and autonomy as fundamentally opposed concepts or the failure to adequately acknowledge the conceptual relationship between them at common law. The second part of this aim is to draw upon developments in analytic feminist philosophy to illustrate how standard approaches to autonomy are ill-equipped to capture the autonomy issues of capacitous vulnerable adults when their decisions regarding care and treatment are at stake. The second (normative) aim is to develop an account of self-authorised, intersubjective autonomy on the basis of analytic feminist insights into the relational practices of recognition. This account not only attempts to capture the autonomy of capacitous vulnerable adults and account for the necessary harms to their autonomy that arise from standard common law responses to their situational vulnerability, it is also predicated on the distinctions between mental capacity, the satisfaction of conditions for informed consent and the exercise of autonomy, meaning that it is better placed to fulfil the primary aim of the inherent jurisdiction – to facilitate the autonomy of vulnerable adults with capacity. (shrink)

In health care, the provision of pertinent information to patients is not just a moral imperative but also a legal obligation, often articulated through the lens of obtaining informed consent. Codes of medical ethics and many national laws mandate the disclosure of basic information about diagnosis, prognosis, and treatment alternatives. However, within publicly funded health care systems, other kinds of information might also be important to patients, such as insights into the health care priorities that underlie treatment (...) offers made. While conventional perspectives do not take this as an obligatory part of the information to be shared with patients, perhaps through viewing it as clinically “non-actionable,” we advocate for a paradigm shift. Our proposition diverges from the traditional emphasis on actionability. We contend that honoring patients as equal moral agents necessitates, among other principles, a commitment to honesty. Withholding specific categories of information pertinent to patients’ comprehension of their situation is inherently incompatible with this principle. In this article, we advocate for a recalibration of the burden of proof. Rather than requiring special justifications for adding to the standard set of information items, we suggest that physicians should be able to justify excluding relevant facts about the patient’s situation and the underlying considerations shaping health care professionals’ choices. This perspective prioritizes transparency and empowers patients with a comprehensive understanding, aligning with the ethos of respect for the patient as person. (shrink)

In clinical research, decision-making capacity is often equated with unspecified conceptions of autonomy, and autonomy is often equated with personhood. On this view, the loss of decision-making capacity is seen as a loss of autonomy, and the loss of autonomy subsumes a loss of personhood. An ethical concern arises at the intersection of those philosophical considerations with the legal considerations in informed consent. Because persons with inadequate decision-making capacity cannot provide legally effective consent, enrollment in research can (...) occur only if a surrogate gives permission on the person’s behalf. Federal regulations and resulting institutional policies allow permission from surrogates empowered under state law to consent to medical treatment procedures, typically in a hierarchy of legislatively prioritized relationships lacking regard for what the surrogate actually knows about the current research-related values and preferences of the potential subject. As a result, the research enterprise often countenances reliance on surrogates who have no relational or informational basis for an enrollment decision that aligns with the values and preferences of the subject. Arguing from the perspective that losing decision-making capacity does not alter the moral status of persons, and that respect for persons rather than respect for autonomy is the central ethical obligation, I assess the ethical implications of allowing persons with no knowledge of the values and preferences of the potential subject to make enrollment decisions, concluding that reliance on uninformed surrogates is not an ethically defensible approach to enrolling subjects in clinical research. (shrink)