Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

The requirement of informed consent (IC) to medical treatments is almost invariably justified with appeal to patient autonomy. Indeed, it is common to assume that there is a conceptual link between the principle of respect for autonomy and the requirement of IC, as in the influential work of Beauchamp and Childress. In this paper I will argue that the possible relation between the norm of respecting (or promoting) patient autonomy and IC is much weaker than conventionally conceived. One consequence of (...) this is that it is possible to exercise your autonomy without having the amount of and the kind of information that are assumed in the standard requirement of IC to medical treatments. In particular, I will argue that with a plausible conception of patient autonomy, the respect for and the promotion of patient autonomy are in certain circumstances better protected by giving patients the right to give their negatively informed consent to medical treatments. (shrink)

In this paper, I argue that a modified version of well-being subjectivism can avoid the standard, yet unintuitive, conclusion that morally horrible acts may contribute to an agent’s well-being. To make my case, I argue that “Modified Subjectivists” need not accept such conclusions about well-being so long as they accept the following three theoretical addenda: 1) there are a plurality of values pertaining to well-being, 2) there are some objective goods, even if they do not directly contribute to well-being, and (...) 3) some of these values and goods are bound-up with one another. (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)

This special thematic issue of The Journal of Medicine and Philosophy brings together a cross-cultural set of scholars from Asia, Europe, and North America critically to explore foundational questions of familial authority and the implications of such findings for organ procurement policies designed to increase access to transplantation. The substantial disparity between the available supply of human organs and demand for organ transplantation creates significant pressure to manipulate public policy to increase organ procurement. As the articles in this issue explore, (...) however, even if well intentioned, the desire to maximize organ procurement does not justify undermining foundational elements of human flourishing, such as the family. While defending at times quite different understandings of autonomy, informed consent, and familial authority, each author makes clear that a principled appreciation of the family is necessary. Otherwise, health care practice will treat the family in a cynical and instrumental fashion unlikely to support social or individual good. (shrink)

According to the doctrine of informed consent medical procedures are morally permissible when a patient has consented to the treatment. Problematically it is possible for a patient to consent to or refuse treatment which consequently leads to a decline in her best interests. Standardly, such conflicts are resolved by prioritising the doctrine of informed consent above the requirement that the medical practitioner acts in accordance with the duty of care. This means that patient free choice is respected regardless as to (...) whether her choice leads to a decline in her best interests, since to disrespect patient choice would be an instance of ‘unwarranted’ paternalism. This thesis defends the claim that in cases where patient consent comes into conflict with her best interests, paternalistic interference is in fact justified. The ambition of the thesis is thus twofold: in the first place I argue that the doctrine of informed consent cannot be used as an ethical guarantor for medical decision making. Secondly I will conclude that hard paternalism is justified in medical practice, thereby calling for a reversal of the prioritisation of informed consent procedures over the medical practitioner’s duty of care. (shrink)

This work clarifies the role of the best interest standard (BIS) as ethical principle in the medical care of children. It relates the BIS to the ethical framework of medical practice. The BIS is shown to be a general principle in medical ethics, providing grounding to prima facie obligations. The foundational BIS of Kopelman and Buchanan and Brock are reviewed and shown to be in agreement with the BIS here defended. Critics describe the BIS as being too demanding, narrow, opaque, (...) not taking the family into account and not suitable as limiting principle. This work responds to these criticisms, showing that they do not stand up to scrutiny. They either do not apply to the BIS, only apply to misuses of the BIS or criticise a BIS that is not seriously defended in the literature. (shrink)

Bioethicists often draw sharp distinctions between hope and states like denial, self-deception, and unrealistic optimism. But what, exactly, is the difference between hope and its more suspect cousins? One common way of drawing the distinction focuses on accuracy of belief about the desired outcome: Hope, though perhaps sometimes misplaced, does not involve inaccuracy in the way that these other states do. Because inaccurate beliefs are thought to compromise informed decision making, bioethicists have considered these states to be ones where intervention (...) is needed either to correct the person’s mental state or to persuade the person to behave differently, or even to deny the person certain options. In this article, we argue that it is difficult to determine whether a patient is really in denial, self-deceived, or unrealistically optimistic. Moreover, even when we are confident that beliefs are unrealistic, they are not always as harmful as critics contend. As a result, we need to be more permissive in our approach to patients who we believe are unrealistically optimistic, in denial, or self-deceived—that is, unless patients significantly misunderstand their situation and thus make decisions that are clearly bad for them, we should not intervene by trying to change their mental states or persuade them to behave differently, or by paternalistically denying them certain options. (shrink)

Person-centered care offers a promising way to manage clinicians’ conscientious objection to providing services they consider morally wrong. Health care centered on persons, rather than patients, recognizes clinicians and patients on the same stratum. The moral interests of clinicians, as persons, thus warrant as much consideration as those of other persons, including patients. Interconnected moral interests of clinicians, patients, and society construct the clinician as a socially embedded and integrated self, transcending the simplistic duality of private conscience versus public role (...) expectations. In this milieu of blurred boundaries, person-centered care offers a constructive way to accommodate conscientious objection by clinicians. The constitutionally social nature of clinicians commits and enables them, through care mechanisms such as self-care, to optimize the quality of health care and protect the welfare of patients. To advance these conditions, it is recommended that the medical profession develop a person-centered culture of care, along with clinician virtues and skills for person-centered communication. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. (...) To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

I argue that public officials and health workers ought to respect and protect women’s rights to make risky choices during childbirth. Women’s rights to make treatment decisions ought to be respected even if their decisions expose their unborn children to unnecessary risks, and even if it is wrong to put unborn children at risk. I first defend a presumption of medical autonomy in the context of childbirth. I then draw on women’s birth stories to show that women’s medical autonomy is (...) often ignored during labor. Medical interventions are performed during childbirth without women’s consent. Childbirth is risky and some coercive medical interventions may be understood as attempts to protect children and to prevent mothers from acting impermissibly. However, even if it is wrong to make risky choices during childbirth, women have rights to do wrong in these cases. Therefore, coercive medical interventions are impermissible during childbirth and institutions should adopt specific protections for obstetric autonomy. (shrink)

I argue that it is impermissible to use nudges as a tool to influence patients in the context of informed consent. The motivation for such nudges is that their use can help reconcile potential conflicts between a physician’s duty of beneficence and duty to respect patient autonomy. I argue that their use places physicians in a position of domination over patients. That is, it violates the republican freedom of patients because it grants physicians the power to arbitrarily interfere. I also (...) argue that if one tries to adjust the duty of beneficence to avoid this conclusion, then the republican freedom of patients is still threatened under conditions of clinical equipoise. As ways to avoid the inevitability of nudging, I suggest the alternative of boosting or the pairing of patients with physicians who share their deep values. This latter option achieves the benefits nudging patients is supposed to provide without violating the republican freedom of those patients. (shrink)

Medical decisions for children are usually justified by the claim that they are in a child's best interests. More recently, following criticisms of the best interests standard, some advocate that the family's interests should influence medical decisions for children, although what is meant by family interests is often not made clear. I argue that at least two senses of family interests may be discerned. There is a ‘weak’ sense of family interests and a ‘strong’ sense. I contend that there are (...) problems with both approaches in making medical decisions for children but that the weak sense is more plausible. Despite this, I argue that claims for family interests are not helpful in making medical decisions for children. (shrink)

Recent professional guidelines published by the General Medical Council instruct physicians in the UK to be honest and open in any financial agreements they have with their patients and third parties. These guidelines are in addition to a European policy addressing disclosure of physician financial interests in the industry. Similarly, In the US, a national open payments program as well as Federal regulations under the Affordable Care Act re-address the issue of disclosure of physician financial interests in America. These new (...) professional and legal changes make us rethink the fiduciary duties of providers working under new organizational and financial schemes, specifically their clinical fidelity and their moral and professional obligations to act in the best interests of patients. The article describes the legal changes providing the background for such proposals and offers a prima facie ethical analysis of these evolving issues. It is argued that although disclosure of conflicting interest may increase trust it may not necessarily be beneficial to patients nor accord with their expectations and needs. Due to the extra burden associated with disclosure as well as its implications on the medical profession and the therapeutic relationship, it should be held that transparency of physician financial interest should not result in mandatory disclosure of such interest by physicians. It could lead, as some initiatives in Europe and the US already demonstrate, to voluntary or mandatory disclosure schemes carried out by the industry itself. Such schemes should be in addition to medical education and the address of the more general phenomenon of physician conflict of interest in ethical codes and ethical training of the parties involved. (shrink)

”Merely fact-minded sciences make merely factminded people.”“ …the positivistic concept of science in our time is, historically speaking, a residual concept. It has dropped all the questions which had been considered under the now narrower, now broader concepts of metaphysics….all these ‘metaphysical’ questions, taken broadly – commonly called specifically philosophical questions – surpass the world understood as the universe of mere facts. They surpass it precisely as being questions with the idea of reason in mind. And they all claim a (...) higher dignity than questions of fact, which are subordinated to them even in the order of inquiry. Positivism, in a manner of speaking, decapitates philosophy.”Edmund HusserlIn ethical literature associated with controversies at the beginning and end of human life, there is often a two-part structure: first, basic facts about the topic are presented in a more or less descriptive format, then there is the ethics or policy. (shrink)

The reuse of single use medical items is a complex ethical issue that many healthcare providers are faced with, for while recommendations and literature do not advocate the reuse of these items, the reality is that many single use items are frequently reused. Further, many healthcare workers are ethically divided over whether or not to share this information with their patients, or who should reveal this information. While single use items are convenient to use, the reality of the cost to (...) the healthcare system and the environment is being realised. Three distinct issues in regard to reuse of single use items are explored: patient consent, fiscal responsibility and environmental stewardship. Exploring these issues through the ethical frameworks of utilitarianism, contractarianism, and land ethic or holism can offer guidance in attending to the question “is once always enough?” Applying an integrated ethical framework can further assist healthcare providers and stakeholders to make informed, ethical choices in regard to choosing single use medical devices and items. Short, fictionalised narratives based on authentic events are used to illustrate the ethical context of the reuse issue. (shrink)

Patient responsibilities in primary health care are controversial and, by comparison, the responsibilities of high need patients are less clear. This paper aims to suggest why high need patients receiving targeted entitlements in primary health care are free to have prima facie special responsibilities; why, given this freedom, these patients morally have special responsibilities; what these responsibilities are, and how publicly funded health systems ought to be able to respond when these remain unmet. It is suggested that the special responsibilities (...) and their place in public policy acquire moral significance as a means to discharge a moral debt, share special knowledge, and produce desirable consequences in regard to personal and collective interests. Special responsibilities magnify ordinary patient responsibilities and require patients not to hesitate regarding attendance for primary health care. Persistent patient disregard of special responsibilities may necessitate limiting the scope of these responsibilities, removing system barriers, or respecifying special rights. (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 author examines the motives for the behaviour and actions of Dr. Skreta, the main character of Kundera’s novel The Farewell Waltz. The starting point of the novel was the social and political situation in totalitarian Czechoslovakia at the turn of the 1960s and 1970s. He compares it to the situation in the developed western world and comes to a realization that there were many similarities in medicine; however, there were significant differences with regard to external factors. The health care (...) system in western democratic societies were placed in contrast with Czechoslovakia, where a doctor’s activities and the system of health care were subordinated to the political, ideological, and social intentions of totalitarian power. In this context, the author has come to the conclusion that Dr. Skreta’s motives for acting arose from his moral responsibility for the country’s future. Dr. Skreta waged a latent personal “moral war” against the totalitarian regime. This was also reflected in his opposition to the preferred morality of socialist health care professionals. Part of this was his eugenics project. According to the author, in the context of ethics of social consequences, Dr. Skreta was a responsible moral agent seeking a better future not only for the country and its people, but his personal selfish interests. (shrink)

One of the most contentious ethical issues in the neonatal intensive care unit is the withdrawal of life-sustaining treatment from infants who may otherwise survive. In practice, one of the most important factors influencing this decision is the prediction that the infant will be severely intellectually disabled. Most professional guidelines suggest that decisions should be made on the basis of the best interests of the infant. It is, however, not clear how intellectual disability affects those interests. Why should intellectual disability (...) be more important than physical disability to the future interests of an infant? Is it discriminatory to base decisions on this? This paper will try to unravel the above questions. It seems that if intellectual disability does affect the best interests of the child it must do so in one of three ways. These possibilities will be discussed as well as the major challenges to the notion that intellectual disability should have a role in such decisions. The best interests of the child can be affected by severe or profound intellectual disability. It is, though, not as clear-cut as some might expect. (shrink)

Observers who note the increasing popularity of bioethics discussions often complain that the social sciences are poorly represented in discussions about things like abortion and stem-cell research. Critics say that bioethicists should be incorporating the methods and findings of social scientists, and should move towards making the discipline more empirically oriented. This way, critics argue, bioethics will remain relevant, and truly reflect the needs of actual people. Such recommendations ignore the diversity of viewpoints in bioethics, however. Bioethics can gain much (...) from the methods and findings from ethnographies and similar research. But it is misleading to suggest that bioethicists are unaware of this potential benefit. Not only that, bioethicists are justified in having doubts about the utility of the social science approach in some cases. This is not because there is some inherent superiority in non-empirical approaches to moral argument. Rather, the doubts concern the nature of the facts that the sciences would provide. Perhaps the larger point is that disagreements about the relationship between facts and normative arguments should be seen as part of the normal inquiry in bioethics, not evidence that reform is needed. (shrink)

Families and clinicians approaching a child’s death in the paediatric intensive care unit (PICU) frequently encounter questions surrounding medical decision-making at the end of life (EOL), including defining what is in the child’s best interest, finding an optimal balance of benefit over harm, and sometimes addressing potential futility and moral distress. The best interest standard (BIS) is often marshalled by clinicians to help navigate these dilemmas and focuses on a clinician’s primary ethical duty to the paediatric patient. This approach does (...) not consider a clinician’s potential duty to the patient’s family. This paper argues that when a child is dying in the PICU, the physician has a duty to serve both the patient and the family, and that in some circumstances, the duty to serve the family becomes as important as that owed to the child. We detail the limitations of the BIS in paediatric EOL care and propose the relational potential standard as an additional ethical framework to guide our decisions. (shrink)

In this essay, I argue that prescription drug laws violate patients' rights to self-medication. Patients have rights to self-medication for the same reasons they have rights to refuse medical treatment according to the doctrine of informed consent (DIC). Since we should accept the DIC, we ought to reject paternalistic prohibitions of prescription drugs and respect the right of self-medication. In section 1, I frame the puzzle of self-medication; why don't the same considerations that tell in favour of informed consent also (...) justify a right of self-medication? In section 2, I show that the prescription drug system was historically motivated by paternalism. In section 3, I outline the justifications for the DIC in more detail. I show that consequentialist, epistemic, and deontic considerations justify the DIC. In sections 4–6, I argue that these considerations also justify rights of self-medication. I then propose that rights of self-medication require non-prohibitive prescription policies in section 7. I consider two objections in sections 8 and 9: that patients ought not to make medically risky or deadly decisions, and that unrestricted access to prescription-grade pharmaceuticals would result in widespread misuse and abuse. Section 10 concludes. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels (...) of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

End-of-life decision-making is controversial. There are different views about when it is appropriate to limit life-sustaining treatment, and about what palliative options are permissible. One approach to decisions of this nature sees consensus as crucial. Decisions to limit treatment are made only if all or a majority of caregivers agree. We argue, however, that it is a mistake to require professional consensus in end-of-life decisions. In the first part of the article we explore practical, ethical, and legal factors that support (...) agreement. We analyse subjective and objective accounts of moral reasoning: accord is neither necessary nor sufficient for decisions. We propose an alternative norm for decisions – that of ‘professional dissensus’. In the final part of the article we address the role of agreement in end-of-life policy. Such guidelines can ethically be based on dissensus rather than consensus. Disagreement is not always a bad thing. (shrink)

Bioethics has dedicated itself to exploring and defending both reasons for and against certain aspects of clinical care, biomedical research and health policy, including what decisions must be made, who should make them, and how they should be made. In pediatrics, it’s widely acknowledged that parents’ reasons may matter pragmatically; attending to parents’ reasons is important if we want to work with families. Yet the conventional view in pediatric ethics is that parents’ reasons are irrelevant to whether a decision is (...) permissible or impermissible according to accepted ethical standards. In this paper, we explore whether parents’ reasons matter ethically and, if so, in what way and for whom. First, we clarify what we mean by ‘reasons.’ Second, we provide an overview of how reasons are typically treated in medical decision-making and pediatric ethics. Third, we analyze a hypothetical pediatric case to illustrate how changing reasons can transform ethical analyses, including by contributing to where and how clinicians and ethicists draw the boundaries intrinsic to common pediatric ethical frameworks. We push back against the conventional view and argue that parents’ reasons matter ethically in several ways. We call for further research on the role of parents’ reasons in clinical ethics deliberation. (shrink)

Over the past several decades, medical ethics has gained a solid foothold in medical education and is now a required course in most medical schools. Although the field of medical ethics is by nature eclectic, moral philosophy has played a dominant role in defining both the content of what is taught and the methodology for reasoning about ethical dilemmas. Most educators largely rely on the case‐based method for teaching ethics, grounding the ethical reasoning in an amalgam of theories drawn from (...) moral philosophy, including consequentialism, deontology, and principlism.In this article we hope to make a case for augmenting the focus of education in medical ethics. We propose complementing the traditional approach to medical ethics with a more embedded approach, one that has been described by others as “microethics,” the ethics of everyday clinical practice. (shrink)

In this essay I argue that the same considerations that justify the strong commitment to anti-paternalism that has been affirmed in bioethics over the past half century, also calls for anti-paternalistic public health policies. First, I frame the puzzle—why are citizens morally entitled to make unhealthy and medically inadvisable decisions as patients but not as consumers? I then briefly sketch the reasons why bioethicists typically reject paternalism. Next, I argue that those same reasons tell against paternalism in public health ethics (...) as well. Patients do not waive their rights to make medically inadvisable decisions when they leave their physician’s care. James Wilson disagrees. After I sketch Wilson’s arguments for paternalism in public health policy, I then argue, contra Wilson, that public health paternalism is wrong for the same reason that medical paternalism is wrong, and that the prevalence of paternalism in public policy does not mean that paternalism is morally permissible. I discuss the state’s authority to enforce paternalistic policies and I sketch an anti-paternalist vision for health policymakers. To close, I consider several objections. (shrink)

Objectives: To elicit the perceptions and preferences of patients with rheumatoid arthritis regarding information and participation in treatment decision-making. To analyse the patients’ narratives on the background of the ethical discourse on various approaches to treatment decision-making. Design: In-depth interviews with themes identified using principles of grounded theory. Participants: 22 patients with long-standing rheumatoid arthritis. Main outcome measures: Qualitative data on patients’ perceptions and preferences regarding information and participation in decision-making about treatment. Results: Decision-making about treatment has been described by (...) the patients as a process consisting of different stages with shifting loci of control and responsibility. Patients initially received one treatment recommendation and were not aware of alternative treatment options. Those participants in this study who wanted information about negative effects of a treatment cited “interest in one’s own health” and the potential “use of information” as reasons for their preference. The physicians’ expert knowledge and clinical experience regarding the effects of medication were cited as arguments by patients for a treatment recommendation. Conclusions: The patients’ accounts of decision-making about treatment differ from models of physician–patient relationship that have been put forward in ethical discourse. These differences may be relevant with respect to the starting point of an ethical analysis of treatment decision-making. Patients’ accounts with respect to a lack of information on treatment alternatives point to ethically relevant challenges regarding treatment decision-making in clinical practice. (shrink)

The importance of values in occupational therapy is generally agreed, however there is no consensus about their nature or their influence on practice. It is widely assumed that occupational therapists hold and act on a body of shared values, yet there is a lack of evidence to support this. The research tested the hypothesis that occupational therapists’ responses to ethically challenging situations would reveal common values specific to the occupational therapy profession. 156 occupational therapists were asked to decide what should (...) be done in 5 common-place yet ethically complex situations, presented as scenarios for debate. The results show that while most occupational therapists share very general values, they frequently disagree about what to do in practice situations, often justifying their choices with different and sometimes conflicting specific values. In some cases, the same respondents espouse contradictory values in similar situations. The extensive literature about decision-making - together with the study’s results – confirm that when occupational therapists make decisions, they draw on multiple factors, consciously and unconsciously. These factors vary between individuals. Value judgements are one part only of a complex process which includes personal experience, intuition, social influences, culture, psychological influences and relationships with both colleagues and clients. (shrink)

Hip fractures are common and serious injuries in the geriatric population. Obtaining informed consent for surgery in geriatric patients can be difficult due to the high prevalence of comorbid cognitive impairment. Given that virtually all patients with hip fractures eventually undergo surgery, and given that delays in surgery are associated with increased mortality, we argue that there are select instances in which it may be ethically permissible, and indeed clinically preferable, to initiate surgical treatment in cognitively impaired patients under the (...) doctrine of presumed consent. In this paper, we examine the boundaries of the license granted by presumed consent and use the example of geriatric hip fracture to build an ethical framework for understanding the doctrine of presumed consent. The license to act under presumed consent requires three factors: patient incapacity, clinical urgency and clarity on the correct course of action. All three can apply to geriatric hip fracture. The typical patient frequently lacks capacity. Delays in initiating surgical treatment are associated with markedly increased mortality rates. Last, there appears to be consensus that surgery is the preferred treatment. Nonetheless, because there is a window of safe delay during which treating physicians can stabilize the patient, address reversible causes of cognitive impairment and identify surrogate decision makers, presumed consent should be invoked only as a method of last resort. A medical situation need not be characterized by risk of imminent and certain death for presumed consent to be relevant. Rather, there are two distinct windows that must be considered: the time interval in which action may be delayed without danger, and the time interval needed to obtain a better form of consent. Presumed consent is appropriate only when the latter exceeds the former. (shrink)

For many years the prevailing paradigm for medical decision making for children has been the best interest standard. Recently, some authors have proposed that Mill’s “harm principle” should be used to mediate or to replace the best interest standard. This article critically examines the harm principle movement and identifies serious defects within the project of using Mill’s harm principle for medical decision making for children. While the harm principle proponents successfully highlight some difficulties in present-day use of the best interest (...) standard, the use of the harm principle suffers substantial normative and conceptual problems. A medical decision-making framework for children is suggested, grounded in the four principles. It draws on the best interest standard, incorporates concepts of harm, and provides two questions that can act as guide and limit in medical decision making for children. (shrink)

The traditional contrast between naturalist and normativist disease concepts fails to capture the most salient features of the health concepts debate. By using health concepts as a window on background notions of medical science and ethics, I show how Christopher Boorse (an influential naturalist) and Lennart Nordenfelt (an influential normativist) actually share deep assumptions about the character of medicine. Their disease concepts attempt, in different ways, to shore up the same medical model. For both, health concepts function like demarcation criteria (...) in the philosophy of science: they mark off the jurisdiction of medical science, and protect it from an inappropriate intrusion of socioeconomic factors, which threaten the integrity of modern medicine. These views are challenged by new developments in healthcare such as managed care and total quality review. To frame the health concepts debate in a way that better captures the issues integral to these new developments, I advance a new way of reading the distinction between weak and strong normativists. Strong normativists are skeptical of the demarcation project, think facts and values cannot be disentangled, and hold that socioeconomic conditions unavoidably influence how pathology is understood. The new health concepts debate should be framed as one between weak and strong normativists, and it concerns how we should respond to the current developments in health care. (shrink)

Clinician gate-keeping is the process whereby healthcare providers prevent access to eligible patients for research recruitment. This paper contends that clinician gate-keeping violates three principles that underpin international ethical guidelines: respect for persons or autonomy; beneficence or a favourable balance of risks and potential benefits; and justice or a fair distribution of the benefits and burdens of research. In order to stimulate further research and debate, three possible strategies are also presented to eliminate gate-keeping: partnership with professional researchers; collaborative research (...) design and clinician education. (shrink)

Life-sustaining treatment is sometimes withdrawn or withheld from critically ill newborn infants with poor prognosis. Guidelines relating to such decisions place emphasis on the best interests of the infant. However, in practice, parental views and parental interests are often taken into consideration.In this paper I draw on the example of newborn infants with severe muscle weakness (for example spinal muscular atrophy). I provide two arguments that parental interests should be given some weight in decisions about treatment, and that they should (...) be given somewhat more weight in decisions about newborns than for older children. Firstly, the interests of the infant and of parents intersect, and are hard to separate. Parents’ views about treatment may be relevant to an assessment of the infant’s interests, and they may also affect those interests. Secondly, the interests of the infant in her future are relatively reduced by her developmental immaturity. In some situations parents’ welfare interests outweigh those of the infant. However, I argue that this would not justify treatment limitation except in the setting of severe impairment. (shrink)

This article is based on the findings of a study that elicited the views of terminally ill patients ( n = 15), their carers ( n = 10) and bereaved carers ( n = 19) on the palliative care services they received. It explores the range of ethical issues revealed by the data. Although the focus of the original study was on community services, the participants frequently commented on all aspects of their experience. They described some of its positive and (...) negative aspects. Of concern was the reported lack of sensitivity to the role of the family among health professionals. The family, as carers, service users and advocates, represent a challenge to professional boundaries and the ethical norms of confidentiality and best interest. The accounts reveal the complexity of the ethical issues that characterize terminal care, issuing specific ethical challenges to nurses and other health professionals involved in this field. (shrink)

Autonomy has been hailed as the foremost principle of bioethics, and yet patients’ decisions and research subjects’ voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased (...) and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others.Clinical research settings are even more prone to erode subjects’ autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings.Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy. (shrink)

This thesis discusses implications of framing bioethical concerns in international legal discourse. It starts from the observation that legal approaches to questions of bioethical relevance have become dominant frameworks for addressing many bioethical concerns at the international level. In particular, the UN General Assembly has long attempted to regulate human cloning processes through an international Convention. Similarly, UNESCO and the Council of Europe have both addressed a variety of bioethically relevant issues, such as the processing of human genetic data, the (...) ethics of research or organ transplantation within international legal standards. It is in the context of this strong connection between international law, international legal discourse and bioethics that this thesis seeks to analyse what exactly happens when issues of bioethical relevance are discussed within such a framework, how this affects the way bioethical issues are conceptualized, conceived of and dealt with, and, ultimately, how well-suited or successful international legal discourse is in its attempt to resolve current bioethical questions. Following the methodological approach of discourse theory, this thesis bases its analysis on the assumption that where and when international legal standards, as manifestations of an international legal discourse, serve as framework for bioethical debate that also somewhat defines how bioethically relevant issues are approached, thought of and dealt with within that framework, that it somewhat determines what methods are used to resolve such issues and that it somewhat limits the range of conceivable and viable solutions to these issue. The thesis thereby does not aim to demonise or abrogate legal approaches to bioethics and it does not understand the implications discussed in this thesis to be necessarily good or bad. To the contrary, it will be shown that legal approaches to bioethics can and have contributed to the development of the field in several important ways. Yet, this thesis also shows that it is worthwhile to closely examine implications that follow from a specific legal approach to bioethical issues as these implications are not always easily perceived. Given the important, and often dominant or near exclusive role of international law and legal discourse in the area of bioethics as well as the former's strong influence on bioethical debates as a whole, the implications of addressing questions of bioethical relevance within an international legal discourse should at least be understood and acknowledged, a contribution that this thesis aims to make. Moreover, only if these implications are understood is it possible to ask whether engaging in that type of discourse is at all a valuable enterprise and whether or not international legal standards directly addressed to questions of bioethical relevance constitute a suitable means to effectively address questions in the area of bioethics. (shrink)

When making decisions for adults who lack decision-making capacity and have no discernable preferences, widespread support exists for using the Best Interests Standard. This policy appeals to adults and is compatible with many important recommendations for persons facing end-of-life choices.Common objections to the policy are discussed as well as different meanings of this Standard identified, such as using it to express goals or ideals and to make practical decisions incorporating what reasonable persons would want. For reasons of consistency, fairness, and (...) compassion, this standard should be used for all incapacitated persons. (shrink)

There are ethical guidelines that form the foundation of the traditional doctor–patient relationship in medicine. Health care providers are under special obligations to their patients. These include obligations to disclose information, to propose alternative treatments that allow patients to make decisions based on their own values, and to have special concern for patients’ best interests. Furthermore, patients know that these obligations exist and so come to their physicians with a significant level of trust. In this sense, therapeutic medicine significantly differs (...) from straightforward business practices such as the buying and selling of houses, cars, cell phones, etc. However, we argue that this relationship differs when medicine is used for enhancement rather than therapy. When patients seek enhancements they are not as vulnerable as when they are ill. And in an enhancement setting, physicians have little role outside of medical risks to discuss motivation and alternatives. Therefore, we conclude that a more reasonable alternative may be for doctors and patients to use ethical norms associated more with straightforward business practices, specifically sales. We believe that full disclosure of this different set of norms will benefit both physicians and patients. (shrink)

Consent ought to be required to withhold treatment that is in a patient’s best interests to receive. Do not resuscitate orders are examples of best interests assessments at the end of life. Such assessments represent value judgments that cannot be validly ascertained without patient input. If patient input results in that patient dissenting to the DNR order then individual physicians are not justified in overriding such dissent. To do so would give unjustifiable primacy to the values of the individual physician. (...) Therefore patient consent is effectively required to write a DNR order. Patient dissent to a DNR order should trigger a fair process mechanism to resolve the dispute. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. (...) To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

In this paper I put forward an ethical argument for the provision of extensive patient choice by the British National Health Service. I base this argument on traditional liberal rights to freedom of choice, on a welfare right to health care, and on a view of health as values-based. I argue that choice, to be ethically sustainable on this basis, must be values-based and rational. I also consider whether the British taxpayer may be persuadable with regard to the moral acceptability (...) of patient choice, making use of Rawls’ theory of political liberalism in this context. I identify issues that present problems in terms of public acceptance of choice, and also identify a boundary issue with regard to public health choices as against individual choices. (shrink)

An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health . There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. (...) If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented by conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communities in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures. (shrink)