END‐OF‐LIFE CARE IN THE 21st CENTURY: ADVANCE DIRECTIVES IN UNIVERSAL RIGHTS DISCOURSE

This article explores universal normative bases that could help to shape a workable legal construct that would facilitate a global use of advance directives. Although I believe that advance directives are of universal character, my primary aim in approaching this issue is to remain realistic. I will make three claims. First, I will argue that the principles of autonomy, dignity and informed consent, embodied in the Oviedo Convention and the UNESCO Declaration on Bioethics and Human Rights, could arguably be regarded as universal bases for the global use of advance directives. Second, I will demonstrate that, despite the apparent consensus of ethical authorities in support of their global use, it is unlikely, for the time being, that such consensus could lead to unqualified legal recognition of advance directives, because of different understandings of the nature of the international rules, meanings of autonomy and dignity which are context‐specific and culture‐specific, and existing imperfections that make advance directives either unworkable or hardly applicable in practice. The third claim suggests that the fact that the concept of the advance directive is not universally shared does not mean that it should not become so, but never as the only option in managing incompetent patients. A way to proceed is to prioritize work on developing higher standards in managing incompetent patients and on progressing towards the realization of universal human rights in the sphere of bioethics, by advocating a universal, legally binding international convention that would outlaw human rights violations in end‐of‐life decision‐making.     

Genetic research and consent: On the crossroads of human and data research

This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke the requirement of obtaining consent prior to using an individual’s biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio‐samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research.     

End‐of‐life decision‐making and advance care directives in Italy. A report and moral appraisal of recent legal provisions

The present article reviews the state of public debate and legal provisions concerning end‐of‐life decision‐making in Italy and offers an evaluation of the moral and legal issues involved. The article further examines the content of a recent law concerning informed consent and advance treatment directives, the main court pronouncements that formed the basis for the law, and developments in the public debate and important jurisprudential acts subsequent to its approval. The moral and legal grounds for a positive evaluation of this law, which attests that the patient may withhold or withdraw from life‐prolonging treatment, will be offered with reference to liberal approaches and particularly to the frameworks of care and virtue ethics; but reasons will also be offered in order to consider not only the latter but also broader range of end‐of‐life treatment decisions as morally apt options. In this light, we argue in favour of a further development of the Italian legislation to encompass forms of assisted suicide and active euthanasia.     

Advancing an advance directive debate

A challenge has recently been levelled against the legal and/or moral legitimacy of some advance directives. It has been argued that in certain cases an advance directive carries no weight in a decision on whether to withhold treatment, since the individual in the debilitating state is not the same person as the person who created the advance directive. In the first section of this paper, I examine two formulations of the argument against the moral legitimacy of the advance directives under review. The second section reviews, and criticizes, an objection to such arguments. In the penultimate section, possible models supporting the viability of the advance directives are considered. The final section makes good on an obligation incurred by the title of the paper.     

Social Responsibility and the State's Duty to provide Healthcare: An Islamic Ethico‐Legal Perspective

The United Nations Educational, Scientific and Cultural Organization's (UNESCO) Declaration on Bioethics and Human Rights asserts that governments are morally obliged to promote health and to provide access to quality healthcare, essential medicines and adequate nutrition and water to all members of society. According to UNESCO, this obligation is grounded in a moral commitment to promoting fundamental human rights and emerges from the principle of social responsibility. Yet in an era of ethical pluralism and contentions over the universality of human rights conventions, the extent to which the UNESCO Declaration can motivate behaviors and policies rests, at least in part, upon accepting the moral arguments it makes. In this essay I reflect on a state's moral obligation to provide healthcare from the perspective of Islamic moral theology and law. I examine how Islamic ethico‐legal conceptual analogues for human rights and communal responsibility, ?uqūq al‐’ibād and far? al‐kifāyah and other related constructs might be used to advance a moral argument for healthcare provision by the state. Moving from theory to application, I next illustrate how notions of human rights and social responsibility were used by Muslim stakeholders to buttress moral arguments to support American healthcare reform. In this way, the paper advance discourses on a universal bioethics and common morality by bringing into view the concordances and discordances between Islamic ethico‐legal constructs and moral arguments advanced by transnational health policy advocates. It also provides insight into applied Islamic bioethics by demonstrating how Islamic ethico‐legal values might inform the discursive outputs of Muslim organizations.     

Advanced directives. Legal and practical aspects of negative instructions concerning medical treatment

The right of a competent patient to stipulate in advance of possible non-competence, medical treatment he does not want, is based on the fundamental legal principle that a person cannot be medically treated without his informed consent. It is in Dutch law a strong and almost unqualified right. There are indications in the international literature, however, that advance directives in many cases may not have much influence on medical treatment at the end of life. Very little is known about the social practice of advance directives in the Netherlands.     

A proposal for the use of advance directives in the treatment of incompetent mentally ill persons

[M]y question is how these patients while competent might be able to give their own informed consent to treatment, despite being both unwilling and incompetent to do so when treatment is to be begun, thereby reducing the need to relax the dangerousness criteria for involuntary commitment. It is uncontroversial that the dangerousness requirement would be too restrictive for all treatment of mental illness. When competent patients voluntarily seek and/or accept treatment for their mental illness, neither public policy nor medical practice restricts treatment to those patients judged to be dangerous. Instead, criteria should be and generally are comparable to those for the treatment of physical illness -- whether the patient is ill, in this case mentally ill, and likely to benefit from treatment. Through use of advance directives, it would be possible for mentally ill persons who are currently refusing treatment to give prior consent, while competent and with their disease in remission, to treatment at a later time when they are incompetent, have become noncompliant, and are refusing treatment. My proposal is certainly not entirely novel, since others have made similar proposals under the heading of Ulysses contracts and voluntary commitment contracts. Addressing briefly some of the criticisms of these earlier proposals will bring out one fundamental difference between them and my proposal here for a new use of advance directives -- whether the patient must then be incompetent when the contract or directive made earlier is later invoked -- a difference I shall argue strongly favors my proposal.     

The ethics of managing affective and emotional states to improve informed consent: autonomy, comprehension, and voluntariness

Over the past several decades the 'affective revolution' in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification.     

The conjoined twins and the limits of rationality in applied ethics

In this article I consider the case of the surgical separation of conjoined twins resulting in the immediate and predictable death of the weaker one. The case was submitted to English law by the hospital, and the operation permitted against the parents' wishes. I consider the relationship between the legal decision and the moral reasons adduced in its support, reasons gaining their force against the framework of much mainstream normative ethical theory. I argue that in a few morally dilemmatic situations, such a legalistic–theoretical approach cannot plausibly accommodate certain irreducible and ineliminable features of the ethical experience of any concrete individual implicated in the situation, and that this failure partly undermines its self–appointed role of guiding such an individual's conduct. For example, the problem as experienced by the judge and by the parents might not be the same problem at all, and some of their respective reasons may be mutually unintelligible or impotent. I certainly do not argue for a rejection of law or of moral theory; I merely challenge their implicit claim to comprehensiveness and their fixation with an idealised and putatively universal rationality modelled on converging scientific enquiry. Finally, I claim that at least in the twins' case there may be insufficient normative robustness to the conclusions reached, or indeed reachable, by the court in a situation where intuitions and moral reasons pull in fundamentally incommensurable directions; as such, there may be room for an acknowledgement of the spiritual, through a humble abstention from making a decision – which is not to be confused with deciding to do nothing.     

Pascal's Wager and the persistent vegetative state

I've argued that a version of Pascal's Wager applies to PVS so forcefully that no one who declines continued life without considering it makes a reasoned and informed decision. Thomas Mappes objects that my argument is much more limited than I realize. Of special interest is his appeal to an emerging diagnostic category, the 'minimally conscious state; to argue that there is much to lose in gambling on life. I will defend the Wager. Along the way I maintain that the chance of recovery from long-term PVS is much better than represented (as is the prospect of regaining independence if one recovers consciousness), and that the 1994 Multi-Society Task Force definitions of 'permanent' PVS are confused in ways that make crafting advance directives dangerously difficult. Valid advance directives require informed consent, I argue; the Wager needs to be part of the process. A consequence of my argument is that withdrawing medically-delivered nutrition and hydration from PVS patients is much harder to justify.     

Biomedical Enhancements as Justice

Biomedical enhancements, the applications of medical technology to make better those who are neither ill nor deficient, have made great strides in the past few decades. Using Amartya Sen's capability approach as my framework, I argue in this article that far from being simply permissible, we have a prima facie moral obligation to use these new developments for the end goal of promoting social justice. In terms of both range and magnitude, the use of biomedical enhancements will mark a radical advance in how we compensate the most disadvantaged members of society.     

Adversaries at the Bedside: Advance Care Plans and Future Welfare

Advance care planning refers to the process of determining how one wants to be cared for in the event that one is no longer competent to make one's own medical decisions. Some have argued that advance care plans often fail to be normatively binding on caretakers because those plans do not reflect the interests of patients once they enter an incompetent state. In this article, we argue that when the core medical ethical principles of respect for patient autonomy, honest and adequate disclosure of information, institutional transparency, and concern for patient welfare are upheld, a policy that would allow for the disregard of advance care plans is self‐defeating. This is because when the four principles are upheld, a patient's willingness to undergo treatment depends critically on the willingness of her caretakers to honor the wishes she has outlined in her advance care plan. A patient who fears that her caretakers will not honor her wishes may choose to avoid medical care so as to limit the influence of her caretakers in the future, which may lead to worse medical outcomes than if she had undergone care. In order to avoid worse medical outcomes and uphold the four core principles, caregivers who are concerned about the future welfare of their patients should focus on improving advance care planning and commit to honoring their patients’ advance care plans.     

FURTHERING INJUSTICES AGAINST WOMEN: GENETIC INFORMATION, MORAL OBLIGATIONS, AND GENDER

The purpose of this paper is to show that a decontextualized approach to ethical issues is not just unhelpful for the decision making process of real, situated human beings, but dangerous. This is so, because by neglecting the context in which people make moral decisions we run the risk of reinforcing or furthering injustices against already disadvantaged groups. To show this, I evaluate three moral obligations that our ability to obtain genetic information has made salient: the duty to obtain genetic information about ourselves, the obligation to inform family members about genetic risks and the duty not to reproduce when we know that there is a high risk of transmitting a serious disease or defect. I will argue here that in ignoring the context in which these moral obligations are put into practice, and in particular the situation of women in our society, those who defend these moral duties might be furthering injustices against women.     

Ethical dilemmas in early detection of dementia. An inventory of moral intuitions in practice

In this article we present an inventory of the moral intuitions of the health care workers who work in the field of early detection of dementia. The effects of pharmacological treatment and professional care and support may improve when dementia is detected in an early stage. Furthermore, the patient (and his family) can prepare themselves for the period to come. Health care workers recognize moral problems and tensions concerning early detection that are related to the question whether persons will benefit from knowledge in an earlier stage of dementia, because this knowledge can be a heavy burden. We asked general practitioners, home care workers, employees of the so-called 'Memory clinic' and specialists, what ethical intuitions they recognize in practice. They mentioned the following questions: when are health care professionals allowed to take initiative, is causing worries and concerns problematic, and should a diagnosis always to be told? We conclude after a first analysis that many moral questions derive from the fact that many health care professionals lack knowledge of the wishes and interests of the elderly. At the same time they try to justify their actions on the (presupposed) consent of the elderly person. We suggest that the general norm 'only act when the patient wants to be helped' in health care should also apply to detection of dementia, although it should not be taken too strictly. Another justification for early detection can be found in the benefits for the elderly people, when their wishes are no longer expressed.     

The role and responsibilities of witnesses in the informed consent process

Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.     

Protecting Future Children from In‐Utero Harm

The actions of pregnant women can cause harm to their future children. However, even if the possible harm is serious and likely to occur, the law will generally not intervene. A pregnant woman is an autonomous person who is entitled to make her own decisions. A fetus in‐utero has no legal right to protection. In striking contrast, the child, if born alive, may sue for injury in‐utero; and the child is entitled to be protected by being removed from her parents if necessary for her protection. Indeed, there is a legal obligation for health professionals to report suspected harm, and for authorities to protect the child's wellbeing. We ask whether such contradictory responses are justified. Should the law intervene where a pregnant woman's actions risk serious and preventable fetal injury? The argument for legal intervention to protect a fetus is sometimes linked to the concept of ‘fetal personhood’ and the moral status of the fetus. In this article we will suggest that even if the fetus is not regarded as a separate person, and does not have the legal or moral status of a child, indeed, even if the fetus is regarded as having no legal or moral status, there is an ethical and legal case for intervening to prevent serious harm to a future child. We examine the arguments for and against intervention on behalf of the future child, drawing on the example of excessive maternal alcohol intake.     

Medical Ghostwriting and Informed Consent

Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author‐institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.     

RISK AND MID‐LEVEL MORAL PRINCIPLES

We discuss ethical aspects of risk‐taking with special focus on principlism and mid‐level moral principles. A new distinction between the strength of an obligation and the degree to which it is valid is proposed. We then use this distinction for arguing that, in cases where mid‐level moral principles come into conflict, the moral status of the act under consideration may be indeterminate, in a sense rendered precise in the paper. We apply this thought to issues related to pandemic influenza vaccines. The main conclusion of the paper is that on a principlist approach some acts may be neither right nor wrong (or neither permissible nor impermissible), and we claim that this has important implications for how we ought to make decisions under risk.     

Ethical issues relating to supply of human tissue to the commercial biomedical sector

Demand for an ethical supply of human tissue for research in the commercial biomedical sector is increasing substantially. This article sets out to review ethical issues specifically relating to acquisition of tissue from patients in a publicly funded national health service (NHS), for research use in a commercial setting. Some of the background to recent high profile Inquiries in England is discussed and is used to illustrate legal and ethical differences between living and dead people. Issues relating to patient consent are investigated and the case is made for a clear distinction between tissue acquisition and tissue processing. Future possibilities for regulation are discussed. This revised version was published online in July 2006 with corrections to the Cover Date.