This paper challenges the foundational claim that the human family is no more than a social construction. It advances the position that the family is a central category of experience, being, and knowledge. Throughout, the analysis argues for the centrality of the family for human flourishing and, consequently, for the importance of sustaining family-oriented practices within social policy, such as more family-oriented approaches to consent to medical treatment. Where individually oriented approaches to medical decision-making accent an ethos of isolated personal (...) autonomy family-oriented approaches acknowledge the central social and moral reality of the family. I argue that the family ought to be appreciated as more than a mere network of personal relations and individual undertakings; the family possesses a being that is social and moral such that it realizes a particular structure of human good and sustains the necessary conditions for core areas of human flourishing. Moreover, since the family exists as a nexus of face-to-face relationships, the consent of persons, including adults, to be members of a particular family, subject to its own respective account of family sovereignty, is significantly more amply demonstrated than the consent of citizens to be under the authority of a particular state. As a result, in the face of a general Western bioethical affirmation of the autonomy of individuals, as if adults and children were morally and socially isolated agents, this paper argues that social space must nevertheless be made for families to choose on behalf of their own members. (shrink)

In few other areas of bioethical inquiry exists as close a connection between bioethical professional advice and policy development as is the case with HIV and AIDS. Historically, the reasons for this have much to do with one of the groups initially affected most severely by HIV and AIDS, namely well-educated middle-class gay men in developed countries. This particular group of people, highly sophisticated and used to political activism in its pursuit of civil rights-related objectives, engaged the medical profession as (...) well as regulatory agencies such as the US Food and Drug Administration, and legislators (more so in the USA than in other countries) in a number of bioethically interesting policy areas. Many of the controversies of the times were framed as civil rights and/or ethical disputes. The initial areas of concern and inquiry focused on: informed consent to HIV testing and trial participation, the confidentiality of HIV test results, access to trials as a means of access to experimental drugs, the length of time it took to get an experimental drug to the market approval stage, and end-of-life decision-making. This line-up of issues explains why AIDS has become such an interesting topic for bioethicists. Bioethicists concerned about the traditional breadand- butter themes of medical ethics themes of the doctor - patient relationship (e.g., Daniels, 1991; Boyd, 1992), as well as bioethicists more concerned about policy and regulatory issues in the drug research and approval process (e.g., Edgar & Rothman, 1990; Salisbury & Schechter, 1990), found research topics worthy of vigorous pursuit. No surprise, then, that HIV/AIDS led to a probably unprecedented number of books and articles in professional journals (Manuel et al., 1990). HIV/AIDS has become a permanent fixture in all major mainstream bioethics textbooks (e.g., Kuhse & Singer, 1998; Arras & Steinbock, 1999). Reference series in medicine, ethics and law provide for dedicated volumes on AIDS.1 Even specialist bioethics textbooks, for instance those directed at dentistry students, carry chapters on HIV/AIDS (Ozar & Sokol, 2002). 128 Udo Schuklenk AIDS, designated by the medical profession a pandemic lives up to its classification. It did not stop at the borders of developed countries. As one would expect of a primarily sexually transmitted illness in the age of globalisation, it spread rapidly across the globe. Indeed, in many countries it has become one of the main causes of death, as in sub- Saharan Africa (Shisana & Simbayi, 2002). Dramatic increases in the number of AIDS cases are predicted for many Eastern European countries as well as for the two most populous nations on earth, India and China. Some of the HIV/AIDS-related bioethical and policy issues of concern to developed countries remain the same for developing countries. However, in ethically important ways they are dwarfed by concerns over drug prices, intellectual property rights, and affordable access to essential AIDS drugs for the impoverished masses of infected people in such countries. Of increasing importance have become ethical issues pertaining to the ever-growing research industry associated with clinical trials undertaken in developing countries. Indeed, major funding initiatives both in the USA and UK have brought clinical research in developing countries into focus. Some have questioned whether this attention is appropriate, considering other bioethical problems of arguably greater importance to developing countries (Chadwick & Schuklenk, 2003). Standards of clinical care in a study, and after a trial has concluded, as well as community benefits and access to the trial regime after the trial’s conclusion remain contentious issues. It is worth noting that more often than not it was an AIDS-related trial or policy decision that led to a great deal of bioethical analysis, yet the issues discussed almost always have ramifications far beyond AIDS. For instance, decisions about the question of what (if any) standards of care failures in preventive trials (of HIV vaccines or microbicides) ought to receive have important implications for non-AIDS prevention trials. (shrink)

Ethicists widely accept the notion that scientists have moral responsibilities to benefit society at large. The dissemination of scientific information to the public and its political representatives is central to many of the ways in which scientists serve society. Unfortunately, the task of providing information can often give rise to moral quandaries when scientific experts participate in politically charged debates over issues that are fraught with uncertainty. This paper develops a theoretical framework for an “ethics of expertise” (EOE) based on (...) the notion that scientists have responsibilities to provide information in a way that promotes autonomous decision-making on the part of the public and its representatives. Moreover, insofar as the principle of informed consent has developed in biomedical ethics as a way for physicians to promote autonomous decision-making on the part of their patients, this paper suggests that the informed-consent concept may suggest a set of criteria and guidelines that can help scientists to fulfill their similar ethical responsibilities to the public. In order to illustrate how the resulting EOE could provide practical guidance for scientific experts, the paper examines a case study involving the dissemination of information about the low-dose biological effects of toxic chemicals and carcinogens. (shrink)

Individual autonomy is a concept highly appreciated in modern Western societies. Its significance is reflected by the central importance and broad use of the model of informed consent in all fields of medicine. In predictive genetic testing, individual autonomy gains particular importance, for what is in focus here is not so much a concrete medical treatment but rather options for taking preventive measures and the influence that the test results have on long-term lifestyle and preferences. Based on an analysis of (...) autonomy-related issues in predictive genetic diagnosis and genetic screening programmes, this contribution stresses the central relevance of a broad notion of autonomy for the discussion of ethical issues raised in connection with predictive genetic testing and genetic screening programmes. Only against the background of such a broad notion of autonomy, which stresses not only free and informed decision-making but also the relevance of long-term prospects for leading a self-determined life in familial and social contexts, can the manifold autonomy-related issues linked to predictive genetic testing be given adequate consideration. (shrink)

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...) to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

Courts are divided as to whether abortion informed consent mandates violate the First Amendment. This article argues that given the doctor's and patient's unique expertise, the patient's strong interests in autonomous decision making, and the fact that these laws regulate speech, rather than conduct, heighted or strict scrutiny should apply to such mandates.

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

The ethical principle of respect for patient autonomy is essential for balanced doctor–patient relationship. Understanding and following proper procedure for informed consent is the goal for a healthcare provider. There are clinical scenarios which are often encountered and are still challenging. In this article, those cases are described which presented dilemma at the time of obtaining informed consent and an ethical approach is described.

Informed consent to medical procedures tends to be construed in terms of principle-based ethics and one or other form of expected utility theory. These constructions leave problems created by imperfect communication; subjective distress and other emotions; imperfect knowledge and incomplete understanding; complexity, and previous experience or the lack of it. There is evidence that people giving consent to therapy or to research participation act intuitively and assess consequences holistically, being influenced more by the magnitude of outcomes than their probability. People (...) avoid decisions they may regret, but modern regret theory has received little attention in discussions of informed consent. This essay suggests ways in which regret may be acknowledged in the consent process and in the assessment of the information that is an intrinsic part of it. (shrink)

This essay argues that individual-oriented informed consent is inadequate to protect human research subjects in mainland China. The practice of family-oriented decision-making is better suited to guide moral research conduct. The family’s role in medical decision-making originates from the mutual benevolence that exists among family members, and is in accordance with family harmony, which is the aim of Confucian society. I argue that the practice of informed consent for medical research on human subjects ought to remain family-oriented in mainland China. (...) This essay explores the main features of this model of informed consent and demonstrates the proper authority of the family. The family’s participation in decision-making as a whole does not negate or deny the importance of the individual who is the subject of the choice, but rather acts more fully to protect research subjects. (shrink)

ZusammenfassungKlinische Therapieentscheidungen werden zumeist auf dem Boden einer medizinischen (bzw. ärztlichen) Indikationsstellung und der entsprechenden informierten Zustimmung des Patienten zu der vorgeschlagenen Behandlungsmaßnahme gefällt. Das Recht des Patienten, eine Behandlungsmaßnahme abzulehnen, ist in der juristischen und ethischen Bewertung breit abgesichert. Hingegen ist unklar, welche Rolle ein (positiv geäußerter) Wunsch des Patienten oder gar seiner Angehörigen nach einer bestimmten Behandlung im normativen Entscheidungsprozess spielen sollte, wenn überhaupt. Dieser Beitrag erörtert den Stellenwert des eigenständigen Patientenwunsches aus studienbezogener, klinischer und normativer Sicht. Ein (...) authentisches Fallbeispiel verdeutlicht das Spektrum zugrunde liegender Autonomiekonzepte und das Dilemma divergierender Bewertungsmaßstäbe zwischen Arzt und Patient in der Tumortherapie und Palliativmedizin. Der Beitrag zeigt auf, wie bestehende Konzepte von Autonomie und Indikation genutzt werden können, um einerseits den Behandlungswunsch eines Patienten konkret in den Entscheidungsprozess einzubeziehen, andererseits eine klare Abgrenzung zu einer unreflektierten „wunscherfüllenden Medizin“ aufrecht zu erhalten. (shrink)