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)

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)

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)

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)

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)

BackgroundMany medical emergency practices are regulated by written procedures that normally provide reliable guidelines for action. In some cases, however, the consequences of following rule-based instructions can have unintended negative consequences. The article discusses a case - described on a type level - where the consequences of following a rule formulation could have been fatal.Case presentationA weak and elderly patient has cardiac arrest, and a Do Not Resuscitate clause is written in the patient’s medical record. Paramedics at the scene cannot (...) see that the patient’s general appearance match conditions which would indicate the DNR clause, so they start cardiopulmonary resuscitation, and the patient survives. This turns out to be a crucial decision. The DNR clause is from an earlier bout with serious disease from which the patient has recovered, against all odds, and someone has forgotten to remove the clause from the medical record.AnalysisIn order to be able to interpret the validity of written guidelines, paramedics and other health workers need to develop personal skills that transcend the ability simply to follow written instructions. Within traditional virtue ethics, personal judgment is conceived of as crucial for being able to make ‘good’ autonomous decisions. Virtue ethical analyses, decision-making abilities and non-technical communication skills are important as conceptual tools when health workers need to make difficult clinical decisions.ConclusionThe case study accentuates the significance of prudent judgment in medical practice. In the case described, the consequence of trusting the written advance directive could have been fatal, but the point is general: for the purpose of achieving excellent organizational performance, it is insufficient for health workers to rely uncritically on rules and procedures. Even the clearest rule formulations must be interpreted contextually in order to determine ethically correct behavior and avoid potential negative consequences that are not in the patient’s best interests. (shrink)

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)

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)

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)

An increase in autonomy and freedom is often considered one ofthe main arguments in favour of a broad use of genetic testing.Starting from Gerald Dworkin's reflections on autonomy and choicethis article examines some of the implications which accompanythe increase in choices offered by prenatal genetic diagnosis.Although personal autonomy and individual choice are importantaspects in the legitimation of prenatal genetic diagnosis, itseems clear that an increase in choice offered by prenatalgenetic diagnosis also leads to various implications that maynegatively influence the freedom (...) of the persons involved. (shrink)