BackgroundThe methodology of medical ethics during the last few decades has shifted from a predominant use of normative-philosophical analyses to an increasing involvement of empirical methods. The articles which have been published in the course of this so-called 'empirical turn' can be divided into conceptual accounts of empirical-normative collaboration and studies which use socio-empirical methods to investigate ethically relevant issues in concrete social contexts.DiscussionA considered reference to normative research questions can be expected from good quality empirical research in medical ethics. (...) However, a significant proportion of empirical studies currently published in medical ethics lacks such linkage between the empirical research and the normative analysis. In the first part of this paper, we will outline two typical shortcomings of empirical studies in medical ethics with regard to a link between normative questions and empirical data: (1) The complete lack of normative analysis, and (2) cryptonormativity and a missing account with regard to the relationship between 'is' and 'ought' statements. Subsequently, two selected concepts of empirical-normative collaboration will be presented and how these concepts may contribute to improve the linkage between normative and empirical aspects of empirical research in medical ethics will be demonstrated. Based on our analysis, as well as our own practical experience with empirical research in medical ethics, we conclude with a sketch of concrete suggestions for the conduct of empirical research in medical ethics.SummaryHigh quality empirical research in medical ethics is in need of a considered reference to normative analysis. In this paper, we demonstrate how conceptual approaches of empirical-normative collaboration can enhance empirical research in medical ethics with regard to the link between empirical research and normative analysis. (shrink)

Empirical-ethical research constitutes a relatively new field which integrates socio-empirical research and normative analysis. As direct inferences from descriptive data to normative conclusions are problematic, an ethical framework is needed to determine the relevance of the empirical data for normative argument. While issues of normative-empirical collaboration and questions of empirical methodology have been widely discussed in the literature, the normative methodology of empirical-ethical research has seldom been addressed. Based on our own research experience, we discuss one aspect of this normative (...) methodology, namely the selection of an ethical theory serving as a background for empirical-ethical research. (shrink)

This article gives a brief introduction to the MacArthur Competence Assessment Tool-Treatment (MacCAT-T) and critically examines its theoretical presuppositions. On the basis of empirical, methodological and ethical critique it is emphasised that the cognitive bias that underlies the MacCAT-T assessment needs to be modified. On the one hand it has to be admitted that the operationalisation of competence in terms of value-free categories, e.g. rational decision abilities, guarantees objectivity to a great extent; but on the other hand it bears severe (...) problems. Firstly, the cognitive focus is in itself a normative convention in the process of anthropological value-attribution. Secondly, it misses the complexity of the decision process in real life. It is therefore suggested that values, emotions and other biographic and context specific aspects should be considered when interpreting the cognitive standards according to the MacArthur model. To fill the gap between cognitive and non-cognitive approaches the phenomenological theory of personal constructs is briefly introduced. In conclusion some main demands for further research to develop a multi-step model of competence assessment are outlined. (shrink)

The Hannover qualifying programme ‘ethics consultation in hospitals’, conducted by a four-institution cooperation partnership, is an interdisciplinary, scientifically based programme for healthcare professionals interested in ethics consultation services and is widely acknowledged by hospital managements and healthcare professionals. It is unique concerning its content, scope and teaching format. With its basic and advanced modules it has provided training and education for 367 healthcare professionals with 570 participations since 2003 (until February 2010). One characteristic feature is its attractiveness for health professionals (...) from different backgrounds. Internationally, the Hannover programme is one of the few schedules with both academics and non-academics as target groups and a high participation rate of physicians. The concept of the Hannover programme is in great demand, and its schedule is continuously optimised through evaluation. The goals of enabling healthcare professionals from different professional backgrounds to define and reflect ethical problems, to facilitate and support the process of decision-making and to work out structures for their own institutions seem to have been achieved. However, in order to obtain effective and sustainable results, participation in the programme should be supplemented regularly by in-house training sessions or individual expert consultations. Future challenges include new thematic courses and providing a network for former participants, especially when they come from non-academic hospitals. The network is a reasonable platform to discuss participants' experiences, successes and pitfalls. A further task will be research on how the programme's concept can support the sustainability of ethics structures in the various institutions. (shrink)

The four-principle approach to biomedical ethics is used worldwide by practitioners and researchers alike but it is rather unclear what exactly people do when they apply this approach. Ranking, specification, and balancing vary greatly among different people regarding a particular case. Thus, a sound and coherent applicability of principlism seems somewhat mysterious. What are principlists doing? The article examines the methodological strengths and weaknesses of the applicability of this approach. The most important result is that a sound and comprehensible application (...) of the four principles is additionally ensured by making use of the organizing meta-principle of common morality, which is the starting point and constraining framework of moral reasoning. (shrink)

Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research (...) on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. (shrink)

Forschungs- und Therapieansätze einer „personalisierten Medizin“ erhalten gegenwärtig große Aufmerksamkeit und Förderung in Forschung, Wirtschaft und Politik und erwecken große Hoffnungen. Auf der Grundlage molekulargenetischer Biomarker soll ein zielgerichtetes, stratifiziertes Vorgehen im Bereich der Prävention, Diagnostik und Therapie erreicht werden. Häufig wird der Begriff „personalisierte Medizin“ als Synonym für medizinischen Fortschritt überhaupt benutzt und eine persönlichere, bessere und kostengünstigere Medizin versprochen. 1) Fortschritte in der genetischen Forschung können nicht mit besseren medizinischen Behandlungsmöglichkeiten für eine Vielzahl von Patienten gleichgesetzt werden. In (...) Wirklichkeit beschränken sich die aktuellen Fortschritte einer an genetischen Biomarkern ausgerichteten Diagnostik und Therapie auf Untergruppen von Patienten. Die Mehrheit der Kranken hat bisher keinen Vorteil. 2) Der Begriff „personalisierte Medizin“ ist unangemessen und irreführend. Vielmehr handelt es sich um eine auf genetischen Biomarkern basierte stratifizierende Medizin und nicht um eine patienten- oder personenzentrierte Medizin. 3) Die sog. „personalisierte Medizin“ ist ein stark forschungs- und industriegetriebener Bereich der Medizin. Globale Stakeholder bestimmen die Entwicklung, unabhängig finanzierte Forschung gibt es kaum. Daher besteht die Gefahr, dass wissenschaftlicher Erkenntnisgewinn durch wirtschaftliche Einzelinteressen behindert wird. Empirische Erfahrungen, z. B. der Preisentwicklung neuer Krebsmedikamente, zeigen, dass das Versprechen der Kostenersparnis jeder Evidenz entbehrt. 4) Die hohen Investitionen in die „personalisierte Medizin“ werfen wichtige ethische Fragen nach Opportunitätskosten und Prioritätensetzungen im öffentlichen Gesundheitswesen auf. Derzeit profitieren wenige Patientengruppen von den hohen Forschungs- und Behandlungskosten der „personalisierten Medizin.“ Gleichzeitig bleiben Forschung und Versorgung in anderen wichtigen medizinischen Bereichen unterfinanziert. Eine öffentliche Debatte über die Prioritäten in medizinischer Forschung und Versorgung sowie darüber, wie diese in demokratischen Gesellschaften und in öffentlichen Gesundheitssystemen umgesetzt werden können, ist erforderlich. Eine an genetischen Biomarkern ausgerichtete sog. „personalisierte Medizin“ führt nicht zu einer persönlicheren Behandlung des einzelnen Patienten und ist von einer personen- oder patientenzentrierten Medizin zu unterscheiden. Von den bisherigen Therapiefortschritten profitieren Untergruppen von Patienten, z. B. in der Onkologie. Für die Mehrheit der Patienten konnten keine Verbesserungen erzielt werden. Für eine Kostenersparnis im Gesundheitswesen fehlt jegliche empirische Evidenz, vielmehr muss nach bisherigen Erfahrungen mit Kostensteigerungen gerechnet werden. (shrink)

Advance patient directives are various forms of anticipatory medical directives made by competent individuals for the eventuality of future incompetence. They are therefore appropriate instruments for competent patients in the early stage of Alzheimer's disease to document their self-determined will in the advanced stages of dementia. Theoretical objections have been expressed against the concept of advance patient directives (problems of authenticity and identity) which, however, cannot negate the fundamental moral authority of advance patient directives. Therefore, patients, family members, and physicians (...) should make use of the appropriate form of advance directive as part of common treatment and care planning. Advance directives, when utilized intelligently, represent appropriate instruments for shared decision-making by patient, family members and physician. They should be utilized to a greater extent, particularly for the treatment planning of demented patients. (shrink)

Historische, theoretische und ethische Aspekte der Medizin sind Lehrinhalte des medizinischen Ausbildungscurriculums, die in dem neu eingeführten Querschnittsbereich 2 "Geschichte, Theorie, Ethik der Medizin" (GTE) vermittelt werden sollen. Gegenstand dieser Arbeit ist die Darstellung von Unterrichtskonzept und Evaluationsergebnissen eines medizinhistorische und -ethische Inhalte intergrierenden Lehrmoduls zum Thema der Aufklärung und Einwilligung in Klinik und medizinischer Forschung. Die integrierte Vermittlung medizinethischer und -historischer Inhalte wurde von den Studierenden positiv bewertet. Die von den Kursteilnehmenden im Rahmen der Evaluation gezeigten Kenntnisse sowie die (...) Selbsteinschätzung ausgewählter Fähigkeiten und Fertigkeiten können als Hinweis für eine effektive Vermittlung der korrespondierenden Lehrinhalte gewertet werden. Die Definition fachübergreifender Lehrziele sowie die Entwicklung geeigneter Evaluationsinstrumente sind Voraussetzungen für die die Evaluation zukünftiger Lehrveranstaltungen, in denen historische und ethische Aspekte integriert vermitteltwerden sollen. Neben einem Beitrag zur wissenschaftlich fundierten medizinischen Ausbildung im Querschnittsbereich GTE bieten interdisziplinäre Lehrprojekte mit Begleitforschung auch die Möglichkeit das Verhältnis von Geschichte und Ethik (in) der Medizin hinsichtlich der für beide Fächer relevanten Lehrinhalte und Lehrmethoden zu reflektieren. (shrink)

Across normative and empirical disciplines, considerable attention has been devoted to the prevalence and ethics of the non-medical use of prescription and illegal stimulants for neuroenhancement among students. A predominant assumption is that neuroenhancement is prevalent, in demand, and calls for appropriate policy action. In this paper, we present data on the prevalence, views and knowledge from a large sample of German students in three different universities and analyze the findings from a moral pragmatics perspective. The results of our study (...) indicate that neuroenhancement is a well-known phenomenon among German students, but not prevalent. 2.2 % of our sample reported having used a prescription medication for neuroenhancement. Exams and competitive situations were predominant motivators of use. Students were unenthusiastic and critical about neuroenhancement in the academic context and disapproved of neuroenhancement for professionals. The majority of respondents agreed that neuroenhancing substances should be regulated by the state. These stances were based on strong beliefs in resisting peer pressure, avoiding the creation of injustice and valuing of hard work. From a moral pragmatics standpoint, these results challenge the assumption that policy on neuroenhancement is necessary in academic environments. (shrink)

Empirical studies on people's moral attitudes regarding ethically challenging topics contribute greatly to research in medical ethics. However, it is not always clear in which ways this research adds to medical ethics as a normative discipline. In this article, we aim to provide a systematic account of the different ways in which attitudinal research can be used for normative reflection. In the first part, we discuss whether ethical judgements can be based on empirical work alone and we develop a sceptical (...) position regarding this point, taking into account theoretical, methodological and pragmatic considerations. As empirical data should not be taken as a direct source for normative justification, we then delineate different ways in which attitudes research can be combined with theoretical accounts of normative justification in the second part of the article. Firstly, the combination of attitudes research with normative-ethical theories is analysed with respect to three different aspects: The extent of empirical data which is needed, the question of which kind of data is required and the ways in which the empirical data are processed within the framework of an ethical theory. Secondly, two further functions of attitudes research are displayed which lie outside the traditional focus of ethical theories: the exploratory function of detecting and characterising new ethical problems, and the field of ‘moral pragmatics’. The article concludes with a methodological outlook and suggestions for the concrete practice of attitudinal research in medical ethics. (shrink)

Objectives To determine the frequencies and types of limitation of medical treatment performed by physician members of the German Society for Palliative Medicine and to analyse the findings with respect to clinical and ethical aspects of end-of-life practices. Design Cross-sectional postal survey. Setting Data collection via the secretary of the German Society for Palliative Medicine using the German language version of the EURELD survey instrument. Subjects All 1645 physician members of the German Society for Palliative Medicine. Main outcome measures Types (...) and frequencies of limitation of treatment and possible determinants. Results 901 physicians participated in the study (response rate 55.8%). Participants reported limitation of treatment in 69.1% of cases. These decisions most often affected artificial nutrition (19%), chemotherapy (14%), antibiotics (11%) and medication other than antibiotics (11%). In the majority of eligible cases, physicians estimated the life-shortening effect of limitation of treatment to be <7 days. However, estimations differ depending on the medical measures in question. Bivariate statistical analysis indicated that withholding of treatment was performed significantly more frequently for patients aged ≥65 years (p=0.019). In addition, there were significant associations between the incidence of limitation of treatment and the different diseases reported by respondents as the underlying cause of death. Conclusion The findings of this study provide information on the current state of an ethically and clinically challenging aspect of clinical practice and can serve as a starting point for further interdisciplinary research on normative and empirical aspects of treatment decision-making at the end of life. (shrink)

Background: Today in vitro fertilisation is a widespread and important technique of reproductive medicine. When the technique was first used, it was considered ethically controversial. This is the first study conducted of adult IVF-offspring in order to learn about their ethical opinions and personal attitudes towards this medical technology.Methods: We recruited the participants from the first cases of in vitro fertilisation in Germany at the Gynaecological Clinic of the University Hospital Erlangen. Our qualitative interview study consisted of in-depth, face-to-face interviews (...) with 16 adults who had been conceived by IVF. Our data was analysed with methods of Grounded Theory.Results: For these adults, the most important factor influencing their personal attitudes towards IVF was the knowledge that they were deeply wanted children. The artificiality of their conception seemed irrelevant for their ethical opinion. All participants mentioned that it was important for them to be informed about the circumstances of their conception by their parents.Conclusions: IVF seems to be a medical technique which, although it affects intimate aspects of human existence, can be integrated into the lives of the affected persons without any great difficulties. The findings suggest that parents should inform their children about their fertilisation at an early age and as part of a process over time, not only on a single occasion. Physicians should advise IVF-parents accordingly. (shrink)

Definition of the problem: Attitudes and practice of doctors regarding physician-assisted suicide (PAS) in patients with AIDS became considerably more liberal over the last 15 years in large U.S. cities. However, it remains an open question how the highly active antiretroviral therapies (HAART) have influenced the situation since the late 1990s. Methods and results: In 1999/2000 a nonrepresentative sample of medical doctors, psychologists, social workers, nurses and other health care professionals (n=69) in San Francisco und New York gave semistructured interviews (...) about the present situation of PAS in patients with AIDS. On the basis of written protocols a qualitative evaluation of the expert interviews has been performed. The majority of the health care professionals are familiar with PAS in their professional work. With HAART the requests for PAS in gay patients with AIDS dropped rapidly. PAS has not been noted in other subgroups of patients. However, unsolved problems exist in timing, execution and accompaniment of PAS and in competence assessment of PAS patients. No hints of a slippery slope abuse could be identified in the interviews. Conclusion: Although tolerated, the majority of the doctors still feel uncomfortable with PAS and regard PAS as alien to their professional ethos. In practice PAS takes place on request of a subgroup of AIDS patients only. However, the professional experience with PAS in patients with AIDS has changed the attitude of doctors toward a stronger acceptance of their patients autonomy and partnership with them. Open questions remain regarding the competence assessment of seriously ill and dying patients. (shrink)

Das Recht von Patienten, selbst über ihre Behandlung zu bestimmen, erfährt in der Radioonkologie eine zunehmende Bedeutung. Damit verknüpft ist die Diskussion um Patientenverfügungen, die trotz großer allgemeiner Akzeptanz in der klinischen Praxis nur selten verwendet werden. Ziel dieser qualitativen Studie war es, die Einstellungen von Patienten, Ärzten und dem Pflegepersonal zur Mitbestimmung von Patienten bei aktuellen Therapieentscheidungen und gegenüber Patientenverfügungen zu untersuchen.Es wurden 15 Patienten, 7 Ärzte und 13 Pflegende einer radioonkologischen Universitätsklinik in halboffenen, leitfadengestützten Interviews zu folgenden Themen (...) befragt: Kenntnis von Patientenverfügungen, Vor- und Nachteile von Patientenverfügungen, Beteiligung von Patienten an aktuellen Therapieentscheidungen, Gründe für eine Nicht-Beteiligung an Therapieentscheidungen. Die Interviews wurden mit der Methode der qualitativen Inhaltsanalyse ausgewertet.Bei Patienten kann hinsichtlich ihres Wunsches nach Beteiligung bei Therapieentscheidungen zwischen einer „aktiven“ und einer „passiven“ Gruppe differenziert werden. Ärzte und Pflegepersonal betonen die hohe psychische und körperliche Belastung der Patienten durch Diagnosemitteilung und Therapie. Patientenverfügungen werden generell positiv bewertet und als Mittel zur Ausübung der Selbstbestimmung von Patienten verstanden. Jedoch sehen Patienten selbst im fortgeschrittenen Krankheitsverlauf nur selten die Notwendigkeit, eine Patientenverfügung zu erstellen. In der radioonkologischen Praxis kommunizieren Patienten und Ärzte nur selten über Patientenverfügungen.Aussagefähige Patientenverfügungen setzen eine rechtzeitige und angemessene Kommunikation über Krankheitsverlauf und Therapieoptionen zwischen Arzt und Patient voraus. In dem untersuchten radioonkologischen Behandlungssetting haben Patientenverfügungen nur eine begrenzte praktische Bedeutung. (shrink)

Die öffentliche Diskussion um die „personalisierte Medizin“ legt nahe, dass mit diesem medizinischen Ansatz hohe Erwartungen an einen Beitrag zur klinischen Versorgung verbunden werden. Über die Wahrnehmungen und Bewertungen klinisch tätiger Ärzte ist jedoch wenig bekannt. Die vorliegende qualitative Interviewstudie gibt einen Einblick bezüglich des Einflusses „personalisierter Medizin“ auf die klinische Praxis aus ärztlicher Perspektive. Die Ärzte im vorliegenden Sample nehmen „personalisierte Medizin“ zwar als einen medizinischen Fortschritt wahr, sehen allerdings keine grundsätzliche Veränderung der bisherigen medizinischen Praxis. Als zentrales Problem (...) wird die Handhabung und Verwertung von molekulargenetischen Informationen für Diagnose und Therapie in der klinischen Praxis thematisiert. In Anbetracht der Ergebnisse muss infrage gestellt werden, ob „personalisierte Medizin“ nicht das Gegenteil von dem, was ihr Name nahe legt – eine personenorientiertere Medizin – bewirkt. Die Strategien im Umgang mit den Informationsmassen produzieren selbst neue Herausforderungen, die ein Hindernis für eine personenorientierte Medizin darstellen könnten. (shrink)

This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services for different reasons over several decades. However, while a lot has been said about the concepts and methodological challenges of evaluating CESS up to the present time, (...) relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. (shrink)

Definition of the problem: The differentiation between ”therapeutic” and ”non-therapeutic” research has found broad acceptance within clinical research, law and medical ethics and is part of national law and international declarations. However, this terminology is problematic on the medical (descriptive) as well as on the ethical (normative) level. Arguments: On theoretical grounds and with an example from clinical practice it is argued that e.g. the terms ”therapeutic research” and ”experimental treatment” are rather manipulative to the patient. Conclusion: In obtaining informed (...) consent from human subjects in medical research the individual risk-benefit-assessment should be pointed out clearly rather than arguing in the category of ”therapeutic” versus ”non-therapeutic” research. (shrink)