Zusammenfassung Die Forschungs- und Regulierungsebene bei datenintensiver Forschung in der Medizin liegen auseinander. Ein heterogenes Feld aus regulierenden Institutionen mit regional ungleichen Regelungen, sowohl hinsichtlich der Dichte als auch der Restriktivität von Regelungen, steht einer globalen Entwicklung der Technologien entgegen. Trotz oder gerade wegen mangelnder global-gültiger Regulierungen können auch unverbindliche oder nur bedingt verbindliche normative Vorgaben der Orientierung dienen. Doch wie soll eine solche normative Regulierung angesichts datenintensiver Forschung in der Medizin ausgestaltet werden und woran soll sie sich orientieren? Die (...) Frage, wie konkret und detailliert man eine solche Forschung regulieren sollte, lässt sich nur im Einzelfall für bestimmte Situationen und Institutionen beantworten. Ob dabei neue Normen oder Gewichtungen von Normen vorgenommen werden sollen, oder ob die Normen und deren Gewichtung weiterhin bestehen bleiben sollen, lässt sich nur mit Verweis auf starke normative Argumente beantworten. An zwingenden Argumenten für neue Normen angesichts der datenintensiven medizinischen Forschung mangelt es bisher. Dennoch ist eine Umsetzungsarbeit von Normen, egal ob neue oder alte, und deren Anwendung auf eine neue Methode oder Technologie allemal zu erbringen. Es bedarf daher – wie schon bisher – beider: sowohl etablierter und transparent kommunizierter Normen als auch des unabhängigen Urteils zur Anwendung dieser Normen. Angesichts der besonderen Eignung für diese Aufgabe sollten auch weiterhin Ethik-Kommissionen als prozedurale Instanz bei der Bewilligung von datenintensiver Forschung in der Medizin gefordert und befähigt werden, die als unabhängige Institution ein Urteil im Einzelfall anhand vorgegebener Normen fällen. Nichtsdestotrotz können sich die veränderten Praktiken datenintensiver Forschungsprojekte auch in neuen Anforderungen an Ethik-Kommissionen niederschlagen, denen mit Reformen der Arbeitsweise begegnet werden sollte. (shrink)

Kairos has been a key concept in medicine for millennia and is frequently understood as “the right time” in relation to treatment. In this study we scrutinize kairos in the context of diagnostics. This has become highly topical as technological developments have caused diagnostics to be performed ever earlier in the disease development. Detecting risk factors, precursors, and predictors of disease (in biomarkers, pre-disease, and pre-pre-disease) has resulted in too early diagnoses, i.e., overdiagnoses. Nonetheless, despite vast advances in science and (...) technology, diagnoses also come too late. Accordingly, timing diagnostics right is crucial. In this article we start with giving a brief overview of the etymology and general use of the concepts of kairos and diagnosis. Then we delimit kairos in diagnostics by analysing “too early” and “too late” diagnosis and by scrutinizing various phases of diagnostics. This leads us to define kairos of diagnostics as the time when there is potential for sufficient information for making a diagnosis that is most helpful for the person. It allows us to conclude that kairos is as important in diagnostics as in therapeutics. (shrink)

The article critically responds to "A Planetary Health Pledge for Health Professionals in the Anthropocene" which was published by Wabnitz et al. in The Lancet in November 2020. It focuses on the different roles and responsibilities of a physician. The pledge is criticised because it neglects the different roles, gives no answers in case of conflicting goals, and contains numerous inconsistencies. The relationship between the Planetary Health Pledge and the Declaration of Geneva is examined. It is argued that the Planetary (...) Health Pledge should have supplemented the Declaration of Geneva instead of changing it. (shrink)

The World Medical Association has announced that a new revision process of the Declaration of Helsinki has been started. This article will identify the criticisms that have been made in the bioethics literature, particularly since the last revision. In addition, criticisms are discussed that were made in the literature even before the last revision and have not fallen silent. The plausibility of the recommendation for a change in the Declaration of Helsinki is examined.

In March 2020, the rapid increase in severe COVID‐19 cases overwhelmed the healthcare systems in several European countries. The capacities for artificial ventilation in intensive care units were too scarce to care for patients with acute respiratory disorder connected to the disease. Several professional associations published COVID‐19 triage recommendations in an extremely short time: in 21 days between March 6 and March 27. In this article, we compare recommendations from five European countries, which combine medical and ethical reflections on this (...) situation in some detail. Our aim is to provide a detailed overview on the ethical elements of the recommendations, the differences between them and their coherence. In more general terms we want to identify shortcomings in regard to a common European response to the current situation. (shrink)

The Hippocratic Oath and the Declaration of Geneva of the World Medical Association are compared in terms of content and origin. Their relevance for current medical practice is investigated. The status which is ascribed to these documents will be shown and the status which they can reasonably claim to have will be explored. Arguments in favor of the Hippocratic Oath that rely on historical stability or historical origin are being examined. It is demonstrated that they get caught up in paradoxes. (...) Should doctors swear the Hippocratic Oath or the Declaration of Geneva? The Hippocratic Oath is a remarkable historic document, which contains important elements still relevant for medical ethics today. Its interpretation as a timeless, still valid medical code is unfounded. The historical arguments, that should justify its validity, are untenable. The Declaration of Geneva, and not the Hippocratic Oath, can legitimately claim to come close to representing the most important principles of professional medical conduct in today’s globalised world. (shrink)

Personalized medicine plays an important role in the development of current medicine. Among the numerous statements regarding the future of personalized medicine, some can be found that accord medicine a new scientific status. Medicine will be transformed from an art to a science due to personalized medicine. This prognosis is supported by references to models of historical developments. The article examines what is meant by this prognosis, what consequences it entails, and how feasible it is. It refers to the long (...) tradition of epistemological thinking in medicine and the use of historical models for the development of medicine. The possible answers to the question “art or science” are systematized with respect to the core question about the relationship between knowledge and action. The prediction for medicine to develop from an ‘empirical healing art’ to a ‘rational, molecular science’ is nonsensical from an epistemological point of view. The historical models employed to substantiate the development of personalized medicine are questionable. (shrink)

In Germany — as probably worldwide — in vitro fertilization has provoked disapproval, fears, and dread, but it also raises hope and gives feelings of pride and satisfaction in a new scientific achievement. Critics look for convincing argu- ments that could ban IVF completely or at least restrict it considerably. Some of the most important arguments are outlined below.The main aspect of IVF that was new to society was that conception could take place outside the female body. Although this fact (...) has made a deep impression on us, no ethical relevance has been attributed to it. One must look further for arguments against IVF. (shrink)

The article presents the judgment of the German Federal Constitutional Court from 26 February 2020 on assisted suicide. The statements regarding human dignity, human rights and the relationship between citizens and the state are examined. Furthermore, the consequences resulting from this interpretation of human dignity for states that are pluralistic and based on human rights will be laid out. The court’s judgment limits the power of parliaments and poses a challenge to many laws in states that see themselves as pluralistic, (...) human rights-based states. There are no data in this work. (shrink)

Die Frage, ob sie eine Kunst oder eine Wissenschaft sei, begleitet die Medizin seit der Antike. Die vorliegende Arbeit untersucht die Frage insbesondere im Hinblick auf den Einfluss Kants, Fichtes und Schellings auf das Selbstverstandnis der Medizin. Sie zeichnet die geschichtlichen Linien nach, die zum Verstandnis der gegenwartigen Situation fuhren und liefert wichtige Argumente zu einem zeitgemassen Selbstverstandnis der Medizin, das fur die wissenschaftstheoretische und ethische Diskussion in der Medizin von heute unverzichtbar ist. Since antiquity, the question has been whether (...) medicine is an art or a science. This work explores the question, in particular in view of Kants, Fichtes and Schellings influence on the self-conception of medicine. It traces the historical timelines which help to understand the current situation and provides important arguments for a timely self-conception of medicine which is indispensable for the discussion of scientific theory and ethics in todays medicine. (shrink)

ZusammenfassungDer Artikel untersucht die Frage, ob es sinnvoll ist, Doping im Sport unter ärztlicher Kontrolle freizugeben. Dazu werden die Auswirkungen einer Freigabe untersucht, die stets nur eine begrenzte Freigabe wäre, allein wegen der Risiken. Die unangenehmen Begleiterscheinungen der Dopingkontrollen würden nicht entfallen. Die Auswirkungen einer Freigabe von Doping im Wettkampfsport wären entweder unsinnig oder aber mit Nachteilen behaftet. Es ist nicht notwendig, die Frage zu klären, was die „Idee des Sportes“ ausmacht und ob sie verändert werden darf. Allein unter praktischen (...) Aspekten zeigt sich, dass dem Sport mit einer Freigabe des Dopings keine Vorteile, aber viele Nachteile erwachsen. (shrink)

Kaum ein Thema scheint im privaten wie gesellschaftlichen Leben so umstritten zu sein wie die gesunde Lebensfuhrung - Pravention ist ein Kampfplatz von politischen Steuerungsinteressen, okonomischem Kalkul und weltanschaulichen Positionen. Durch die Aufarbeitung der soziohistorischen Entwicklung verschiedener Praventionsverstandnisse tragt dieser interdisziplinare Sammelband zu einem umfassenden Verstandnis von Gesundheitsfursorge und -vorsorge bei und lasst die politischen, soziologischen, rechtlichen und philosophischen Aspekte klar hervortreten.

The article aims to illuminate the recent debate in Germany about the legitimacy of circumcision for religious reasons. The aim is both to evaluate the new German law allowing religious circumcision, and to outline the resulting conflict between the surrounding ethical and legal issues. We first elucidate the diversity of legal and medical views on religious circumcision in Germany. Next we examine to what extent invasive and irreversible physical interventions on infant boys unable to given their consent should be carried (...) out for non-medical reasons. To this end, the potential benefits and harms of circumcision for non-medical reasons are compared. We argue that circumcision does not provide any benefits for the ‘child as a child’ and poses only risks to boys. We then set out to clarify and analyse political justifications of the new circumcision law. We demonstrate through this analysis how the circumcision debate in Germany has been transformed from a legal and ethical problem into a political issue, due at least in part to Germany's unique historical context. Although such a particular political sensibility is entirely comprehensible, it raises particular problems when it comes to framing and responding to medical ethical issues – as in the case of religious circumcision. (shrink)

The article tries to clarify the relation between history of medicine and medical ethics. Therefore it distinguishes between the double meaning of the german word Geschichte , which means both: development of events and story . For the first option no systematic relation between history and ethics can be reconstructed. In the second sense historical knowledge can be a readable and worth reading text for the ethical debate. Therefore the methodological professionality of the historian is required.

Theranostics or theragnostics are new terms which start to appear occasionally in publications from 2001 onwards, with a marked increase in references from 2011. In the last few years more than 1100 articles using this term were published each year. In 2011 the journal Theranostics was founded. This paper addresses the question of whether this new term is appropriate. The etymology of the term is analysed. A literature search for definitions of “theranostics” is carried out and the definitions examined as (...) to whether they give grounds for justifying the use of a new term. The differences between diagnostics and therapy are explored. A broad and a narrow definition are found. According to the broad definition theranostics provides a closer relationship between diagnostics and therapy. According to the narrow definition diagnostics and therapy become a single intervention. On closer examination it turns out that in the narrow definition the diagnostics capacities are limited to monitoring. Neither the broad nor the narrow definition actually demonstrate a new concept in medicine. Rather, they describe the well-known practice of medical decision making. In this respect, the new term cannot be justified. The level of diagnostics is new but not the relationship between diagnostics and therapy. The term theranostics is misleading as it obscures the existing differences between diagnostics and therapy and wrongly insinuates that steps between diagnostics and therapy could be omitted. (shrink)

DieBeratungklinische EthikberatungArzt-Patienten-BeziehungArztArzt-Patientenbeziehung ist durch ein asymmetrisches Verhältnis geprägt, welches sich bereits aus den Umständen seines Zustandekommens ergibt. Der Patient begegnet dem Arzt in einer Situation existentieller NotNot als jemand, der unter Schmerzen und/oder Angst leidet und Hilfe sucht. Er ist dabei angewiesen auf ein vertrauensvolles Verhältnis zu seinem Arzt, der seine Sorgen und Ängste ernstnimmt und durch seine Fachkompetenz die vorliegende KrankheitKrankheit feststellen und heilen oder zumindest lindern kann.

The article is devoted to the question of how the moral integrity of the physician's role can be maintained under the pressure of economic and social interests. First, the moral basis of the doctor's role is discussed and areas of conflict are systematized. Second, a preference for cases of conflict is recommended and allocational decisions are examined. The primary question of whether the doctor's role in its current moral orientation should be maintained is answered clearly in the affirmative under reference (...) to history, to the patient's self-determination and to undesirable results that are to be feared. Der Aufsatz widmet sich der Frage, wie unter dem Druck ökonomischer und gesellschaftlicher Interessen die moralische Integrität der Arztrolle gewahrt bleiben kann. Zunächst wird die moralische Grundlegung der Arztrolle dargestellt; anschließend werden Konfliktfelder systematisiert. Danach wird eine Präferenz in Konfliktfällen vorgeschlagen und ein Blick auf Allokationsentscheidungen geworfen. Die vorgängige Frage, ob die Arztrolle in ihrer jetzigen moralischen Ausrichtung bestehen bleiben soll, wird mit Verweis auf die Geschichte, auf die Selbstbestimmung der Patienten und auf zu befürchtende unerwünschte Erscheinungen eindeutig bejaht. (shrink)

When the 15-year-old Auguste Böhmer, daughter of Caroline Schlegel and stepdaughter of August Wilhelm Schlegel, died on 12th July 1800, Friedrich Wilhelm Joseph Schelling was accused of being responsible for this tragic event, because he tried to treat her according to the medical system of John Brown. The ensuing scandal became a symbol for the danger of every progressive movement of that time: the Romantic literature, the natural philosophy of Schelling and Brownianism in its German version, represented by Andreas Röschlaub. (...) An attempt is made to analyse the social and political background of the scandal and to argue the historical meaning as a fight against a fundamental reform of medicine. (shrink)

Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for clinical research have (...) been developed to reduce possible harm for research participants without abandoning necessary investigations. Here we examine whether clinical research trials of nanomedicine need new regulations and conclude that the established rules should suffice. (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 19 Heft: 1 Seiten: 253-276.

Der Beitrag untersucht die ethischen Konflikte, die einer Regelung der Arbeitszeit von Ärzten zugrunde liegen. Als oberstes ethisches Prinzip ist die Vermeidung von Schäden zu beachten, die durch Überarbeitung der Ärzte sowie durch übermäßige Aufteilung der Arbeit entstehen. Zudem sind andere ethische Prinzipien zu berücksichtigen, insbesondere die Schadensvermeidung und Nutzenmehrung für zukünftige Patienten sowie für die Ärzte. Der Beitrag begründet Präferenzen bei konfligierenden ethischen Prinzipien und untersucht überdies die strukturellen Schwierigkeiten, die unvermeidlich bei der Regelung einer komplexen Tätigkeit, wie der (...) ärztlichen, anfallen. (shrink)

ABSTRACT Definition of the problem: The regulation of residents' work hours involves several ethical conflicts which need to be systematically analysed and evaluated. Arguments and conclusion: The most important ethical principle when regulating work hours is to avoid the harm resulting from the over‐work of physicians and from an excessive division of labour. Additionally, other ethical principles have to be taken into account, in particular the principles of nonmaleficence and beneficence for future patients and for physicians. The article presents arguments (...) for balancing the relevant ethical principles and analyses the structural difficulties that occur unavoidably in any regulation of the complex activities of physicians. (shrink)

The article examines the statements made by Immanuel Kant with reference to medicine as well as the impact of his philosophy on medicine. It describes the initial reaction of Kantian philosophy on medicine in the late 18th and early 19th century and its influence in the late 20th century.

To what extent can postmodern developments be observed in modern medicine and which theories of postmodern philosophy can we draw on with regard to medicine's theoretical problem? This article explores these questions with special emphasis on the epistemological status of medicine, the concept of disease, and the anthropological model. It is examined whether medicine's inherent duty to act can be questioned in the light of the plurality that characterizes postmodernity. It is concluded that, according to postmodern philosophy, medicine should be (...) characterized by a justified variety of paradigms. Cooperation within the variety must continue to be guaranteed, always in favor of the constitutive moral duty of medicine. (shrink)

In reference to historical developments, this article introduces the topic of this special issue of Theoretical Medicine and Bioethics, that is, the relationship(s) between theory and practice. The authors emphasize the need for scientific research in this neglected area for the sake of both clinical practice and medical education.

ABSTRACT The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions (...) justifying placebo‐use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo‐use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptabililty of placebo‐use. (shrink)

Some of the recent criticisms published during and after the last revision process of the Declaration of Helsinki are directed at its basic legitimacy. In this article we want to have a closer look at the two criticisms we consider to be the most fundamental. The first criticism questions the legitimate authorship of the World Medical Association to publish a document such as the Declaration. The second fundamental criticism we want to examine argues that the last revision process failed to (...) meet the standards for fair, democratic procedures. Although both criticisms deny the formal legitimacy of the Declaration in the most fundamental way, they have never been addressed in detail in a single article. We refute most of the related arguments. However, acknowledging some of the points made, improvements for future revision processes and versions of the Declaration of Helsinki are outlined. (shrink)

The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions justifying (...) placebo‐use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo‐use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptabililty of placebo‐use. (shrink)

ZusammenfassungDie Zulässigkeit genetischer Untersuchungen an Arbeitnehmern wird in Deutschland neu diskutiert, nachdem einer hessischen Lehrerin die Verbeamtung auf Probe zunächst verweigert wurde, weil ihr Vater an der Huntington-Krankheit leidet. Es soll untersucht werden, ob eine gesetzliche Regelung genetischer Untersuchungen in der Arbeitsmedizin wünschenswert ist und welche ethischen Maßstäbe dabei zu berücksichtigen wären. Gendiagnostische Untersuchungsverfahren im engeren Sinn finden noch keine breite Anwendung in der Arbeits- und Betriebsmedizin. Die Nutzung genetischer Informationen gehört aber auch hier zum Standard. Damit sind verschiedene ethische (...) Konflikte verbunden, die insbesondere die Bereiche Autonomie und Diskriminierung betreffen. Gesetzliche Regelungen sollten sich daher nicht an der jeweiligen gendiagnostischen Technologie orientieren, sondern an der prognostisch-prädiktiven Qualität genetischen Wissens. Das Machtungleichgewicht am Arbeitsplatz und die immanenten Interessenkonflikte machen gesetzliche Regelungen erforderlich, die angesichts der zunehmenden Verfügbarkeit prädiktiver medizinischer Informationen Personenrechte schützen und einen fairen Interessenausgleich fördern. (shrink)

ZusammenfassungDie Zulässigkeit genetischer Untersuchungen an Arbeitnehmern wird in Deutschland neu diskutiert, nachdem einer hessischen Lehrerin die Verbeamtung auf Probe zunächst verweigert wurde, weil ihr Vater an der Huntington-Krankheit leidet. Es soll untersucht werden, ob eine gesetzliche Regelung genetischer Untersuchungen in der Arbeitsmedizin wünschenswert ist und welche ethischen Maßstäbe dabei zu berücksichtigen wären. Gendiagnostische Untersuchungsverfahren im engeren Sinn finden noch keine breite Anwendung in der Arbeits- und Betriebsmedizin. Die Nutzung genetischer Informationen gehört aber auch hier zum Standard. Damit sind verschiedene ethische (...) Konflikte verbunden, die insbesondere die Bereiche Autonomie und Diskriminierung betreffen. Gesetzliche Regelungen sollten sich daher nicht an der jeweiligen gendiagnostischen Technologie orientieren, sondern an der prognostisch-prädiktiven Qualität genetischen Wissens. Das Machtungleichgewicht am Arbeitsplatz und die immanenten Interessenkonflikte machen gesetzliche Regelungen erforderlich, die angesichts der zunehmenden Verfügbarkeit prädiktiver medizinischer Informationen Personenrechte schützen und einen fairen Interessenausgleich fördern. (shrink)