This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of (...) ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)

The concept of “translational bioethics” has received considerable attention in recent years. Most publications draw an analogy to translational medicine and describe bioethical research that aims at implementing and evaluating ethical interventions. However, current accounts of translational bioethics are often rather vague and seem to differ with regard to conceptual and methodological assumptions. It is not clear and scarcely analyzed what exactly “translation” in the field of bioethics means, in particular regarding goals and processes so that it is justified to (...) appeal to translational medicine. In this article, we thus explore possible analogies and disanalogies between translational medicine and translational bioethics to establish whether the often occurring reference to concepts of translational medicine in the field of bioethics can be justified by substantial analogies. We will first provide an account of different models of translational medicine. In a second step, we will propose an analytic definition that explicitly articulates the essential characteristics of “translational research” irrespective of the research field (i.e., biomedicine, bioethics). Subsequently, we will explore whether and in how far general characteristics and phases of translational research in medicine can be applied to translational research in bioethics. Based on our analyses, we will come to the skeptical conclusion that at present there are considerable conceptual disanalogies and unsolved conceptual problems that disallow using “translational bioethics” in a meaningful analogy to respective accounts in biomedicine. Nevertheless, we will demonstrate that some insights gained by the conceptual accounts of translational medicine can contribute to advance current research activities in bioethics. (shrink)

Researchers in applied ethics, and some areas of bioethics particularly, aim to develop concrete and appropriate recommendations for action in morally relevant real-world situations. When proceeding from more abstract levels of ethical reasoning to such concrete recommendations, however, even with regard to the very same normative principle or norm, it seems possible to develop divergent or even contradictory recommendations for action regarding a certain situation. This may give the impression that such recommendations would be arbitrary and, hence, not well justified. (...) Against this background, we, first, aim at showing that ethical recommendations for action, although being contingent in some sense, are not arbitrary if developed appropriately. For this purpose, we examine two types of contingencies arising in applied ethics reasoning based on recent examples of recommendations for action in the context of the COVID-19 pandemic. In doing so, we refer to a three-step model of ethical reasoning towards recommendations for actions. This, however, leaves open the question of how applied ethics may cope with contingent recommendations for action. Therefore, in a second step, we analyze the role of bridge principles for developing ethically appropriate recommendations for action, i.e., principles which connect normative claims with relevant empirical information to justify certain recommendations for action in a given morally relevant situation. Finally, we discuss some implications for reasoning and reporting in empirically informed ethics. (shrink)

Background In the last years, there has been an increase in publication of systematic reviews of normative literature or of normative information in bioethics. The aim of a systematic review is to search, select, analyse and synthesise literature in a transparent and systematic way in order to provide a comprehensive and unbiased overview of the information sought, predominantly as a basis for informed decision-making in health care. Traditionally, one part of the procedure when conducting a systematic review is an appraisal (...) of the quality of the literature that could be included. Main text However, while there are established methods and standards for appraising e.g. clinical studies or other empirical research, quality appraisal of normative literature in the context of a systematic review is still rather a conundrum – not only is it unclear how it could or should be done, but also the question whether it necessarily must be done is not settled yet. Based on a pragmatic definition of “normative literature” as well as on a typology of different types of systematic reviews of normative literature/information, this paper identifies and critically discusses three possible strategies of conducting quality appraisal. Conclusions The paper will argue that none of the three strategies is able to provide a general and satisfying solution to the problems associated with quality appraisal of normative literature/information. Still, the discussion of the three strategies allows outlining minimal conditions that elaborated strategies have to meet in future, and facilitates sketching a theoretically and practically promising strategy. (shrink)

Central to Elements is an assay of the attributional union properties and relations have with their subjects, a topic historically left metaphorical. The work critiques eight Aristotelian assumptions concerning attribute dependence and ‘inherence’, per se subjects, attributes as agent-organizers, and unity-by-a-shared-one. Groups of these assumptions are seen to yield contradiction, vicious regress, or other problems. This analysis, joined with insights from an assay of ubiquitous structure, motivate ten theses explicating attribution and its primary ontic status. The theses detail: attributes proper (...) as individuated instances, structure as instance-generated facts and their two forms of composition, the conditioning role and universal nature of instances’ component intensions, the primacy of attribute instances for generating all forms of composition and complex entities, and identity and indiscernibility criteria for the latter. Principal is the insight that attribution is intension-determined combinatorial agency. It is its systematizing implications that provide solutions to classic problems, e.g., Composition, Individuation, and Universals, and in net generate a comprehensive one-category structuralist ontology. (shrink)

With the prevalence of complementary and alternative medicine (CAM) increasing in western societies, questions of the ethical justification of these alternative health care approaches and practices have to be addressed. In order to evaluate philosophical reasoning on this subject, it is of paramount importance to identify and analyse possible arguments for the ethical justification of CAM considering contemporary biomedical ethics as well as more fundamental philosophical aspects. Moreover, it is vital to provide adequate analytical instruments for this task, such as (...) separating ‘CAM as belief system’, and ‘CAM as practice’, Findings show that beneficence and non-maleficence are central issues for an ethical justification of CAM as practice, while freedom of thought and religion are central to CAM as belief system. Many justification strategies have limitations and qualifications that have to be taken into account. Singularly descriptive premises in an argument often prove to be more problematic than universal ethical principles. Thus, non-ethical issues related to a general philosophical underpinning - e.g. epistemology, semantics, and ontology - are highly relevant for determining a justification strategy, especially when strong metaphysical assumptions are involved. Even if some values are shared with traditional biomedicine, axiological differences have to be considered as well. Further research should be done about specific CAM positions. These could be combined with applied qualitative social research methods. (shrink)

ABSTRACTThis article examines the way in which some biomedical ethicists have constructed sexually transmitted AIDS as a significant threat to women's health. We demonstrate that the familiar claim that‘women are the fastest growing group'— whether of HIV‐infected or of AIDS patients — is misleading because it obscures the distinction between proportional rate of growth and absolute increase. Feminist ethicists have suggested that misogyny of a male dominated health care system has led to underreporting of women AIDS cases in order to (...) support these feminists’claim of AIDS being a real threat to women's health. Given the apparent rarity of tertiary transmissions of AIDS, the assertion that most or even many women are at significant risk for AIDS seem wrong. Particularly disturbing in this campaign is the fact that the theme of‘risky sex’has been extended all the way to lesbians, even though their risk to acquire AIDS sexually is non‐existent to minuscule. We argue that actual harm is done to women by this exaggeration of their risk of contracting AIDS sexually. The scare has led to misappropriations of scarce health care funds. AIDS disproportionately affects women who inject drugs, and who suffer other diseases, poverty and malnutrition. It would have been better to concentrate health care efforts in this area instead of‘educating’women not at risk for AIDS how to prevent the acquisition of this disease. Unjustifiable AIDS anxiety has been created in women and has resulted in millions of unnecessary HIV‐tests, and many broken relationships. This anxiety has inevitably reduced the pleasure of having sex for many women. We reject the kind of‘victim ideology’that lies at the heart of this strategy which has, unfortunately, been supported by a number of influential feminist ethicists. (shrink)

Academic publications of empirical public health research often entail recommendations for moral action that address practitioners and policy makers. These recommendations are regularly based on implicit moral judgments with the underlying reasons not explicitly stated. In this paper, we elaborate on the moral relevance of such judgments and the need to explain them in order to account for academic argumentation. We argue for an explicit reporting of bridge principles to increase the transparency of the reporting of public health research. The (...) reporting of bridge principles can inform readers, support them in understanding the relationship between empirical and normative claims in a specific paper, and may pave new ways for the rigorous reporting of empirical research that has moral implications. Furthermore, it can be used to classify studies to systematically address the justification for their argumentation. (shrink)

D. W. Mertz provides a "new" competitor in the universals debate by reviving, developing, and defending the medieval doctrine of Moderate Realism. This book is a substantial contribution to ontology and logic, combining interesting new arguments for polyadic relations and unit attributes, careful and thorough historical studies, and a logic that could solve many old problems.

Therapieentscheidungen lösen in klinischen Teams häufig Unsicherheiten und Konflikte aus, insbesondere wenn es um schwerkranke Patienten geht. Fallen Entscheidungen vornehmlich situationsgeleitet, sind bestimmte Patientengruppen einem Risiko der Unter-, Über- oder Ungleichversorgung ausgesetzt. Der Metap-Leitfaden unterstützt Ärzte, Pfleger und Therapeuten daher in ihrer ethisch reflektierten Entscheidungskompetenz mit verschiedenen Orientierungs- und Entscheidungsinstrumentarien. Diese berücksichtigen eine gerechte Zuteilung der Ressourcen.

L’avènement de la biomédecine moderne est souvent considéré comme une avancée majeure. Cependant, l’ humanisme médical remet en question l’idée que la biomédecine actuelle et son système de santé soient (encore) suffisamment tournés vers des valeurs humanistes telles que la dignité, l’autonomie, l’individualité, l’empathie ou l’humilité. À côté de la biomédecine, il existe cependant de nombreuses approches relevant de la médecine non conventionnelle qui affirment fréquemment être davantage holistiques ou empathiques que la biomédecine. Cette contribution souhaite donc examiner si la (...) médecine dite complémentaire, alternative et intégrative (MCAI) pourrait mieux correspondre aux valeurs attribuées à l’humanisme médical que la biomédecine. (shrink)

In this paper we assume that ‘theory’ is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES.A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist (...) in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including ‘how-to’ questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics).In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three ‘pillars’ as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP.We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. (shrink)

In this paper we assume that ‘theory’ is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES.A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist (...) in North‐America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including ‘how‐to’ questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end‐of‐life decisions (major ethical topics).In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi‐centre context in several healthcare institutions. We conceptualize three ‘pillars’ as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP.We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. (shrink)

Applying the rules and systems of mathematics and logic to instance ontology, this work argues for the validity and problem-solving capacities of instance ontology, and associates it with a version of the realist position which is named by the author as moderate realism.

Ethische Leitlinien für die klinische Praxis erfreuen sich zunehmender Beliebtheit. Damit klinisch-ethische Leitlinien aber überhaupt erfolgreich wirksam werden können, ist noch Pionierarbeit zu leisten. Solche Leitlinien müssen wissenschaftlich stärker fundiert und ihre praktische Anwendbarkeit muss verbessert werden. In dieser Arbeit werden die ersten Schritte des Projekts METAP zur methodischen Entwicklung und praktischen Implementierung einer Leitlinie für eine patientengerechte Versorgung am Krankenbett beschrieben und zur Diskussion gestellt. Das Projekt orientiert sich methodisch an der Entwicklung medizinischer Leitlinien und generiert damit eine forschungs- (...) und konsensgestützte Leitlinie, die systematischer Evaluation und Modifikation unterliegt und Rechenschaft über ihre wissenschaftliche Fundierung gibt. Zusätzlich zur Leitlinie bietet das Projekt in der Form eines Handbuchs ein Entscheidungsfindungsverfahren an, welches unter anderem deliberative Aspekte unterstützt. Das Handbuch konzentriert sich auf ethische Fragen der Mikroallokation und liefert darüber hinaus Informationen über empirische, ethische und rechtliche Grundlagen für Therapieentscheidungen. Anhand eines Eskalationsmodells können unterschiedliche Instrumente nach Bedarf als ethische Lösungsstrategien eingesetzt werden, von der Kurzfassung im Kitteltaschenformat („Leporello“) mit den wichtigsten Fakten, weiterführenden Texten und Empfehlungen mit normativen und prozeduralen Hinweisen, über stationsinterne Lösungsversuche bis hin zum Ethikkonsil. Klinische Partner sind von Beginn an aktiv in den Entwicklungsprozess eingebunden und verbessern so die Praxistauglichkeit und Akzeptanz sowie die Ausrichtung des Instrumentariums an den tatsächlichen Bedürfnissen. Dieses partnerschaftliche, partizipative Vorgehen scheint eine wichtige Voraussetzung dafür zu sein, dass METAP in der Klinik Fuß fassen konnte. (shrink)

We propose a step‐by‐step methodological framework of translational bioethics that aims at changing medical practice according to normative–ethical requirements, which we will thus call “transformative medical ethics.” The framework becomes especially important when there is a gap between widely acknowledged, ethically justified normative claims and their realization in the practice of biomedicine and technology (ought–is gap). Building on prior work on translational bioethics, the framework maps a process with six different phases and 12 distinct translational steps. The steps involve various (...) research activities including conceptual philosophical inquiry and (socio‐)empirical research. On the one hand, the framework can be used as a heuristic tool to identify barriers to the transformation process. On the other hand, it can provide guidance for researchers and practitioners to develop appropriate (conceptual action and practice) models, which are then implemented and evaluated in specific practice contexts. We use the example of realizing the norm of respect for autonomy in the practice of medical decision‐making to illustrate the framework. Further research is required, for example, to theoretically underpin the framework, to apply it to other ought–is gaps, and to evaluate its feasibility and effectiveness in various practice areas. Overall, the framework of transformative medical ethics suggests a strategic process to investigate and promote practice change that is ethically informed in all phases. (shrink)

Recently, ethical guidelines for clinical practice have gained increased popularity, but in order to become useful they require more pioneer’s work. Clinical-ethical guidelines need to be based on a scientific foundation and their practicability must be improved. We present and put to discussion the initial steps of the METAP Project about the development and practical implementation of a clinical-ethical guideline dedicated to a fair resource-allocation at the bedside. -/- With its methodological orientation, the project represents a guideline which is based (...) on both research and consensus-building, undergoing systematic evaluation and modification. In addition to the guideline, the project comes with a manual (a tool kit) including a procedural instrument for making decisions supporting deliberative aspects. It focuses on issues of micro-allocation; furthermore, it provides empirical, ethical and legal basics for making fair treatment decisions that should help to prevent overtreatment, undertreatment or discrimination in patient care. We propose an Escalation Model with various instruments serving as problem solving strategies that correspond to the respective needs; these instruments include a pocket-summary (“Leporello”) with the most important facts; further reading material; normative and procedural recommendations; ward-specific strategies, and also the option of clinical ethics consultation. -/- Clinical partners have been actively involved in the developmental process from the beginning and contributed to the practical applicability, acceptance and a valid need-orientation of the whole tool kit. This partnership and the participatory approach seem to have helped METAP to gain a foothold in the clinic. (shrink)

Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE (...) study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. (shrink)

Eine patientengerechte Versorgung ist ein hohes Ziel. Unangemessene Behandlung wie Unter- oder Überversorgung zu erkennen und zu vermeiden, stellt Ärztinnen/Ärzte und Pflegende am Krankenbett vor schwierige Entscheidungen. Hier ist die Entwicklung von praxistauglichen Orientierungshilfen angezeigt, die wissenschaftlichen Kriterien genügen und nicht allein auf Konsens beruhen. Die vorliegende Arbeit versucht, zentrale Normen zur Vermeidung von Über- und Unterversorgung zu formulieren und theoretisch zu fundieren. Dafür wird auf Basis einer Interessen-basierten Ethik eine Graduierung der Autonomie vorgenommen, indem zwischen schwacher und starker Autonomie (...) unterschieden wird. (shrink)

Eine patientengerechte Versorgung ist ein hohes Ziel. Unangemessene Behandlung wie Unter- oder Überversorgung zu erkennen und zu vermeiden, stellt Ärztinnen/Ärzte und Pflegende am Krankenbett vor schwierige Entscheidungen. Hier ist die Entwicklung von praxistauglichen Orientierungshilfen angezeigt, die wissenschaftlichen Kriterien genügen und nicht allein auf Konsens beruhen. Die vorliegende Arbeit versucht, zentrale Normen zur Vermeidung von Über- und Unterversorgung zu formulieren und theoretisch zu fundieren. Dafür wird auf Basis einer Interessen-basierten Ethik eine Graduierung der Autonomie vorgenommen, indem zwischen schwacher und starker Autonomie (...) unterschieden wird. (shrink)

Empirical bioethics is commonly understood as integrating empirical research with normative-ethical research in order to address an ethical issue. Methodological analyses in empirical bioethics mainly focus on the integration of socio-empirical sciences and normative ethics. But while there are numerous multidisciplinary research projects combining life sciences and normative ethics, there is few explicit methodological reflection on how to integrate both fields, or about the goals and rationales of such interdisciplinary cooperation. In this paper we will review some drivers for the (...) tendency of empirical bioethics methodologies to focus on the collaboration of normative ethics with particularly social sciences. Subsequently, we argue that the ends of empirical bioethics, not the empirical methods, are decisive for the question of which empirical disciplines can contribute to empirical bioethics in a meaningful way. Using already existing types of research integration as a springboard, five possible types of research which encompass life sciences and normative analysis will illustrate how such cooperation can be conceptualized from a methodological perspective within empirical bioethics. We will conclude with a reflection on the limitations and challenges of empirical bioethics research that integrates life sciences. (shrink)

In a recent article [Mertz 2001] in this journal I argued for the virtues of a realist ontology of relation instances (unit attributes). A major strength of this ontology is an assay of ontic ('material') predication that yields an account of individuation without the necessity of positing and defending 'bare particulars'. The crucial insight is that it is the unifying agency or combinatorial aspect of a relation instance as predicable that is for ontology the principium individuationis [Mertz 2002; (...) 1996]. Or in short, what is ontically predicable, precisely as such, is the cause of individuation. As a preface to this positive doctrine I offered arguments against the coherence of bare particulars as defended in an article by J. P. Moreland [1998]. In a reply contained in this issue Moreland and Timothy Pickavance (hereafter M/P) propose to answer my objections [2002]. The response that follows provides reasons why, I contend, M/P have not succeeded in parrying my objections to bare particulars. (shrink)

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. (...) Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research. (shrink)

This insightful Research Handbook provides a definitive overview of the New Legal Realism (NLR) movement, reaching beyond historical and national boundaries to form new conversations. Drawing on deep roots within the law-and-society tradition, it demonstrates the powerful virtues of new legal realist research and its attention to the challenges of translation between social science and law. It explores an impressive range of contemporary issues including immigration, policing, globalization, legal education, and access to justice, concluding with and examination of how different (...) social science disciplines intersect with NLR. (shrink)

The systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics. One such review was carried out for the question of why post-trial access to trial drugs should or need not be provided. The objective of this study was to empirically validate this review using an author check method. The article also reports on methodological challenges faced by our study.

It can be assumed that value judgements, which are needed to judge what is ‘good’ or ‘better’ and what is ‘bad’ or ‘worse’, are involved in every decision-making process. The theoretical understanding and analysis of value judgements is, therefore, important in the context of bioethics, for example, to be able to ethically assess real decision-making processes in biomedical practice and make recommendations for improvements. However, real decision-making processes and the value judgements inherent in them must first be investigated empirically (‘empirical (...) bioethics’). For this to succeed, what exactly a ‘value judgement’ is and of what components it might consist must initially be theoretically clarified. A corresponding conceptual model can then support or even enable empirical data collection and analysis and, above all, subsequent ethical analysis and evaluation. This paper, therefore, presents a value judgement model with its theoretical derivation. It also illustrates its application in an interview study of decision-making between animal experimentation and alternative methods in the context of biomedical research. Though the model itself can be theoretically deepened and extended, the application of the model works in general and helps to uncover what value judgements can enter into decision-making. However, the empirical methods, for example, qualitative interviews, can also be better oriented towards eliciting value judgements (as understood according to the model). Further applications of the model to other topics or by means of other empirical methods are conceivable. (shrink)

Medizinethische Entscheidungsfindungsmodelle müssen nachweisen können, weshalb die mit ihnen getroffenen Entscheidungen richtig oder zumindest „belastbar“ sind. Hierfür sind theoretische Rechtfertigungsansätze aus der Ethik unverzichtbar. Der Klinischen Ethik wird aber mitunter ein Mangel an theoretischer Fundierung vorgeworfen. Um diesem Vorwurf entgegenzutreten, soll unter Bezugnahme auf ein Projekt der Klinischen Ethik („METAP“) die ethische Unterstützung in Form der ethischen Fallbesprechung und der Ethikkonsultation mittels Prinzipienethik und Diskursethik gerechtfertigt werden. Prinzipienethik und Diskursethik können einander über das Medium der ethischen Fallbesprechung oder Ethikkonsultation fruchtbar (...) ergänzen. So können einige theoretische und praktische Schwächen der beiden Ansätze durch den jeweils anderen abgefedert werden. Die Diskursethik übernimmt bspw. die Sicherung der ethischen Gültigkeit von moralischen Entscheidungen bzw. Handlungsnormen und vermindert dadurch ein Rechtfertigungsdefizit, welches bei einem rein prinzipienorientierten Verfahren auftritt. Umgekehrt antwortet die Prinzipienethik u. a. auf Fragen der ethischen Angemessenheit und dient v. a. der adäquaten Einzelfallentscheidung. Durch die Integration des einen Ansatzes in den anderen ist eine umfassendere Rechtfertigungsleistung erzielbar als bei einem alleinigen Einsatz von Prinzipienethik oder Diskursethik. Selbst wenn einige Herausforderungen bestehen bleiben und auch das integrierte Modell moralische Dissense nicht immer verhindern kann, vermag es durch seine „doppelte“ Absicherung (Prinzipien und Diskurs) ein praktisches Vertrauen in die getroffene ethische Entscheidung zu stärken und so der Klinischen Ethik mehr „Robustheit“ zu geben, als sie bisher besitzt. (shrink)