Sabine Salloch

Research across the disciplines: a road map for quality criteria in empirical ethics research

BackgroundResearch 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.DiscussionWhile empirical and normative-ethical research projects have quality criteria in their own right, we focus on the specific quality criteria for EE research. We develop a tentative list of quality criteria – a “road map” – tailored to interdisciplinary research in EE, to guide assessments of research quality. These quality criteria fall into the categories of primary research question, theoretical framework and methods, relevance, interdisciplinary research practice and research ethics and scientific ethos.SummaryEE research is an important and innovative development in bioethics. However, a lack of standards has led to concerns about and even rejection of EE by various scholars. Our suggested orientation list of criteria, presented in the form of reflective questions, cannot be considered definitive, but serves as a tool to provoke systematic reflection during the planning and composition of an EE research study. These criteria need to be tested in different EE research settings and further refined.

Medical Expertise and Patient Involvement: A Multiperspective Qualitative Observation Study of the Patient’s Role in Oncological Decision Making

BACKGROUND Decision making in oncology poses intricate ethical questions because treatment decisions should account not only for evidence-based standards but also for the patients individual values and preferences. However, there is a scarcity of empirical knowledge about patient involvement in oncological decision making. METHODS Direct, nonparticipant observation was used as a qualitative research method to gain an understanding of the interplay between medical expertise and patient participation in oncological decision making. Based on a multiperspective approach, observations were performed in three settings (tumor conference, ward round, and outpatient clinic) in the oncology department of a German university hospital. The observation transcripts were analyzed using central features of qualitative data analysis. RESULTS Major differences were identified regarding the decision-making processes in the three settings related to the patients presence or absence. When the patient was absent, his or her wishes were cited only irregularly; however, patients actively advanced their wishes when present. Preselection of treatments by physicians was observed, narrowing the scope of options that were finally discussed with the patient. Dealing with decisions about risky treatments was especially regarded as part of the physicians professional expertise. CONCLUSION The study reveals aspects of decision making for cancer patients that have been underexposed in the empirical and theoretical literature so far. Among these are the relevance of structural aspects for the decisions made and the practice of preselection of treatment options. It should be further discussed how far medical expertise reaches and whether therapeutic decisions can be made without consulting the patient.

The normative background of empirical-ethical research: first steps towards a transparent and reasoned approach in the selection of an ethical theory

BackgroundEmpirical-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.DiscussionWhereas criteria for a good ethical theory in philosophical ethics are usually related to inherent aspects, such as the theory’s clarity or coherence, additional points have to be considered in the field of empirical-ethical research. Three of these additional criteria will be discussed in the article: (a) the adequacy of the ethical theory for the issue at stake, (b) the theory’s suitability for the purposes and design of the empirical-ethical research project, and (c) the interrelation between the ethical theory selected and the theoretical backgrounds of the socio-empirical research. Using the example of our own study on the development of interventions which support clinical decision-making in oncology, we will show how the selection of an ethical theory as a normative background for empirical-ethical research can proceed. We will also discuss the limitations of the procedures chosen in our project.SummaryThe article stresses that a systematic and reasoned approach towards theory selection in empirical-ethical research should be given priority rather than an accidental or implicit way of choosing the normative framework for one’s own research. It furthermore shows that the overall design of an empirical-ethical study is a multi-faceted endeavor which has to balance between theoretical and pragmatic considerations.

Ethics by opinion poll? The functions of attitudes research for normative deliberations in medical ethics

Empirical studies on peoples 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: (a) The extent of empirical data which is needed, (b) the question of which kind of data is required and (c) 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.

Was ist ein ethisches Problem und wie finde ich es? Theoretische, methodologische und forschungspraktische Fragen der Identifikation ethischer Probleme am Beispiel einer empirisch-ethischen Interventionsstudie

ZusammenfassungEine wichtige Aufgabe empirischer Sozialforschung in der Medizinethik besteht darin, bisher unbekannte ethische Probleme zu identifizieren und zu beschreiben. Die Frage, welche Sachverhalte in den Gegenstandsbereich der Medizinethik fallen, ist jedoch sowohl aus wissenschaftlicher Sicht voraussetzungsreich als auch in der Praxis umstritten. Im Beitrag werden theoretische, methodologische und forschungspraktische Aspekte der Identifikation und Auswahl ethischer Probleme diskutiert und das Vorgehen am Beispiel einer konkreten empirisch-ethischen Studie illustriert. Der Schwerpunkt des Artikels liegt hierbei auf den Vorbedingungen sowie dem konkreten Vorgehen bei der Integration von Laien- und Expertenperspektive. Im ersten Teil wird zunächst vorbereitend die Frage nach der Abgrenzung zwischen ethischen Problemen und anderen praktischen Herausforderungen adressiert. Dies geschieht unter Rückgriff auf die philosophisch-ethische Systematik sowie unter Berücksichtigung des stark praxisorientierten Charakters von Medizinethik. Anschließend wird ein Vorschlag zur Unterscheidung zweier Typen ethischer Probleme gemacht und die Frage nach der Definitionsmacht zur Auszeichnung ethischer Probleme auf den spezifischen Kontext empirisch-ethischer Forschung übertragen. Aufbauend auf diesen theoretischen Überlegungen wird im dritten Abschnitt des Beitrags schließlich ein Vorgehen zur Identifikation ethischer Probleme am Beispiel des ETHICO-Projektes als einer empirisch-ethischen Interventionsstudie im Bereich der Onkologie vorgestellt. Zusammenfassend vertritt der Beitrag die These, dass die Identifikation ethischer Probleme in der Medizin ein theoretisch komplexes und methodisch anspruchsvolles Unterfangen ist, bei dem nicht allein die Perspektive philosophischer Theorie eingenommen werden sollte, sondern vielmehr Formen der Integration von Laien- und Expertenperspektive entwickelt werden müssen.AbstractDefinition of the problemA main function of empirical social research in medical ethics is the identification and description of formerly unknown ethical problems. The question which issues fall within the scope of medical ethics is, however, disputable from a scientific as well as from a practical perspective. In this article theoretical, methodological and practical aspects of identifying and selecting ethical problems, which are illustrated using the example of a concrete empirical–ethical study, are discussed. The special focus lies on the preconditions and the concrete procedure in the integration of expert and lay perspectives.ArgumentsThe first section of the article addresses the difference between ethical problems and other types of practical problems by reference to philosophical–ethical classifications and in regard of the practice-oriented character of medical ethics. Subsequently, the article makes a suggestion for a distinction between two types of ethical problems and discusses the question which persons should have the “definitory power” to determine whether an ethical problem is present. Both ideas will then be related to the specific context of empirical–ethical research. In the third section an approach for the identification of ethical problems applied in the ETHICO project as an empirical-ethical intervention study in oncology is presented.ConclusionThe identification of ethical problems in medicine is a theoretically and methodologically demanding enterprise which should not be exclusively dominated by the perspective of ethical theory but develop methods for integrating lay and expert perspectives.

Same same but different: why we should care about the distinction between professionalism and ethics

Medical professionalism forms a belief system which is used to defend physicians’ ethos against counterforces which might threaten the integrity of medical practice. The current debates on professionalism, however, are characterized by the lack of a clear distinction between professional and ethical aspects of physicians’ conduct. This article argues that a differentiation between professionalism and ethics is not of mere academic interest. Instead, it is of great practical importance with regard to morally contentious issues in medicine.A short analysis of the discussions in history and social sciences reveals that professionalism is more than a catchphrase of modern medical debates but has a complex theoretical background which is still not conclusively understood. Whereas professionalism is clearly linked to the honorable aims of providing services to the individual and the society, it potentially entails problematic aspects, such as elitism, monopoly or the maintaining of power and privileges. With regard to morally contentious topics, the professional ethos of physicians must be differentiated from the perspective of ethics which can take a universal standpoint and has the potential to critically assess context-specific moral norms. The example of the current regulation on suicide assistance in German professional law is taken as an example to demonstrate how professional bodies tend to overstep the limits of their expertise and regulatory power with regard to issues which need an ethical evaluation.The article concludes that the narrowing of ethics and professionalism in public discussions and in medical education should be seen as problematic and that morally contentious topics in modern societies should be open to a participatory and inclusive discussion and democratic decision procedures.

Standards of practice in empirical bioethics research: towards a consensus.

BackgroundThis paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds.MethodsThe consensus process used a modified Delphi approach.ResultsConsensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise).ConclusionsThrough articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of practice of empirical bioethics research can develop and evolve further.

„Evidenzbasierte Ethik“? – Über hypothetische und kategorische Handlungsnormen in der Medizin

Im Zuge des „empirical turn“ der Medizin- und Bioethik ist von verschiedenen Autoren in den vergangenen Jahren die Idee einer „evidenzbasierten Ethik“ diskutiert worden. Die Analogie zwischen evidenzbasierter Medizin und „evidenzbasierter Ethik“ soll in diesem Beitrag kritisch diskutiert und dabei gezeigt werden, dass der Ausdruck „evidenzbasierte Ethik“ irreführend ist. Zentraler Ausgangspunkt der Kritik ist die unterschiedliche Bedeutung, die empirische Informationen für das medizinisch-klinische Urteil zum einen und das ethische Urteil in der Medizin zum anderen haben. Im medizinisch-klinischen Urteil können mit Hilfe empirischer Informationen hypothetische Handlungsnormen generiert werden, welche auf den der Medizin inhärenten Zwecksetzungen basieren. Bei Fragen der Ethik in der Medizin hingegen sind die Handlungsziele selbst Gegenstand des Urteils; diese aber können allein aus empirischem Wissen heraus nicht zureichend bestimmt werden. Die Diskussion um die Möglichkeit einer „evidenzbasierten Ethik“ eröffnet weiterhin aufschlussreiche Perspektiven in Bezug auf empirische Forschung und den Umgang mit empirischen Informationen in der Angewandten Ethik und das Aufgabenfeld der Medizinethik. Definition of the problem In the context of the so-called “empirical turn” in bioethics, the idea of “evidence-based ethics” has been discussed by several authors in recent years. This article will critically discuss the analogy between evidence-based medicine and “evidence-based ethics” to show that “evidence-based ethics” is a misleading concept. Arguments The criticism will be based on the different significance which empirical information has for clinical judgments, on the one hand, and ethical judgments in medicine, on the other. In clinical judgments, empirical information can be used to generate hypothetical practical norms which are based on the inherent aims of clinical medicine. In contrast to this, ethical judgments in medicine are concerned with the aims of action themselves. These aims cannot be determined sufficiently by empirical knowledge alone. Conclusion The discussion about “evidence-based ethics” opens further perspectives regarding empirical research and the integration of empirical information in applied ethics as well as regarding the central tasks of medical ethics as a scientific discipline.

Selbstbestimmung bis zuletzt - Möglichkeiten und Grenzen der Autonomieausübung im stationären Hospiz aus der Perspektive haupt- und ehrenamtlicher Mitarbeiter

ZusammenfassungHospize verstehen sich als Orte einer ganzheitlichen Sterbebegleitung, welche nicht allein die Behandlung körperlicher und psychischer Symptome, sondern auch die soziale und spirituelle Betreuung der Sterbenden beinhaltet. Eine zentrale Bedeutung innerhalb dieser umfassenden Begleitung am Lebensende hat die Idee der Selbstbestimmung. Dem Hospizgast soll ermöglicht werden, im Sinne einer größtmöglichen Autonomie über die eigenen Belange bis zuletzt selbst entscheiden zu können. Diese zentrale Zielsetzung der Hospizarbeit wurde in der Literatur bisher überwiegend in theoretisch-programmatischer Weise thematisiert, es liegen jedoch kaum Untersuchungen zu der Frage vor, wie die Idee der „Selbstbestimmung bis zuletzt“ im Alltag der Hospize praktisch umgesetzt wird. Über die besonderen Umstände der Pflege in stationären Hospizen hinaus ist der hier zugrunde gelegte Begriff von Autonomie auch von grundsätzlichem medizinethischen Interesse. Das ganzheitlich-palliative Konzept von Behandlung und Pflege, welches bereits im Hospiz als Institution fest verankert ist, legt nahe, dass die Idee der Selbstbestimmung in diesem Umfeld anders konzeptualisiert wird als im Bereich der „klassischen“, zumeist kurativ orientierten Medizin.Die qualitative Interviewstudie mit haupt- und ehrenamtlichen Mitarbeiterinnen und Mitarbeitern konnte zeigen, dass in stationären Hospizen ein Konzept von Selbstbestimmung vertreten wird, welches über rein medizinische Entscheidungen weit hinausgeht. Zugleich konnte aber auch herausgearbeitet werden, wo nach Ansicht der Mitarbeiterinnen und Mitarbeiter mögliche Grenzen der Selbstbestimmung des Gastes im Hospiz liegen.AbstractDefinition of the problem Hospices consider themselves as places that practice a holistic form of terminal care, encompassing not only physical and psychological symptoms, but also the social and spiritual support for a dying patient. The idea of patients’ self-determination is of central importance in comprehensive end-of-life care. Arguments Hospice patients should be able to make decisions about their personal affairs until their lives end. So far, this programmatic aim in hospice care has been largely treated in terms of a normative–theoretical discussion. Little is known, however, about the practical implications of this idea of autonomy with respect to everyday hospice work. Furthermore, self-determination in hospice care is of systematic interest for medical ethics. The holistic, palliative concept of care already firmly established in hospices suggests that self-determination here has a different implication than the concept of patient autonomy in standard medicine, where the primary concern is to cure patients. Conclusion The qualitative interview study with full-time and voluntary workers in German hospices shows that in-patient hospices implement a concept of autonomy that goes far beyond the mere medical facets of end-of-life care. Moreover, it reveals where there are possible limitations in the concept of self-determination in the eyes of the interviewees.

Unsolicited Diagnosis of Mental Disorder: Epistemic and Normative Perspectives

O’Leary (2018) convincingly depicts and evaluates ethical questions related to medically unexplained symptoms (MUS) as highly important in clinical practice. This comment contributes to the debate by focusing on the problem of the unsolicited diagnosis of mental disorder that O’Leary raises in the context of informed consent. The author discusses the question of “unsolicited mental health care,” arising when doctors offer psychogenic diagnoses to patients presenting with bodily symptoms seeking “biological care.” Specifically, the issue at stake here is that doctors recommend exploring psychosocial causes to these patients instead of the biological care they seek. This comment proceeds from an epistemic model, explaining why physicians’ and patients’ perspectives may contrast with respect to MUS, to a normative analysis of the question of whether physicians may be justified or even obligated to disclose such an unsolicited diagnosis. Clinical situations dealing withMUS are often characterized by the fact that the explanatory models of professionals and patients differ. Both parties start fromdifferent premises regarding their understanding of the patient’s medical condition. The conceptual duo of “disease” and “illness” (Twaddle 1994; Boyd 2000) as developed and discussed in the philosophy of medicine can serve as a valuable heuristic that enables a more nuanced discussion of conflicts occurring in the context ofMUS, especially epistemic challenges in physician–patient relationships. “Disease” refers to the biomedical perspective understood as an objectively measurable anomaly of a physiological state and/or functioning (Twaddle 1994; Boyd 2000). It reflects the paradigm of Western medicine based on a scientific, disease-driven understanding of medical conditions. The diagnostic process is seen as an objective assessment that reveals deviation from normal processes and structures leading to the application of sciencebased medical therapies. MUS remind us of the boundaries inherent in understanding medicine as an applied natural science seeking ultimate truth and offering causal explanations. Medical culture makes it hard to accept etiological vagueness and the “gray-scale space” (Simpkin and Schwartzstein 2016, 1714) of diagnostic uncertainty. Furthermore, patients’ narratives can lose their meaning if physicians argue that patients’ lay views do not provide any contribution to solving the medical problem of disease. Denying the intrinsic value of patients’ own perspectives can lead to marginalization and feelings of irrelevance, a phenomenon Fricker calls “testimonial injustice” (Fricker 2007). In contrast, “illness” describes the perspective of those who are affected: the subjective experience of symptoms and irregular bodily functions (Twaddle 1994; Boyd 2000). This concept reflects what O’Leary (9) calls “first-person experience.” The “illness” perspective emphasizes patients’ knowledge; it represents the epistemic privilege they hold through their firsthand experience. O’Leary notices that clinical ethics is rooted in an understanding of health care focused on “biological diagnosis” (6) and therefore on the concept of disease. Using the concepts of disease and illness as theoretical backgrounds with regard to MUS makes the danger of one-sided epistemic injustice clear (Kidd and Carel 2017). Through the lens of disease only, patients’ reports may be taken less seriously, leading to diagnostic error. Vice versa, through the lens of illness only, effective treatment may be hindered as well. Concerning the unsolicited diagnosis of mental disorder, this entails that pragmatic as well as justice-related reasons speak for taking patients’ illness narratives seriously—even if they deviate from the standard biological explanation models. Notwithstanding this basic respect toward patients’ own interpretation of their condition, there are reasons from a medico-professional perspective that suggest informing patients of the (likelihood of a) certain diagnosis, even if they did not ask for it. A small body of literature has addressed the general topic of unsolicited medical opinions in nonemergency cases. One recent article (Preller and Salloch 2018) focuses on the unsolicited clinical diagnosis in informal settings, for example, when off-duty physicians make a diagnosis of melanoma in a stranger outside of formal practice. Based on a utilitarian viewpoint, the article argues in favor of offering unsolicited medical opinions. It is argued that if it is in physicians’