From book to bedside? A critical perspective on the debate about "translational bioethics".

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.

Transformative medical ethics: A framework for changing practice according to normative-ethical requirements.

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.

A systematic review documenting reasons whether physicians should provide treatment to their family and friends.

BACKGROUND: Physicians are likely to be asked to provide medical care to relatives or friends. Evidence suggests that most physicians treat loved ones during their active years. However, in the academic literature, critical approaches to the matter are dominating. Ethical guidelines often discourage physicians from treating family members and friends outside of exceptional circumstances. OBJECTIVE: This systematic review aims to identify reasons for and against treating family and friends as portrayed in the literature published. METHODS: A search string designed for the database "PubMed," snowball sampling, and hand searching was used to identify possibly eligible publications. Seventy-six publications were screened for all reasons presented in favour of and against physicians treating loved ones. Qualitative content analysis was used for data extraction. Combining a deductive and inductive approach, a coding system was developed. RESULTS: Many publications analysed represent articles portraying personal experiences; fewer show original research. Reasons against and in favour of treating family and friends were identified. Several publications specify conditions under which the treatment of loved ones may be legitimate. The reasons identified can be assigned to a micro or macro level of human interaction. CONCLUSIONS: This systematic review shows that the discourse of physicians treating loved ones is held predominantly in the context of personal experiences. The majority of authors seem to have a rather pragmatic interest in the topic, and systematic or analytic approaches are rare. While most authors mention various codes of ethics, several publications criticize these or consider them insufficient.

Ethical guidelines, such as the Code of Medical Ethics of the American Medical Association, ask physicians not to treat their family members and friends. However, studies show that most physicians are confronted with loved ones asking for medical interventions during their careers. The divide between the ethical guidelines and the physicians' actual practice demonstrates the ethical dilemma at hand. In this systematic review, literature addressing the topic of physicians treating family and friends (PTFF) is analysed. The majority of publications voice concerns about PTFF. A common reason against PTFF is the risk of losing objectivity. Other publications endorse PTFF, mentioning, for example, the possibility of saving costs. Specific situations in which PTFF is justified are presented as well. The analysis of publications on the topic indicates a rather clinical approach, less of a philosophical one. Several authors criticize too little assistance in this matter of the ethical guidelines. The examination of the existing literature on the topic of PTFF suggests that, as the circumstances are very context-specific, a universal answer applying to each case of PTFF will hardly be found.

How to derive ethically appropriate recommendations for action? A methodology for applied ethics.

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.

States of Uncertainty, Risk-Benefit Assessment and Early Clinical Research: A Conceptual Investigation.

It can be argued that there is an ethical requirement to classify correctly what is known and what is unknown in decision situations, especially in the context of biomedicine when risks and benefits have to be assessed. This is because other methods for assessing potential harms and benefits, decision logics and/or ethical principles may apply depending on the kind or degree of uncertainty. However, it is necessary to identify and describe the various epistemic states of uncertainty relevant to such estimates in the first place. Therefore, this paper aims to develop a category system of different epistemic states of uncertainty which, although not exclusively, is primarily intended to be applied to early clinical trials. It is formed on the basis-and various combinations-of three dimensions of uncertainty that represent certain parts of incomplete knowledge: outcome (type of event), probability (of outcome) and evaluation (assessment of outcome). Furthermore, it is argued that uncertainty can arise from three different sources (the structure of the object of research, the state of the evidence, or individual handling of the research and already existing knowledge). The categories developed are applied to actual examples from gene therapy and genome editing to illustrate that they can be helpful for a more precise definition of the respective uncertainties, especially in the context of risk-benefit assessment. The categories allow a differentiated perspective of decision-making situations from the point of view of incomplete knowledge in general, but particularly, for example, in early clinical research, and may thereby support a more acceptable ethical assessment of potential harms and benefits.

Systematic reviews of empirical literature on bioethical topics: Results from a meta-review.

BACKGROUND: In bioethics, especially nursing ethics, systematic reviews are increasingly popular. The overall aim of a systematic review is to provide an overview of the published discussions on a specific topic. While a meta-review on systematic reviews on normative bioethical literature has already been performed, there is no equivalent for systematic reviews of empirical literature on ethical topics. OBJECTIVE: This meta-review aims to present the general trends and characteristics of systematic reviews of empirical bioethical literature and to evaluate their reporting quality. RESEARCH DESIGN: Literature search was performed on PubMed and Google Scholar. Qualitative content analysis and quantitative approaches were used to evaluate the systematic reviews. Characteristics of systematic reviews were extracted and quantitatively analyzed. The reporting quality was measured using an adapted PRISMA checklist. FINDINGS: Seventy-six reviews were selected for analysis. Most reviews came from the field of nursing (next to bioethics and medicine). Selected systematic reviews investigated issues related to clinical ethics (50%), followed by research ethics (36%) and public health ethics or organizational ethics (14%). In all, 72% of the systematic reviews included authors' ethical reflections on the findings and 59% provided ethical recommendations. Despite the heterogeneous reporting of the reviews, reviews using PRISMA tended to score better regarding reporting quality. DISCUSSION: The heterogeneity currently observed is due both to the interdisciplinary nature of nursing ethics and bioethics, and to the emerging nature of systematic review methods in these fields. These results confirm the findings of our previous review of systematic reviews on normative literature, thereby highlighting a recurring methodological gap in systematic reviews of bioethical literature. This also indicates the need to develop more robust methodological standards. CONCLUSION: Through its extensive overview of the characteristics of systematic reviews of empirical literature on ethical topics, this meta-review is expected to inform further discussions on minimal standards and reporting guidelines.

How to tackle the conundrum of quality appraisal in systematic reviews of normative literature/information? Analysing the problems of three possible strategies (translation of a German paper).

BACKGROUND: In the last years, there has been an increase in publication of systematic reviews of normative ("argument-based") literature or of normative information (such as ethical issues) 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 (or normative information) 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.

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

BACKGROUND: This 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. METHODS: The consensus process used a modified Delphi approach. RESULTS: Consensus 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). CONCLUSIONS: Through 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.

Beyond integrating social sciences: Reflecting on the place of life sciences in empirical bioethics methodologies.

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 (e.g. sociology or psychology) 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.

Current state of ethics literature synthesis: a systematic review of reviews.

BACKGROUND: Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed. METHODS: A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature. RESULTS: We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information. CONCLUSIONS: While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

Did we describe what you meant? Findings and methodological discussion of an empirical validation study for a systematic review of reasons.

BACKGROUND: 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. METHODS: We emailed a questionnaire to the 64 corresponding authors of those papers that were assessed in the review of reasons on post-trial access. The questionnaire consisted of all quotations ("reason mentions") that were identified by the review to represent a reason in a given author's publication, together with a set of codings for the quotations. The authors were asked to rate the correctness of the codings. RESULTS: We received 19 responses, from which only 13 were completed questionnaires. In total, 98 quotations and their related codes in the 13 questionnaires were checked by the addressees. For 77 quotations (79%), all codings were deemed correct, for 21 quotations (21%), some codings were deemed to need correction. Most corrections were minor and did not imply a complete misunderstanding of the citation. CONCLUSIONS: This first attempt to validate a review of reasons leads to four crucial methodological questions relevant to the future conduct of such validation studies: 1) How can a description of a reason be deemed incorrect? 2) Do the limited findings of this author check study enable us to determine whether the core results of the analysed SRR are valid? 3) Why did the majority of surveyed authors refrain from commenting on our understanding of their reasoning? 4) How can the method for validating reviews of reasons be improved?

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

BACKGROUND: 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. DISCUSSION: While 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. SUMMARY: EE 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.

Why Do I Choose an Animal Model or an Alternative Method in Basic and Preclinical Biomedical Research? A Spectrum of Ethically Relevant Reasons and Their Evaluation.

BACKGROUND: Research model selection decisions in basic and preclinical biomedical research have not yet been the subject of an ethical investigation. Therefore, this paper aims, (1) to identify a spectrum of reasons for choosing between animal and alternative research models (e.g., based on in vitro or in silico models) and (2) provides an ethical analysis of the selected reasons. METHODS: In total, 13 researchers were interviewed; the interviews were analyzed qualitatively. The ethical analysis was based on the principlism approach and a value judgement model. RESULTS: This paper presents 66 reasons underlying the choice of researchers using animal (27 reasons) or alternative models (39). Most of the reasons were assigned to the work environment (29) and scientific standards (22). Other reasons were assigned to personal attitudes (11) and animal welfare (4). Qualitative relevant normative differences are presented in the ethical analysis. Even if few reasons can be rejected outright from an ethical point of view, there are good reasons to give some more weight than others. CONCLUSIONS: The spectrum of reasons and their ethical assessment provide a framework for reflection for researchers who may have to choose between animal models and (investing in) alternatives. This can help to reflect on and ethically justify decisions.

Inclusion of ethical issues in dementia guidelines: a thematic text analysis.

BACKGROUND: Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care. METHODS AND FINDINGS: To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained. CONCLUSIONS: Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines. Please see later in the article for the Editors' Summary.

The full spectrum of ethical issues in dementia care: systematic qualitative review.

BACKGROUND: Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. AIMS: To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. METHOD: We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. RESULTS: The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. CONCLUSIONS: The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

Values, decision-making and empirical bioethics: a conceptual model for empirically identifying and analyzing value judgements.

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.

Ethical Requirements for Human Challenge Studies: A Systematic Review of Reasons.

Human challenge studies (HCS) are controlled clinical trials in which participants are deliberately infected with a pathogen. Such trials are being developed for an increasing number of diseases. Partly as a result of the coronavirus disease 2019 (COVID-19) pandemic, there has been a recent ethical debate about the reasons for and against HCS in general, or rather, about the requirements that individual HCS must fulfill to be ethically acceptable. A systematic review was conducted to categorize and summarize such requirements and the reasons given for them. Ethics literature was searched in PubMed, Google Scholar, BELIT, and PhilPapers; eligibility criteria were articles published in a scientific/scholarly journal (original research, reviews, editorials, opinion pieces, and conference/meeting reports). Of 1,322 records identified, 161 publications were included, with 183 requirements (with associated reasons) in 10 thematic categories extracted via qualitative content analysis. In synthesizing and interpreting the requirements and their reasons, three issues emerge as particularly sensitive in the case of HCS: the meaning of the right to withdraw from research procedures, communication of researchers with the public and various stakeholders, and the conditions of informed consent. However, four other issues, not specific to HCS, stand out as the most controversial: the acceptable level of risk to participants, payment of participants, protection of vulnerable groups, and standards for international collaborations. Controversies in these areas indicate that further debate is warranted, possibly leading to more specific instructions in ethics guidance documents.

Additional treatment with mistletoe extracts for patients with breast cancer compared to conventional cancer therapy alone - efficacy and safety, costs and cost-effectiveness, patients and social aspects, and ethical assessment.

Background: Chemotherapy is often used in the treatment of breast cancer in women. Side effects such as diarrhea, fatigue, hair loss, fever or disturbances in blood formation impair the women's quality of life. An essential treatment goal of the accompanying mistletoe therapy (MT) used in complementary medicine is to improve the health-related quality of life during cancer therapy. Aim and methods: The HTA report on which this article is based examines the medical efficacy and safety, costs and cost-effectiveness, patient and social aspects, and ethical aspects of MT in women with breast cancer. Systematic reviews were conducted for this purpose. The search period of the literature search ranged from 2004 to October 2020. Results: A total of 2 evidence-based medical guidelines, 3 randomized trials assessing efficacy and 1 additional non-randomized intervention trial, as well as 3 observational studies assessing safety, a cost analysis, 12 cross-sectional studies on patient aspects and 17 articles on ethical evaluation were included. Improvements in health-related quality of life compared to the control group were small to moderate. Due to the high risk of bias in the studies, it is possible that the difference is not caused by MT. One study with a small sample size showed no effect on progression-free survival after 5 years. Studies on the effect of MT on overall survival are lacking. In seven studies, local skin reactions of low and moderate severity were reported in a median of 25% (range 5 to 94%) of patients, and mild to moderate systemic reactions in a median of 2% (range 0 to 8%) of patients. A comparative cost analysis from Germany reported significantly lower medical costs within 5 years after surgery for patients with MT than for patients without MT, but the underlying observational study did not control for systematic bias. With regard to patient aspects, the frequency of use and the reasons for use from the patient's or practitioner's point of view were mainly investigated. A median of 25% (range 7 to 46%) of patients with breast cancer and 29% (range 29 to 79%) of treatment providers use MT. The main motivations of patients for use were to reduce side effects, strengthen the immune system and take an active role in the treatment process. Patients felt insufficiently advised. Studies on other aspects are lacking. The ethical evaluation was able to identify 6 overarching themes; the central challenge is the insufficient evidence on efficacy and safety.

Evidence - competence - discourse: the theoretical framework of the multi-centre clinical ethics support project METAP.

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.