Background: Publications and discussions of survey research in empirical bioethics have steadily increased over the past two decades. However, findings often differ among studies with similar research questions. As a consequence, ethical reasoning that considers only parts of the existing literature and does not apply systematic reviews tends to be biased. To date, we lack a systematic review (SR) methodology that takes into account the specific conceptual and practical challenges of empirical bioethics. Methods: The steps of systematically reviewing empirical findings (...) in bioethics are presented and critically discussed. In particular, (a) the limitations of traditional SR methodologies in the field of empirical bioethics are critically discussed, and (b) conceptual and practical recommendations for SRs in empirical bioethics that are (c) based on the authors’ review experiences in healthcare ethics are presented. Results: A 7-step approach for SRs of empirical bioethics is proposed: (1) careful definition of review question; (2) selection of relevant databases; (3) application of ancillary search strategies; (4) development of search algorithms; (5) relevance assessment of the retrieved references; (6) quality assessment of included studies; and (7) data analysis and presentation. Conceptual and practical challenges arise because of various peculiarities in reviewing empirical bioethics literature and can lead to biased results if they are not taken into account. Conclusions: If suitably adapted to the peculiarities of the field, SRs of empirical bioethics provide transparent information for ethical reasoning and decision-making that is less biased than single studies. (shrink)

Although rationing of scarce health-care resources is inevitable in clinical practice, there is still limited and scattered information about how physicians perceive and execute this bedside rationing (BSR) and how it can be performed in an ethically fair way. This review gives a systematic overview on physicians’ perspectives on influences, strategies, and consequences of health-care rationing. Relevant references as identified by systematically screening major electronic databases and manuscript references were synthesized by thematic analysis. Retrieved studies focused on themes that fell (...) under three major headings: (i) conditions and influences of BSR, (ii) strategies of BSR, and (iii) consequences of BSR. The range of themes indicates that physicians’ rationing behavior is highly variable, strongly influenced by context-related factors, and consists mainly of implicit rationing strategies. Torn between patient advocacy and the obligation to contain costs, physicians experience various role conflicts. The development of explicit rationing strategies seems necessary to avoid arbitrary BSR and allow a fair allocation of health-care resources. (shrink)

Background While there are many guidelines on how to make ethical decisions at the end of life, there is little evidence regarding the quality of this sort of ethical guidelines. Objectives First, this study aims to demonstrate the conceptual transferability of the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument for the quality assessment of ethical guidelines. Second, it aims to illustrate the status quo of the quality of guidelines on end-of-life decision-making by using the AGREE instrument in a (...) first practice test. Method The transferability of the AGREE instrument on the quality assessment of ethical guidelines is demonstrated by conceptual analysis. Guidelines on end-of-life decisions in medicine are identified through a systematic search in MEDLINE (from June 1999 to June 2009). The quality of all included guidelines was assessed with a slightly modified AGREE instrument. Results Of 103 guidelines identified, 34 were included as relevant. The majority of the guidelines analysed in this study were assessed as qualitatively insufficient in five out of six AGREE quality domains. A few guidelines demonstrated, however, that a high level of quality in accordance with the AGREE requirements is possible. Conclusion This review concludes that the quality of many ethical guidelines should and can be improved in all quality domains specified by the AGREE instrument. Furthermore, conceptual analysis indicates that a slightly modified AGREE instrument is transferable to the comprehensive evaluation of the quality of ethical guidelines. Nevertheless, future research is needed to improve the assessment of the presentation of the guidelines' normative basis. (shrink)

Most contributions to the current debate about the consideration and application of empirical information in ethics scholarship deal with epistemological issues such as the role and the meaning of empirical research in ethical reasoning. Despite the increased publication of empirical data in ethics literature we still lack systematic analyses and conceptual frameworks that would help us to understand the rarely discussed methodological and practical problems in appraising empirical research. This paper demonstrates the need for critical appraisal and its crucial methodological (...) role in the application of empirical information in ethical reasoning. Furthermore, it systematically examines the criteria and the appropriate appraisal of empirical research and the associated challenges by highlighting current problems in empirical ethics literature. These problems reveal the following challenges for a critical and responsible consideration of empirical information in ethical reasoning: (i) training in the basic skills of locating and communicating empirical data from the relevant studies; (ii) training in basic knowledge of how to critically appraise empirical (qualitative and quantitative) research and its results; (iii) determination of quality standards for empirical ethics research; (iv) adequate reporting of the methodology and results of empirical ethics research in scientific journals. (shrink)

Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug (...) and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. (shrink)

BackgroundThe concept of evidence-based medicine has strongly influenced the appraisal and application of empirical information in health care decision-making. One principal characteristic of this concept is the distinction between "evidence" in the sense of high-quality empirical information on the one hand and rather low-quality empirical information on the other hand. In the last 5 to 10 years an increasing number of articles published in international journals have made use of the term "evidence-based ethics", making a systematic analysis and explication of (...) the term and its applicability in ethics important.DiscussionIn this article four descriptive and two normative characteristics of the general concept "evidence-based" are presented and explained systematically. These characteristics are to then serve as a framework for assessing the methodological and practical challenges of evidence-based ethics as a developing methodology. The superiority of evidence in contrast to other empirical information has several normative implications such as the legitimization of decisions in medicine and ethics. This implicit normativity poses ethical concerns if there is no formal consent on which sort of empirical information deserves the label "evidence" and which does not. In empirical ethics, which relies primarily on interview research and other methods from the social sciences, we still lack gold standards for assessing the quality of study designs and appraising their findings.ConclusionThe use of the term "evidence-based ethics" should be discouraged, unless there is enough consensus on how to differentiate between high- and low-quality information produced by empirical ethics. In the meantime, whenever empirical information plays a role, the process of ethical decision-making should make use of systematic reviews of empirical studies that involve a critical appraisal and comparative discussion of data. (shrink)

Several quantitative surveys have been conducted internationally to gather empirical information about physicians’ general attitudes towards health care rationing. Are physicians ready to accept and implement rationing, or are they rather reluctant? Do they prefer implicit bedside rationing that allows the physician–patient relationship broad leeway in individual decisions? Or do physicians prefer strategies that apply explicit criteria and rules?

Systematic reviews, which were developed to improve policy-making and clinical decision-making, answer an empirical question based on a minimally biased appraisal of all the relevant empirical studies. A model is presented here for writing systematic reviews of argument-based literature: literature that uses arguments to address conceptual questions, such as whether abortion is morally permissible or whether research participants should be legally entitled to compensation for sustaining research-related injury. Such reviews aim to improve ethically relevant decisions in healthcare, research or policy. (...) They are better tools than informal reviews or samples of literature with respect to the identification of the reasons relevant to a conceptual question, and they enable the setting of agendas for conceptual and empirical research necessary for sound policy-making. This model comprises prescriptions for writing the systematic review's review question and eligibility criteria, the identification of the relevant literature, the type of data to extract on reasons and publications, and the derivation and presentation of results. This paper explains how to adapt the model to the review question, literature reviewed and intended readers, who may be decision-makers or academics. Obstacles to the model's application are described and addressed, and limitations of the model are identified. (shrink)

Mit dem Konzept der Evidenz-basierten Medizin wurde die Verwendungsweise von empirischen Informationen in den Gesundheitswissenschaften stark verändert. Ein grundlegendes Charakteristikum dieses Konzeptes ist die Unterscheidung zwischen empirischen Informationen per se und „Evidenzen“ im Sinne von qualitativ hochwertigeren empirischen Informationen. Dieses Konzept der Evidenzbasierung findet sich zunehmend auch im Kontext der angewandten Ethik. In der internationalen Fachpresse sind in den letzten 5 bis 10 Jahren zunehmend Arbeiten publiziert worden, die den Begriff „Evidenz-basierte Ethik“ in unterschiedlicher Weise verwenden. Um die ethisch akzeptable (...) Verwendungsweise dieses neuen Konzeptes in der Ethik beurteilen zu können, bedarf es seiner systematischen und kritischen Explikation und Analyse.Der Artikel unterscheidet verschiedene deskriptive und normative Dimensionen des Konzeptes einer Evidenzbasierung und stellt diese in einer Systematik vor. Die Problembereiche im Zusammenhang mit den normativen Dimensionen werden an Praxisbeispielen der Evidenz-basierten Medizin dargestellt, um anschließend die methodischen und praxisorientierten Besonderheiten einer Evidenz-basierten Ethik herauszustellen.Die Höherwertigkeit von Evidenzen gegenüber anderen empirischen Informationen impliziert verschiedene normative Dimensionen wie die der Handlungslegitimation. Die Handlungslegitimation durch den Verweis auf Evidenzen wird dann zu einem ethischen Problem, wenn kein Konsens besteht zu der Frage, wann man bei spezifischen empirischen Informationen von Evidenz sprechen sollte und wann nicht. Durch die im Rahmen der empirischen Ethik hauptsächlich verwendeten sozialempirischen Studienansätze und die noch fehlenden Goldstandards zur Bewertung ihrer Qualität, führt die Übertragung des Evidenz-Konzeptes auf die Ethik zu weiteren methodischen und praktischen Problembereichen. Von einer Verwendung des Begriffspaares „Evidenz-basiert“ in der angewandten Ethik ist solange abzuraten, bis diese Problembereiche konsensfähig gelöst wurden. In der Zwischenzeit wäre eine „Informations-kritische“ Ethik zu fordern, deren Aufgabenspektrum in diesem Artikel vorgestellt wird. (shrink)

Imperfect efficiency in healthcare delivery is sometimes given as a justification for refusing to ration or even discuss how to pursue fair rationing. This paper aims to clarify the relationship between inefficiency and rationing, and the conditions under which bedside rationing can be justified despite coexisting inefficiency. This paper first clarifies several assumptions that underlie the classification of a clinical practice as being inefficient. We then suggest that rationing is difficult to justify in circumstances where the rationing agent is or (...) should be aware of and contributes to clinical inefficiency. We further explain the different ethical implications of this suggestion for rationing decisions made by clinicians. We argue that rationing is more legitimate when sufficient efforts are undertaken to decrease inefficiency in parallel with efforts to pursue unavoidable but fair rationing. While the qualifier ‘sufficient’ is crucial here, we explain why ‘sufficient efforts’ should be translated into ‘benchmarks of efficiency’ that address specific healthcare activities where clinical inefficiency can be decreased. Referring to recent consensus papers, we consider some examples of specific clinical situations where improving clinical inefficiency has been recommended and consider how benchmarks for efficiency might apply. These benchmarks should state explicitly how much inefficiency shall be reduced in a reasonable time range and why these efforts are ‘sufficient’. Possible strategies for adherence to benchmarks are offered to address the possibility of non-compliance. (shrink)

Die finanziellen Ressourcen im deutschen Gesundheitssystem sind begrenzt. Diese Mittelknappheit führt im Rahmen der ärztlichen Tätigkeit zu medizinischen, ökonomischen, juristischen und ethischen Problemen, welche sich in den kommenden Jahren weiter verschärfen dürften. Aus ethischer Perspektive sind die Probleme einer gerechten Verteilung knapper Ressourcen sowie mögliche Rollen- oder Gewissenskonflikte der ärztlichen Profession besonders relevant. Mit Hilfe von qualitativen Interviewstudien lässt sich der aktuelle ärztliche Umgang mit der Mittelknappheit in der klinischen Versorgung in seiner Komplexität und seinen ethisch relevanten Aspekten untersuchen. An (...) fünf Kliniken mit unterschiedlichem Versorgungsauftrag wurden Tiefeninterviews mit fünfzehn leitenden Ärzten in den Bereichen Intensivmedizin und Kardiologie durchgeführt. Die auf Tonband aufgezeichneten Interviews wurden nach dem Verfahren der Grounded Theory ausgewertet. Die Ärzte berichten ein heterogenes Spektrum von Einflussfaktoren, Konsequenzen und Reaktionen im Zusammenhang mit ihrem Handeln bei Mittelknappheit. Zuteilungskriterien wie der medizinische Nutzen oder die Kosteneffektivität werden von den befragten Ärzten sehr unterschiedlich interpretiert und führen damit möglicherweise zu inkonsistenten Allokationsentscheidungen. Gleichzeitig bestätigen die Untersuchungen aber auch, dass die Ärzte nicht leichtfertig mit den Allokationsentscheidungen umgehen, im Gegenteil: Die Mittelknappheit und die dadurch hervorgerufenen Verteilungsprobleme können zu Gewissenskonflikten, emotionalem Stress und Gefühlen der Überforderung führen. Um Lösungskonzepte für ethische Probleme im Umgang mit der Mittelknappheit in der klinischen Praxis entwickeln und erfolgreich implementieren zu können, müssen die in dieser Arbeit systematisch zusammengestellten Verständnisweisen, Einflussfaktoren und Konsequenzen im Zusammenhang mit dem Kostendruck berücksichtigt werden. (shrink)

There are many ethical decisions in the practice of health research and care, and in the creation of policy and guidelines. We argue that those charged with making such decisions need a new genre of review. The new genre is an application of the systematic review, which was developed over decades to inform medical decision-makers about what the totality of studies that investigate links between smoking and cancer, for example, implies about whether smoking causes cancer. We argue that there is (...) a need for similarly inclusive and rigorous reviews of reason-based bioethics, which uses reasoning to address ethical questions. After presenting a brief history of the systematic review, we reject the only existing model for writing a systematic review of reason-based bioethics, which holds that such a review should address an ethical question. We argue that such a systematic review may mislead decision-makers when a literature is incomplete, or when there are mutually incompatible but individually reasonable answers to the ethical question. Furthermore, such a review can be written without identifying all the reasons given when the ethical questions are discussed, their alleged implications for the ethical question, and the attitudes taken to the reasons. The reviews we propose address instead the empirical question of which reasons have been given when addressing a specified ethical question, and present such detailed information on the reasons. We argue that this information is likely to improve decision-making, both directly and indirectly, and also the academic literature. We explain the limitations of our alternative model for systematic reviews. (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.

ZusammenfassungDie finanziellen Ressourcen im deutschen Gesundheitssystem sind begrenzt. Diese Mittelknappheit führt im Rahmen der ärztlichen Tätigkeit zu medizinischen, ökonomischen, juristischen und ethischen Problemen, welche sich in den kommenden Jahren weiter verschärfen dürften. Aus ethischer Perspektive sind die Probleme einer gerechten Verteilung knapper Ressourcen sowie mögliche Rollen- oder Gewissenskonflikte der ärztlichen Profession besonders relevant. Mit Hilfe von qualitativen Interviewstudien lässt sich der aktuelle ärztliche Umgang mit der Mittelknappheit in der klinischen Versorgung in seiner Komplexität und seinen ethisch relevanten Aspekten untersuchen. An (...) fünf Kliniken mit unterschiedlichem Versorgungsauftrag wurden Tiefeninterviews mit fünfzehn leitenden Ärzten in den Bereichen Intensivmedizin und Kardiologie durchgeführt. Die auf Tonband aufgezeichneten Interviews wurden nach dem Verfahren der Grounded Theory ausgewertet. Die Ärzte berichten ein heterogenes Spektrum von Einflussfaktoren, Konsequenzen und Reaktionen im Zusammenhang mit ihrem Handeln bei Mittelknappheit. Zuteilungskriterien wie der medizinische Nutzen oder die Kosteneffektivität werden von den befragten Ärzten sehr unterschiedlich interpretiert und führen damit möglicherweise zu inkonsistenten Allokationsentscheidungen. Gleichzeitig bestätigen die Untersuchungen aber auch, dass die Ärzte nicht leichtfertig mit den Allokationsentscheidungen umgehen, im Gegenteil: Die Mittelknappheit und die dadurch hervorgerufenen Verteilungsprobleme können zu Gewissenskonflikten, emotionalem Stress und Gefühlen der Überforderung führen. Um Lösungskonzepte für ethische Probleme im Umgang mit der Mittelknappheit in der klinischen Praxis entwickeln und erfolgreich implementieren zu können, müssen die in dieser Arbeit systematisch zusammengestellten Verständnisweisen, Einflussfaktoren und Konsequenzen im Zusammenhang mit dem Kostendruck berücksichtigt werden. (shrink)

„Früh entdecken, effizienter therapieren!“ — Die innereLogik des Früherkennungskonzeptes ist äußerst öffentlichkeitswirksam und wird von den unterschiedlichsten medizinischen und gesellschaftlichen Institutionen unterstützt. In dieser Arbeit werden die vorrangig medizin-ethischen und wissenschaftstheoretischen Bedingungen untersucht, die erfüllt sein müssten, damit sich die Theorie einer Krebsfrüherkennung zum Wohl des Patienten umsetzen lässt: Wer ist kompetent, den jeweils stochastisch zu interpretierenden Nutzen und Schaden adäquat gegeneinander abzuwägen? Was sind angemessene Evaluationsparameter? Gibt es Grenzen der Informationsvermittlung in einer partnerschaftlichen Arzt-Patienten-Beziehung? Vor dem Hintergrund der früherkennungsspezifischen (...) Relativität von medizinischem Wissen und der unklaren Nutzenbestimmung stellt sich die Frage, wie verantwortungsvolles ärztliches Handeln aussehen kann. Der alleinige Hinweis auf die ärztliche Pflicht zur Aufklärung und Stärkung der Eigenverantwortung von Patienten verliert sich dabei zum Teil in paradoxen Scheinlösungen. Durch die genannten Probleme in der Krebsfrüherkennung wird deutlich, dass die Bedingungen für die Möglichkeit von patientenorientierter Informationsvermittlung nur schwer erfüllbar sind. (shrink)

This study described the relationships between academic class and student moral sensitivity and reasoning and between curriculum design components for ethics education and student moral sensitivity and reasoning. The data were collected from freshman (n = 506) and senior students (n = 440) in eight baccalaureate nursing programs in South Korea by survey; the survey consisted of the Korean Moral Sensitivity Questionnaire and the Korean Defining Issues Test. The results showed that moral sensitivity scores in patient-oriented care and conflict were (...) higher in senior students than in freshman students. Furthermore, more hours of ethics content were associated with higher principled thinking scores of senior students. Nursing education in South Korea may have an impact on developing student moral sensitivity. Planned ethics content in nursing curricula is necessary to improve moral sensitivity and moral reasoning of students. (shrink)

BackgroundEmpirical research can become relevant for bioethics in at least two ways. First, by informing the development or refinement of ethical recommendations. Second, by evaluating how ethical recommendations are translated into practice. This study aims to investigate the scope and objectives of empirical studies evaluating how ethical recommendations are translated into practice. MethodsA sample of the latest 400 publications from four bioethics journals was created and screened. All publications were included if they met one of the following three criteria: (1) (...) evaluative empirical research, (2) non-evaluative empirical research and (3) borderline cases. For all publications categorized as evaluative empirical research we analyzed which objects (norms and recommendations) had been evaluated.Results234 studies were included of which 54% (n = 126) were categorized as non-evaluative empirical studies, 36% (n = 84) as evaluative empirical studies, and 10% (n = 24) as borderline cases. The object of evaluation were aspirational norms in 5 of the 84 included evaluative empirical studies, more specific norms in 14 (16%) studies and concrete best practices in 65 (77%) studies. The specific best practices can be grouped under five broader categories: ethical procedures, ethical institutions, clinical or research practices, educational programs, and legal regulations.ConclusionsThis mapping study shows that empirical evaluative studies can be found at all stages in the translational process from theory to best practices. Our study suggests two intertwined dimensions for structuring the field of evaluative/translational empirical studies in bioethics: First, three broader categories of evaluation objects and second five categories for types of best practices.Trial registration: The methodology used was described in a study protocol that was registered publicly on the Open Science Framework (https://osf.io/r6h4y/). (shrink)

Faden, R. & Shebaya, S, Public Health Ethics. The Stanford Encyclopedia of Philosophy (Summer 2010 Edition), Edward N. Zalta (ed.). Available from: htt : lato.stanford.edu archives sum2010 entries ublichealth-ethics (accessed ...

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)

Brody (2011) claims that clarifying conflict of interest (COI) is important for several reasons. Brody's paper seems to focus on the importance of raising awareness of the impact of COI and the nee...

ZusammenfassungSeit vielen Jahren zeigen Untersuchungen, dass die Ergebnisse klinischer Studien häufig selektiv publiziert werden mit einer statistisch signifikanten und im klinischen Ausmaß sehr bedeutenden Übervorteilung positiver Studienergebnisse. Diese selektive Publikation führt zu einer systematischen Fehlleitung verschiedener medizinischer Entscheidungen bzw. der diesen Entscheidungen zu Grunde liegenden Nutzen-Schaden-Abwägungen. Man muss davon ausgehen, dass solche Fehlleitungen die Patientenversorgung, die Patientenaufklärung, den Probandenschutz und die medizinische Lehre verschlechtern und somit in vielerlei Hinsicht ethisch unakzeptable Konsequenzen haben. Studienregister stellen die international bevorzugte Strategie dar, um (...) der selektiven Publikation entgegenzutreten. Wann und in welchem Umfang für in Deutschland durchgeführte klinische Studien eine Verpflichtung zur Studienregistrierung faktisch etabliert wird ist weiterhin offen. Der vorliegende Artikel führt unter Verweis auf zentrale internationale Literatur in die theoretischen und empirischen Hintergründe zum selektiven Publizieren und zur Studienregistrierung ein. Die ethischen Probleme des selektiven Publizierens werden systematisch dargestellt. Hierauf aufbauend wird für die Notwendigkeit einer restriktiven Regulierung der Studienregistrierung seitens der deutschen Gesundheitspolitik und der medizinischen Selbstverwaltung zur deutlichen Reduktion des selektiven Publizierens argumentiert. Abschließend diskutiert der Beitrag, inwieweit den deutschen Institutionen der medizinischen und forschenden Selbstverwaltung eine prospektive und retrospektive Verantwortung für eine effektive Regulierung der Studienregistrierung (bzw. für das Fehlen eben dieser) zugeschrieben werden kann. (shrink)

Seit vielen Jahren zeigen Untersuchungen, dass die Ergebnisse klinischer Studien häufig selektiv publiziert werden mit einer statistisch signifikanten und im klinischen Ausmaß sehr bedeutenden Übervorteilung positiver Studienergebnisse. Diese selektive Publikation führt zu einer systematischen Fehlleitung verschiedener medizinischer Entscheidungen bzw. der diesen Entscheidungen zu Grunde liegenden Nutzen-Schaden-Abwägungen. Man muss davon ausgehen, dass solche Fehlleitungen die Patientenversorgung, die Patientenaufklärung, den Probandenschutz und die medizinische Lehre verschlechtern und somit in vielerlei Hinsicht ethisch unakzeptable Konsequenzen haben. Studienregister stellen die international bevorzugte Strategie dar, um (...) der selektiven Publikation entgegenzutreten. Wann und in welchem Umfang für in Deutschland durchgeführte klinische Studien eine Verpflichtung zur Studienregistrierung faktisch etabliert wird ist weiterhin offen. Der vorliegende Artikel führt unter Verweis auf zentrale internationale Literatur in die theoretischen und empirischen Hintergründe zum selektiven Publizieren und zur Studienregistrierung ein. Die ethischen Probleme des selektiven Publizierens werden systematisch dargestellt. Hierauf aufbauend wird für die Notwendigkeit einer restriktiven Regulierung der Studienregistrierung seitens der deutschen Gesundheitspolitik und der medizinischen Selbstverwaltung zur deutlichen Reduktion des selektiven Publizierens argumentiert. Abschließend diskutiert der Beitrag, inwieweit den deutschen Institutionen der medizinischen und forschenden Selbstverwaltung eine prospektive und retrospektive Verantwortung für eine effektive Regulierung der Studienregistrierung (bzw. für das Fehlen eben dieser) zugeschrieben werden kann. (shrink)

BackgroundPublic involvement activities are promoted as measures for ensuring good governance in challenging fields, such as biomedical research and innovation. Proponents of public involvement activities include individual researchers as well as non-governmental and governmental organizations. However, the concept of ‘public’ in public involvement deserves more attention by researchers because it is not purely theoretical: it has important practical functions in the guidance, evaluation and translation of public involvement activities.DiscussionThis article focuses on collective agency as one property a public as a (...) small group of participants in a public involvement activity could exhibit. It introduces a prominent theoretical approach to collective agents as one specific kind of social entities and demonstrates how this approach can be applied to current practice in public involvement activities. A brief discussion of different types of representation as they are used in the existing literature on this topic is also included because representation and collective agency can be closely related to each other. Suggestions and ideas that are derived from this reasoning include the proposal to use a ‘validity check’ for the generation of collective agents as a regular element of certain types of public involvement activities, the consequences of combining collective agency and representativeness as a further property a public could exhibit, and standards for reporting the content of public involvement activities in scientific publications.SummaryThis article discusses the importance of the concept of ‘public’ in public involvement activities, with a focus on biomedical research and innovation. It introduces various practically relevant ideas that are based on a theoretical analysis of collective agency as an important property a public can possess. (shrink)

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)

"By combining recent advances in the physical sciences with some of the novel ideas, techniques, and data of modern biology, this book attempts to achieve a new and different kind of evolutionary synthesis. I found it to be challenging, fascinating, infuriating, and provocative, but certainly not dull."--James H, Brown, University of New Mexico "This book is unquestionably mandatory reading not only for every living biologist but for generations of biologists to come."--Jack P. Hailman, Animal Behaviour , review of the first (...) edition "An important contribution to modern evolutionary thinking. It fortifies the place of Evolutionary Theory among the other well-established natural laws."--R.Gessink, TAXON. (shrink)

For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers’ understanding and reactions. We tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with (...) members from the documents’ target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process. Focus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic. Our results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers’ understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future. (shrink)

This work presents the concepts of translation and conservative translation between logics. By using algebraic semantics we introduce several conservative translations involving the classical propositional calculus and the many-valued calculi of Post and Lukasiewicz.

Leading philosopher of religion D. Z. Phillips argues that intellectuals need not see their task as being for or against religion, but as one of understanding it. What stands in the way of this task are certain methodological assumptions about what enquiry into religion must be. Beginning with Bernard Williams on Greek gods, Phillips goes on to examine these assumptions in the work of Hume, Feuerbach, Marx, Frazer, Tylor, Marett, Freud, Durkheim, Le;vy-Bruhl, Berger and Winch. The result exposes confusion, but (...) also gives logical space to religious belief without advocating personal acceptance of that belief, and shows how the academic study of religion may return to the contemplative task of doing conceptual justice to the world. Religion and the Hermeneutics of Contemplation extends in important ways D. Z. Phillips' seminal 1976 book Religion Without Explanation. It will be of interest to scholars and students of philosophy, anthropology, sociology and theology. (shrink)

RésuméLa croyance que l'on est (ou pas) dans un état de douleur est singulière en ceci qu'elle semble pouvoir être qualifiée d'infaillibilité ou d'incorrigibilité logique, de même que le cogito. Mais comment se peut-il que l'existence d'une croyance (vraie) et l'existence du fait qui est l'objet de cette croyance puisssent constituer la même existence? Je propose ici une réponse à cette question. Parfois, une croyance peut être un désir.

One of Hume's most well-known works and a masterpiece of philosophy, A Treatise of Human Nature is indubitably worth taking the time to read.

One of Hume's most well-known works and a masterpiece of philosophy, A Treatise of Human Nature is indubitably worth taking the time to read.

Preface: The Shameful face of Philosophy In fact, Socrates talks about laden asses, blacksmiths, cobblers and tanners1 Whether one looks for a ...

Without denying the contradictory character of Marx s thought, the French philosopher Daniel Bensaid sets out to demonstrate that it was not a philosophy of the ...

We propose a kernel method for using combinations of features across example pairs in learning pairwise classifiers. Pairwise classifiers, which identify whether two examples belong to the same class or not, are important components in duplicate detection, entity matching, and other clustering applications. Existing methods for learning pairwise classifiers from labeled training data are based on string edit distance or common features between two examples. However, if two examples from the same class have few common features, these methods have difficulties (...) in finding these pairs and achieving high recall. One typical example is to check whether two abbreviated author names in different citations refer to the same person or not. Since similarities between examples from the same class become close to zero, classifiers fail to distinguish positive pairs from negative pairs. One approach to avoiding the problem of zero similarities is using conjunctions of different features across examples, but implementing this idea straightforwardly makes the computational cost prohibitive for practical problems. Using a kernel on pair instances, our method can use feature conjunctions across examples without actually doing feature mappings, which are computationally expensive. The kernel is a tensor product of two inner products on the original feature space. The corresponding feature mapping generates conjunctions of features only across the two different examples while that of the conventional polynomial kernel also generates conjunctions of features from the same example, which are irrelevant to pairwise classification and cause deterioration of accuracy. Our experiments on the author matching problem show that this method can give a precision 4 to 8 times higher than that of previous methods at medium recall levels. (shrink)