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)

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...

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)

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)

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?

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)

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)

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)

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)

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)

„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)

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 ...

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)

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)

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.

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)

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)

Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union to monitor (...) and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low. (shrink)

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and (...) synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding social value, scientific validity, favourable risk–benefit ratio, informed consent, independent review, fair selection of trial participants, and respect for study participants. Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies. (shrink)

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)

A pioneering work in the philosophy of mind, Content and Consciousness brings together the approaches of philosophers and scientists to the mind--a connection that must occur if genuine analysis of the mind is to be made. This unified approach permits the most forbiddingly mysterious mental phenomenon--consciousness--to be broken down into several distinct phenomena, and these are each given a foundation in the physical activity of the brain. This paperback edition contains a preface placing the book in the context of recent (...) work in the area. (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)

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)

In this book by the award-winning author of Just Healthcare, Norman Daniels develops a comprehensive theory of justice for health that answers three key questions: what is the special moral importance of health? When are health inequalities unjust? How can we meet health needs fairly when we cannot meet them all? Daniels' theory has implications for national and global health policy: can we meet health needs fairly in ageing societies? Or protect health in the workplace while respecting individual liberty? Or (...) meet professional obligations and obligations of justice without conflict? When is an effort to reduce health disparities, or to set priorities in realising a human right to health, fair? What do richer, healthier societies owe poorer, sicker societies? Just Health: Meeting Health Needs Fairly explores the many ways that social justice is good for the health of populations in developed and developing countries. (shrink)

In this book Daniel Wegner offers a novel understanding of the relation of consciousness, the will, and our intentional and voluntary actions. Wegner claims that our experience and common sense view according to which we can influence our behavior roughly the way we experience that we do it is an illusion.

The _Physics_ is a foundational work of western philosophy, and the crucial one for understanding Aristotle's views on matter, form, essence, causation, movement, space, and time. This richly annotated, scrupulously accurate, and consistent translation makes it available to a contemporary English reader as no other does—in part because it fits together seamlessly with other closely associated works in the New Hackett Aristotle series, such as the _Metaphysics_, _De Anima_, and forthcoming _De Caelo_ and _On Coming to Be and Passing Away_. (...) Eventually the series will include all of Aristotle's works. Sequentially numbered endnotes provide the information most needed at each juncture, while a detailed Index of Terms indicates places where focused discussion of key notions occurs. An illuminating general Introduction describes the book that lies ahead, explaining what sort of work it is and what sorts of evidence it relies on. (shrink)

How should medical services be distributed within society? Who should pay for them? Is it right that large amounts should be spent on sophisticated technology and expensive operations, or would the resources be better employed in, for instance, less costly preventive measures? These and others are the questions addreses in this book. Norman Daniels examines some of the dilemmas thrown up by conflicting demands for medical attention, and goes on to advance a theory of justice in the distribution of health (...) care. The central argument is that health care, both preventive and acute, has a crucial effect on equality of opportunity, and that a principle guaranteeing equality of opportunity must underly the distribution of health-care services. Access to care, preventive measures, treatment of the elderly, and the obligations of doctors and medical administrations are fully discussed, and the theory is shown to underwrite various practical policies in the area. (shrink)

Reasoning about situations we take to be impossible is useful for a variety of theoretical purposes. Furthermore, using a device of impossible worlds when reasoning about the impossible is useful in the same sorts of ways that the device of possible worlds is useful when reasoning about the possible. This paper discusses some of the uses of impossible worlds and argues that commitment to them can and should be had without great metaphysical or logical cost. The paper then provides an (...) account of reasoning with impossible worlds, by treating such reasoning as reasoning employing counterpossible conditionals, and provides a semantics for the proposed treatment. (shrink)

Précis for a book symposium, with contributions from Meg Wallace, Louis deRosset, and Chris Tillman and Joshua Spencer.

Our ability to locate moral responsibility is often thought to be a necessary condition for conducting morally permissible medical practice, engaging in a just war, and other high-stakes endeavors. Yet, with increasing reliance upon artificially intelligent systems, we may be facing a wideningresponsibility gap, which, some argue, cannot be bridged by traditional concepts of responsibility. How then, if at all, can we make use of crucial emerging technologies? According to Colin Allen and Wendell Wallach, the advent of so-called ‘artificial moral (...) agents’ (AMAs) is inevitable. Still, this notion may seem to push back the problem, leaving those who have an interest in developing autonomous technology with a dilemma. We may need to scale-back our efforts at deploying AMAs (or at least maintain human oversight); otherwise, we must rapidly and drastically update our moral and legal norms in a way that ensures responsibility for potentially avoidable harms. This paper invokes contemporary accounts of responsibility in order to show how artificially intelligent systems might be held responsible. Although many theorists are concerned enough to develop artificial conceptions ofagencyor to exploit our present inability to regulate valuable innovations, the proposal here highlights the importance of—and outlines a plausible foundation for—a workable notion ofartificial moral responsibility. (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)

One of the world’s leading philosophers offers aspiring thinkers his personal trove of mind-stretching thought experiments. Over a storied career, Daniel C. Dennett has engaged questions about science and the workings of the mind. His answers have combined rigorous argument with strong empirical grounding. And a lot of fun. Intuition Pumps and Other Tools for Thinking offers seventy-seven of Dennett’s most successful "imagination-extenders and focus-holders" meant to guide you through some of life’s most treacherous subject matter: evolution, meaning, mind, (...) and free will. With patience and wit, Dennett deftly deploys his thinking tools to gain traction on these thorny issues while offering readers insight into how and why each tool was built. Alongside well-known favorites like Occam’s Razor and reductio ad absurdum lie thrilling descriptions of Dennett’s own creations: Trapped in the Robot Control Room, Beware of the Prime Mammal, and The Wandering Two-Bitser. Ranging across disciplines as diverse as psychology, biology, computer science, and physics, Dennett’s tools embrace in equal measure light-heartedness and accessibility as they welcome uninitiated and seasoned readers alike. As always, his goal remains to teach you how to "think reliably and even gracefully about really hard questions." A sweeping work of intellectual seriousness that’s also studded with impish delights, Intuition Pumps offers intrepid thinkers—in all walks of life—delicious opportunities to explore their pet ideas with new powers. (shrink)

In this paper I will present a puzzle about epistemic akrasia, and I will use that puzzle to motivate accepting some non-standard views about the nature of epistemological judgment. The puzzle is that while it seems obvious that epistemic akrasia must be irrational, the claim that epistemic akrasia is always irrational amounts to the claim that a certain sort of justified false belief—a justified false belief about what one ought to believe—is impossible. But justified false beliefs seem to be possible (...) in any domain, and it’s hard to see why beliefs about what one ought to believe should be an exception. I will argue that when we get clearer about what sort of psychological state epistemic akrasia is, we can resolve the puzzle in favor of the intuitive view that epistemic akrasia is always irrational. (shrink)

The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy. In order to manage the risks to individuals posed by these privacy challenges, some have suggested codifying new privacy rights, including a right to “mental privacy.” In this paper, we consider these arguments and conclude that while neurotechnologies do raise significant privacy concerns, such concerns are—at least for now—no different from those raised by other well-understood data collection (...) technologies, such as gene sequencing tools and online surveillance. To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum’s “contextual integrity” theory. To illustrate the importance of context, we examine neurotechnologies and the information flows they produce in three familiar contexts—healthcare and medical research, criminal justice, and consumer marketing. We argue that by emphasizing what is distinct about brain privacy issues, rather than what they share with other data privacy concerns, risks weakening broader efforts to enact more robust privacy law and policy. (shrink)

This collection of essays explores the metaphysical thesis that the living world is not made up of substantial particles or things, as has often been assumed, but is rather constituted by processes. The biological domain is organised as an interdependent hierarchy of processes, which are stabilised and actively maintained at different timescales. Even entities that intuitively appear to be paradigms of things, such as organisms, are actually better understood as processes. Unlike previous attempts to articulate processual views of biology, which (...) have tended to use Alfred North Whitehead’s panpsychist metaphysics as a foundation, this book takes a naturalistic approach to metaphysics. It submits that the main motivations for replacing an ontology of substances with one of processes are to be found in the empirical findings of science. Biology provides compelling reasons for thinking that the living realm is fundamentally dynamic, and that the existence of things is always conditional on the existence of processes. The phenomenon of life cries out for theories that prioritise processes over things, and it suggests that the central explanandum of biology is not change but rather stability, or more precisely, stability attained through constant change. This edited volume brings together philosophers of science and metaphysicians interested in exploring the consequences of a processual philosophy of biology. The contributors draw on an extremely wide range of biological case studies, and employ a process perspective to cast new light on a number of traditional philosophical problems, such as identity, persistence, and individuality. (shrink)

This paper proposes a new account of bounded or minimal doxastic rationality (in the sense of Cherniak 1986), based on the notion that beliefs are answers to questions (à la Yalcin 2018). The core idea is that minimally rational beliefs are linked through thematic connections, rather than entailment relations. Consequently, such beliefs are not deductively closed, but they are closed under parthood (where a part is an entailment that answers a smaller question). And instead of avoiding all inconsistency, minimally rational (...) believers only avoid blatant inconsistencies (where some beliefs are blatantly inconsistent when they contradict one another on a particular question). Rather than cohering into a single overall world view, beliefs are more loosely connected in what is best described as a web of questions. This view of minimally rational belief naturally gives rise to an account of deductive inquiry on which deductive reasoning is a matter of posing new questions. (shrink)

Supporters of open borders sometimes argue that the state has no pro tanto right to restrict immigration, because such a right would also entail a right to exclude existing citizens for whatever reasons justify excluding immigrants. These arguments can be defeated by suggesting that people have a right to stay put. I present a new form of the exclusion argument against closed borders which escapes this “right to stay put” reply. I do this by describing a kind of exclusion that (...) has not been discussed in depth, which I call “territorial exclusion.” Territorial exclusion is the process according to which the group that wishes to exclude current citizens secedes from the territory in which those citizens reside. I argue that the wrongness of territorial exclusion explains why there is no pro tanto right for a state to exclude immigrants, because otherwise there would be a pro tanto right for the state to kick people out by seceding from the territory they inhabit. Because kicking people out like this is typically wrong, borders cannot be closed. (shrink)

I defend the cosmopolitan instrumentalist theory of secession, according to which a group has a right to secede only if this would promote cosmopolitan justice. I argue that the theory is preferable to other theories of secession because it is an entailment of cosmopolitanism, which is independently attractive, and because, unlike other theories of secession, it allows us to give the answers we want to give in cases like secession of the rich or secession that would make things worse for (...) minorities. I defend the view against the objections that it allows for colonialism and annexation, that it is not a distinct theory, and that it is impractical. (shrink)