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)
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)
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)
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)
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?
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)
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)
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)
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)
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)
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)
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)
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)
„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 ...
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.
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)
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)
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)