In March 2020, the rapid increase in severe COVID‐19 cases overwhelmed the healthcare systems in several European countries. The capacities for artificial ventilation in intensive care units were too scarce to care for patients with acute respiratory disorder connected to the disease. Several professional associations published COVID‐19 triage recommendations in an extremely short time: in 21 days between March 6 and March 27. In this article, we compare recommendations from five European countries, which combine medical and ethical reflections on this (...) situation in some detail. Our aim is to provide a detailed overview on the ethical elements of the recommendations, the differences between them and their coherence. In more general terms we want to identify shortcomings in regard to a common European response to the current situation. (shrink)

Symptom Checker Applications (SCA) are mobile applications often designed for the end-user to assist with symptom assessment and self-triage. SCA are meant to provide the user with easily accessible information about their own health conditions. However, SCA raise questions regarding ethical, legal, and social aspects (ELSA), for example, regarding fair access to this new technology. The aim of this scoping review is to identify the ELSA of SCA in the scientific literature. A scoping review was conducted to identify the ELSA (...) of SCA. Ten databases (e.g., Web of Science and PubMed) were used. Studies on SCA that address ELSA, written in English or German, were included in the review. The ELSA of SCA were extracted and synthesized using qualitative content analysis. A total of 25,061 references were identified, of which 39 were included in the analysis. The identified aspects were allotted to three main categories: (1) Technology; (2) Individual Level; and (3) Healthcare system. The results show that there are controversial debates in the literature on the ethical and social challenges of SCA usage. Furthermore, the debates are characterised by a lack of a specific legal perspective and empirical data. The review provides an overview on the spectrum of ELSA regarding SCA. It offers guidance to stakeholders in the healthcare system, for example, patients, healthcare professionals, and insurance providers and could be used in future empirical research to investigate the perspectives of those affected, such as users. (shrink)

Social Justice, Health Inequities, and Access to New Age-Related Interventions Content Type Journal Article Category Original Paper Pages 281-295 DOI 10.1007/s12376-009-0027-3 Authors Hans-Jörg Ehni, University of Tuebingen, Tuebingen, Baden-Württemberg Germany Georg Marckmann, University of Tuebingen, Tuebingen, Baden-Württemberg Germany Journal Medicine Studies Online ISSN 1876-4541 Print ISSN 1876-4533 Journal Volume Volume 1 Journal Issue Volume 1, Number 3.

Background Symptom checker apps (SCAs) are mobile or online applications for lay people that usually have two main functions: symptom analysis and recommendations. SCAs ask users questions about their symptoms via a chatbot, give a list with possible causes, and provide a recommendation, such as seeing a physician. However, it is unclear whether the actual performance of a SCA corresponds to the users’ experiences. This qualitative study investigates the subjective perspectives of SCA users to close the empirical gap identified in (...) the literature and answers the following main research question: How do individuals (healthy users and patients) experience the usage of SCA, including their attitudes, expectations, motivations, and concerns regarding their SCA use? Methods A qualitative interview study was chosen to clarify the relatively unknown experience of SCA use. Semi-structured qualitative interviews with SCA users were carried out by two researchers in tandem via video call. Qualitative content analysis was selected as methodology for the data analysis. Results Fifteen interviews with SCA users were conducted and seven main categories identified: (1) Attitudes towards findings and recommendations, (2) Communication, (3) Contact with physicians, (4) Expectations (prior to use), (5) Motivations, (6) Risks, and (7) SCA-use for others. Conclusions The aspects identified in the analysis emphasise the specific perspective of SCA users and, at the same time, the immense scope of different experiences. Moreover, the study reveals ethical issues, such as relational aspects, that are often overlooked in debates on mHealth. Both empirical and ethical research is more needed, as the awareness of the subjective experience of those affected is an essential component in the responsible development and implementation of health apps such as SCA. Trial registration German Clinical Trials Register (DRKS): DRKS00022465. 07/08/2020. (shrink)

The World Medical Association has announced that a new revision process of the Declaration of Helsinki has been started. This article will identify the criticisms that have been made in the bioethics literature, particularly since the last revision. In addition, criticisms are discussed that were made in the literature even before the last revision and have not fallen silent. The plausibility of the recommendation for a change in the Declaration of Helsinki is examined.

ABSTRACT The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions (...) justifying placebo‐use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo‐use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptabililty of placebo‐use. (shrink)

Advancements in biological ageing research have shown that age-related diseases may be fought more effectively in the future by directly intervening into the ageing process. This prospect is associated with hopes for solving problems of demographic change. It also addresses raising awareness for complex ethical, legal and social issues that have hardly been a topic of discussion to date. Therefore, as the objective of our project, an interdisciplinary discourse module entitled “Ethics of Biogerontology” was developed to initiate a social debate (...) on the ethical, legal, and societal implications of biogerontology. The discourse module focuses on competences and argumentation skills and was developed with experts from relevant disciplines, e.g. biogerontology, social gerontology, philosophy, geriatrics, and medical ethics. Concepts of age and ageing are tightly interlinked with biogerontology and are as such relevant as teaching contents of the discourse module. The course module was tested in eight discourse teaching projects in research, medicine, and education in various partner institutions and evaluated based on an ethical competence model. This article describes the conception, including the learning objectives, of such a teaching course and the associated teaching contents. It also gives a justification for their selection. Finally, we summarize the results of the evaluation. (shrink)

The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions justifying (...) placebo‐use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo‐use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptabililty of placebo‐use. (shrink)

Background: Research activities in sub-Saharan Africa may be limited to delegated tasks due to the strong control from Western collaborators, which could lead to scientific production of little value in terms of its impact on social and economic innovation in less developed areas. However, the current contexts of international biomedical research including the development of public-private partnerships and research institutions in Africa suggest that scientific activities are growing in sub-Saharan Africa. This study aims to describe the patterns of clinical research (...) activities at a sub-Saharan biomedical research center. Methods: In-depth interviews were conducted with a core group of researchers at the Medical Research Unit of the Albert Schweitzer Hospital from June 2009 to February 2010 in Lambarene, Gabon. Scientific activities running at the MRU as well as the implementation of ethical and regulatory standards were covered by the interview sessions. Results: The framework of clinical research includes transnational studies and research initiated locally. In transnational collaborations, a sub-Saharan research institution may be limited to producing confirmatory and late-stage data with little impact on economic and social innovation. However, ethical and regulatory guidelines are being implemented taking into consideration the local contexts. Similarly, the scientific content of studies designed by researchers at the MRU, if local needs are taken into account, may potentially contribute to a scientific production with long-term value on social and economic innovation in sub-Saharan Africa. Conclusion: Further research questions and methods in social sciences should comprehensively address the construction of scientific content with the social, economic and cultural contexts surrounding research activities. (shrink)

Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von Kriterien (...) darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können. (shrink)

Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von Kriterien (...) darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können. (shrink)

Alternsprävention mit Hilfe von biotechnologischen Eingriffen ist der Biologie des Alterns oder Biogerontologie bereits im Laborversuch bei unterschiedlichen Organismen gelungen. Durch die Manipulation einzelner Gene, durch die sogenannte Kalorienrestriktion, d. h. einem Labortier werden nur 70 % der Kalorien zur Verfügung gestellt, die es sonst zu sich nehmen würde, und durch Pharmazeutika wurde die Lebensspanne von Labororganismen wie Nematoden oder Hefen bis zu zehnfach verlängert. Vergleichbare Eingriffe sollen ebenfalls beim Menschen möglich sein, was speziesübergreifende, ähnliche Mechanismen der Alterung nahelegen.

The treatment of the control group in externally sponsored clinical trials is the issue of one of the most heated debates in international research ethics. The paradigmatic cases are the mother-to-child HIV-transmission trials that took place in 16 developing countries in 1997, where the control group received a placebo while proven treatment was available in industrialized countries. From this circumstance results the controversy as to whether the sponsor and researchers of externally sponsored trials have to supply a treatment that is (...) usually not available in the host country. From the beginning of the debate the controversial level of treatment has been called “standard of care”. However, besides the disagreement about the quality of the care that has to be supplied, there is as yet no widely accepted clear meaning of this concept. This article examines the fundamental ambiguity of the term and its formal function as an ethical criterion including suggestions on its further use. (shrink)