In order to build on the information that was obtained in the course of the first study, a follow-up survey was conducted first by phone and subsequently in a written form between August and October 2014. We contacted 1.858 hospitals in all of Germany for the follow-up survey by phone. In cases where a hospital had not participated in the first study, the willingness to participate in the follow-up survey was established in advance. The survey’s dispatch was ensured in the (...) case of acceptance. The same structured survey was used as a research tool. The data of the first study and the follow-up survey were merged and evaluated. 654 surveys could be evaluated altogether. Our survey by phone revealed that 912 hospitals in all of Germany have at least one form of clinical ethics consultation available. The health care ethics committee is the most frequently implemented structure of clinical ethics consultation. The implementation of clinical ethics consultation is dependent on sponsorship and hospital size. Recommendations to deliver structures of clinical ethics consultations have a smaller influence on the implementation compared to the certification by KTQ respectively proCum Cert. The rate of implementation in regard to the structures of clinical ethics consultation has steadily increased for years. The establishment of clinical ethics consultation in German hospitals should be further promoted. It would be desirable further to develop suitable juridical regulations in order to implement clinical ethics consultation as well as structural parameters. (shrink)

Since 1989, clinical ethics consultation in form of hospital ethics committees was established in most of the transition countries of Central and Eastern Europe. Up to now, the similarities and differences between HECs in Central and Eastern Europe and their counterparts in the U.S. and Western Europe have not been determined. Through search in literature databases, we have identified studies that document the implementation of clinical ethics consultation in Central and Eastern Europe. These studies have been analyzed under the following (...) aspects: mode of establishment of HECs, character of consultation they provide, and their composition. The results show that HECs in the transition countries of Central and Eastern Europe differ from their western-European or U.S. counterparts with regard to these three aspects. HECs were established because of centrally imposed legal regulations. Little initiatives in this area were taken by medical professionals interested in resolving emerging ethical issues. HECs in the transition countries concentrate mostly on review of research protocols or resolution of administrative conflicts in healthcare institutions. Moreover, integration of non-professional third parties in the workings of HECs is often neglected. We argue that these differences can be attributed to the historical background and the role of medicine in these countries under the communist regime. Political and organizational structures of healthcare as well as education of healthcare staff during this period influenced current functioning of clinical ethics consultation in the transition countries. (shrink)

Recent years have witnessed intensive efforts to specify which requirements ethical artificial intelligence (AI) must meet. General guidelines for ethical AI consider a varying number of principles important. A frequent novel element in these guidelines, that we have bundled together under the term explicability, aims to reduce the black-box character of machine learning algorithms. The centrality of this element invites reflection on the conceptual relation between explicability and the four bioethical principles. This is important because the application of general ethical (...) frameworks to clinical decision-making entails conceptual questions: Is explicability a free-standing principle? Is it already covered by the well-established four bioethical principles? Or is it an independent value that needs to be recognized as such in medical practice? We discuss these questions in a conceptual-ethical analysis, which builds upon the findings of an empirical document analysis. On the example of the medical specialty of radiology, we analyze the position of radiological associations on the ethical use of medical AI. We address three questions: Are there references to explicability or a similar concept? What are the reasons for such inclusion? Which ethical concepts are referred to? (shrink)

The executive board of the Academy for Ethics in Medicine and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between (...) September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly. (shrink)

German medical schools have not yet sufficiently introduced students to the field of good scientific practice. In order to prevent scientific misconduct and to foster scientific integrity, courses on GSP must be an integral part of the curriculum of medical students. Based on a review of the literature, teaching units and materials for two courses on GSP were developed and tested in a pilot course. The pilot course was accompanied by a pre-post evaluation that assessed students’ knowledge and attitudes towards (...) scientific integrity and scientific misconduct. A syllabus was designed that comprised the following six topics: theoretical foundations of GSP; scientific publishing; empirical data; scientific supervision and teamwork; clinical research; personal interests. The comparison pre versus post-intervention yielded statistically significant changes in regard to the participants’ knowledge and attitude toward all forms of scientific misconduct treated in the course. As the majority of participants was not familiar with the fundamental regulations or guidelines of GSP, it seems crucial to train students in actively applying such norms to real-world conflicts. Students’ unfamiliarity with the fundamentals of GSP can be linked to the fact that many students have already experienced forms of scientific misconduct. Thus, GSP syllabi should be closely adjusted to a student’s realm of experience. All in all, courses on GSP can be seen as a potential means to increase the number of young scholars. (shrink)

Climate change, pollution, and deforestation have a negative impact on global mental health. There is an environmental justice dimension to this challenge as wealthy people and high-income countries are major contributors to climate change and pollution, while poor people and low-income countries are heavily affected by the consequences. Using state-of-the art data mining, we analyzed and visualized the global research landscape on mental health, climate change, pollution and deforestation over a 15-year period. Metadata of papers were exported from PubMed®, and (...) both relevance and relatedness of terms in different time frames were computed using VOSviewer. Co-occurrence graphs were used to visualize results. The development of exemplary terms over time was plotted separately. The number of research papers on mental health and environmental challenges is growing in a linear fashion. Major topics are climate change, chemical pollution, including psychiatric medication in wastewater, and neurobiological effects. Research on specific psychiatric syndromes and diseases, particularly on their ethical and social aspects is less prominent. There is a growing body of research literature on links between mental health, climate change, pollution, and deforestation. This research provides a graphic overview to mental healthcare professionals and political stakeholders. Social and ethical aspects of the climate change-mental health link have been neglected, and more research is needed. (shrink)

Die Wissensvermittlung in Gesundheitsethik ermöglicht es Auszubildenden der Pflege, sich in ihrer zukünftigen Tätigkeit bei Entscheidungsprozessen des Behandlungsteams hinsichtlich pflegeethischer Fragestellungen einzubringen. Vor diesem Hintergrund wurde anhand der vorliegenden Studie die Entwicklung moralischer Positionen sowie pflegeethischer Kenntnisse von Pflegeauszubildenden sichtbar gemacht. An zwei Krankenpflegeschulen (Berlin und Fürth) wurden im Rahmen einer Panelstudie von August 2010 bis März 2011 Daten einer ersten Querschnittserhebung von Auszubildenden in der Pflege erhoben. Für die Studie wurde ein strukturierter Fragebogen verwendet. Die Studienteilnahme erfolgte freiwillig. Alle (...) Auszubildenden hatten vor der Befragung in unterschiedlichem Umfang Unterricht in Gesundheitsethik erhalten. An beiden Standorten zeigten die Teilnehmenden einen Zuwachs an pflegeethischen Kenntnissen. Auszubildende, die bislang keine praktische Erfahrung mit Sterbehilfe gemacht hatten, zeigten Schwierigkeiten in der theoretischen Handhabung dieser Maßnahmen. Für alle Auszubildenden zeigte sich ein allgemeiner Trend zu einer Befürwortung des partizipativen Interaktionsmodells und damit zu einer Förderung der Patientenselbstbestimmung. Zugleich schätzten die Studienteilnehmenden die Fähigkeiten von Patienten, medizinisch richtige Therapieentscheidungen zu treffen, als gering ein. Die Ausbildung in Gesundheitsethik besitzt ein großes Potential, Kenntnisse zu vermitteln und dadurch die ethische Kompetenzentwicklung zu befördern. Unsere Ergebnisse werfen die Frage auf, inwieweit es einer Integration praktischer Erfahrungen mit Fragestellungen der Gesundheitsethik bedarf, um eine praxisrelevante und wissenschaftlich fundierte Wissensvermittlung zu gewährleisten. (shrink)

Telemedicine is a complex field including various applications and target groups. Especially telehealthcare is seen by many as a means to revolutionize medicine. It gives patients the opportunity to take charge of their own health by using self-tracking devices and allows health professionals to treat patients from a distance. To some, this means an empowerment of patient autonomy as well as an improvement in the quality of care. Others state the dangers of depersonalization of medicine and the pathologization of daily (...) life. This paper examines the ethical implications of telehealthcare, focusing on patient autonomy and quality of care by analyzing metareviews, randomized controlled trials and narrative ethical analyses on the topic. As a result, we conclude that the technically enhanced encounter between patients and health professionals may mean an empowerment of patient autonomy when it goes along with a personal relationship based on trust, assistance and support. When it comes to the quality of care, telehealthcare may lead to an improvement as long it is adopted to the patient’s individual needs. (shrink)

Historische, theoretische und ethische Aspekte der Medizin sind Lehrinhalte des medizinischen Ausbildungscurriculums, die in dem neu eingeführten Querschnittsbereich 2 "Geschichte, Theorie, Ethik der Medizin" (GTE) vermittelt werden sollen. Gegenstand dieser Arbeit ist die Darstellung von Unterrichtskonzept und Evaluationsergebnissen eines medizinhistorische und -ethische Inhalte intergrierenden Lehrmoduls zum Thema der Aufklärung und Einwilligung in Klinik und medizinischer Forschung. Die integrierte Vermittlung medizinethischer und -historischer Inhalte wurde von den Studierenden positiv bewertet. Die von den Kursteilnehmenden im Rahmen der Evaluation gezeigten Kenntnisse sowie die (...) Selbsteinschätzung ausgewählter Fähigkeiten und Fertigkeiten können als Hinweis für eine effektive Vermittlung der korrespondierenden Lehrinhalte gewertet werden. Die Definition fachübergreifender Lehrziele sowie die Entwicklung geeigneter Evaluationsinstrumente sind Voraussetzungen für die die Evaluation zukünftiger Lehrveranstaltungen, in denen historische und ethische Aspekte integriert vermitteltwerden sollen. Neben einem Beitrag zur wissenschaftlich fundierten medizinischen Ausbildung im Querschnittsbereich GTE bieten interdisziplinäre Lehrprojekte mit Begleitforschung auch die Möglichkeit das Verhältnis von Geschichte und Ethik (in) der Medizin hinsichtlich der für beide Fächer relevanten Lehrinhalte und Lehrmethoden zu reflektieren. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical studies in (...) the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Der Unterricht in Medizinethik soll Medizinstudierenden die Grundlagen dafür vermitteln, in ihrer zukünftigen ärztlichen Tätigkeit gute Entscheidungen treffen zu können. Im Rahmen einer Panelstudie wird derzeit die Entwicklung moralischer Positionen, medizinethischer Kenntnisse und Motivationen von Medizinstudierenden der Ludwig-Maximilians-Universität München über den Verlauf des Studiums untersucht. Für die Datenerhebung wurde ein Fragebogen entwickelt, der medizinethische Positionen und Kenntnisse sowie Motivationen erfasst. Im Wintersemester 2009/10 wurde die erste Querschnittsuntersuchung mit Studierenden im 1., 3. und 8. Semester sowie im Praktischen Jahr durchgeführt. Die (...) Mehrzahl der Befragten verfügte über einen geringen Kenntnisstand in verschiedenen Themenbereichen des Unterrichtsfachs GTE. Rechtliche Grundlagen und praktische Umsetzung von Therapiebegrenzungsmaßnahmen waren bis ins PJ-Semester vielen Studierenden nicht bekannt. Im Verlauf des Studiums veränderten sich die Motivationen weg von der Motivation, Menschen helfen zu wollen, hin zu Wissenserwerb und dem Ergreifen eines sicheren Berufs. Obwohl viele Befragte ein hohes Interesse an medizinethischen Fragestellungen und Unterricht im Bereich GTE angaben, zeigte sich kein nachhaltiger Zuwachs an medizinethischen Kenntnissen im Laufe des Studiums. In der Zusammenschau werfen die Ergebnisse die Frage auf, inwieweit verschiedene Ausbildungskonzepte Einfluss auf die individuelle ethische Entwicklung Medizinstudierender nehmen können. Eine Untersuchung dieser Fragestellung bleibt Gegenstand weitergehender Forschung. (shrink)

Background: Smart sensors have been developed as diagnostic tools for rehabilitation to cover an increasing number of geriatric patients. They promise to enable an objective assessment of complex movement patterns. -/- Objective: This research aimed to identify and analyze the conflicting ethical values associated with smart sensors in geriatric rehabilitation and provide ethical guidance on the best use of smart sensors to all stakeholders, including technology developers, health professionals, patients, and health authorities. -/- Methods: On the basis of a systematic (...) literature search of the scientific databases PubMed and ScienceDirect, we conducted a qualitative document analysis to identify evidence-based practical implications of ethical relevance. We included 33 articles in the analysis. The practical implications were extracted inductively. Finally, we carried out an ethical analysis based on the 4 principles of biomedical ethics: autonomy, beneficence, nonmaleficence, and justice. The results are reported in categories based on these 4 principles. -/- Results: We identified 8 conflicting aims for using smart sensors. Gains in autonomy come at the cost of patient privacy. Smart sensors at home increase the independence of patients but may reduce social interactions. Independent measurements performed by patients may result in lower diagnostic accuracy. Although smart sensors could provide cost-effective and high-quality diagnostics for most patients, minorities could end up with suboptimal treatment owing to their underrepresentation in training data and studies. This could lead to algorithmic biases that would not be recognized by medical professionals when treating patients. -/- Conclusions: The application of smart sensors has the potential to improve the rehabilitation of geriatric patients in several ways. It is important that patients do not have to choose between autonomy and privacy and are well informed about the insights that can be gained from the data. Smart sensors should support and not replace interactions with medical professionals. Patients and medical professionals should be educated about the correct application and the limitations of smart sensors. Smart sensors should include an adequate representation of minorities in their training data and should be covered by health insurance to guarantee fair access. (shrink)

With the arrival of new methods of genome editing, especially CRISPR/cas 9, new perspectives on germline interventions have arisen. Supporters of germ line genome editing claim that the procedure could be used as a means of disease prevention. As a possible life-saving therapy, it provides benefits that outweigh its risks. Opponents of GGE claim that the medical and societal risks, especially the use of GGE for genetic enhancement, are too high. In our paper, we analyze the risks and benefits of (...) GGE. We show that the medical risk on an individual level might be reduced by further research in the near future so that they may be outweighed by the benefits. We also show that the societal risks of the procedure, i.e. genetic enhancement, are manageable by establishing a regulative framework before the GGE is implemented. Since the effects of modifying genes for the genepool of a given population are extremely difficult to model, the medical risks on the population level might be too high. (shrink)

ZusammenfassungHistorische, theoretische und ethische Aspekte der Medizin sind Lehrinhalte des medizinischen Ausbildungscurriculums, die in dem neu eingeführten Querschnittsbereich 2 "Geschichte, Theorie, Ethik der Medizin" vermittelt werden sollen. Gegenstand dieser Arbeit ist die Darstellung von Unterrichtskonzept und Evaluationsergebnissen eines medizinhistorische und -ethische Inhalte intergrierenden Lehrmoduls zum Thema der Aufklärung und Einwilligung in Klinik und medizinischer Forschung. Die integrierte Vermittlung medizinethischer und -historischer Inhalte wurde von den Studierenden positiv bewertet. Die von den Kursteilnehmenden im Rahmen der Evaluation gezeigten Kenntnisse sowie die Selbsteinschätzung (...) ausgewählter Fähigkeiten und Fertigkeiten können als Hinweis für eine effektive Vermittlung der korrespondierenden Lehrinhalte gewertet werden. Die Definition fachübergreifender Lehrziele sowie die Entwicklung geeigneter Evaluationsinstrumente sind Voraussetzungen für die die Evaluation zukünftiger Lehrveranstaltungen, in denen historische und ethische Aspekte integriert vermitteltwerden sollen. Neben einem Beitrag zur wissenschaftlich fundierten medizinischen Ausbildung im Querschnittsbereich GTE bieten interdisziplinäre Lehrprojekte mit Begleitforschung auch die Möglichkeit das Verhältnis von Geschichte und Ethik der Medizin hinsichtlich der für beide Fächer relevanten Lehrinhalte und Lehrmethoden zu reflektieren. (shrink)

Surveys of the German public have revealed a high acceptance of social freezing, i.e. oocyte conservation without medical indication. Up to now, there are no investigations available on the experiences and attitudes of health professionals towards social freezing. Between August 2015 and January 2016, we surveyed gynecologists Germany-wide on the topic social freezing. Five gynecologists specialized in reproductive medicine and five office-based gynecologists in standard care were chosen for the survey. The survey was conducted with an explorative, qualitative research design. (...) The demand for social freezing in Germany is low. With regard to their fertility age, most women attend consultations too late, they have only little previous knowledge and false expectations. The gynecologists consider it the duty of society and politics to provide for the compatibility of family and work. They relate late parenthood to disadvantages primarily for the children. A majority of the gynecologists interviewed tend to advise natural reproduction. Social freezing is often mistaken as a kind of fertility insurance. Thus, it is necessary that physicians inform women early about the possibilities and limitations of social freezing. In the first place, social freezing is not a medical or medical-ethical topic. Women consider the method as a possibility to ensure the compatibility of family and work. This compatibility should be mostly perceived as a political topic. It cannot be a medical task to solve this issue. In fact, a debate in society as a whole is necessary that includes all relevant actors. (shrink)

Organisation auftritt, würde es sich um strukturelle Diskriminierung eines einzelnen oder wiederum einer Gruppe von ... zum Rahmenthema » Stigmatisierung – Diskriminierung in Medizin und Psychotherapie«, in dem Florian Steger vor allem ...

Biomarker-based predictive tests for subjectively asymptomatic Alzheimer’s disease (AD) are utilized in research today. Novel applications of artificial intelligence (AI) promise to predict the onset of AD several years in advance without determining biomarker thresholds. Until now, little attention has been paid to the new ethical challenges that AI brings to the early diagnosis in asymptomatic individuals, beyond contributing to research purposes, when we still lack adequate treatment. The aim of this paper is to explore the ethical arguments put forward (...) for AI aided AD prediction in subjectively asymptomatic individuals and their ethical implications. The ethical assessment is based on a systematic literature search. Thematic analysis was conducted inductively of 18 included publications. The ethical framework includes the principles of autonomy, beneficence, non-maleficence, and justice. Reasons for offering predictive tests to asymptomatic individuals are the right to know, a positive balance of the risk-benefit assessment, and the opportunity for future planning. Reasons against are the lack of disease modifying treatment, the accuracy and explicability of AI aided prediction, the right not to know, and threats to social rights. We conclude that there are serious ethical concerns in offering early diagnosis to asymptomatic individuals and the issues raised by the application of AI add to the already known issues. Nevertheless, pre-symptomatic testing should only be offered on request to avoid inflicted harm. We recommend developing training for physicians in communicating AI aided prediction. (shrink)

The development of new methods in the field of prenatal testing leads to an expansion of information that needs to be provided to expectant mothers. The aim of this research is to explore opinions and attitudes of gynecologists in Germany, Poland and Russia towards access to prenatal testing and diagnostics in these countries. Semi-structured interviews were conducted with n = 18 gynecologists in Germany, Poland and Russia. The interviews were analyzed using the methods of content analysis and thematic analysis. Visible (...) in all three countries is a connection of prenatal medicine with the politically and socially contentious issue of pregnancy termination. Respondents in Poland and Russia concentrated on the topic of inadequate resources. Quality of information for expectant mothers is an important point in all three countries. Only in Germany was the issue of language barriers in communication raised. With regard to non-invasive prenatal testing (NIPT) respondents in Germany focused on the ethical issues of routinization of testing; in Poland and Russia they concentrated on fair access to NIPT. Challenges in all three countries arise from structural factors such as imprecise and prohibitive regulations, lack of resources or organization of healthcare services. These should be addressed on a political and medico-ethical level. (shrink)

New technologies such as smart sensors improve rehabilitation processes and thereby increase older adults’ capabilities to participate in social life, leading to direct physical and mental health benefits. Wearable smart sensors for home use have the additional advantage of monitoring day-to-day activities and thereby identifying rehabilitation progress and needs. However, identifying and selecting rehabilitation priorities is ethically challenging because physicians, therapists, and caregivers may impose their own personal values leading to paternalism. Therefore, we develop a discussion template consisting of a (...) series of adaptable questions for the patient–physician encounter based on the capability approach. The goal is to improve geriatric rehabilitation and thereby increase participation in social life and well-being. To achieve this goal, we first analyzed what is considered important for participation on basis of the capability approach, human rights, and ethics of care. Second, we conducted an ethical analysis of each of the four identified dimensions of participation: political, economic, socio-cultural, and care. To improve compliance with rehabilitation measures, health professionals must align rehabilitation measures in an open dialogue with the patient’s aspiration for participation in each dimension. A discussion template based on the capability approach allows for a proactive approach in patient information and stimulates a critical assessment of treatment alternatives while reducing the risk of imposing personal values. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of hydroxychloroquine, remdesivir (...) and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions. (shrink)

Die Pränatalmedizin kann neben optimaler Therapie und Geburtsplanung auch Entscheidungshilfe zum Fortsetzen oder Beenden einer Schwangerschaft geben. Nach einer diagnostizierten schweren fetalen Fehlbildung stimmt retrospektiv etwa ein Drittel der Frauen ihrer Entscheidung zum Verlauf (Austragen versus Schwangerschaftsabbruch) nicht mehr umfassend zu, ein weiteres Drittel ist sehr verunsichert. Welchen Einfluss hat das Lebensumfeld der Schwangeren auf ihre Entscheidung in dieser existenziellen Situation? Wie werden die getroffene Entscheidung und die damit verbundenen Erfahrungen nach Abschluss der Schwangerschaft bewertet? Was kann aus Sicht der (...) Betroffenenperspektive von Medizinern erwartet werden? Es wurden problemzentrierte teilnarrative Interviews mit 11 Frauen geführt. Einschlusskriterium war eine abgeschlossene Schwangerschaft mit pränatal diagnostizierter schwerer fetaler Fehlbildung, die eine Entscheidung zum Austragen oder Beendigen nach medizinischer Indikationsstellung und im gesetzlichen Rahmen zuließ. Die Auswertung der transkribierten Interviews erfolgte mittels qualitativer Inhaltsanalyse nach Mayring, computergestützt durch die Software ATLAS.ti. Die Zufriedenheit mit der Entscheidung im Rückblick ergibt sich aus der individuellen Lösung eines bestehenden Konfliktes zwischen der Grundhaltung zum Leben (eigene Erfahrungen, Vorwissen und Werte) und dem tatsächlich vorhandenen Lebensumfeld (Lebensplanung, Familie, finanzielle Aspekte). Entsprechend der individuellen Bewertung der Erfahrungen wurden 4 Prototypen klassifiziert. Frauen mit starkem Grundkonflikt erlebten die Geburt eher negativ und litten länger unter psychopathologischen Symptomen. Eine ausreichend lange Bedenkzeit sowie ein positives und akzeptierendes Entscheidungsumfeld (Patient-Arzt-Kommunikation, angemessene psychosoziale Begleitung) trugen deutlich zur Zufriedenheit der Befragten bei. Aus Sicht der betroffenen Frauen werden Erwartungen an Pränatalmediziner weitergegeben. (shrink)

ZusammenfassungDer weltweit erste Mitochondrien-Transfer, auch als Erzeugung eines „Drei-Eltern-Kindes“ bezeichnet, hat 2016 eine intensive Debatte ausgelöst. Hinsichtlich des Verfahrens, das bisher nur in Großbritannien zugelassen ist, werden auch verschiedene ethische Aspekte angesprochen. Dazu gehören die Risikoabwägung, die reproduktive Selbstbestimmung und die psychosoziale Entwicklung eines Kindes, das von drei Individuen abstammt. Dabei fällt auf, dass zentrale konzeptuelle Fragen hinsichtlich des Mitochondrien-Transfers nicht geklärt sind. Ist der Mitochondrien-Transfer eine genetische Intervention in die Keimbahn? Handelt es sich bei dem Verfahren um eine medizinisch (...) indizierte Therapie oder um eine elektive Behandlung assistierter Reproduktion? Welche Konzepte von Identität und Elternschaft liegen der Auffassung eines „Drei-Eltern-Kindes“ zugrunde? Im Kontext dieser konzeptuellen Fragen muss eine ethische Analyse des Mitochondrien-Transfers durchgeführt werden. In den meisten Fällen zeigt sich allerdings, dass die ethische Analyse zu stark auf Einzelaspekte fokussiert ist, wodurch diese konzeptuellen Fragen aus dem Blick geraten. Daher verbinden wir in unserem Beitrag die ethische Analyse mit konzeptuellen Überlegungen. Dabei ist es von zentraler Bedeutung, auch die biomedizinischen Grundlagen des Verfahrens eingehend zu erörtern, um die konzeptuellen Aspekte angemessen einordnen zu können. In einem ersten Schritt erläutern wir die unterschiedlichen Verfahren des Mitochondrien-Transfers. In einem zweiten Schritt schlagen wir eine konzeptuelle Klärung der drei genannten Fragen vor. Diese konzeptuelle Klärung dient als Grundlage, um die ethischen Aspekte der reproduktiven Selbstbestimmung, Risikoabwägung sowie Elternschaft und Identitätskonzeption zu analysieren. In einem dritten Schritt fassen wir die Ergebnisse zusammen. (shrink)

Der Schwerpunkt des diesjahrigen Bandes steht unter dem Titel "Medien und Medizin" und vereint die Ergebnisse einer 2009 in der Carl Friedrich von Siemens Stiftung Munchen ausgerichteten Tagung. Hinzu kommen Originalbeitrage zu Louis Pasteur und der Neuerfindung des Lebens sowie zu der Autorin Christa Wolf. Die Essays behandeln die Bibliothek des Bundesverbandes deutscher Schriftstellerarzte e.V. sowie den Literat und Psychiater Mario Tobino. Wie immer schliessen sich zahlreiche Rezensionen aktueller Publikationen an.

Das Interesse an 'Schnittstellen' von Literatur und Medizin ist groß und nimmt stetig zu, die Thematik ist vielfältig und nicht leicht überschaubar. Hier bietet das im Entstehen begriffene Lexikon Orientierung und Überblick. Es schafft Grundlagen und fördert darüber hinaus den Dialog zwischen Geistes- und Naturwissenschaften. Sachlich-systematisch orientiert und alphabetisch angeordnet sind einschlägige medizinische Sujets verzeichnet, die in der Literatur von der Antike bis in die Gegenwart eine Rolle spielen. In über 250 Artikeln von Abtreibung bis Zwang wird die medizinische und (...) historische Begriffsgeschichte sowie die geistes-, ideen- und kulturhistorische Bedeutung im Wandel der Zeiten dargestellt. Zu jedem Artikel gibt es weiterführende Literaturhinweise; Personen-, Werk- und Sachregister erleichtern das Suchen und Nachschlagen. (shrink)

In March 2019, the German Gemeinsamer Bundesausschuss (G‑BA; Federal Joint Committee) presented the result of the method assessment process on non-invasive prenatal testing (NIPT). The aim of this method assessment process was to decide whether NIPT should become a publicly funded procedure of routine prenatal care. The G‑BA decided in favor of NIPT, making the implementation of NIPT very likely, provided that other healthcare and political institutions also agree. This development could be interpreted as empowering from the perspective of reproductive (...) autonomy, since NIPT allows pregnant women to obtain valuable information on the health of the fetus in a fast and easy manner and without the risks of invasive methods. However, the routinization of NIPT also implies ethical challenges. Will the routinization lead to a normalization of prenatal quality control? Will it lead to an expansion to women outside the high-risk group? What would be the ethical implications of such a development? How should physicians, geneticists, and patients deal with the increased amount of obtainable information? What are the implications for choice and decision-making in the prenatal care context? In this paper, we analyze the ethical aspects of the routinization of NIPT, focusing on information and the counseling process, the burden of choice, and the threats to reproductive autonomy by societal interests linked to NIPT. (shrink)

In March 2019, the German Gemeinsamer Bundesausschuss (G‑BA; Federal Joint Committee) presented the result of the method assessment process on non-invasive prenatal testing (NIPT). The aim of this method assessment process was to decide whether NIPT should become a publicly funded procedure of routine prenatal care. The G‑BA decided in favor of NIPT, making the implementation of NIPT very likely, provided that other healthcare and political institutions also agree. This development could be interpreted as empowering from the perspective of reproductive (...) autonomy, since NIPT allows pregnant women to obtain valuable information on the health of the fetus in a fast and easy manner and without the risks of invasive methods. However, the routinization of NIPT also implies ethical challenges. Will the routinization lead to a normalization of prenatal quality control? Will it lead to an expansion to women outside the high-risk group? What would be the ethical implications of such a development? How should physicians, geneticists, and patients deal with the increased amount of obtainable information? What are the implications for choice and decision-making in the prenatal care context? In this paper, we analyze the ethical aspects of the routinization of NIPT, focusing on information and the counseling process, the burden of choice, and the threats to reproductive autonomy by societal interests linked to NIPT. (shrink)

In March 2019, the German Gemeinsamer Bundesausschuss (G‑BA; Federal Joint Committee) presented the result of the method assessment process on non-invasive prenatal testing (NIPT). The aim of this method assessment process was to decide whether NIPT should become a publicly funded procedure of routine prenatal care. The G‑BA decided in favor of NIPT, making the implementation of NIPT very likely, provided that other healthcare and political institutions also agree. This development could be interpreted as empowering from the perspective of reproductive (...) autonomy, since NIPT allows pregnant women to obtain valuable information on the health of the fetus in a fast and easy manner and without the risks of invasive methods. However, the routinization of NIPT also implies ethical challenges. Will the routinization lead to a normalization of prenatal quality control? Will it lead to an expansion to women outside the high-risk group? What would be the ethical implications of such a development? How should physicians, geneticists, and patients deal with the increased amount of obtainable information? What are the implications for choice and decision-making in the prenatal care context? In this paper, we analyze the ethical aspects of the routinization of NIPT, focusing on information and the counseling process, the burden of choice, and the threats to reproductive autonomy by societal interests linked to NIPT. (shrink)

Current developments in the area of neuroenhancement pose multiple ethical and societal questions. Improvements in general cognitive capacities can have important positive effects. With the use of several interventions, ranging from pharmaceutics through microsurgery to non-invasive and invasive methods, new possibilities of enhancing human abilities can be achieved. Yet, they have to be critically evaluated from the point of view of both individual and societal consequences that are involved. The aim of this paper is to address societal benefits and challenges (...) that are related to these interventions. These new developments, especially in the specific area of their military application, pose important questions with regard to safety of their use, long-term results, coercion to use them, and issues of inequality. Often, these consequences are unforeseeable at the present moment and can greatly interfere with development of both individuals and societies. Therefore, as in both areas – civilian and military – the long-term consequences are still difficult to predict, prudency is prescribed. Consequently, any use of the methods of enhancement should be under exceptional scrutiny from the ethical as well as legal and social point of view. (shrink)

In March 2019, the German Gemeinsamer Bundesausschuss (G‑BA; Federal Joint Committee) presented the result of the method assessment process on non-invasive prenatal testing (NIPT). The aim of this method assessment process was to decide whether NIPT should become a publicly funded procedure of routine prenatal care. The G‑BA decided in favor of NIPT, making the implementation of NIPT very likely, provided that other healthcare and political institutions also agree. This development could be interpreted as empowering from the perspective of reproductive (...) autonomy, since NIPT allows pregnant women to obtain valuable information on the health of the fetus in a fast and easy manner and without the risks of invasive methods. However, the routinization of NIPT also implies ethical challenges. Will the routinization lead to a normalization of prenatal quality control? Will it lead to an expansion to women outside the high-risk group? What would be the ethical implications of such a development? How should physicians, geneticists, and patients deal with the increased amount of obtainable information? What are the implications for choice and decision-making in the prenatal care context? In this paper, we analyze the ethical aspects of the routinization of NIPT, focusing on information and the counseling process, the burden of choice, and the threats to reproductive autonomy by societal interests linked to NIPT. (shrink)

In den Jahren 1944–1945 wurden mehr als 1.400 Mädchen und junge Frauen aus der polnischen Stadt Łódź nach Ulm in Deutschland gebracht und zur Arbeit gezwungen. Während ihres Aufenthalts in Ulm waren diese Mädchen schweren Lebensbedingungen ausgesetzt. Dies führte auch zu Krankheiten. Tägliche Entbehrung und Ausbeutung kennzeichneten den Leidensweg dieser Zwangsarbeiterinnen. Ein solches Ausbeutungssystem ist symptomatisch für die späte Kriegsphase, in der die Bemühungen zur Steigerung der Rüstungsproduktion Vorrang vor der Gesundheit ausländischer Arbeiterinnen und Arbeiter hatten. Wir verfolgen in diesem (...) Aufsatz das Ziel, die Erfahrungen der Betroffenen historisch aufzuarbeiten, wobei der medizinischen Versorgung besondere Aufmerksamkeit geschenkt wird. Wir stellen das Ausmaß der medizinischen Behandlung der Arbeiterinnen vor, deren Ziel primär die Wiederherstellung ihrer weiteren Arbeitsfähigkeit war. (shrink)

Between 1983 and 1990, at least 163 Western drugs were tested in the GDR. On the basis of archival documentation, relevant literature, and interviews we examined the clinical trials of five drugs more thoroughly; two of these individual case studies are introduced in this article. In the case of the clinical trials of the synthetic human growth hormone Saizen we found extensive trial and patient documentation, which allows for a detailed analysis of ethical aspects such as parent information and informed (...) patient consent. In the case of the clinical trials of the „abortion pill“ Mifepristone for the World Health Organization we uncovered irregularities with regard to the ethical evaluation. However, taken together, we could not find any serious violation of ethical norms in connection with our cases studies. (shrink)

Die Konzepte „Informationsmetabolismus“ von Antoni Kępiński und „Autopoiesis“ von Niklas Luhmann rekurrieren auf die Struktur biologischer Zellen. Beide Autoren übertragen diese biologischen Strukturen auf ihre jeweiligen Anwendungsfelder. Während Kępiński die Funktionsweise der Psyche zu bestimmen sucht, integriert Luhmann den biologischen Ansatz in seine Systemtheorie der lebenden und psychischen Systeme. Bei der Lektüre von Kępińskis und Luhmanns Arbeiten wird deutlich, dass beide Autoren das Verhältnis zwischen einerseits Psyche und andererseits psychischem System mit ihrer jeweiligen Umwelt näher bestimmen. In Luhmanns Werk ist (...) das Verhältnis zwischen System und Umwelt umfangreich beschrieben und ausgearbeitet. Vor diesem Hintergrund werden seine Ausführungen im Folgenden verwendet, um Kępińskis Überlegungen zum „Informationsmetabolismus“, dem Verhältnis von Psyche und Umwelt, zu reflektieren. (shrink)

In the GDR, women from the age of 12 onwards have been committed to closed venerology wards. The involuntarily committed had not been informed about the medical treatment on the wards; it was performed without their consent – impinging on their physical integrity. The closed venerology wards have been controlled by the Ministry of State Security. Unofficial employee reported to the Ministry on the medical personnel and on the patients on the wards. Due to this information the Ministry of State (...) Security knew at all times, what was taking place within the closed venerology ward in Halle and who was being compulsory admitted to this ward. The Ministry of State Security diversely used this information. Physicians were simultaneously involved as unofficial employees in operational processes against individual patients. (shrink)

In 1978 and 1979 around 6.770 women in the GDR were infected with the hepatitis C virus after they had received a contaminated Anti-D-Immunprophylaxis. This prophylaxis was used after delivery, abortion or miscarriage. Until September 1979 2.769 women came down with Hepatitis. The reaction of the state showed how closely medicine and politics were linked in the GDR and what kind of influence governmental decisions had on medical action. The state wanted to keep everything as a secret. The producer of (...) the Anti-D-Immunglobulin in the GDR was sentenced as a pawn sacrifice in a non-public trial. The Ministry of State Security was also involved. Many of the infected women were traumatized by not being informed what had happened and had to fight for recognition and compensation until today. (shrink)

German medical students are not sufficiently introduced to the ethical principles and pitfalls of scientific work. Therefore, a compulsory course on good scientific practice has been developed and implemented into the curriculum of medical students, with the goal to foster scientific integrity and prevent scientific misconduct. Students’ knowledge and attitudes towards GSP were evaluated by a pre-post-teaching questionnaire survey. Most participants initially had startling knowledge gaps in the field. Moreover, they were not acquainted with core institutions on GSP, the office (...) of ombudsperson and the nationally binding guidelines on GSP. The pre-post-teaching comparison showed statistically significant improvement in all areas tested; moreover, after the course participants confided more trust in GSP institutions. Applying ethical rules into practice can be challenging; therefore, students need to learn to work independently with guidelines on GSP and should be introduced to institutions providing further guidance. As our study has shown, students are very willing to pursue a scientific career based on integrity and honesty, however, they lack the knowledge how to do so. In light of our results, we therefore recommend to integrate courses on GSP already at an early time into the mandatory curriculum of medical students. (shrink)