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)

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)

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)

Introduction: There is currently no binding, internationally accepted and successful approach to ensure global equitable access to healthcare during a pandemic. The aim of this ethical analysis is to bring into the discussion a legally regulated vaccine allocation as a possible strategy for equitable global access to vaccines. We focus our analysis on COVAX (COVID-19 Vaccines Global Access) and an existing EU regulation that, after adjustment, could promote global vaccine allocation. -/- Methods: The main documents discussing the two strategies are (...) examined with a qualitative content analysis. The ethical values reasonableness, openness and transparency, inclusiveness, responsiveness and accountability serve as categories for our ethical analysis. -/- Results: We observed that the decision-making processes in a legal solution to expand access to vaccines would be more transparent than in COVAX initiative, would be more inclusive, especially of nation states, and the values responsiveness and accountability could be easily incorporated in the development of a new regulation. -/- Discussion: A legal strategy that offers incentives to the pharmaceutical industry in return for global distribution of vaccines according to the Fair Priority Model is an innovative way to achieve global and equitable access to vaccines. However, in the long term, achieving the Sustainable Development Goals will require from all nations to work in solidarity to find durable solutions for global vaccine research and development. Interim solutions, such as our proposed legal strategy for equitable access to vaccines, and efforts to find long-term solutions must be advanced in parallel. (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)

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)

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)

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)

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 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)