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)

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)

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)

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)

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)

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)

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)

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)