Scarce resources, public health and professional care: the COVID-19 pandemic exacerbating bioethical conflicts - findings from global qualitative expert interviews.

BACKGROUND: Since spring 2020, the SARS-CoV-2 virus has spread worldwide, causing dramatic global consequences in terms of medical, care, economic, cultural and bioethical dimensions. Although the resulting conflicts initially appeared to be quite similar in most countries, a closer look reveals a country-specific intensification and differentiation of issues. Our study focused on understanding and highlighting bioethical conflicts that were triggered, exposed or intensified by the COVID-19 pandemic in low and middle-income countries (LMICs) and high-income countries (HICs). METHODS: We conducted qualitative interviews with 39 ethics experts from 34 countries (Argentina, Australia, Austria, Brazil, Canada, Colombia, Denmark, Ecuador, Ethiopia, France, Germany, India, Italy, Israel, Japan, Kyrgyzstan, Mexico, Nigeria, Oman, Pakistan, Paraguay, Poland, Romania, Russia, Singapore, South Korea, Spain, Sweden, South Africa, Tunisia, Türkiye, United-Kingdom, United States of America, Zambia) from November 2020 to March 2021. We analysed the interviews using qualitative content analysis. RESULTS: The scale of the bioethical challenges between countries differed, as did coping strategies for meeting these challenges. Data analysis focused on: a) Resource scarcity in clinical contexts: Scarcity of medical resources led to the need to prioritize the care of some COVID-19 patients in clinical settings globally. Because this entails the postponement of treatment for other patients, the possibility of serious present or future harm to deprioritized patients was identified as a relevant issue. b) Health literacy: The pandemic demonstrated the significance of health literacy and its influence on the effective implementation of health measures. c) Inequality and vulnerable groups: The pandemic highlighted the context-sensitivity and intersectionality of the vulnerabilities of women and children in LMICs and the aged in HICs. d) Conflicts surrounding healthcare professionals: The COVID-19 outbreak underscored the tough working conditions for nurses and other health professionals, raising awareness of the need for reform. CONCLUSION: The pandemic exposed pre-existing structural problems in LMICs and HICs. Without neglecting individual contextual factors in the observed countries, we created a mosaic of different voices of experts in bioethics across the globe, drawing attention to the need for international solidarity in the context of a global crisis.

Mapping trust relationships in organ donation and transplantation: a conceptual model.

The organ donation and transplantation (ODT) system heavily relies on the willingness of individuals to donate their organs. While it is widely believed that public trust plays a crucial role in shaping donation rates, the empirical support for this assumption remains limited. In order to bridge this knowledge gap, this article takes a foundational approach by elucidating the concept of trust within the context of ODT. By examining the stakeholders involved, identifying influential factors, and mapping the intricate trust relationships among trustors, trustees, and objects of trust, we aim to provide a comprehensive understanding of trust dynamics in ODT. We employ maps and graphs to illustrate the functioning of these trust relationships, enabling a visual representation of the complex interactions within the ODT system. Through this conceptual groundwork, we pave the way for future empirical research to investigate the link between trust and organ donation rates, informed by a clarified understanding of trust in ODT. This study can also provide valuable insights to inform interventions and policies aimed at enhancing organ donation rates.

[Nursing ethics and the mandate of care-current limits using the example of inpatient care for the elderly]. / Pflegeethik und der Auftrag der Pflege ­ Gegenwärtige Grenzen am Beispiel der stationären Altenpflege.

The central guiding ethical principles of professional care are dignity, care, justice, and respect. The current framework conditions and circumstances in the care of the elderly mean that professional care ethics are no longer feasible in many cases. This leads not only to enormous (moral) burdens among the nursing staff, but also to a comprehensive degree to professional dissatisfaction and to leaving the profession. The term "Pflexit" (based on the German word "Pflege" = care) was first raised during the corona pandemic and has not faded. In order to ensure ethically justified and dignified care for the elderly that is also oriented towards human rights, as is conveyed politically in charters and rightly expected by people in need of care, rapid and comprehensive social and political intervention is required.In this context, dignity and respect are also a social mandate. Dignified professional care based on ethical values can only be implemented if nurses are shown this same respect. The clear warnings of a "nursing climate crisis" must finally be followed by action to stop the exodus from the profession. In this discussion paper, the importance of a professional care ethic is first explained. In a second step, the framework and current problems that oppose a comprehensive implementation of core values in nursing care for the elderly are highlighted. The focus here is on the effects of the precarious personnel situation.

Attitudes of European students towards family decision-making and the harmonisation of consent systems in deceased organ donation: a cross-national survey.

BACKGROUND: European countries are increasingly harmonising their organ donation and transplantation policies. Although a growing number of nations are moving to presumed consent to deceased organ donation, no attempts have been made to harmonise policies on individual consent and the role of the family in the decision-making process. Little is known about public awareness of and attitudes towards the role of the family in their own country and European harmonisation on these health policy dimensions. To improve understanding of these issues, we examined what university students think about the role of the family in decision-making in deceased organ donation and about harmonising consent policies within Europe. METHODS: Using LimeSurvey© software, we conducted a comparative cross-sectional international survey of 2193 university students of health sciences and humanities/social sciences from Austria (339), Belgium (439), Denmark (230), Germany (424), Greece (159), Romania (190), Slovenia (190), and Spain (222). RESULTS: Participants from opt-in countries may have a better awareness of the family's legal role than those from opt-out countries. Most respondents opposed the family veto, but they were more ambivalent towards the role of the family as a surrogate decision-maker. The majority of participants were satisfied with the family's legal role. However, those who were unsatisfied preferred to limit family involvement. Overall, participants were opposed to the idea of national sovereignty over consent policies. They favoured an opt-out policy harmonisation and were divided over opt-in. Their views on harmonisation of family involvement were consistent with their personal preferences. CONCLUSIONS: There is overall division on whether families should have a surrogate role, and substantial opposition to granting them sole authority over decision-making. If European countries were to harmonise their policies on consent for organ donation, an opt-out system that grants families a surrogate decision-making role may enjoy the widest public support.

My Data, My Choice? - German Patient Organizations' Attitudes towards Big Data-Driven Approaches in Personalized Medicine. An Empirical-Ethical Study.

Personalized medicine (PM) operates with biological data to optimize therapy or prevention and to achieve cost reduction. Associated data may consist of large variations of informational subtypes e.g. genetic characteristics and their epigenetic modifications, biomarkers or even individual lifestyle factors. Present innovations in the field of information technology have already enabled the procession of increasingly large amounts of such data ('volume') from various sources ('variety') and varying quality in terms of data accuracy ('veracity') to facilitate the generation and analyzation of messy data sets within a short and highly efficient time period ('velocity') to provide insights into previously unknown connections and correlations between different items ('value'). As such developments are characteristics of Big Data approaches, Big Data itself has become an important catchphrase that is closely linked to the emerging foundations and approaches of PM. However, as ethical concerns have been pointed out by experts in the debate already, moral concerns by stakeholders such as patient organizations (POs) need to be reflected in this context as well. We used an empirical-ethical approach including a website-analysis and 27 telephone-interviews for gaining in-depth insight into German POs' perspectives on PM and Big Data. Our results show that not all POs are stakeholders in the same way. Comparing the perspectives and political engagement of the minority of POs that is currently actively involved in research around PM and Big Data-driven research led to four stakeholder sub-classifications: 'mediators' support research projects through facilitating researcher's access to the patient community while simultaneously selecting projects they preferably support while 'cooperators' tend to contribute more directly to research projects by providing and implemeting patient perspectives. 'Financers' provide financial resources. 'Independents' keep control over their collected samples and associated patient-related information with a strong interest in making autonomous decisions about its scientific use. A more detailed terminology for the involvement of POs as stakeholders facilitates the adressing of their aims and goals. Based on our results, the 'independents' subgroup is a promising candidate for future collaborations in scientific research. Additionally, we identified gaps in PO's knowledge about PM and Big Data. Based on these findings, approaches can be developed to increase data and statistical literacy. This way, the full potential of stakeholder involvement of POs can be made accessible in discourses around PM and Big Data.

"I would rather have it done by a doctor"-laypeople's perceptions of direct-to-consumer genetic testing (DTC GT) and its ethical implications.

Direct-to-consumer genetic testing (DTC GT) has been available for several years now, with varying degrees of regulation across different countries. Despite a restrictive legal framework it is possible for consumers to order genetic tests from companies located in other countries. However, German laypeople's awareness and perceptions of DTC GT services is still unexplored. We conducted seven focus groups (participants n = 43) with German laypeople to explore their perceptions of and attitudes towards commercial genetic testing and its ethical implications. Participants were critical towards DTC GT. Criticism was directed at health-related, predictive testing, while lifestyle tests were accepted and even welcomed to some extent. Participants expressed strong reservations regarding commercial provision of genetic diagnostics and expressed a lack of trust in respective companies. They preferred non-commercial distribution within the public healthcare system. Participants also expressed high expectations of physicians' abilities to interpret information obtained via DTC GT companies and provide counseling. Legal restrictions on commercial distribution of genetic tests were opposed, with participants arguing that it should be available to consumers. DTC GT companies are not perceived as trustworthy when compared to the public healthcare system and its professional ethical standards and practices. Laypeople rated general consumer autonomy higher than their own concerns, thus recommending against strong legal regulation. We conclude that medicine's trustworthiness may be negatively affected if commercial provision is not visibly opposed by the medical professions, while DTC GT companies may gain in trustworthiness if they adapt to standards and practices upheld in medicine.

Impact of gender and professional education on attitudes towards financial incentives for organ donation: results of a survey among 755 students of medicine and economics in Germany.

BACKGROUND: There is an ongoing expert debate with regard to financial incentives in order to increase organ supply. However, there is a lacuna of empirical studies on whether citizens would actually support financial incentives for organ donation. METHODS: Between October 2008 and February 2009 a quantitative survey was conducted among German students of medicine and economics to gain insights into their point of view regarding living and deceased organ donation and different forms of commercialization (n = 755). RESULTS: The average (passive) willingness to donate is 63.5% among medical students and 50.0% among students of economics (p = 0.001), while only 24.1% of the respondents were actually holding an organ donor card. 11.3% of students of economics had signed a donor card, however, the number is significantly higher among students of medicine (31.9%, p < 0.001). Women held donor cards significantly more often (28.6%) than men (19.4%, p = 0.004). The majority of students were against direct payments as incentives for deceased and living donations. Nevertheless, 37.5% of the respondents support the idea that the funeral expenses of deceased organ donors should be covered. Women voted significantly less often for the coverage of expenses than men (women 31.6%, men 44.0%, p = 0.003). The number of those in favor of allowing to sell one's organs for money (living organ donation) was highest among students of economics (p = 0.034). CONCLUSION: Despite a generally positive view on organ donation the respondents refuse to consent to commercialization, but are in favor of removing disincentives or are in favor of indirect models of reward.

Research across the disciplines: a road map for quality criteria in empirical ethics research.

BACKGROUND: Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. DISCUSSION: While empirical and normative-ethical research projects have quality criteria in their own right, we focus on the specific quality criteria for EE research. We develop a tentative list of quality criteria--a "road map"--tailored to interdisciplinary research in EE, to guide assessments of research quality. These quality criteria fall into the categories of primary research question, theoretical framework and methods, relevance, interdisciplinary research practice and research ethics and scientific ethos. SUMMARY: EE research is an important and innovative development in bioethics. However, a lack of standards has led to concerns about and even rejection of EE by various scholars. Our suggested orientation list of criteria, presented in the form of reflective questions, cannot be considered definitive, but serves as a tool to provoke systematic reflection during the planning and composition of an EE research study. These criteria need to be tested in different EE research settings and further refined.

Public perceptions of predictive testing for rheumatoid arthritis compared to breast cancer and early-onset Alzheimer's disease: a qualitative study.

BACKGROUND: There is increasing research focus on prediction and prevention of rheumatoid arthritis (RA). Information about risk of RA is increasingly available via direct-to-consumer testing. However, there is limited understanding of public perceptions around predictive testing for RA. This study explores public perceptions of predictive testing for RA in comparison to breast cancer (BC) and early-onset Alzheimer's disease (AD). METHODS: Four focus groups with 21 members of the public were conducted using hypothetical vignettes about predictive testing for each disease. Transcripts of focus group proceedings were analysed inductively using thematic analysis. RESULTS: Thematic analysis of the data produced three key themes: decision-making factors, consequences, and consumer needs. Factors suggested that might influence decision-making about predictive testing included family history, fear, and perceived severity and treatability of the illness. RA was perceived to be less severe and more treatable than BC/AD. Potential consequences of predictive testing across all diseases included lifestyle modification, planning for the future and discrimination by employers or insurers. Predictive testing for RA was perceived to have less potential for negative psychological consequences than other diseases. Participants highlighted that individuals undertaking predictive testing should be signposted to appropriate support services and receive information on the accuracy of predictive testing. It was suggested that strategies to mitigate concerns regarding communication and confidentiality of risk results are required. CONCLUSIONS: The findings of this study reflect public misunderstandings regarding RA that may impact the uptake of and responses to predictive testing, and key informational needs of individuals considering a predictive test. Predictive strategies should be accompanied by awareness-raising initiatives and informational resources.

Should the family have a role in deceased organ donation decision-making? A systematic review of public knowledge and attitudes towards organ procurement policies in Europe.

GOAL: To assess public knowledge and attitudes towards the family's role in deceased organ donation in Europe. METHODS: A systematic search was conducted in CINHAL, MEDLINE, PAIS Index, Scopus, PsycINFO, and Web of Science on December 15th, 2017. Eligibility criteria were socio-empirical studies conducted in Europe from 2008 to 2017 addressing either knowledge or attitudes by the public towards the consent system, including the involvement of the family in the decision-making process, for post-mortem organ retrieval. Screening and data collection were performed by two or more independent reviewers for each record. RESULTS: Of the 1482 results, 467 studies were assessed in full-text form, and 33 were included in this synthesis. When the deceased has not expressed any preference, a majority of the public support the family's role as a surrogate decision-maker. When the deceased expressly consented, the respondents' answers depend on whether they see themselves as potential donors or as a deceased's next-of-kin. Answers also depend on the relationship between the deceased and the decision-maker(s) within the family, and on their ethnic or cultural background. CONCLUSIONS: Public views on the authority of the family in organ donation decision-making requiere further research. A common conceptual framework and validated well-designed questionnaires are needed for future studies. The findings should be considered in the development of Government policy and guidance regarding the role of families in deceased organ donation.

Governance quality indicators for organ procurement policies.

BACKGROUND: Consent policies for post-mortem organ procurement (OP) vary throughout Europe, and yet no studies have empirically evaluated the ethical implications of contrasting consent models. To fill this gap, we introduce a novel indicator of governance quality based on the ideal of informed support, and examine national differences on this measure through a quantitative survey of OP policy informedness and preferences in seven European countries. METHODS: Between 2017-2019, we conducted a convenience sample survey of students (n = 2006) in Austria (AT), Belgium (BE), Denmark (DK), Germany (DE), Greece (GR), Slovenia (SI) and Spain (ES), asking participants about their donation preferences, as well as their beliefs and views about the policy in place. From these measures, we computed indices of informedness, policy support, and fulfilment of unexpressed preferences, which we compared across countries and consent systems. RESULTS: Our study introduces a tool for analyzing policy governance in the context of OP. Wide variation in policy awareness was observed: Most respondents in DK, DE, AT and BE correctly identified the policy in place, while those in SI, GR and ES did not. Respondents in opt-out countries (AT, BE, ES and GR) tended to support the policy in place (with one exception, i.e., SI), whereas those in opt-in countries (DE and DK) overwhelmingly opposed it. These results reveal stark differences in governance quality across countries and consent policies: We found a preponderance of informed opposition in opt-in countries and a general tendency towards support-either informed or uninformed-in opt-out countries. We also found informed divergence in opt-in countries and a tendency for convergence-either informed or uninformed-among opt-out countries. CONCLUSION: Our study offers a novel tool for analyzing governance quality and illustrates, in the context of OP, how the strengths and weaknesses of different policy implementations can be estimated and compared using quantitative survey data.

German and Italian Users of Web-Accessed Genetic Data: Attitudes on Personal Utility and Personal Sharing Preferences. Results of a Comparative Survey (n=192).

Genetic information is increasingly provided outside of the traditional clinical setting, allowing users to access it directly via specialized online platforms. This development is possibly resulting in changing ethical and social challenges for users of predictive genetic tests. Little is known about the attitudes and experiences of users of web-accessed genetic information. This survey analyzes data from two European countries with regard to the utility of genetic information, the users' ways of making use of and dealing with information, and their sharing behavior. Particular focus is given to ethical and social questions regarding the motivation to share personal genetic results with others. Social factors tested for are national background, gender, and marital, parental, and educational status. This study will contribute to public discourse and offer ethical recommendations. The study will also serve to validate the developed questionnaire for use in population representative surveys.

An ethical comparison of living kidney donation and surrogacy: understanding the relational dimension.

BACKGROUND: The bioethical debates concerning living donation and surrogacy revolve around similar ethical questions and moral concepts. Nevertheless, the ethical discourses in both fields grew largely isolated from each other. METHODS: Based on a review of ethical, sociological and anthropological research this paper aims to link the ethical discourses on living kidney donation and surrogacy by providing a comparative analysis of the two practices' relational dimension with regard to three aspects, i.e. the normative role of relational dynamics, social norms and gender roles, and reciprocity. Based on this analysis, we derive conclusions for the framing of living organ donation and surrogacy in ethical theory and practice. RESULTS: First, our analysis emphasizes the relevance of acknowledging the complex relational implications of living kidney donation and surrogacy. Underestimating this relational dimension may not only lead to individual crises but endanger existing as well as newly emerging familial relationships. Second, we point out differences in the normative assessment of social norms and gender roles in the ethical debates about living kidney donation and surrogacy. In particular, we show how different evaluations of altruism affect the understanding of autonomy in both contexts. In addition, we sensitize for biased perceptions of gender roles. Finally, we argue that challenges resulting from unresolved reciprocity are an issue in living kidney donation and surrogacy independent of whether the exchange of body parts or bodily services is framed as a gift or commercial exchange. By pointing out the limits of financial compensation, we stress the relevance of non-material, relational rewards as potential remedy.

How Uncertainty Influences Lay People's Attitudes and Risk Perceptions Concerning Predictive Genetic Testing and Risk Communication.

The interpretation of genetic information in clinical settings raises moral issues about adequate risk communication and individual responsibility about one's health behavior. However, it is not well-known what role numeric probabilities and/or the conception of disease and genetics play in the lay understanding of predictive genetic diagnostics. This is an important question because lay understanding of genetic risk information might have particular implications for self-responsibility of the patients. Aim: Analysis of lay attitudes and risk perceptions of German lay people on genetic testing with a special focus on how they deal with the numerical information. Methods: We conducted and analyzed seven focus group discussions (FG) with lay people (n = 43). Results: Our participants showed a positive attitude toward predictive genetic testing. We identified four main topics: (1) Anumeric risk instead of statistical information; (2) Treatment options as a factor for risk evaluation; (3) Epistemic and aleatory uncertainty as moral criticism; (4) Ambivalence as a sign of uncertainty. Conclusion: For lay people, risk information, including the statistical numeric part, is perceived as highly normatively charged, often as an emotionally significant threat. It seems necessary to provide lay people with a deeper understanding of risk information and of the limitations of genetic knowledge with respect to one's own health responsibility.

Organizations Towards "Big Data"-Driven Approaches in Personalized Medicine? An Empirical-Ethical Study in Health-Related IT.

Personalized medicine (PM) operates with sensitive biological data to optimize prevention and therapy. Therefore, ethical concerns by stakeholders such as patient organizations (POs) need to be reflected. We used an empirical-ethical approach including a website-analysis and 30 telephone-interviews for gaining in-depth insight into POs attitudes towards PM and Big Data. Three different types of stakeholder commitment can be derived from our data: 'Biomaterial donors' support research projects through tissue donation while 'financers' provide financial aid. The 'independent' keep control over their tissue donations and decide what it is used for. Our insights allow to shape future innovations in IT towards stakeholder's needs.