Silke Schicktanz

Technological approaches are increasingly discussed as a solution for the provision of support in activities of daily living as well as in medical and nursing care for older people. The development and implementation of such assistive technologies for eldercare raise manifold ethical, legal, and social questions. The discussion of these questions is influenced by theoretical perspectives and approaches from medical and nursing ethics, especially the principlist framework of autonomy, non-maleficence, beneficence, and justice. Tying in with previous criticism, the present contribution is taking these principles as a starting point and as a frame of reference to be critically re-examined. It thus aims to outline how existing ethical frameworks need to be extended or reconsidered to capture the ethical issues posed by technological developments regarding care for older people. In a first step, we provide a brief overview of assistive technologies in eldercare according to their purposes and functions. In the next step, we discuss how the questions and problems raised by new technologies in eldercare call for an expansion, re-interpretation, and revision of the principlist framework. We underline that the inclusion of ethical perspectives from engineering and computer science as well as a closer consideration of socio-political dimensions and fundamental anthropological and praxeological questions are needed.

This volume presents the ethical implications of risk information as related to genetics and other health data for policy decisions at clinical, research and societal levels. Ethical, Social and Psychological Impacts of Genomic Risk Communication examines the introduction of new types of health risk information based on faster, cheaper and larger sets of genetic or genomic analysis. Synthesising the results of a five-year interdisciplinary project, it explores the unsolved ethical and social questions around the sharing of this data, such as: What is best practice in risk communication? What are the normative presumptions and ethical consequences of an increased individual responsibility for ones' health? And how does one deal with the gap between the knowledge of risk and the lack of therapeutic options which often exist for complex diseases, such as dementia or some types of cancer? Drawing on contributions from over twenty experts in the field, this collection examines these questions from a liberal bioethics' perspective, advocating for contextual and cultural-sensitive ethical discussions. This book will be of great interest to students and scholars of theoretical and clinical medical ethics, medical sociology, risk communication and ethics of risk, as well as professionals in clinical genetics.

Recent advances in biomarkers may soon make it possible to identify persons at high risk for late-onset Alzheimer’s disease at a presymptomatic stage. Popular demand for testing is increasing despite the lack of cure and effective prevention options and despite uncertainties regarding the predictive value of biomarker tests. This underscores the relevance of the ethical, cultural and social implications of predictive testing and the need to advance the bioethical debate beyond considerations of clinical consequences. Our qualitative study included three groups of affected persons: People with mild neurocognitive disorder, their relatives and family caregivers of people with dementia. We explored their moral motivations regarding predictive, biomarker-based testing and preclinical diagnostics. We interviewed affected individuals in Germany and Israel. Transcripts of 12 focus groups and 12 semistructured interviews were content analysed with a focus on the moral motivations of affected persons in their justification of why they accept or reject predictive testing and early diagnosis. We grouped the underlying aspects of moral motivation into four ethical categories: beneficence as a form of personal utility focusing on well-being, the ties of responsibility linking families and their individual members, the importance of self-determination by later life planning and notions of a good life. In general, cultural parallels among these motives were very obvious. Cultural variation occurred mainly in openness to suicide, scepticism about test validity and emphasis on personal autonomy. The study underscores the importance of counselling for life-planning issues and of informing test candidates about problems with test validity and about the ambiguity of test results. All data relevant to the study are included in the article or uploaded as supplementary information.

Assistive reproductive technologies are increasingly used to control the biology of fertility and its temporality. Combining historical, theoretical, and socio-empirical insights, this paper aims at expanding our understanding of the way temporality emerges and is negotiated in the contemporary practice of cryopreservation of reproductive materials. We first present an historical overview of the practice of cryo-fertility to indicate the co-production of technology and social constructions of temporality. We then apply a theoretical framework for analysing cryobiology and cryopreservation technologies as creating a new epistemic perspective interconnecting biology and temporality. Thereafter, we focus on the case of ‘social egg freezing’ to present socio-empirical findings illustrating different reproductive temporalities and their connection to the social acceptance of and expectations towards the practice. SEF is a particularly interesting case as it aims to enable women to disconnect their reproductive potential from their biological rhythms. Based on 39 open interviews with Israeli and German SEF users, the cross-cultural comparative findings reveal three types of attitudes: postponing motherhood/reproductive decisions ; singlehood and “waiting” for a partner ; and the planning of and hope for multiple children. For theory building, this analysis uncovers temporality formations embedded in gender and reproductive moral values; including the ‘extended present’, ‘waiting’, and ‘reproductive futurism’. We conclude by discussing the contribution of our findings by advancing the theoretical framework of ‘cryopolitics’ highlighting the theoretical implications and importance of gendered and cultural imaginaries constructing medical technological innovations and related temporalities.

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 require 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.

Unter dem Begriff ›Anti-Aging‹ wird seit etwa drei Jahrzehnten eine wachsende Anzahl medizinischer wie außermedizinischer Präparate bzw. Verfahren konzipiert, entwickelt und eingesetzt, die allgemein der Bekämpfung des Alterns dienen sollen. Die so genannte Anti-Aging-Medizin will in den Alterungsprozess des menschlichen Körpers eingreifen, um ihn zu verlangsamen, aufzuhalten oder rückgängig zu machen. Dabei variieren die konkreten Angriffspunkte, Vorgehensweisen und Zielsetzungen der einzelnen Ansätze durchaus beträchtlich.

This collection features comprehensive overviews of the various ethical challenges in organ transplantation. International readings well-grounded in the latest developments in the life sciences are organized into systematic sections and engage with one another, offering complementary views. All core issues in the global ethical debate are covered: donating and procuring organs, allocating and receiving organs, as well as considering alternatives. Due to its systematic structure, the volume provides an excellent orientation for researchers, students, and practitioners alike to enable a deeper understanding of some of the most controversial issues in modern medicine.

Slippery slope‐, taboo‐breaking‐ or Nazi‐analogy‐arguments are common, but not uncontroversial examples of the complex relationship between bioethics and the various ways of using historical arguments in these debates. In our analysis we examine first the relationship between bioethics and medical history both as separate disciplines and as argumentative practices. Secondly, we then analyse six common types of historical arguments in bioethics (slippery slope‐, analogy‐, continuity‐, knockout/taboo‐, ethical progress‐ and accomplice‐arguments), some as arguments within the academic debate of bioethics, others as arguments within political and public debates over bioethical issues. We conclude by suggesting to bioethicists to better understand historical arguments as socially and culturally embedded practices of critical reflection of power, medical and government paternalism and possible future scenarios. More interdisciplinarity between ethicists and medical historians is needed to appropriately rationalize and understand the different legacies.

Given the need for organs, public organizations use social marketing strategies to increase the number of donors. Their campaigns employ a variety of moral appeals. However, their effects on audiences are unclear. We identified 14 campaigns in Germany from over the last 20 years. Our approach combined a multimodal analysis of categorized posters with a qualitative analysis of responses, collected in interviews or focus groups, of 53 persons who were either skeptical or undecided about organ donation. The combined analyses revealed that the posters failed to motivate laypersons in general to donate, and were even less effective on skeptical or undecided individuals. We explain this in terms of the types of moral messages found on posters and the limits of such social marketing strategies. Furthermore, we discuss certain ethical aspects of organ donation campaigns pertaining to communicating norms and trust in public institutions.

Als Xenotransplantation werden medizinische Interventionen bezeichnet, die die Transplantation oder Infusion lebender tierischer Zellen, Gewebe oder Organe in den Menschen beinhalten. Der Begriff schließt auch all jene Maßnahmen ein, in denen menschliche Körperflüssigkeiten, Zellen, Gewebe oder Organe exvivo in Kontakt mit lebenden tierischen Zellen, Gewebe oder Organen kommen. Im weiteren Sinne steht der Begriff Xenotransplantation für jede Form von artenübergreifender Transplantation.Der in der biomedizinischen Forschung seit Ende der 1990er Jahre vorrangig verfolgte Ansatz der Xenotransplantation zielt darauf ab, Schweine als Organquelle für den Menschen zu gewinnen und solide Schweineorgane wie Niere, Herz und Leber auf den Menschen zu verpflanzen. Hierfür müssen die Schweine gentechnisch verändert werden. Darüber hinaus wurden in einigen Fällen exvivo Schweinelebern auch zur temporären Perfusion eingesetzt, um akutes Leberversagen bei Patientinnen und Patienten zu überbrücken. Weitere Ziele sind u. a. der Einsatz von eingekapselten Inselzellen von Schweinen in der Diabetestherapie oder der Einsatz von fötalen Nervenzellen aus Schweinen in der Behandlung von Parkinsonpatienten. Die Transplantation von inaktiven Materialien tierischen Ursprungs, wie z. B. Herzklappen von Schweinen, fällt nicht unter diese Definition, da sie kein lebendes Gewebe mehr sind.

This chapter gives a brief overview of the composition of the volume and explains why it is important to undertake a detailed scholarly analysis and comparison of the following ethico-legal regimes of surrogacy and egg donation: the permissive-unregulated but transitory regime of India; the permissive regime of Israel, although highly regulated by professional, medical and religious norms, and the extremely restrictive regime of Germany, being legally permeable for particular forms of cross-border reproductive practice despite the non-permissive national law. It uses an interdisciplinary lens to examine how the ethical, social, legal and cultural issues are interwoven in each regime. Moreover, we highlight the importance of a comparative analysis to understand how local developments cannot be isolated from each other, but deeply influence each other through transnational markets, modern media and the transfer of knowledge, people and body parts.

My following comparative analysis is based on two main questions: How can we best understand and describe the social practices of modern medicine in a particular cultural context? And: What can we learn for our moral thinking from such a comparative approach? I will answer these two questions by engaging the comprehensive studies from law, medical sociology/anthropology and ethics in this volume from three different cultural/national contexts: Germany, Israel and India in a fictional, comparative discourse. Hereby, I identify three cross-themes of surrogacy which I will discuss from a normative point of view: unsolved ethical concerns such as exploitation, child’s best interest and unethical motivations, a naturalised parenthood as global-cultural imperative, and the need for transnational discourses beyond relativism.

Background Biomarker research is gaining increasing attention focusing on the preclinical stages of the disease. Such interest requires special attention for communication and disclosure in clinical contexts. Many countries give dementia a high health policy priority by developing national strategies and by improving guidelines addressing disclosure of a diagnosis; however, risk communication is often neglected. Main text This paper aims to identify the challenges of disclosure in the context of dementia prediction and to find out whether existing clinical guidelines sufficiently address the issues of disclosing a dementia diagnosis and of disclosing the risk of developing dementia in asymptomatic and MCI stage. We will examine clinical guidelines and recommendations of three countries regarding predictive testing and diagnostic disclosure in dementia and Mild Cognitive Impairment to show their potentials and limits. This will provide a background to address ethical implications of predictive information and to identify ways how to proceed further. We will start by examining the guidelines and recommendations by focusing on what there is already and what is missing regarding the challenges of disclosing dementia prediction and MCI. Then, we will highlight the novel ethical issues generated by the shift to identify preclinical stages of the disease by biomarkers. We will argue for the need to develop guidelines for disclosing a risk status, which requires different considerations then disclosing a diagnosis of dementia. Finally, we will make some suggestions on how to address the gap and challenges raised by referring to German Stakeholder Conference, which presents us a good starting point to the applicability of involving stakeholders. Conclusions This paper underlines the need to develop empirically based guidelines that address the ethical and social strategies for risk communication of dementia prediction by genetic as well as non-genetic biomarkers. According to our analysis, the guidelines do not address the new developments sufficiently. International efforts should aim for specific guidelines on counseling, communicating risk and disclosing results. We argue that guidelines on disclosure should be developed by involving various stakeholders and should be informed by socio-empirical studies involving laypersons’ needs and wishes regarding risk communication.

This book is the first to bring together an interdisciplinary collection of essays on surrogacy and egg donation from three socially, legally and culturally distinct countries - India, Israel and Germany. It presents contributions from experts in the field of social and cultural sciences, bioethics, law as well as psychology and provides critical-reflective comparative analysis of the socio-ethical factors shaping surrogacy and egg donation practices across these three countries. This book highlights the importance of a comparative perspective to ‘make sense’ of controversies and transitions in this highly contested area of artificial reproductive technologies. It demonstrates how local developments cannot be isolated from global events and vice versa. Therefore, this volume can be used as a standard reference for anyone seeking to understand surrogacy and egg donation from a macro-perspective in the next decade.

Background: Several countries have recently changed their model of consent for organ donation from opt-in to opt-out. We undertook a systematic review to determine public knowledge and attitudes towards these models in Europe. Methods: Six databases were explored between 1 January 2008 and 15 December 2017. We selected empirical studies addressing either knowledge or attitudes towards the systems of consent for deceased organ donation by lay people in Europe, including students. Study selection, data extraction, and quality assessment were conducted by two or more reviewers independently. Findings: Awareness of the consent model was lower in opt-out countries than in opt-in countries. A majority of the public agrees with opt-in, regardless of the law in their own country. There are ambivalent attitudes regarding the opt-out system. The public tend to prefer opt-in and mandatory choice over opt-out when several options are offered. Interpretation: The assumption that people in opt-out countries are aware of the legal requirements to be excluded from the pool of potential donors is not supported by the results of this review. This is a concern, since ignorance hinders people's autonomy regarding organ donation decision-making. Higher awareness of consent model in opt-in countries may reflect greater efforts to inform the public through campaigns to motivate donation. Legal moves towards opt-out are at odds with people's expressed preferences. Main limitations of this review are the lack of data from some countries, study population heterogeneity, and methodological shortcomings.

Patient organizations are increasingly involved in national and international bioethical debates and health policy deliberations. In order to examine how and to what extent cultural factors and organizational contexts influence the positions of patient organizations, this study compares the positions of German and Israeli patient organizations (POs) on issues related to end-of-life medical care. We draw on a qualitative pilot study of thirteen POs, using as a unit of analysis pairs comprised of one German PO and one Israeli PO that were matched on the basis of organizational category. Bioethical positions that emanated from the interviews concerned advance directives—general views, recent legal framework, and formalization; as well as active and passive euthanasia, withholding and withdrawing of treatment, and physician-assisted suicide. In addition to the unifying, within-country impact of cultural factors, we found that constituency-based organizations and partner organizations in both countries often share common views, whereas disease-based support organizations have very heterogeneous positions. We conclude by discussing how organizational contexts provide a source of uniformity as well as diversity in the positions of POs

ZusammenfassungDas Paradigma einer „personalisierten Medizin“ in der klinischen Forschung und Praxis wirft verschiedene Fragen nach Notwendigkeit, Erwartung, Chancen und Risiken auf. In einer laufenden empirisch-ethischen Studie untersuchen wir klinische Forscher- und Patientenperspektiven hinsichtlich des zukünftigen Einsatzes „personalisierter Medizin“ beim Rektumkarzinom. Ziel der Studie ist es, mittels Interviews mit Ärzten/forschern und Patienten und teilnehmender Beobachtung bei Arzt-Patient-Gesprächen ethisch relevante Aspekte der Erforschung und Behandlung im Kontext „personalisierter Medizin“ zu explorieren. Die Analyse von Unterschieden und Gemeinsamkeiten zwischen den Gruppierungen dient der Detektion von Konfliktfeldern in der klinischen Praxis. Es zeigt sich, dass Patienten und Ärzte unterschiedliche Annahmen von „personalisierter Medizin“ haben. Dies könnte zu Konflikten in der klinischen Praxis führen, die so früh wie möglich geklärt werden sollten.

Der Beitrag analysiert Techniken öffentlicher Gesundheitskommunikation und skizziert im Ausblick Minimalbedingungen für ihre ethische Vertretbarkeit. Dazu wird erstens an einem aktuellen Beispiel veranschaulicht, wie mittels Text und Bild die Öffentlichkeit überzeugt werden soll, ein bestimmtes Gesundheitsverhalten an den Tag zu legen. Zweitens werden anhand der internationalen Ethik-Debatte fünf Grundtypen von Techniken in der Gesundheitskommunikation (Information, Argumentation, Persuasion, Manipulation und Zwang) rekonstruiert und entlang von Mittel, Zweck, Folgen für Adressaten sowie Implikationen für Autonomie aus ethischer Sicht unterschieden. Am besonders ambivalenten Beispiel der Persuasion wird dann drittens diskutiert, welche ethischen Fallstricke es bei Gesundheitskommunikation zu bedenken gibt. Schließlich zeigen wir argumentativ auf, dass es in sensiblen bioethischen Themenfeldern wichtig ist, zwischen verschiedenen Techniken der Gesundheitskommunikation analytisch zu differenzieren. Ziel sollte die Ermöglichung einer fairen und transparenten Diskussion für breite Bevölkerungsgruppen sein.

This paper analyses self-declared aims and representation of dementia patient organizations and advocacy groups in relation to two recent upheavals: the critique of social stigmatization and biomedical research focusing on prediction. Based on twenty-six semi-structured interviews conducted in 2016–2017 with members, service recipients, and board representatives of POs in Germany and Israel, a comparative analysis was conducted, based on a grounded theory approach, to detect emerging topics within and across the POs and across national contexts. We identified a heterogeneous landscape, with the only Israeli PO focusing strongly on caretakers, whereas in Germany several POs claim to represent this patient collective. Shared aims of all POs were fighting social stigma, balancing the loss of patients’ individual autonomy, and the well-being of caretakers. By highlighting the emergence of new groups of dementia self-advocacy against the more traditional advocacy by others, this study highlights how advocacy and representation in the context of AD are embedded in the discursive context of stigmatization and revised disease conception. Future developments in early diagnosis and prediction of dementia, with more affected people likely to conduct dementia self-advocacy, might challenge existing representation structures even more.

Healthcare collectives, such as patient organizations, advocacy groups, disability organizations, professional associations, industry advocates, social movements, and health consumer organizations have been increasingly involved in healthcare policymaking. Such collectives are based on the idea that individual interests can be aggregated into collective interests by participation, deliberation, and representation. The topic of collectivity in healthcare, more specifically collective representation, has only rarely been addressed in bioethics. This symposium, entitled: “Collective Representation in Healthcare Policy” of the Journal of Bioethical Inquiry draws attention to this understudied topic from a variety of disciplines, within a variety of socio-cultural contexts. We draw attention to important ethical, cultural, and social questions, and into the practices, justifications for, and implications of collective representation of patients in healthcare policy.

The acquisition of genetic information (GI) confronts both the affected individuals and healthcare providers with difficult, ambivalent decisions. Genetic responsibility (GR) has become a key concept in both ethical and socioempirical literature addressing how and by whom decision-making with respect to the morality of GI is approached. However, despite its prominence, the precise meaning of the concept of GR remains vague. Therefore, we conducted a systematic literature review on the usage of the concept of GR in qualitative, socioempirical studies, to identify the main interpretations and to provide conceptual clarification. The review identified 75 studies with primarily an Anglo-American setting. The studies focused on several agents: the individual, the family, the parent, the healthcare professional, and the institution and refer to the concept of GR on the basis of either a rational/principle-oriented approach or an affective/relational approach. A subtype of the rational/principle-oriented approach is the reactive approach. The review shows how the concept of GR is useful for analyzing and theorizing about socioempirical findings within qualitative socioempirical studies and also reveals conceptual deficits in terms of insufficient theoretical accuracy and heterogeneity, and in the rarity of reflection on cultural variance. The vagueness and multiplicity of meanings for GR in socioempirical studies can be avoided by more normative-theoretical explication of the underlying premises. This would provide a higher degree of differentiation of empirical findings. Thereby, the complex findings associated with the individual and social implications of genetic testing in empirical studies can be better addressed from a theoretical point of view and can subsequently have a stronger impact on normative and policy debates.

In clinical research – whether pharmaceutical, genetic or biomarker research – it is important to protect research participants’ autonomy and to ensure or strengthen their control over health-related decisions. Empirical–ethical studies have argued that both the ethical concept and the current legalistic practice of informed consent should be adapted to the complexity of the clinical environment. For this, a better understanding of recruitment, for which also the physician–patient relationship plays an important role, is needed. Our aim is to ethically reflect communication processes by identifying patterns used by physicians to motivate patients’ participation in clinical research and to assess whether patients also use these patterns in formulating their own research motivation. We conducted a secondary analysis with empirical data from a research project involving physicians and patients in a clinical research setting of a biomarker study for rectal cancer treatment. Our empirical data included observations of physician–patient consultations ( n = 54) and semi-structured interviews with patients ( n = 40). Overall, we collected 93 interviews. We found two dominant communication patterns, which physicians applied for motivating patients to take part in this research study. Some forms of these patterns tend to mislead patients’ understanding, while others could justifiably be applied in this consultation setting without undermining patients’ autonomy. This insight that the physician–patient communication has a strong influence on patients increases the importance to strengthen physicians’ ethically acceptable communication patterns regarding research participation. We further suggest that there is a need for a critical reflection of the ethics committee’s requirements for information regarding research participation.

Commercial genetic testing offered over the internet, known as direct-to-consumer genetic testing (DTC GT), currently is under ethical attack. A common critique aims at the limited validation of the tests as well as the risk of psycho-social stress or adaption of incorrect behavior by users triggered by misleading health information. Here, we examine in detail the specific role of advertising communication of DTC GT companies from a medical ethical perspective. Our argumentative analysis departs from the starting point that DTC GT operates at the intersection of two different contexts: medicine on the one hand and the market on the other. Both fields differ strongly with regard to their standards of communication practices and the underlying normative assumptions regarding autonomy and responsibility. Following a short review of the ethical contexts of medical and commercial communication, we provide case examples for persuasive messages of DTC GT websites and briefly analyze their design with a multi-modal approach to illustrate some of their problematic implications. We observe three main aspects in DTC GT advertising communication: (1) the use of material suggesting medical professional legitimacy as a trust-establishing tool, (2) the suggestion of empowerment as a benefit of using DTC GT services and (3) the narrative of responsibility as a persuasive appeal to a moral self-conception. While strengthening and respecting the autonomy of a patient is the focus in medical communication, specifically genetic counselling, persuasive communication is the normal mode in marketing of consumer goods, presuming an autonomous, rational, independent consumer. This creates tension in the context of DTC GT regarding the expectation and normative assessment of communication strategies. Our analysis can even the ground for a better understanding of ethical problems associated with intersections of medical and commercial communication and point to perspectives of analysis of DTC GT advertising.

Direct-to-consumer genetic testing 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 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.

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low- -income countries – summarized as transnational biomedical research – has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV-vaccine-trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre-assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects.