Over the last two decades, there was an upsurge of research and innovation in biotechnology and related fields, leading to exciting new discoveries in areas such as the engineering of biological processes, gene editing, stem cell research, CRISPR-Cas9 technology, Synthetic Biology, recombinant DNA, LMOs and GMOs, to mention only a few. At the same time, these advances generated concerns about biosafety, biosecurity and adverse impacts on biodiversity and the environment, leading to the establishment of Research Ethics Committees (RECs) at Higher (...) Education and Research Institutions dedicated to reviewing research with implications for biosafety and the environment. -/- These Biosafety and Environment Research Ethics Committees, referred to as EBRECs, are in the early stages of their establishment and formalisation, and there is much uncertainty about their composition, scope, procedures of decision-making and the principles that should guide their deliberations and assessments. In many respects, EBRECs are venturing into uncharted territory, facing a very wide range of complex research fields, far-reaching research practices and deep concerns new to Review Boards, raising the question to what extent EBRECs can fall back on the fairly well-established principles and procedures of RECs focusing on Human, Health or Animal research, and to what extent they need new or adapted principles and procedures. -/- Against this background, I set out to answer the following three main research questions in this thesis: 1. What is the current state of ethical principles for ethics reviews in the field of environmental and biosafety research ethics? Which principles are currently used in this context, and how? 2. What are the shortcomings of the current principles used by EBRECs and how can they be overcome? 3. What ethical principles must be adopted by environmental and biosafety research ethics committees and guide them in their decision-making? -/- In order to prepare the ground and set the scene for my discussion of these questions, I also formulated four supporting research questions: i. What is environmental research ethics in action? ii. What is biosafety research ethics in action? iii. How are environmental and biosafety ethics related to one another? iv. How should the guidelines and ethical principles related to these two overlapping fields be implemented in the ethics review process? Following my introduction and problem statement in Chapter 1, I devoted Chapters 2 and 3 to an overview of my supporting questions to set the scene for Environmental and Biosafety Research Ethics. In Chapter 4, I turned to my main research question with a discussion of national and international declarations, frameworks and legislation and an investigation of principles in the different research areas to get a picture of applicable principles that can guide EBRECs. -/- The main finding of my thesis is that due to the complexity of EBR, different categories of principles could be the solution for EBRECs. I elaborate on this in Chapter 5, my concluding chapter, in which I also propose a list of core principles that can serve as an accessible and easy-to-use guide for EBRECs in their decision-making. In this proposal, I cluster different kinds of principles in terms of four categories: 1. Principles as a Moral Concept 2. Principles as a Social Concept 3. Principles as a Legal Concept 4. Principles as a Safety Concept . (shrink)

Bioethics became applied ethics when it was assimilated to moral philosophy. Because deduction is the rationality of moral philosophy, subsuming facts under moral principles to deduce conclusions about what ought to be done became the prescribed reasoning of bioethics, and bioethics became a theory comprised of moral principles. Bioethicists now realize that applied ethics is too abstract and spare to apprehend the specificity, particularity, complexity and contingency of real moral issues. Empirical ethics and contextual ethics are needed to incorporate these (...) features into morality, not just bioethics. The relevant facts and features of problems have to be identified, investigated and framed coherently, and potential resolutions have to be constructed and assessed. Moreover, these tasks are pursued and melded within manifold contexts, for example, families, work and health care systems, as well as societal, economic, legal and political backgrounds and encompassing worldviews. This naturalist orientation and both empirical ethics and contextual ethics require judgment, but how can judgment be rational? Rationality, fortunately, is more expansive than deductive reasoning. Judgment is rational when it emanates from a rational process of deliberation, and a process of deliberation is rational when it uses the resources of non-formal reason: observation, creative construction, formal and informal reasoning methods and systematic critical assessment. Empirical ethics and contextual ethics recognize that finite, fallible human beings live in complex, dynamic, contingent worlds, and they foster creative, critical deliberation and employ non-formal reason to make rational moral judgments. (shrink)

Advance directives for withholding life-saving treatment are controversial for dementia patients whose previously expressed wishes conflict with their currently expressed desires. To illustrate this ethical dilemma, McMahan conceives a hypothetical case in which an intellectually proud creative woman signs an advance directive stipulating her refusal to receive life-saving treatment if she contracts a fatal condition with dementia. However, when she develops dementia and forgets this advance directive, she contracts pneumonia and now expresses a desire to live. In response to such (...) dilemmas, scholars like Norman Cantor have defended the moral authority of advance directives by giving credence to one’s prior competent wishes over one’s current incompetent preferences. I argue that their arguments, which are rooted in the principle of respect for autonomy, operate under ableist assumptions about incompetent persons and exclude other important features of respect. I propose an ethics of care model as an alternative moral approach that reconceptualises respect as a matter of caring about people’s contemporaneous interests, even if they are not competently conceived. It fosters the virtues of care by encouraging healthcare providers to recognise dementia patients as legitimate narrative agents capable of authoring their own evolving life story. I argue that the ethics of care model not only provides an ethical defence of the creative woman’s current incompetent desire to live despite her advance directive, but also vindicates our moral intuitions about what it means to demonstrate respect to dementia patients. (shrink)

Since the publication of the first edition of Tom Beauchamp and James Childress’s Principles of Biomedical Ethics there has been much debate about what a proper method in medical ethics should look like. The main rival for Beauchamp and Childress’s account, principlism, has consistently been casuistry, an account that recommends argument by analogy from paradigm cases. Admirably, Beauchamp and Childress have modified their own view in successive editions of Principles of Biomedical Ethics in order to address the concerns proponents of (...) casuistry and others have had about principlism. Given these adjustments to their view, some have claimed that principlism and casuistry no longer count as distinct methods. Even so, many still consider these two conceptions of bioethical methodologies as rivals. Both accounts of the relationship between casuistry and principlism are wrong. These two conceptions of methodology in biomedical ethics are significantly different, but the differences are not the ones pointed out by those who still claim that they are distinct positions. In this article, I explain where the real similarities and differences lie between these two views. (shrink)

The wide reflective equilibrium (WRE) is considered the most important method of ethical justification and is intensively discussed in the scientific community. However, it is unclear to what extent it is actually applied in the ethical literature. The objective of this paper is to fill this gap by providing a critical overview of its explicit applications. Explicit application refers to studies that, following Daniels’ definition, contain three levels, name their elements, and provide a connection between the levels. Philosophers Index, ProQuest, (...) PubMed, Web of Science, and Scopus were searched for studies that explicitly used the WRE method and were written in German or English. All topics, disciplines, and publication forms were considered. Nineteen studies were found in which the WRE was applied 23 times. In the 23 applications, 50 equilibria were discussed, and 19 times it was reported that an equilibrium state was reached. The authors applied the WRE in various disciplines, for different purposes, and to diverse topics. The applications themselves differed considerably regarding the application procedure and the scope. Differences can be seen in particular with regard to the presentation of the adjustment process and the WRE criteria used. The results indicate that the WRE can be successfully applied, but the number of explicit applications is still very low. Further research is needed to develop the WRE into an established method of justification. In particular, standards are needed for adjustment and for WRE criteria. (shrink)

Bioethics has developed approaches to address ethical issues in health care, similar to how technology ethics provides guidelines for ethical research on artificial intelligence, big data, and robotic applications. As these digital technologies are increasingly used in medicine, health care and public health, thus, it is plausible that the approaches of technology ethics have influenced bioethical research. Similar to the “empirical turn” in bioethics, which led to intense debates about appropriate moral theories, ethical frameworks and meta-ethics due to the increased (...) use of empirical methodologies from social sciences, the proliferation of health-related subtypes of technology ethics might have a comparable impact on current bioethical research. This systematic journal review analyses the reporting of ethical frameworks and non-empirical methods in argument-based research articles on digital technologies in medicine, health care and public health that have been published in high-impact bioethics journals. We focus on articles reporting non-empirical research in original contributions. Our aim is to describe currently used methods for the ethical analysis of ethical issues regarding the application of digital technologies in medicine, health care and public health. We confine our analysis to non-empirical methods because empirical methods have been well-researched elsewhere. Finally, we discuss our findings against the background of established methods for health technology assessment, the lack of a typology for non-empirical methods as well as conceptual and methodical change in bioethics. Our descriptive results may serve as a starting point for reflecting on whether current ethical frameworks and non-empirical methods are appropriate to research ethical issues deriving from the application of digital technologies in medicine, health care and public health. (shrink)

The article is dedicated to the application questions of a case study method known as casuistry. In its long tradition, it focuses on an influential variant of the early modern period and reconstructs its functionality. In the course of reading recent receptions, it is noted that some studies speak of a “casuistic revival” in moral case deliberation in health care. As a result of this revival, casuistry has been modified in such a way that it guides case discussions in practice (...) with the help of a tripartite methodology. However, as it turns out, casuistry, a case comparison method of ethical judgement based on reasoning logic, is less suitable for moral case deliberations in direct patient care. This stems from the fact that casuistry is a detailed procedure of ethical learning beneficial to institutionalized ethics committees or similar forms of ethics consultation in health care. (shrink)

Geographical variations are documented for a wide range of health care services. As many such variations cannot be explained by demographical or epidemiological differences, they are problematic with respect to distributive justice, quality of care, and health policy. Despite much attention, geographical variations prevail. One reason for this can be that the ethical issues of geographical variations are rarely addressed explicitly. Accordingly, the objective of this article is to analyse the ethical aspects of geographical variations in the provision of health (...) services. Applying a principlist approach the article identifies and addresses four specific ethical issues: injustice, harm, lack of beneficence, and paternalism. Then it investigates the normative leap from the description of geographical variations to the prescription of right care. Lastly, the article argues that professional approaches such as developing guidelines, checklists, appropriateness criteria, and standards of care are important measures when addressing geographical variations, but that such efforts should be accompanied and supported by ethical analysis. Hence, geographical variations are not only a healthcare provision, management, or a policy making problem, but an ethical one. Addressing the ethical issues with geographical variations is key for handling this crucial problem in the provision of health services. (shrink)