The patent law morality criterion has become the focus of much attention as the central means of questioning the social implementation of modern applications of biotechnology. In consequence, the precise nature of this legal provision has become the source of much speculation and contention. This thesis assesses the meaning of the provision and whether the morality criterion represents a clear, reliable and valid mechanism for examining human and animal biotechnology within a patent law context. It also considers alternative approaches to regulating morality through this legal provision and whether they can be operated by the European and UK patent systems justifiably and transparently in comparison with present practice. This thesis contends that biotechnology is capable of being regulated, meeting all of the requirements placed upon public decision-making, but that it must adopt an amended form to that currently practised by the European Patent Office. While the 'morality' criterion currently prescribes the point at which the assessment occurs, the facets of the innovation which are assessed, that the evidence considered cannot be limited solely to legislation and arguably that morality cannot have any boundaries to proscribe the analysis, it omits the essential parameters for making a moral assessment. Consequently, this thesis identifies that an 'abhorrence' standard, utilising a 'rebuttable presumption' methodology and the widest range of evidential sources, in some instances extending to public opinion polls/surveys, would lend important validity to current practice as well as meeting the needs of regulating biotechnology through patent law.

This thesis addresses enhancement technologies and their ethical permissibility through a contextual, bottom up approach based on case studies. The first chapter presents various definitions of 'enhancement', arguments for and against, and discusses the therapy/enhancement distinction. The second chapter discusses applying genetic technologies from bendh to bedside, analysing: the objections to reprogenetics grounded in 'eugenics'; and, how pre-implantation genetic diagnosis (PGD) and other embryonic genetic screening techniques, as well as genetic tests sold online directly-to-the-consumer (DTC) to measure children's athletic potential raise a conflict between parental reproductive freedom and children's rights to an open future and capacity for self-determination. Chapter 3 turns to how genetic technologies are translated directly from the molecular medicine laboratory to "track & field," analysing: the scientific and regulatory context of gene enhancement, and on which basis it is classified as doping; how the International Olympic Committee and the International Association for Athletics Federation incorrectly consider hyperandrogenism an unfair advantage; and, the World Anti­ Doping Agency Code and its current revisions. Chapter 4 discusses enhancements in a democratic society, and addresses the neglected issue of justifying enhancement research (ER). I propose: a model in which cognitive enhancements, currently prescribed under a 'disease' model, could instead be prescribed under an 'enhancement' model; and, a possible justification for ER that translates the ethical criteria justifying clinical research to the enhancement context. I then consider possible changes society would need to implement to accommodate ER. The last chapter attempts to advance the discussion of enhancement by shifting the debate from ethics to policymaking, arguing for a deliberative democracy approach. Throughout, I adopt a casuistic approach to ethics, deploying tools from consequentialist, principled and virtue ethics. I try to break the stalemate between enhancement's proponents and opponents, and discuss the ethical permissibility of technologies in ways that could inform policymaking.

This study challenges the primacy of consent in the history of human experimentation and argues that privileging the cultural frameworks adds nuance to our understanding of the construction of the volunteer in the period 1945 to 1970. Historians and bio-ethicists have argued that medical ethics codes have marked out the parameters of using people as subjects in medical scientific research and that the consent of the subjects was fundamental to their status as volunteers. However, the temporality of the creation of medical ethics codes means that they need to be understood within their historical context. That medical ethics codes arose from a specific historical context rather than a concerted and conscious determination to safeguard the well-being of subjects needs to be acknowledged. The British context of human experimentation is under-researched and there has been even less focus on the cultural frameworks within which experiments took place. This study demonstrates, through a close analysis of the Medical Research Council's Common Cold Research Unit (CCRU) and the government's military research facility, the Chemical Defence Experimental Establishment, Porton Down (Porton), that the `volunteer' in human experiments was a subjective entity whose identity was specific to the institution which recruited and made use of the subject. By examining representations of volunteers in the British press, the rhetoric of the government's collectivist agenda becomes evident and this fed into the institutional construction of the volunteer at the CCRU. In contrast, discussions between Porton scientists, staff members, and government officials demonstrate that the use of military personnel in secret chemical warfare experiments was far more complex. Conflicting interests of the military, the government and the scientific imperative affected how the military volunteer was perceived.

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To date research exploring the nature of ethical deliberations and decision making by healthcare teams has been largely ignored. However studying inter-professional approaches to ethical dilemmas may be valuable in offering insights into the processes of shared decision making and how such problems are addressed. Aim To investigate whether healthcare professionals working in teams embrace ethical and philosophical principles in their decisions. A secondary aim was to construct a model for ethical education informed by study data. Design A multi-methods approach comprising of a comprehensive review of the literature focus group interviews and a survey. Sample/participants A total of 112 healthcare personnel representing 15 disciplines were recruited from four large teaching hospitals within the Southwest region. Recruitment was through a lead consultant in each team who distributed invitations, participant information sheets (that outlined the study) and consent forms. Data collection Following ethical approval, 14 clinical teams were presented with profession specific vignettes and invited to engage in a facilitated discussion. Each team's interactions and decisions were tape recorded. Individuals also completed a modified version of the Decisional Conflict Scale (O'Connor 1995) to elicit their degree of comfort with decision making processes. Data analysis The transcripts from the 14 focus groups interactions were thematically analysed by employing Boyatzis (1998) model. Numerical data from the Decision Conflict questionnaire (DCQ) were entered into SPSS software for descriptive statistical analysis. Results The survey and the focus group data indicated that practitioners experienced varying degrees of conflict with the decision making process and displayed limited articulation and evidence of ethical principles that could be mapped to existing theories or methods. Participants did however employ strategies and shared expertise to overcome imposed restrictions through compromised solutions. The research identified eight key areas for consideration in the decision making process and these areas were developed to create a model for future ethics education and framing of ethical debate. The concept of restricted beneficence was also identified as being an over arching consideration in this area. The DCQ also highlighted that particular elements of the decision making process caused more concern but it highlighted that the team members opinions were valued and this supported the qualitative findings which identified evidence of a team ethos and value system. Conclusion The teams employed a very pragmatic approach to decision making within an environment that reflected the notion of restricted beneficence. It is suggested that the integration of such strategies ethical education this may result in a more practically relevant approach and enrich the quality of reflective debate in this area.

This thesis is a qualitative study of ethics education as experienced by general practitioners in mainland Britain. It draws upon interviews and documents as well as observations and reflections from encounters in the field. Ethics is conceived of as a kind of knowledge and ethics education is seen as involving translational processes shaped by various social forces and tensions. The data analysis is organised according to three concepts outlined by Bernstein: curriculum, pedagogy and evaluation. These broadly map to academia, education and practice,and the purposive sample reflects participants with involvements in these three domains. Ethnographic, phenomenological, and grounded theories are key influences on the method for selecting and organising the empirical data. The findings chapters look at the determination and production of the broad curriculum (chapter 4); the ‘transmission’, or the delivery and reception of, the curriculum (chapter 5); the assessment of ethics education (chapter 6); the ways in which ethical issues are identified and negotiated in practice (chapter 7); and key substantive issues that arise in practice – confidentiality, abortion, payment for performance and resource allocation – which enables an exploration of the negotiation of ethical issues in practice (chapters 8 and 9). The concluding chapter pulls the threads together. Societal forces and tensions are present when curricula are conceived, when knowledge and skills are taught and when GPs attempt to integrate learning into their daily practice. Having understood these forces and tensions better we can conceive better of how to make improvements to ethics education and assessment. The overall aim is to improve the reflexivity of ethics education. Many of ethical shortcomings of doctors have historically been linked to hidden curricula, features of practice and the practice environment that have been unseen or ignored by teachers or learners. Knowing more about these features and about the translational processes, that shape the experiences and enactments of GP ethics, provides the potential ability to adjust for their influence.

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Xenotransplantation centres on the potential of transgenic animal tissues for a range of transplant therapies in the treatment of human pathologies. This thesis focuses on the sociocultural and political aspects of this technology and takes account of its transgressive and hybrid nature and the way it destabilises the human/animal, science/politics boundary. Following a critical Public Understanding of Science (cPUS) approach, a qualitative dialogue on xenotransplantation was conducted with the lay publics in Ireland. This thesis presents their account of xenotransplantation 'politics' and focuses particular attention on the social cultural, moral and political dimensions shaping their perspectives. A moral economy around xenotransplantation was shown to be taking place, formed by prevailing concerns with human bodily ageing, illness and death and in a desire to reproduce human life and the enhancement of health. Promissory expectations were also directed at the potential of xenotransplantation to overcome the emotional challenges associated with human tissue exchange and in the provision of a more scientific and commercially driven transplant service. Anthropocentric relations with animals, transplantation politics and hope were all central elements driving the innovation pathway of mobilising consumer markets and animals as new forms of tissue capital. Within the emerging moral economy were also several sites of tension around the threat of human-animal transgression and hybridity, which exposed a more contested subjective investment in animal transplantation. This thesis presents the salient theoretical and professional debates around the transformations and their implications taking place in human bodily relations, health, human-animal relations and cultural transplant politics. RecOlmnendations for how these issues might be accounted for in future bio-ethical governance and policy debates are outlined, together with a consideration of how greater sustainability might be fostered in human transplantation. Some political recommendations are also directed at revitalising scientific governance in Ireland

The collection, storage, export and use of human biological samples are important research practices in international collaborative research. However, the limitations of current ethical and regulatory frameworks to govern these research practices have resulted in inconsistencies in practice and a number of ethical concerns for researchers, institutions and research ethics committees (RECs). The aim of this thesis was to contribute to an empirically-informed understanding of the ethical issues arising in the export, storage and future uses of human biological samples from sub-Saharan Africa (SSA). The thesis is based on an empirical bioethics project to examine stakeholders' perspectives of and responses to the ethical issues arising in these research practices. I employed a qualitative strategy of inquiry involving document review, observations, semi-structured interviews and focus group discuss ions with key stakeholders in Nairobi and Kilifi in Kenya and Navrongo in Ghana. The project suggests that the ethical issues arising from the use of human biological samples depends on the nature of interactions between key stakeholders in biomedical research. Despite the compelling reasons for sample export, storage and use, and the existence of structures governing these research practices, the stakeholders I interviewed expressed several practical ethical concerns. These relate 10 consent, cultural sensitivities around blood, local control of samples, power-relations, capacity building and trust-relationships. Drawing on these findings and existing literature, I argue that host research institutions bear the ultimate responsibility for the ethical conduct of research and should act as responsible stewards of research samples. I argue that it is important to refocus attention on important values in international research ethics such as trustworthiness to address the issues arising in practice. Recognising the limitations of current governance mechanisms and the uncertainties surrounding future uses of samples, I propose an entrustment framework to strengthen relationships between communities and host research institutions on one hand and between collaborating research institutions for research involving human biological samples in Africa. I also propose a set of 'points-ta-consider' for research institutions, ethics committees and funding agencies.

This study explores the complexities of implementing an interdisciplinary and intercultural medical ethics amongst Taiwanese doctors both in clinical and educational contexts. The purpose, theory, and strategy of doctors' teaching, learning, and practice of medical ethics are sophisticatedly constructed by interviewing 25 local stakeholders and analysing some relevant documents published worldwide. This constructivist qualitative research aims to generate practical insights into how to improve doctors' practice in a new pluralistic Taiwan nowadays. To achieve the aforementioned research aim, the purpose of why non-Western doctors must learn and exercise medical ethics beyond profession and tradition is first addressed. By delineating local doctors' cognitive bewilderment and situational vulnerability in face of the diversity of moral standpoints, a proposition emerges: doctors' learning of normative information is to equip and empower them to practise from a simplistic and rigid manner towards a holistic and sophisticated manner. To specify the meaning of doctors' holistic and sophisticated practice, six kinds of learning milestones of doctors' moral accomplishment are identified and then integrated as a whole within the notion of ethics as empowerment. I argue that by developing various kinds of knowledge, reasoning, skill, competency, habituation, and attributes, doctors can balance between the global and the local, the ideal and the practical, the thinking and the doing. However, such theoretical framework is not proposed for direct generalisation, but for demonstrating the richness of doctors' learning In ethics. To further translate the aforementioned sophisticated learning model into a teaching strategy, I first concentrate on the issues of doctors' power, knowledge, and role. I then argue that doctors' power can be self-limiting by inspiring them with moral philosophy so that a reflective ethical understanding can be gained. I also argue that doctors' knowledge can be holistic by equipping them with academic reasoning capacity. I finally argue that doctors' role can be communal by empowering them with explicit professional duties so that their commitment to patients' welfare can be fulfilled. My thesis offers an alternative perspective, which I argue is practical and holistic, for local practitioners, teachers, and policy-makers to embrace the arising global, multi-disciplinary, and reasoning-based medical ethics.