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The growing demand for novel therapies has raised new ethical dilemmas for society. Vigorous debates have been initiated, especially after the recent Right to Try Act in the US, which aims to facilitate access to new agents, even at an early stage of the investigation process. This article explores the concept of patient’s autonomy in accessing investigational treatments, and discusses the implications of autonomy for patients, researchers and regulatory authorities. We propose that, in cases of adequate understanding of the anticipated (...) |
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One of the most pressing ethical challenges facing phase I cancer research centres is the process of informed consent. Historically, most scholarship has been devoted to redressing therapeutic misconception, that is, the conflation of the nature and goals of research with those of therapy. While therapeutic misconception continues to be a major ethical concern, recent scholarship has begun to recognise that the informed consent process is more complex than merely a transfer of information and therefore cannot be evaluated only according (...) |
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Dissecting Bioethics, edited by Tuija Takala and Matti Hayry, welcomes contributions on the conceptual and theoretical dimensions of bioethics. The department is dedicated to the idea that words defined by bioethicists and others should not be allowed to imprison people’s actual concerns, emotions, and thoughts. Papers that expose the many meanings of a concept, describe the different readings of a moral doctrine, or provide an alternative angle to seemingly self-evident issues are particularly appreciated. To submit a paper or to discuss (...) |
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When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and (...) |
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Child assent is recommended in addition to parental consent when enrolling children in clinical research; however, appreciation and relevance ascribed to these concepts vary in different contexts, and information on attitudes towards storage of biological samples for future research is limited, especially in developing countries. We assessed caregivers’ understanding and appreciation of consent and assent procedures, and their attitudes towards use of stored blood samples for future research prior to enrolling a child in clinical research. A total of 17 in-depth (...) |
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Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal (...) |
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This paper explores the importance of hope as a determining factor for patients to participate in first-in-human trials for synthetic biology therapies. This paper focuses on different aspects of hope in the context of human health and well-being and explores the varieties of hope expressed by patients. The research findings are based on interview data collected from stable gout and diabetes patients. Three concepts of hope have emerged from the interviews: hope as certainty ; hope as reflective uncertainty ; hope (...) |
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