In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various challengers who argue for alternative approaches to what ought or ought not to be permitted. Key themes within this analysis will examine these claims and argue (...) they have implications for the interests of the research subject, research governance and regulation. Using our work with TREAT-NMD, the neuromuscular clinical trials network, we posit that there is a place for advancing the discourse of moral rights and moral duties in the context of research, especially from the perspective of patients and their families, and for including the politics of patient activism and empowerment. At the same time we remain vigilant to the danger that the therapeutic misconception and other serious vulnerabilities for the patient population in clinical trials, are at risk of being overlooked. (shrink)

This paper is a critical reflection on the concepts of Responsible Innovation (RI) and Responsible Research and Innovation (RRI). We offer an account of the emergence of these related but different accounts of responsible innovation that have recently been adopted by funders. We further report on our exploration of the knowledge and understanding of these concepts through the views of senior scientists involved in synthetic biology research projects. Though most of our respondents struggled to provide a clear account of RI/RRI (...) we identified that existing “practices of responsibility” include many aspects of RI/RRI but that this often went unrecognized as such. Most respondents associated RI/RRI with risk avoidance. While some visions of RI/RRI see scientists as taking an active role in shaping the future of innovation, we suggest that it is not for such individuals to take decisions alone on the types of futures a society should have available to it. (shrink)

This paper explores some of the values that underpin health care and how these relate more specifically to the values and ethics of palliative care. The paper focuses on the concept of autonomy because autonomy has emerged as a foundational concept in contemporary health care ethics and because this is an opportunity to scratch the surface of this concept in order to reveal something of its complexity, a necessary precaution when applying the concept to the context of palliative care. The (...) paper begins with a theoretical discussion of autonomy exploring an aspect of its contemporary meaning and relevance to health care. The second part of the paper focuses more closely on how the principle of respect for autonomy can be applied in the context of palliative care. In this section an ethical framework is employed to explore a practical application of this principle within a broader context of respect for persons. (shrink)

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 (...) implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism. (shrink)

This paper presents, from the perspectives of both social scientists and microbiologists, a case study of the implementation and practice of Responsible Innovation (RI) in a UK-based synthetic biology project. We highlight the impact of interdisciplinary working and examine the benefits that arise from creating the time and space for shared reflection on research. Our discussions over the course of the project included concerns about the potential escape to the environment of laboratory-constructed genetic material and alternatives to the role that (...) antibiotic resistance genes play in synthetic biology. As a result, the design of a key product of the project was altered in ways that go beyond normal institutional requirements. We highlight our view of the importance of continued interdisciplinary collaboration and the utility of the framework of Responsible Innovation in achieving this. We conclude with observations on the difficulties of sustaining such collaborations. (shrink)

In this paper it is argued that nurses should be holists whilst at the same time accepting that ‘holism’ is a contentious concept. One of the problems for a supporter of holism is that of which holism -- an attempt to outline the version of holism advocated is made by identifying only two versions of holism: The Strong theory and the Pragmatic theory of holism. By introducing this device it is hoped to avoid, if only by stipulation, some of the (...) more sophisticated nuances of holism drawn by other commentators. However despite a most judicious use of Ockham's Razor some detailed groundwork remains. In the first part of this paper a simple example is used which aims to articulate what are arguably some of the central issues within the holism debate. These issues are then placed within a wider philosophical context. The second part of the paper will offer definitions of Strong and Pragmatic holism. Drawing on specific examples from the nursing context it will be argued that the Pragmatic theory of holism is the theory of holism most compatible with nursing theory and practice. The methods employed in this paper are philosophical. Since the questions considered are conceptual rather than empirical requiring a discursive approach, utilising thought experiments and case implication to explore the issues. (shrink)

In this paper it is argued that nurses should be holists whilst at the same time accepting that ‘holism’ is a contentious concept. One of the problems for a supporter of holism is that of which holism -- an attempt to outline the version of holism advocated is made by identifying only two versions of holism: The Strong theory and the Pragmatic theory of holism. By introducing this device it is hoped to avoid, if only by stipulation, some of the (...) more sophisticated nuances of holism drawn by other commentators. However despite a most judicious use of Ockham's Razor some detailed groundwork remains. In the first part of this paper a simple example is used which aims to articulate what are arguably some of the central issues within the holism debate. These issues are then placed within a wider philosophical context. The second part of the paper will offer definitions of Strong and Pragmatic holism. Drawing on specific examples from the nursing context it will be argued that the Pragmatic theory of holism is the theory of holism most compatible with nursing theory and practice. The methods employed in this paper are philosophical. Since the questions considered are conceptual rather than empirical requiring a discursive approach, utilising thought experiments and case implication to explore the issues. (shrink)

This article is based on the findings of a study that elicited the views of terminally ill patients, their carers and bereaved carers on the palliative care services they received. It explores the range of ethical issues revealed by the data. Although the focus of the original study was on community services, the participants frequently commented on all aspects of their experience. They described some of its positive and negative aspects. Of concern was the reported lack of sensitivity to the (...) role of the family among health professionals. The family, as carers, service users and advocates, represent a challenge to professional boundaries and the ethical norms of confidentiality and best interest. The accounts reveal the complexity of the ethical issues that characterize terminal care, issuing specific ethical challenges to nurses and other health professionals involved in this field. (shrink)

This interdisciplinary collection presents valuable discourse and reflection on the nature of a good death. Bringing together a leading judge and other legal scholars, philosophers, social scientists, practitioners and parents who present varying accounts of a good death, the chapters draw from personal experience as well as policy, practice and academic analysis.Covering themes such as patients' rights to determine their own good death, considering their best interests when communication becomes difficult and the role and responsibilities of health professionals, the book (...) outlines how ethical healthcare might be achieved when dealing with assisted suicide by organizations and how end of life services in general might be improved. It will be of interest to students and academics working the area of medical law and ethics as well as health professionals and policy-makers. (shrink)

This chapter contains sections titled: What if Tattooing is Immoral? Latent Criminals or Degenerate Aristocrats Loos and Amorality Tattooing is Like Murdering? Loos and the Crime of Ornamentation Tattooing and Personal Meaning Tattooing and Liberal Autonomy Attraction and Repulsion.

Some care home residents with dementia have the capacity, some do not. Staff may need to make decisions about administering care interventions to someone whom they believe lacks the capacity to consent to it, but also resists the intervention. Such intervention can be termed forced care. The literature on forced care (especially reflecting empirical work) is scant. This study aims to investigate how the ethics of forced care is navigated in practice, through ten semi-structured interviews with staff in 1 care (...) home in the North East of England. Participants generally avoided situations where there was overt restraint, taking a flexible approach by either modifying their own behaviour or using covert techniques. The underlying justification given for decisions or actions tended to be that the recipients of care should be valued because of their intrinsic worth as fellow human beings. Participants attempted to put themselves in the position of the resident or think about what a beloved elderly relative would want. The intervention seemed acceptable to staff if the resident was not distressed. When staff were presented with scenario-based questions around capacity they were more successful than when asked direct questions relating to the Mental Capacity Act. Scenario-based training may be helpful to reinforce familiarity and facility with the principles of the Mental Capacity Act. (shrink)

This paper argues that the concept of best interests in the context of clinical decisions draws on concepts rooted in the philosophical discipline of axiology. Reflection on the philosophical origins enables a distinction to be drawn between those interests related to clinical goals and those global interests that are axiological in nature. The implication of this distinction is most clearly seen in the context of end of life decisions and it is argued here that greater weight ought to be given (...) to the positive requests, and not merely competent refusals, of patients at the end of life. (shrink)