This paper explores the ethical and conceptual implications of the findings from an empirical study (reported elsewhere) of decision-making capacity in anorexia nervosa. In the study, ten female patients aged thirteen to twenty-one years with a diagnosis of anorexia nervosa, and eight sets of parents, took part in semistructured interviews. The purpose of the interviews was to identify aspects of thinking that might be relevant to the issue of competence to refuse treatment. All the patient-participants were also tested using the (...) MacArthur Competence Assessment Tool—Treatment test of competence. This is a formalized, structured, interviewer-administered test of competence, which is a widely accepted clinical tool for determining capacity. The young women also completed five brief, self-administered questionnaires to assess their levels of psychopathology. The issues identified from the interviews are described under two headings: difficulties with thought processing and changes in values. The results suggest that competence to refuse treatment may be compromised in people with anorexia nervosa in ways that are not captured by traditional legal approaches. (shrink)

BackgroundCurrent guidelines do not clearly outline when assent should be attained from paediatric research participants, nor do they detail the necessary elements of the assent process. This stems from the fact that the fundamental justification behind the concept of assent is misunderstood. In this paper, we critically assess three widespread ethical arguments used for assent: children’s rights, the best interests of the child, and respect for a child’s developing autonomy. We then outline a newly-developed two-fold justification for the assent process: (...) respect for the parent’s pedagogical role in teaching their child to become an autonomous being and respect for the child’s moral worth.DiscussionWe argue that the ethical grounding for the involvement of young children in medical decision-making does not stem from children’s rights, the principle of best interests, or respect for developing autonomy. An alternative strategy is to examine the original motivation to engage with the child. In paediatric settings there are two obligations on the researcher: an obligation to the parents who are responsible for determining when and under what circumstances the child develops his capacity for autonomy and reasoning, and an obligation to the child himself. There is an important distinction between respecting a decision and encouraging a decision. This paper illustrates that the process of assent is an important way in which respect for the child as an individual can be demonstrated, however, the value lies not in the child’s response but the fact that his views were solicited in the first place.SummaryThis paper demonstrates that the common justifications for the process of assent are incomplete. Assent should be understood as playing a pedagogical role for the child, helping to teach him how specific decisions are made and therefore helping him to become a better decision-maker. How the researcher engages with the child supports his obligation to the child’s parents, yet why the researcher engages with the child stems from the child’s moral worth. Treating a child as having moral worth need not mean doing what they say but it may mean listening, considering, engaging or involving them in the decision. (shrink)

It feels like there’s two of you inside—like there’s another half of you, which is my anorexia, and then there’s the real K [own name], the real me, the logic part of me, and it’s a constant battle between the two. The anorexia almost does become part of you, and so in order to get it out of you I think you do have to kind of hurt you in the process. I think it’s almost inevitable. We came to the (...) concept of authenticity belatedly, one might say. We had been talking to people who had a diagnosis of anorexia nervosa about their experiences of living with their condition, and though we had not raised issues of authenticity or identity ourselves, they often did. They struggled with questions of .. (shrink)

Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders (...) involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context. Methods and results We conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups. The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them. Conclusion Global health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders. (shrink)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic (...) bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

The practice of making datasets publicly available for use by the wider scientific community has become firmly integrated in genomic science. One significant gap in literature around data sharing concerns how it impacts on scientists’ ability to preserve values and ethical standards that form an essential component of scientific collaborations. We conducted a qualitative sociological study examining the potential for harm to ethnic groups, and implications of such ethical concerns for data sharing. We focused our empirical work on the MalariaGEN (...) Consortium, one of the first international collaborative genomics research projects in Africa. (shrink)

BackgroundThe concept of benefit sharing to enhance the social value of global health research in resource poor settings is now a key strategy for addressing moral issues of relevance to individuals, communities and host countries in resource poor settings when they participate in international collaborative health research.The influence of benefit sharing framework on the conduct of collaborative health research is for instance evidenced by the number of publications and research ethics guidelines that require prior engagement between stakeholders to determine the (...) social value of research to the host communities. While such efforts as the production of international guidance on how to promote the social value of research through such strategies as benefit sharing have been made, the extent to which these ideas and guidelines have been absorbed by those engaged in global health research especially in resource poor settings remains unclear. We examine this awareness among stakeholders involved in health related research in Kenya.MethodsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.ResultsOur study suggests that although people have a sense of justice and the moral aspects of research, this was not articulated in terms used in the literature and the guidelines on the ethics of global health research.ConclusionThis study demonstrates that while in theory several efforts can be made to address the moral issues of concern to research participants and their communities in resource poor settings, quick fixes such as benefit sharing are not going to be straightforward. We suggest a need to pay closer attention to the processes through which ethical principles are enacted in practice and distil lessons on how best to involve individuals and communities in promoting ethical conduct of global health research in resource poor settings. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Studying Penguins to Understand BirdsJacinta O. A. Tan (bio), Anne Stewart (bio), Ray Fitzpatrick (bio), and Tony Hope (bio)Keywordsanorexia nervosa, treatment decision-making, competence, valuesWe are grateful to Grisso, Appelbaum, Charland, and Vollmann for their thoughtful commentaries on our paper. We would like to respond by picking up on some of the points they make, although we do not address all the issues raised.Our general aims in the paper are (...) less immediately pragmatic than are the central concerns of Grisso and Appelbaum. Our interest is primarily in a number of ethical, and related conceptual, issues that arise from empirical data. In the long run, of course, we believe that these ethical and conceptual issues are important to the care of people with mental disorders, but our focus is philosophical.Our central interest is what justifies overriding treatment refusal. We are unhappy with a "status" approach according to which, for example, the mere fact that a person suffers a mental disorder provides grounds for overriding her wishes. Such an approach, it seems to us, fails to identify reasons, and discriminates against those with mental disorder, a view shared by the Law Commission (The Law Commission 1995). We are, on the other hand, attracted by the approach that grounds any overriding of treatment refusal on lack of capacity (or competence) to make treatment decisions. The concept of capacity has been well developed through legal cases and conceptual analysis, not least by Grisso and Appelbaum themselves. We were struck, however, first through clinical experience, and subsequently from the pilot study reported in our paper, that many patients with anorexia nervosa who refuse treatment do not necessarily lack capacity, using the current criteria, and yet show features or give reasons that raise serious doubts as to whether it is right to respect their refusal of treatment.To avoid reliance on a "status" approach, the issue with which we are grappling is whether the concept of capacity (and therefore lack of capacity) can be developed to encompass some of our findings, and whether it is ethically right to do so. Charland makes the important point that the concept of competence, or capacity, has both a descriptive and a prescriptive component. It is for this reason that the question of whether, for example, we should extend the criteria for capacity is part of the question of when it is morally right to override treatment refusal.Grisso and Appelbaum suggest that our work advances "our thinking about appreciation, rather than requiring that we add new elements" (2006, 297). From our perspective, and at this stage, it is a secondary issue whether we are suggesting a development of appreciation, or a new element (e.g., "pathological values"). The primary issue for us is whether the reasons for refusal to which we draw attention provide grounds for overriding refusal, and if they do how they can be characterized in [End Page 299] such a way as to avoid the ever-present danger of simply overriding autonomy in a patient's best interests.We chose to study anorexia nervosa for various reasons, but we expect that the issues raised have a more general relevance (such as to substance abuse and impulse control disorders as Grisso and Appelbaum and Charland suggest). We do not expect the results to be relevant to all, or even most, mental disorders. Our main interest is not the specific management of people with anorexia, but how the data challenge, and help to develop, the concept of capacity, and the ethical analysis of overriding patient refusal of treatment. Our paper aims to address what we understand Charland to be referring to by the "pretheoretical desiderata" (2006, 283) of the concept of capacity. One reason why we chose anorexia as the focus of this work is because it is different from many mental disorders in the issues that it raises. In this it is, perhaps, rather like studying penguins to better understand the concept of bird just because penguins, although clearly birds, have unusual features.We agree, therefore, with Grisso and Appelbaum's caution that it would be unwise to jump in and change the MacCAT-T on the basis of the results... (shrink)

A family of instruments has been developed over the last twenty five years in order to measure the individual's subjective view of his health. The instruments vary in how broadly they define health. A wide range of critiques have challenged both the validity of these measures and their uses. This paper argues that disproportionate attention has been given to one form of health status measure—the so-called utility-based measures. The ensuing controversies have distracted from the substantial progress achieved in the application (...) of health status measures. This paper identifies the major areas of progress and argues that any serious critique needs to engage with this now sizeable body of applied knowledge. (shrink)

A remarkable surge in efforts to assess the quality of life of patients has occurred in recent years in medical research. Philosophical discussions of these developments have focused, on the one hand, on epistemological reservations about the plausibility of measuring quality of life and, on the other hand, on moral and ethical qualms about the meaning of life conveyed in such assessments. Whilst providing an important note of caution, such critiques fail to recognise two basic principles of quality of life (...) in medical research. Firstly it is intended to provide understanding about groups and categories of patients rather than individuals. Secondly the purpose of such research is to produce generalisations about the relative costs and benefits of specific health care interventions rather than absolute judgements regarding the quality of life of patients per se. Selecting a good quality of life measure for a clinical trial requires balancing criteria such as validity with practical feasibility. Such measures will play an increasingly central role in providing research evidence to improve health care. (shrink)

International health research in malaria-endemic settings may include screening for sickle cell disease, given the relationship between this important genetic condition and resistance to malaria, generating questions about whether and how findings should be disclosed. The literature on disclosing genetic findings in the context of research highlights the role of community consultation in understanding and balancing ethically important issues from participants’ perspectives, including social forms of benefit and harm, and the influence of access to care. To inform research practice locally, (...) and contribute to policy more widely, this study aimed to explore the views of local residents in Kilifi County in coastal Kenya on how researchers should manage study-generated information on sickle cell disease and carrier status. (shrink)