This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of (...) ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)
This interdisciplinary book considers the relationship between language and thought from a philosophical perspective, drawing both on the philosophical study of language and the purely formal study of grammar, and arguing that the two should align. The claim is that grammar provides homo sapiens with the ability to think in certain grammatical ways and that this in turn explains the vast cognitive powers of human beings. Evidence is considered from biology, the evolution of language, language disorders, and linguistic phenomena.
In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples (...) means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. (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)
The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation, to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity (...) in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging what ought to be done and the standards by which this “knowing” or “being better at judging” is determined. We conclude with a discussion of the implications of our analysis for the literature on ethics expertise in CEC. We do think that there are clear domains in which a clinical ethics consultant might be expert but we are skeptical about the possibility that this includes ethics expertise. Clinical ethics consultants should not be referred to as ethics experts. (shrink)
There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake—protecting researchers’ freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy—raise relevant ethical considerations that are reasonably (...) contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments. (shrink)
Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...) the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)
Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to disclosure grounded in considerations (...) of commercial interest, and we argue that these concerns are insufficient to override the moral duty to disclose adverse clinical trial results. However, we also develop a proposal that enables commercial interests to be protected, while promoting the duty to disclose adverse clinical trial results. (shrink)
Conducting large multi-site research within universities highlights inconsistencies between universities in approaches, requirements and responses of research ethics committees. Within the context of a social science research study, we attempted to obtain ethical approval from 101 universities across England to recruit students for a short online survey. We received varied responses from research ethics committees of different universities with the steps to obtaining ethics approval ranging from those that only required proof of approval from our home institution, to universities that (...) facilitated fast-track applications to those that required a full ethics review. Some universities also completely refused. After contacting all 101 universities in England, 60 universities gave clearance to our study. In this article, we present the different approaches universities adopted in response to our application to sample from students in their institution. We consider a number of conceptual and ethical issues pertinent to considering ethics approval for researchers from other universities in England and critically discuss three possible models of ethics governance that would cover all universities in England. (shrink)
A recent article from Archives of Disease in Childhood outlined problems with the act of gaining child assent for research participation. However the arguments used in the article are incomplete or misguided. Rather than being harmful, assent should be seen as an ethically-appropriate way in which we can engage with the child about his participation in research. While additional clarification of the concept of assent is needed, the child's family context can provide us with a valuable guide to the way (...) we involve him in the decision-making process. (shrink)
The story of Ashley, a nine-year-old from Seattle, has caused a good deal of controversy since it appeared in the Los Angeles Times on January 3, 2007.1 Ashley was born with a condition called static encephalopathy, a severe brain impairment that leaves her unable to walk, talk, eat, sit up, or roll over. According to her doctors, Ashley has reached, and will remain at, the developmental level of a three-month-old.
The central issue that I consider in this paper is the use of the so‐called ‘Rule of Rescue’ in the context of resource allocation. This ‘Rule’ has played an important role in resource allocation decisions in various parts of the world. It was invoked in Ontario to overturn a decision not to fund treatment for Gaucher's Disease and it has also been used to justify resource decisions in Israel concerning the same condition. -/- In the paper I consider the nature (...) of the Rule of Rescue and its moral justification. The latter involves consideration of the distinction between agent‐relative and agent‐neutral obligations. If the Rule of Rescue is to be justified, it is plausible to think that it will be in the context of agent‐relative obligations. Two problems with this suggestion are considered: the role of identifiability in the Rule of Rescue and the extent to which policy makers in a health care system can be taken to have such obligations. It is argued that in both cases these problems can be overcome and hence that there is a prima facie obligation to follow the Rule of Rescue. (shrink)
Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related to health justice. For example, such processes are often exclusively disease-driven, meaning they rely heavily on burden of disease considerations. They, therefore, tend to undervalue non-biomedical research topics, which have been identified as essential to helping reduce health disparities. In recognition of these ethical concerns and the limited scholarship and dialogue addressing them, we (...) convened an international workshop in September 2015. The workshop aimed to initiate discussion on the appropriate relationship between global and national levels of health research priority-setting and to begin exploring what might be ethically required for priority-setting at each of those levels. This paper comprises our reflections following the workshop. Its main objective is to launch a research agenda for the ethics of global health research priority-setting. We identify three domains of global health research priority-setting—scope, underlying values and substantive requirements, and procedural considerations. For each domain, specific research questions are highlighted and why they need to be explored is explained. Some preliminary thoughts and normative arguments as to how the research questions might be answered are also offered. For example, we provide initial ideas about the appropriate relationship between different priority-setting levels and what values and substantive considerations should guide or underpin global health research priority-setting as a matter of justice. We anticipate that framing a new research agenda for the ethics of global health research priority-setting will spur ethicists, researchers, and policymakers to refocus their efforts on developing more rigorous and ethically sound approaches to priority-setting. (shrink)
Much has been written in the last decade about how we should understand the value of the sociology of bioethics. Increasingly the value of the sociology of bioethics is interpreted by its advocates directly in terms of its relationship to bioethics. It is claimed that the sociology of bioethics (and related disciplinary approaches) should be seen as an important component of work in bioethics. In this paper we wish to examine whether, and how, the sociology of bioethics can be defended (...) as a valid and justified research activity, in the context of debates about the nature of bioethics. We begin by presenting and arguing for an account of bioethics that does justice to the content of the field, the range of questions that belong within this field, and the justificatory standards (and methodological orientations) that can provide convincing answers to these questions. We then consider the role of sociology in bioethics and show how and under what conditions it can contribute to answering questions within bioethics. In the final section, we return to the sociology of bioethics to show that it can make only a limited contribution to the field. (shrink)
Currently, research ethics committees in the UK meet behind closed doors—their workings and most of the content of their decisions are unavailable to the general public. There is a significant tension between this current practice and a broader societal presumption of openness. As a form of public institution, the REC system exists to oversee research from the perspective of society generally.An important part of this tension turns on the kind of justification that might be offered for the REC system. In (...) this paper I adapt Daniels and Sabin’s accountability for reasonableness model for just resource allocation to the research ethics context to provide some structural legitimacy and to enable progress on the question of openness. After considering the consequences of adopting this model for open REC meetings, I then examine some reasons that might be offered against open meetings. These arguments do not overwhelm the core intuitions behind the presumption of openness but they do, I suggest, give us reason to retreat from fully public meetings. I conclude that there should be important adjustments to the system towards public accountability and that there are grounds for stopping short of fully public meetings. (shrink)
"Dissecting Bioethics," edited by Tuija Takala and Matti Häyry, welcomes contributions on the conceptual and theoretical dimensions of bioethics. The section 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 therefore particularly appreciated. The themes covered in the section (...) so far include dignity, naturalness, public interest, community, disability, autonomy, parity of reasoning, symbolic appeals, and toleration. (shrink)
As the COVID-19 pandemic impacts on health service delivery, health providers are modifying care pathways and staffing models in ways that require health professionals to be reallocated to work in critical care settings. Many of the roles that staff are being allocated to in the intensive care unit and emergency department pose additional risks to themselves, and new policies for staff reallocation are causing distress and uncertainty to the professionals concerned. In this paper, we analyse a range of ethical issues (...) associated with changes to staff allocation processes in the face of COVID-19. In line with a dominant view in the medical ethics literature, we claim, first, that no individual health professional has a specific, positive obligation to treat a patient when doing so places that professional at risk of harm, and so there is a clear ethical tension in any reallocation process in this context. Next, we argue that the changing asymmetries of health needs in hospitals means that careful consideration needs to be given to a stepwise process for deallocating staff from their usual duties. We conclude by considering how a justifiable process of reallocating professionals to high-risk clinical roles should be configured once those who are ‘fit for reallocation’ have been identified. We claim that this process needs to attend to three questions that we consider in detail: how the choice to make reallocation decisions is made, what justifiable models for reallocation might look like and what is owed to those who are reallocated. (shrink)
When it comes to using patient data from the National Health Service for research, we are often told that it is a matter of trust: we need to trust, we need to build trust, we need to restore trust. Various policy papers and reports articulate and develop these ideas and make very important contributions to public dialogue on the trustworthiness of our research institutions. But these documents and policies are apparently constructed with little sustained reflection on the nature of trust (...) and trustworthiness, and therefore are missing important features that matter for how we manage concerns related to trust. We suggest that what we mean by ‘trust’ and ‘trustworthiness’ matters and should affect the policies and guidance that govern data sharing in the NHS. We offer a number of initial, general reflections on the way in which some of these features might affect our approach to principles, policies and strategies that are related to sharing patient data for research. This paper is the outcome of a ‘public ethics’ coproduction activity which involved members of the public and two academic ethicists. Our task was to consider collectively the accounts of trust developed by philosophers as they applied in the context of the NHS and to coproduce an argumentative position relevant to this context. (shrink)
This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.
The use of charged-particle radiation therapy is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is (...) best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields , including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research. (shrink)
This issue of the journal sees a number of exchanges on significant ethical problems. ‘Nudges’ have attracted a good deal of attention recently in the context of the ethics of public health interventions. Martin Wilkinson writes a guest editorial introducing important debate on Yashar Saghai's featured article, Salvaging the concept of nudge . Also, Timothy Murphy locks horns with Katrien Devolder and Ezio Di Nucci on the doctrine of double effect as it applies to research on embryos.One of the exchanges (...) published here involves the legitimacy of research ethics review. Murray Dyck and Gary Allen claim that only in a small minority of cases is research ethics review warranted and that, in the main, responsibility for the ethical conduct of research should lie with the researchers themselves.However, David Hunter Mark Israel (see …. (shrink)
Patient choice, we might think, is the popular version of the ideas of informed consent and the principle of respect for autonomy and intimately connected to the politics of liberal individualism. There are various accounts to be given for why patient choice, in all its forms, has dominated thinking in bioethics and popular culture. All of them, I suggest, will make reference to the decline of paternalism. The bad old days of ‘doctor knows best’ are gone and were replaced by (...) the primacy of patient choice and informed consent.The response to the dominance of the principle of patient choice has been slow in building but it has come in a number of ways. Two sets of papers in this issue of the Journal of Medical Ethics show just how far this response has come and the degree to which the pendulum is swinging back in the other direction. Neil Levy's Feature article, ‘Forced to be free? Increasing patient autonomy by constraining it’, argues that we should go to greater lengths to correct patients' mistaken decisions . In the ‘Author meets critics’ section, Sarah Conly's book, Against Autonomy: Justifying Coercive Paternalism is the focus of comment . Both authors draw on a similar range of empirical evidence to undermine the sanctity of patient and individual choice. An array of commentators draw on these target pieces to give a clear picture of the ways in which the popular view can justifiably be undermined.Levy's paper focuses on the process of informed consent in clinical contexts. He argues that, while this process is crucially important, it systematically fails because of well-documented frailties of human reason. The evidence of these frailties comes from cognitive and social psychology, on biases and heuristics. The key question is how …. (shrink)
For the past 3 years, since acquiring formal training in healthcare ethics and philosophy, I have been one of those physicians who “does” ethics. I teach medical students and residents, write articles, speak at conferences, chair an ethics committee, and informally consult with colleagues on cases where they request advice related to ethical issues in the care of patients. These activities have been a rewarding and challenging part of my practice. There has also been a fair amount of frustration. Unfortunately, (...) both in teaching and patient care, it has been a frequent experience to finish a discussion with physicians only to be told that what I said was nice but had no bearing in the real world. In the words of a medical resident: 'You know, this ethics stuff is really a lot of crap, isn't it?'. (shrink)
Both older persons and those who havedisabilities can encounter discrimination whenthey seek medical care. Just as ageism andstereotypes about older persons mayinappropriately limit medical care for theelderly, limits may be placed on medical carefor those who are disabled simply because ofthe presence of a disability. At the sametime death is the natural end of the lifespanfor all individuals and there are situationswhen aggressive medical care is not indicated. It is not right to always insist on ``doingeverything'' for a person even (...) if that personmay be at risk otherwise for discrimination. Using the example of the elderly, this paperexamines the risks of discrimination and thedangers of overtreatment in caring for olderpersons and suggests parallels in theappropriate care of those who havedisabilities. (shrink)
ObjectiveTo examine health and social care professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales.MethodsA cross-sectional online survey was conducted using a series of vignettes. Participants were asked to select the legally authorised decision-maker in each scenario and provide supporting reasons. Responses were compared with existing legal frameworks and analysed according to their level of concordance.ResultsOne hundred and twenty-seven professionals participated. Levels of discordance between responses and the legal frameworks were high across all (...) five scenarios. Nearly half of the participants provided responses that were discordant in all scenarios. Only two participants provided concordant responses across all five scenarios.DiscussionParticipants demonstrated a lack of knowledge about the legal frameworks, the locus of authority and the legal basis for decision-making. The findings raise concern about the accessibility of research for those who lack capacity, the ability to conduct research involving such groups and the impact on the evidence base for their care.ConclusionThis is the first study to examine health and social care professionals’ knowledge and understanding of the dual legal frameworks in the UK. Health and social care professionals’ understanding and attitudes towards research involving adults with incapacity may warrant further in-depth exploration. The findings from this survey suggest that greater training and education is required. (shrink)
Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of (...) these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach. (shrink)
Some of the best instances of bioethics are applications of ethical conceptual analysis to real-world cases that is done in a way that prompts both reflection on the part of the practitioners involved in the real-world case and reflection by the bioethicist on the way in which the field of bioethics understands the concept in question. Buth et al ’s paper in this issue is a fine example of just this. Their paper brings together three important concepts that straddle the (...) worlds of politics and ethics and are to some extent under-theorised in applied settings. These three concepts – moral narcissism, moral complicity and dirty hands – raise particular problems for the activities of researchers, aid workers and others from richer countries working in poorer or conflict-torn parts of the world. Buth et al set out a general account of these concepts and their relationship. Their focus is substantially on complicity largely because Médecins Sans Frontières have been accused of it in each of the three cases they go on to discuss. These three cases involve MSF interventions in Myanmar, Libya and on the border between Syria and Jordan. Each are importantly different: from the involvement of MSF with the wrongdoers varies from not speaking out and continuing to operate in other parts of the country to being used as a coercive pawn providing aid. The situations are complex and, in the end, Buth et al see the analysis of them in terms of complicity as a useful first step but that is all. There are some important nuances embedded in the paper that are worth bringing out. First, moral narcissism as they define it, comes about at the point at which “an appropriate concern for one’s own moral integrity turns into moral self-indulgence” or a …. (shrink)
In this response, we first tackle what we take to be the core disagreement between ourselves and Hammersley, namely the justification for our model of social research ethics governance. We then consider what follows from our defence of governance for ethics review and show how these claims attend to the specific concerns outlined by Hammersley.
Brierley et al take big polarised political debates deep into the context of paediatric intensive care. They are concerned that ‘deeply held belief in religion leads to children being potentially subjected to burdensome care’. However, it can be argued that they make a mistake in categorising this as a problem derived from religion, religious belief or the depth of religious conviction. Religion here is a red herring.
There is a continued need to consider ways to prevent early adolescent engagement in a variety of harmful risk-taking behaviours for example, violence, road-related risks and alcohol use. The current prospective study examined adolescents? reports of intervening to try and stop friends? engagement in such behaviours among 207 early adolescents (mean age?=?13.51?years, 50.1% females). Findings showed that intervening behaviour after three months was predicted by the confidence to intervene which in turn was predicted by student and teacher support although not (...) parental support. The findings suggest that the benefits of positive relationship experiences might extend to the safety of early adolescent friendship groups particularly through the development of confidence to try and stop friends? risky and dangerous behaviours. Findings from the study support the important role of the school in creating a culture of positive adolescent behaviour whereby young people take social responsibility. (shrink)
Adolescent risk-taking behaviour has potentially serious injury consequences and school-based behaviour change programmes provide potential for reducing such harm. A well-designed programme is likely to be theory-based and ecologically valid; however, it is rare that the operationalisation process of theories is described. The aim of this paper is to outline how the theory of planned behaviour and cognitive behavioural therapy informed intervention design in a school setting. Teacher interviews provided insights into strategies that might be implemented within the curriculum and (...) provided detail used to operationalise theory constructs. Benefits and challenges in applying both theories are described with examples from an injury prevention programme, Skills for Preventing Injury in Youth. (shrink)