Why has autonomy been a leading idea in philosophical writing on bioethics, and why has trust been marginal? In this important book, Onora O'Neill suggests that the conceptions of individual autonomy so widely relied on in bioethics are philosophically and ethically inadequate, and that they undermine rather than support relations of trust. She shows how Kant's non-individualistic view of autonomy provides a stronger basis for an approach to medicine, science and biotechnology, and does not marginalize untrustworthiness, while also explaining why (...) trustworthy individuals and institutions are often undeservingly mistrusted. Her arguments are illustrated with issues raised by practices such as the use of genetic information by the police or insurers, research using human tissues, uses of new reproductive technologies, and media practices for reporting on medicine, science and technology. Autonomy and Trust in Bioethics will appeal to a wide range of readers in ethics, bioethics and related disciplines. (shrink)

Moral Repair examines the ethics and moral psychology of responses to wrongdoing. Explaining the emotional bonds and normative expectations that keep human beings responsive to moral standards and responsible to each other, Margaret Urban Walker uses realistic examples of both personal betrayal and political violence to analyze how moral bonds are damaged by serious wrongs and what must be done to repair the damage. Focusing on victims of wrong, their right to validation, and their sense of justice, Walker presents a (...) unified and detailed philosophical account of hope, trust, resentment, forgiveness, and making amends - the emotions and practices that sustain moral relations. Moral Repair joins a multidisciplinary literature concerned with transitional and restorative justice, reparations, and restoring individual dignity and mutual trust in the wake of serious wrongs. (shrink)

Can we decide to trust? Sometimes, yes. And when we do, we need not believe that our trust will be vindicated. This paper is motivated by the need to incorporate these facts into an account of trust. Trust involves reliance; and in addition it requires the taking of a reactive attitude to that reliance. I explain how the states involved here differ from belief. And I explore the limits of our ability to trust. I then turn to the idea of (...) trusting what others say. I suggest that we sometimes decide to trust people to be sincere and knowledgeable; and that having taken this attitude towards them, we come to believe what they say. I spell out some consequences that this has for an account of testimony, and for van Fraassen's decision theoretic principle of Reflection. (shrink)

I present and defend an account of three-place trustworthiness according to which B is trustworthy with respect to A in domain of interaction D, if and only if she is competent with respect to that domain, and she would take the fact that A is counting on her, were A to do so in this domain, to be a compelling reason for acting as counted on. This is not the whole story of trustworthiness, however, for we want those we can (...) count on to identify themselves so that we can place our trust wisely. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be (...) too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically. (shrink)

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient‐subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient‐subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

What is it to trust someone? What is it for someone to be trustworthy? These are the two main questions that this paper addresses. There are various situations that can be described as ones of trust, but this paper considers the issue of trust between individuals. In it, I suggest that trust is distinct from reliance or cases where someone asks for something on the expectation that it will be done due to the different attitude taken by the trustor. I (...) argue that the trustor takes Holton’s ‘participant stance’ and this distinguishes trust from reliance. I argue that trustworthiness is different from reliability and that an account of trustworthiness cannot be successful whilst ignoring the point that aligning trustworthiness with reliability removes the virtue from being trustworthy. On the question of what it is distinguishes trustworthiness from reliability, I argue that the distinction is in the opportunity for the trustee to act against the wishes of the trustor and the trustee’s consideration of the value of the trust that has been placed in them by the trustor. (shrink)

Trust among current and future patients is essential for the success of biobank research. The submission of an informed consent is an act of trust by a patient or a research subject, but a strict application of the rule of informed consent may not be sensitive to the multiplicity of patient interests at stake, and could thus be detrimental to trust. According to a recently proposed law on “genetic integrity” in Sweden, third parties will be prohibited from requesting or seeking (...) genetic information about an individual. Cumbersome restrictions on research may be lifted, thus creating a more favourable climate for medical research. (shrink)

Regulation and governance of medical research is frequently criticised by researchers. In this paper, we draw on Everett Hughes’ concepts of professional licence and professional mandate, and on contemporary sociological theory on risk regulation, to explain the emergence of research governance and the kinds of criticism it receives. We offer explanations for researcher criticism of the rules and practices of research governance, suggesting that these are perceived as interference in their mandate. We argue that, in spite of their complaints, researchers (...) benefit from the institutions of governance and regulation, in particular by the ways in which regulation secures the social licence for research. While it is difficult to answer questions such as: “Is medical research over-regulated?” and “Does the regulation of medical research successfully protect patients or promote ethical conduct?”, a close analysis of the social functions of research governance and its relationship to risk, trust, and confidence permits us to pose these questions in a more illuminating way. (shrink)

Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of this approach. (...) First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing. (shrink)

I want to argue for two propositions. First, I suggest that what some researchers may take to be a simple trade-off between minor violations of the truth for the sake of access to far greater truths represents a profound miscalculation with far-reaching and cumulative reverberations. Second, I submit that today's research environment, as demanding, competitive, and sometimes bewildering as it is, offers genuine scope for what Murdoch calls truth-seeking, for imagining and questioning, and for relating to facts through both truth (...) and truthfulness; but that, in so doing, it presents hard choices with respect to methods, and, in turn, to personal integrity—not only in particular research projects but also with respect to that fragile research environment in its own right. (shrink)

Biomedical research is an increasingly multidisciplinary activity bringing together a range of different academic fields and forms of expertise to investigate diseases that are increasingly understood to be complex and multifactorial. Recently the discipline of ethics has been starting to find a place in large-scale biomedical collaborations. In this article we draw from our experience of working with the Malaria Genomic Epidemiology Network and other research projects to reflect upon the integration of ethics into biomedical research. We examine the way (...) in which ethics input may be valuable to research, the forms it tends to take, and also the problems and limitations of such collaborations. (shrink)

I want to sound a warning note and suggest some changes that are needed in the practice of ethical review. It is easy to assume that with a policy as high-minded as the policy of reviewing research on human beings, the only difficulties will be the obstacles put in its way by recalcitrant and unreformed paries: by the special-interest groups affected. But this is not always true of high-minded policies and it is not true, in particular, of the policy of (...) reviewing research. Ethical review is endangering valuable research on human beings and, moreover, it is endangering the very ethic that is needed to govern that research. And this is not anyone's fault, least of all the fault of any special-interest groups. The problem is that the process of ethical review has been driven by an institutional dynamic that is not in anyone's control and this dynamic is now driving us, willy nilly, on to some very stony ground. My argument is developed in four sections. In the next section, section two, I look at a model of policy-making which identifies a reactive, institutional dynamic that lies at the origin of certain policy intitiatives. In the third section I argue that this model fits the appearance and development of the ethical review of human research, showing how the process of review has been motored by a dynamic of step-by-step reaction to chilling tales of abuse. In the fourth section I look at the predictions of the future development of ethical review that the extrapolation of that model yields. And then in the fifth and.. (shrink)

Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored by (...) pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an increase in calls to homes by telemarketers and market researchers. Participants also stressed the importance of knowing where their names and contact details were sourced and suggested that this information be available to prospective study participants as a matter of course in the first approach or letter. We provide valuable information to epidemiologists in designing studies. (shrink)

Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study.

Background: Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study. Methods: The study used a rapid assessment incorporating multiple qualitative methods (...) including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrolment of cases and controls were identified, as well as the factors influencing the tailoring of such information. Results: MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research.Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation. Conclusions: It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections.Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important. (shrink)