Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which (...) other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

Biobanks for long-term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides the research participants with some (...) level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes. (shrink)

Health checks identify disease in people without symptoms. They may be offered by the government through population screenings and by other providers to individual users as ‘personal health checks’. Health check providers’ perspective of ‘good’ health checks may further the debate on the ethical evaluation and possible regulation of these personal health checks. In 2015, we interviewed twenty Dutch health check providers on criteria for ‘good’ health checks, and the role these criteria play in their practices. Providers unanimously formulate a (...) number of minimal criteria: Checks must focus on treatable/preventable disease; Tests must be reliable and clinically valid; Participation must be informed and voluntary; Checks should provide more benefits than harms; Governmental screenings should be cost-effective. Aspirational criteria mentioned were: Follow-up care should be provided; Providers should be skilled and experienced professionals that put the benefit of users first; Providers should take time and attention. Some criteria were contested: People should be free to test on any disease; Health checks should only be performed in people at high risk for disease that are likely to implement health advice; Follow up care of privately funded tests should not drain on collective resources. Providers do not always fulfil their own criteria. Their reasons reveal conflicts between criteria, conflicts between criteria and other ethical values, and point to components in the organisation of health care that hinder an ethical provision of health checks. Moreover, providers consider informed consent a criterion that is hard to establish in practice. According to providers, personal health checks should meet the same criteria as population screenings, with the exception of cost-effectiveness. Providers do not always fulfil their own criteria. Results indicate that in thinking about the ethics of health checks potential conflicts between criteria and underlying values should be explicated, guidance in weighing of criteria should be provided and the larger context should be taken into account: other actors than providers need to take up responsibility, and ideally benefits and harms of health checks should be weighed against other measures targeting disease. (shrink)

Health checks identify disease in individuals without a medical indication. More and more checks are offered by more providers on more risk factors and diseases, so we may speak of an omnipresence of health checks. Current ethical evaluation of health checks considers checks on an individual basis only. However, omnipresent checks have effects over and above the effects of individual health checks. They might give the impression that health is entirely manageable by individual actions and strengthen the norm of individual (...) responsibility for health to the point where people hold themselves and others responsible for health outcomes they cannot reasonably be held accountable for. This process of so-called ‘over-responsibilization’ may result in increased feelings of guilt over health, decreased health solidarity and unfairly distributed health outcomes. Moreover, effects on privacy and peace of mind may be observed. Taking into account all possible harms and benefits of health checks in their ethical evaluation requires evaluation of health checks on an individual basis as well as on the level of all checks. Therefore, we urge the amendment of existing ethical evaluation to include the effects of an omnipresence of health checks. We make a first attempt at the formulation of amended criteria. (shrink)

ABSTRACT Biobanks for long‐term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides the research participants with (...) some level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

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)