A decade has passed since the mapping of the human genome—an event that paved the way for many new developments in biomedicine and related fields. In ethics, this milestone was accompanied by calls for changes in ruling ethical frameworks.

This article challenges a key tacit assumption underpinning legal and ethical instruments in health care, namely, that people are ideally bounded, independent, and often also strategically rational individuals. Such an understanding of personhood has been criticized within feminist and other critical scholarship as being unfit to capture the deeply relational nature of human beings. In the field of medicine, however, it also causes tangible problems. I propose that a solidarity-based perspective entails a relational approach and as such helps to formulate (...) new solutions to complex ethical and regulatory questions, ranging from caring for people at the end of their lives to improving policies for organ donation and better governance of health data. It also underscores the importance of universal health care. Although a solidarity-based perspective does not require health to be seen as an individually enforceable right, it does influence our understanding of individual rights: it draws attention to how their meaning is shaped by shared social practices. I conclude by arguing that, in light of current pressures for medicine to become more personalized, using a relational understanding of personhood to shape policies and practices is a much needed endeavor. (shrink)

The notion of “consent” is frequently referred to as “informed consent” to emphasise the informational component of a valid consent. This article considers aspects of that informational component. One misuse of the language of informed consent is highlighted. Attention is then directed to some features of the situation in which consent would not have been offered had certain information been disclosed. It is argued that whether or not such consent is treated as sufficiently informed must, from a moral point of (...) view, take account of four conditions. When these are applied to the operation of consent in relation to criminal responsibility for HIV transmission, the approach in some recent cases is shown to be morally questionable. (shrink)

The present paper constitutes a critique of David Alm’s article “Punishment, Consent and Value”, in which it is argued that the consensual theory of punishment defended by C. S. Nino is false. Whilst Alm believes that this theory is grounded on an inadequate model of normative relations, here I will defend the hypothesis that such an assessment derives from an insufficient conception of human value and respect.

Intento criticar en el presente trabajo el enfoque sobre el poder del consentimiento defendido por David Owens. Según este enfoque, la capacidad de consentir responde a un interés normativo característico, el cual consistiría en permitir que ciertas obligaciones personales sean incumplidas, sin importar lo que materialmente se siga de ello, como la transgresión de nuestros intereses no normativos. Aquí sostendré que el enfoque de Owens confundiría dos planos de consideraciones: el plano relativo a la capacidad general de consentir y el (...) plano relativo al ejercicio de dicha capacidad en casos concretos. Para comprender el primer plano, el enfoque puede ser provechoso. No obstante, para comprender el segundo, lo más razonable sería apelar a la idea de razones personales para actuar, una idea que no parece haber recibido suficiente atención en la literatura habitual sobre el consentimiento. (shrink)

The debate on the ‘right to know’ has simmered on for over 30 years. New examples where a right to be informed is contrasted to a right to be kept in ignorance occasionally surface and spark disagreement on the extent to which patients and research subjects have a right to be self-determining concerning the health related information they receive. Up until now, however, this debate has been unsatisfactory with regard to the question what type of rights—if any—are in play here (...) and to what extent they can provide a normative basis for informed consent. This paper provides an analysis of informed consent in the context of ‘epistemic interventions’: interventions which involve the communication of information. First, I offer an analysis of the concept of a ‘right not to know’ in the context of consent to epistemic interventions. I argue that the scope of the consent is determined by the extent to which this intervention can be seen as an infringement of the private sphere. After that I show how this analysis affects the scope and standards of informed consent. (shrink)

This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, (...) if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly. (shrink)

I argue against various versions of the ‘attitude’ view of consent and of the ‘action’ view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic context, absence of dissent is sufficient for consent: what is crucial is having access to dissent. In the latter part of the paper I illustrate my view of consent (...) by applying it to the case of consenting to being an organ donor. (shrink)

This paper is written from a perspective that is sympathetic to the basic idea of the capability approach. Our aim is to compare Martha Nussbaum’s capability theory of justice with Alan Gewirth’s moral theory, on two points: the selection and the justification of a list of central capabilities. On both counts, we contend that Nussbaum’s theory suffers from flaws that Gewirth’s theory may help to remedy. First, we argue that her notion of a (dignified) human life cannot fulfill the role (...) of a normative criterion that Nussbaum wants it to play in selecting capabilities for her list. Second, we question whether Nussbaum’s method of justification is adequate, discussing both her earlier self-validating argumentative strategy and her more recent adherence to the device of an overlapping consensus. We conclude that both strategies fail to provide the capabilities theory with the firm foundation it requires. Next, we turn to Gewirth’s normative theory and discuss how it can repair these flaws. We show how his theory starts from a fundamental moral principle according to which all agents have rights to the protection of the necessary preconditions of their agency. Gewirth’s justification of this principle is then presented, using a version of a transcendental argument. Finally, we explicitly compare Nussbaum and Gewirth and briefly demonstrate what it would mean for Nussbaum to incorporate Gewirthian elements into her capabilities theory of justice. (shrink)

In 2007, the Ethics and Governance Council of the UK Biobank commissioned a Report on ‘Concepts of Public Good and Pubic Interest in Access Policies’. This study considered the Biobank’s role as a ‘public good’ in respect to supporting and promoting health throughout society. However, the conditions under which access by third parties to UK Biobank are justified in the public interest have not been well considered. In this article, I propose to analyse the conditions that should allow such access. (...) My argument develops UK Biobank’s function as a ‘public good’ and in terms of its responsibilities as a public health institution; both to protect the rights of the participants and in having a role in reinforcing public goals. Although these two tasks may conflict, it is possible that resolute opposition to some third-party access demands—if properly justified in terms of a public interest—will be damaging to, rather than protective of, participants’ rights. To illustrate my argument, I consider the appropriate response to an extraordinary public emergency , such as a serious criminal investigation or disaster response, in terms of an ethical access policy. (shrink)

The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole-genome sequencing and micro-array based analysis enable genome-wide testing for many heterogeneous abnormalities and predispositions simultaneously. This may challenge the feasibility of providing adequate pre-test information and achieving autonomous decision-making. At a symposium held at the 11th World Congress of Bioethics in June 2012 (Rotterdam), organized by (...) the International Association of Bioethics, these challenges were presented for three different areas in which these so-called ‘new genetics’ technologies are increasingly being applied: newborn screening, prenatal screening strategies and commercial personal genome testing. In this article, we build upon the existing ethical framework for a responsible set-up of testing and screening offers and reinterpret some of its criteria in the light of the new genetics. As we will argue, the scope of a responsible testing or screening offer should align with the purpose(s) of testing and with the principle of respect for autonomy for all stakeholders involved, including (future) children. Informed consent is a prerequisite but requires a new approach. We present preliminary and general directions for an individualized or differentiated set-up of the testing offer and for the informed consent process. With this article we wish to contribute to the formation of new ideas on how to tackle the issues of autonomy and informed consent for (public) healthcare and direct-to-consumer applications of the new genetics. (shrink)

Prompted by developments in human genetics, a recurrent bioethical question concerns a person’s ‘right to know’ and ‘right not to know’ about genetic information held that is intrinsically related to or linked to them. In this paper, we will revisit the claimed rights in relation to two particular test cases. One concerns the rights of the 500,000 participants in UK Biobank whose biosamples, already having been genotyped, will now be exome sequenced, and the other concerns the rights of pregnant women (...) who undergo non-invasive prenatal testing —a simple blood test that can reveal genetic information about both a foetus and its mother. This two-part paper is in four principal sections. First, we sketch the relevant features of our two test cases. Secondly, we consider the significance of recent legal jurisprudence in the UK and Singapore. Thirdly, we consider how, the jurisprudence apart, the claimed rights might be grounded. Fourthly, we consider the limits on the rights. We conclude with some short remarks about the kind of genetically aware society that we might want to be and how far there is still an opportunity meaningfully to debate the claimed rights. (shrink)

This paper, guided by the UNESCO Universal Declaration on Bioethics and Human Rights, assumes that regulators should aim to support the development of nanomedicine while, at the same time, putting in place whatever limits or safeguards are indicated by ethical considerations. Relative to this regulatory objective, it is argued that, notwithstanding the importance of precaution (characteristically, concerning health, safety, and the environment), ethical reflection needs to go both broader and deeper. It is suggested that, by attending to the basic matrix (...) of ethical debate and the “bioethical triangle” through which the matrix is currently articulated, the breadth, depth, and conflictual plurality of ethical concerns about nanomedicine will be clarified. In this light, the conventional thinking about precaution is revisited and concerns about human dignity and informed consent (under conditions of extreme uncertainty) are analysed. The paper concludes that, once the range of ethical pluralism is grasped, the extent of the challenge facing regulators will be more clearly appreciated. (shrink)

Alan Gewirth’s claim that agents contradict that they are agents if they do not accept that the principle of generic consistency (PGC) is the supreme principle of practical rationality has been greeted with widespread scepticism. The aim of this article is not to defend this claim but to show that if the first and least controversial of the three stages of Gewirth’s argument for the PGC is sound, then agents must interpret and give effect to human rights in ways consistent (...) with the PGC, or deny that human beings are equal in dignity and rights (which idea defines human rights) or that they are agents (and hence subject to any rules at all). Implications for the interpretation of the international legal system of human rights inspired by the Universal Declaration of Human Rights 1948 are sketched. (shrink)

Many states recognize a legal right to bodily integrity, understood as a right against significant, nonconsensual interference with one’s body. Recently, some have called for the recognition of an analogous legal right to mental integrity: a right against significant, nonconsensual interference with one’s mind. In this chapter, we describe and distinguish three different rationales for recognizing such a right. The first appeals to case-based intuitions to establish a distinctive duty not to interfere with others’ minds; the second holds that, if (...) we accept a legal right to bodily integrity, then we must, on pain of philosophical inconsistency, accept a case for an analogous right over the mind; and the third holds that recent technological developments create a need for a legal right to mental integrity. (shrink)