This article sketches how liberal principles can be coherently set alongside the stewardship responsibilities of regulators. It indicates how this bears on the legitimacy of public health interventions in general and interventions of the kind associated with New York City’s public health programme in particular. The key idea is that stewardship responsibilities relate to the essential infrastructural conditions for human well-being; these conditions need to be protected because they are the staging for all human activity. Liberal principles, by contrast, presuppose (...) that the basic conditions for human well-being are in place; and, given this presupposition, they present a view about how humans should live, about how they should interact and transact and about how they should flourish. Where regulators are guided by a liberal ethic, they act illegitimately if they try to dictate how individuals should lead their lives; but, acting under their stewardship jurisdiction, regulators may legitimately intervene if they are trying to protect the conditions that are essential for any kind of human life. The article concludes by suggesting that while it is a good thing that New York City’s policies provoke debate about the legitimacy of public health interventions, it is the infrastructural conditions, and not the superstructural activities, that are the regulatory priority. (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)

Biobanks that are run on an opt-in basis depend on people having the motivation to give and to trust in those who control their samples. Yet in the UK trust in the healthcare system has been in decline and there have been a number of health-related scandals that have received widespread media and public attention. Given this background, and the previous public consultations on UK Biobank, the paper explores the way people express their trust and mistrust in the area of (...) medical and genetic information through discussions in six focus groups held in different areas of Britain. The themes that emerged in the discussion were the special character of genetic data; the ease with which information spreads; the public/private divide in genetic research; the potential of genetic information to harm people; choice, consent and lack of control; and the difficulty of establishing trustworthy governing arrangements. The expert agenda of policy-makers and medical ethics does not address the broader concerns expressed by participants. It seems that public consultation and the language of openness and transparency may not be sufficient to establish trust in the governance of genetic databases. Donors will be asked to give freely without any return but the participants' perception of those using the samples is that they are motivated by success and profit rather than healthcare priorities. In this context altruism seems naive and even dangerous. In order to place their trust well people need evidence of a relationship with obligations and expectations on both sides. (shrink)

Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. Offers (...) of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (shrink)

Although scientific and commercial excitement about genomic biobanks has subsided since the biotech bust in 2000, they continue to fascinate life scientists, bioethicists, and politicians alike. Indeed, these assemblages of personal health information, human DNA, and heterogeneous capital have become and remain important events in the ethics and politics of the life sciences. For starters, they continue to reveal and produce the central scientific, technological, and economic paradigms so ascendant in biology today: genome, infotech, and market. Biobanks also illustrate what (...) might be called the new distributive politics of biomedical research. Within those politics, the commodification of persons – or at the very least, of their informational representations – has challenged the ontological, ethical, and political underpinnings of the social contract between researchers and their human research subjects. In brief, biobanks are unsettling relations between genes, tissue, medical records, and persons. But it is also clear that these relations are increasingly being restructured by new rights of control, access, exclusion, and use known as “property,” both material and intellectual. (shrink)

We are witnessing is nothing less than a new kind of gold rush, and the territory is the body.