Lars Øystein Ursin

Not worth the paper it's written on? Informed consent and biobank research in a Norwegian context

In January 2003 the Norwegian Parliament passed the Biobanks Act, regulating biobank research in Norway. There have been strong differences of opinion both in the process of making the law as well as in its first years of implementation. The main controversy relates to what kind of informed consent should be required for biobank research. Central to the controversy over current interpretations of the Biobanks Act is the informed consent given by the donors to the biobank of the Nord-Trøndelag Health Study (HUNT), and whether the consent given ‘was worth the paper it was written on’. This article traces the history behind the informed consent procedure of the blood samples in the largest research biobank in Norway, the HUNT biobank. Second, findings from a focus group study with biobank participants are presented. Third, a philosophical analysis is made of the concept of informed consent in light of the findings from the focus-group study as well as the history behind the HUNT biobank. Findings from the focus-group study show that the consenters base their participation on trust in the researchers and the regulation of research in Norwegian society, rather than on specific information on the research in question. The history behind the HUNT biobank fosters trust. The story provides a strong case for not limiting the debate to legalistic and formalistic ethics but also including a research ethics that says that process and trust matter. Otherwise no informed consent in medical research is worth the paper it is written on.

We're not in it for the money—lay people's moral intuitions on commercial use of 'their' biobank

Great hope has been placed on biobank research as a strategy to improve diagnostics, therapeutics and prevention. It seems to be a common opinion that these goals cannot be reached without the participation of commercial actors. However, commercial use of biobanks is considered morally problematic and the commercialisation of human biological materials is regulated internationally by policy documents, conventions and laws. For instance, the Council of Europe recommends that: “Biological materials should not, as such, give rise to financial gain”. Similarly, Norwegian legislation reads: “Commercial exploitation of research participants, human biological material and personal health data in general is prohibited”. Both articles represent kinds of common moral intuitions. A problem, however, is that legislative documents are too vague and provide room for ample speculation. Through the use of focus group interviews with Norwegian biobank donors, we have tried to identify lay intuitions and morals regarding the commercial use of biobanks. Our findings indicate that the act of donation and the subsequent uses of the samples belong to two different spheres. While concerns around dignity and commodification were present in the first, injustice and unfairness were our informants’ major moral concerns in the latter. Although some opposition towards commercial actors was voiced, these intuitions show that it is possible to render commercial use of biobanks ethically acceptable based on frameworks and regulations which hinder commodification of the human body and promote communal benefit sharing.

Biobank research and the right to privacy

What is privacy? What does privacy mean in relation to biobanking, in what way do the participants have an interest in privacy, (why) is there a right to privacy, and how should the privacy issue be regulated when it comes to biobank research? A relational view of privacy is argued for in this article, which takes as its basis a general discussion of several concepts of privacy and attempts at grounding privacy rights. In promoting and protecting the rights that participants in biobank research might have to privacy, it is argued that their interests should be related to the specific context of the provision and reception of health care that participation in biobank research is connected with. Rather than just granting participants an exclusive right to or ownership of their health information, which must be waived in order to make biobank research possible, the privacy aspect of health information should be viewed in light of the moral rights and duties that accompany any involvement in a research based system of health services.

Personal autonomy and informed consent.

Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.

Privacy and Property in the Biobank Context

A research biobank is a collection of personal health and lifestyle information, including genetic samples of yet unknown but possibly large information potential about the participant. For the participants, the risk of taking part is not bodily harm but infringements of their privacy and the harmful consequences such infringements might have. But what do we mean by privacy? Which harms are we talking about? To address such questions we need to get a grip on what privacy is all about and aim for a fruitful perspective on the issues of property and privacy rights in the context of biobanking. This paper argues that the limits and handling of private matters is determined in specific social relations. The crucial point is thus to determine which information and activities are or are not the legitimate concern of others. Privacy and property rights should be seen as balanced by duties, that is as inherently relational interests extending into the public sphere, rather than to see these rights as the control of an object—for instance the participant’s biobank material.

Biobank research and the welfare state project: the HUNT story

Health surveys and biobank research projects involve large groups of people, in the role of participants as well as potential beneficiaries. In this article, the nature of biobank participation in ambitious welfare states is explored by a description and an analysis of the Norwegian HUNT project. The analysis of HUNT material brings forth a transformation of the ethical side of partaking. Different approaches to the overall aim of emancipation of the individual through and from the state – paternalism and autonomy going hand in hand – are spelt out in the three recruitment policies of HUNT 1–3. In this article, I aim to show how the HUNT participant is conceptualised in different ways in the three rounds of recruitment, and how these conceptualisations illustrate essential features of the welfare state project in a period of transition.

Justified by What? Three Ways to Provide an Ethical Basis for Neonatal Policies

Three different ways of justifying neonatal policies are identified and situated, 1 in each of the Scandinavian countries. In this article, I identify 3 ways of justifying neonatal policies of when to provide life-saving treatment to infants who were born extremely premature: by appealing to universal principles or rights, to considerations of the best interests of the children, or to considerations of the best interests of the families. I go on to show how each of these justifications can be used to characterize the discourse on neonatal policies in 1 of the Scandinavian countries.

Gnawing doubt: eating animals and the promise of cultured meat

Envisioned technologies can make and be motivated by ethical spaces. In this paper I will explore the ethical spaces that motivates and are made by the emerging technology of cultured meat. Proponents of cultured - or in vitro - meat argue that it has the potential to present a solution to several of perceived problems of factory farming: Animal welfare issues, environmental concerns, and global access to meat products. Critics of in vitro meat technology argue that the solution it introduces just will aggravate an alienation from farm animals caused by factory farming. In the eyes of the critic, cultured meat would be a technological quick fix that just eases the consequences of a flawed way relating to both food and animals. In this paper I will use the technology of cultured meat as a tool to analyze the moral relation between animals as fellow creatures versus animals as food.

The Health Dugnad: Biobank Participation as the Solidary Pursuit of the Common Good

Rosamond Rhodes and John Harris have recently argued that we all have a general moral duty to participate in medical research. However, neither Rhodes’ nor Harris’ arguments in support of this obligation stand up to scrutiny, and severe and convincing criticism has been levelled against their case. Still, to refute their arguments is not to refute the conclusion. There seems to be some truth to the view that when people are asked to take part in medical research, their choice is not completely morally neutral. In this chapter, we argue that the proper question to ask is when, rather than if, a certain moral duty to volunteer for medical research can be appealed to. To answer this question, we need a denser description of relevant research projects and their context rather than just describing medical research in general. Drawing on our study of participants in the Norwegian HUNT biobank, we use the normative implications of the Norwegian concept “dugnad” as an analogy to discuss the requirement of providing neutral information to potential biobank participants in order to promote their free and informed decision as to whether or not to take part. We suggest that normative recruitment is not just a question of principles and ethics. It is also a question of research design and the creation of the common good in the community where the research takes place.

Duties and Rights of Biobank Participants: Principled Autonomy, Consent, Voluntariness and Privacy

In this chapter the notion of principled autonomy is presented, and the perspective enabled by this notion is applied in the field of biobanking. Some consequences of the perspective of principled autonomy on aspects of biobank recruitment are discussed in relation to concepts of voluntariness, consent, and privacy. These discussions aim to focus on the fruitfulness of the notion of principled autonomy in bringing out the interconnectedness of the duties and rights of biobank participants – both in general, and in a context of taking part in a research-based universal health care system in particular.