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. (shrink)

Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development—protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects are (...) asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or ‘work’, the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context. (shrink)

In this article I consider some central aspects of the naturalist philosophy of science and science and technology studies in dealing with the contested status of technoscience in medicine. Focusing on the concepts of realism and representation, I argue that theories of science-as-practice in naturalist philosophy of science should expand their scope so as to reflect more thoroughly on the social and political context of technoscience. I develop a hermeneutic of technomedical objects in order to highlight the internal connectedness between (...) social action, material agency, and the actions of scientific communities. The framework thus developed is used to re-consider the genomic turn in medicine. Pointing to the discrepancies between socially dominant representations of genomic technology and the actual interventions brought about through those technologies, I raise the question of how and where to address problems of theory and policy. (shrink)

There has been extensive discussion in research ethics literature surrounding the appropriate form of informed consent for biobanking, whether with adapted content, or adapted forms such as broad or tiered consent. These discussions presuppose that it is possible to disclose adequate information at the outset to facilitate an informed choice to donate to a biobank. I will argue that informed consent cannot be achieved because in the biobanking context, we are either consenting to an enterprise that is not research or (...) to future research. Nor is the solution to abandon the idea that informed consent ethically requires the disclosure of a certain minimal amount of information to make an informed choice by misleadingly identifying broad, blanket or even tiered consent as forms of ‘informed’ consent. Rather, we should abandon the idea that informed consent for research can be adapted to the type of endeavor that biobanking is, and understand the goal as to develop alternatives not as alternative forms of informed consent, but rather alternatives to informed consent. (shrink)

Philosophical anthropologies that emphasise the role of the emotions can be used to expand existing notions of moral agency and learning in situations of great moral complexity. In this article we tell the story of one patient facing the tough decision of whether to be tested for Huntington’s disease or not. We then interpret her story from two different but compatible philosophical entry points: Aristotle’s conception of Greek tragedy and Karl Jaspers’ notion of Grenzsituationen (boundary situations). We continue by indicating (...) some ways in which these two positions may be used for reflecting upon different perspectives involved in clinical decision-making, those of patients, clinicians and bioethicists. We conclude that the ideas we introduce can be used as hermeneutic tools for situating learning and dialogue within a broader cultural field in which literature and art may also play important roles. (shrink)

Whereas in the 1970s early bioethicists believed that bioethics is an arena for the application of philosophical theories of utilitarianism, deontology, and natural law thinking, contemporary policy-oriented bioethicists seem rather to be keen on framing ethical issues through political ideologies. Bioethicists today are often labeled “liberal” or “communitarian,” referring to their different understandings of the relationship between the individual and society. Liberal individualism, with its conceptual base of autonomy, dignity, and privacy, enjoyed a long period of dominance in bioethics, but (...) it has increasingly come under attack from ideologies promoting a more salient role for concepts of solidarity, community, and public interest. (shrink)

ABSTRACT A major moral problem in relation to the deCODE genetics database project in Iceland is that the heavy emphasis placed on technical security of healthcare information has precluded discussion about the issue of consent for participation in the database. On the other hand, critics who have emphasised the issue of consent have most often demanded that informed consent for participation in research be obtained. While I think that individual consent is of major significance, I argue that this demand for (...) informed consent is neither suitable nor desirable in this case. I distinguish between three aspects of the database and show that different types of consent are appropriate for each. In particular, I describe the idea of a written authorisation based on general information about the database as an alternative to informed consent and presumed consent in database research. (shrink)

Is genetic information of special ethical significance? Does it require special regulation? There is considerable contemporary debate about this question (the genetic exceptionalism debate). Genetic information is an ambiguous term and, as an aid to avoiding conflation in the genetic exceptionalism debate, a detailed account is given of just how and why genetic information is ambiguous. Whilst ambiguity is a ubiquitous problem of communication, it is suggested that genetic information is ambiguous in a particular way, one that gives rise to (...) the problem of significance creep (i.e., where claims about the significance of certain kinds of genetic information in one context influence our thinking about the significance of other kinds of genetic information in other contexts). A contextual and contrastive methodology is proposed: evaluating the significance of genetic information requires us to be sensitive to the polysemy of genetic information across contexts and then examine the contrast in significance (if any) of genetic, as opposed to nongenetic, information within contexts. This, in turn, suggests that a proper solution to the regulatory question requires us to pay more attention to how and why information, and its acquisition, possession and use, come to be of ethical significance. (shrink)

Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that an informed consent (...) approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large. (shrink)