Trust and regulatory organisations: the role of local knowledge and facework in research ethics review.

While trust is seen as central to most social relations, most writers, including sociologists of science, assume that modern trust relations--especially those in regulatory relationships - tend towards the impersonal. Drawing on ethnographic material from one kind of scientific oversight body--research ethics committees based in the UK NHS--this paper argues that interpersonal trust is crucial to regulatory decision-making and intimately bound up with the way in which these oversight bodies work, and that as such they build on, rather than challenge, the trust-based nature of the scientific community.

It's money that matters: the financial context of ethical decision-making in modern biomedicine.

While the importance of patient autonomy is widely acknowledged and discussed in the bioethics literature, clinicians' autonomy, their ability to make the best choices about patients' care free from outside interference, is far less debated. This paper takes one form of external influence over clinical decisions - the cost of drugs - and applies it to a specific case, that of HER2 positive breast cancer and the use of the drug Herceptin in the UK. Drawing on interviews with clinicians, researchers and policymakers, I explore the way financial decisions about Herceptin shape clinicians' autonomy, and how clinicians as individuals and as professional groups respond to these limits and seek to provide treatment to the highest number of the most deserving patients they can. The point of this paper is not to castigate bioethicists for misguidedly focusing on patient autonomy but point out that clinicians' autonomy may be so circumscribed by external factors that it may make no sense to speak of their actions as stemming from ethical decisions. At the same time, I suggest that financial constraints create areas at the margin of clinical practice which are deserving of bioethical consideration.

Genetic databases and pharmacogenetics: introduction.

Since the inception of the Human Genome Project, human genetics has frequently been conducted through big science projects, combining academic, state and industrial methods, interests and resources. The legitimacy of such projects has been linked to national prestige and images of the nation, the purity of scientific endeavour, the entrepreneurial spirit, medical progress and the public health. A key complication in these discourses is that large-scale genetic research has yet to show major results when considered in terms of the objectives used to legitimate investment and social support for these projects. The main area showing promise at present is the developing field of pharmacogenetics, which is now attracting major industry and government investment. Sociological, ethical and philosophical study of human genetic sample-based research and pharmacogenetics has developed in parallel with inquiry in the biological and biomedical sciences. This paper introduces a symposium on the ethical and social aspects of this field of biomedical research.

Context, ethics and pharmacogenetics.

Most of the literature on pharmacogenetics assumes that the main problems in implementing the technology will be institutional ones (due to funding or regulation) and that although it involves genetic testing, the ethical issues involved in pharmacogenetics are different from, even less than, 'traditional' genetic testing. Very little attention has been paid to how clinicians will accept this technology, their attitudes towards it and how it will affect clinical practice. This paper presents results from interviews with clinicians who are beginning to use pharmacogenetics and explores how they view the ethics of pharmacogenetic testing, its use to exclude some patients from treatment, and how this kind of testing fits into broader debates around genetics. In particular this paper examines the attitudes of breast cancer and Alzheimer's disease specialists. The results of these interviews will be compared with the picture of pharmacogenetics painted in the published literature, as a way of rooting this somewhat speculative writing in clinical practice.

Putting pharmacogenetics into practice.

Genetics is slowly explaining variations in drug response, but applying this knowledge depends on implementation of a host of policies that provide long-term support to the field, from translational research and regulation to professional education.

Critical bioethics: beyond the social science critique of applied ethics.

This article attempts to show a way in which social science research can contribute in a meaningful and equitable way to philosophical bioethics. It builds on the social science critique of bioethics present in the work of authors such as Renee Fox, Barry Hoffmaster and Charles Bosk, proposing the characteristics of a critical bioethics that would take social science seriously. The social science critique claims that traditional philosophical bioethics gives a dominant role to idealised, rational thought, and tends to exclude social and cultural factors, relegating them to the status of irrelevancies. Another problem is they way in which bioethics assumes social reality divides down the same lines/categories as philosophical theories. Critical bioethics requires bioethicists to root their enquiries in empirical research, to challenge theories using evidence, to be reflexive and to be sceptical about the claims of other bioethicists, scientists and clinicians. The aim is to produce a rigorous normative analysis of lived moral experience.

Expansion and uncertainty: cystic fibrosis, classification and genetics.

This paper presents an empirical examination of geneticization, the process where genetic explanations gain ascendancy in medical and social discourse. By focusing on Cystic Fibrosis (CF), this study shows how genetic explanations play a role in the reclassification of Cystic Fibrosis. One result of this geneticization is a nosological expansion, where the boundaries of the disease expand to include a certain form of male infertility. In addition this paper highlights the uncertainty in the CF classification system that results from the use of genetic explanations.