Scandals, ethics, and regulatory change in biomedical research

This paper explores how a particular form of regulation––prior ethical review of research––developed over time in a specific context, testing the claims of standard explanations for such change (which center on the role of exogenous shocks in the form of research scandals) against more recent theoretical approaches to institutional changes, which emphasize the role of gradual change. To makes its case, the paper draws on archival and interview material focusing on the research ethics review system in the UK National Health Service. Key insights center on the minimal role scandals play in shaping changes in this regulatory setting and how these depend upon the absence of a single coherent profession (and accompanying social contract) associated with biomedical research

Selling impact: how is impact peer reviewed and what does this mean for the future of impact in universities?

Despite a wealth of guidance from HEFCE, impact evaluation in the run-up to REF2014 was a relatively new experience for universities. How it was undertaken remains largely opaque. Richard Watermeyer and Adam Hedgecoe share their findings from a small but intensive ethnographic study of impact peer-review undertaken in one institution. Observations palpably confirmed a sense of a voyage into the unknown. Due to the confusion and uncertainty, there was a tendency to prioritise hard (or more immediately certain) impacts over those deemed more soft (or nebulous)

Bioethics and the reinforcement of socio-technical expectations

Over the past few years, considerable interest has been paid to the way in which social expectations (hopes, hypes, fears) about new genomic technologies help shape, and in themselves are shaped by, emerging technologies, regulatory regimes and social concerns. In comparison, little attention has been paid to the role of expectations in related, but non-scientific discourses, such as bioethics. Drawing on a review of publications addressing the ethical issues associated with pharmacogenetics, this paper presents a detailed critique of bioethicists’ contribution to these debates. The review highlights how, almost a decade after bioethical debate around pharmacogenetics started, and in contrast to the profession’s self-perception as a form of regulator, bioethicists still largely restrict themselves to reviews of possible ethical issues raised by this technology, rather than critiquing others’ positions and arguing for specific points of view. In addition the paper argues that bioethicists tend to: accept unquestioningly scientists’ expectations about the development and ethical issues raised by pharmacogenetics; ignore contributions from bioethicists who do question these expectations; and engage in an ethical debate, the boundaries of which have been laid down and defined by academic and industry scientists. The paper concludes by offering some possible explanations for why the bioethical discourse has taken this form

Reputational risk, academic freedom and research ethics review

Drawing on scholarship around academic freedom and new public management, this article explores the way in which research ethics committees in UK universities (URECs) can come to exhibit behaviour – common in their US equivalents – that prioritises the reputational protection of their host institution over and above academic freedom and the protection of research subjects. Drawing on two case studies the article shows both how URECs can serve to restrict research that may be ‘embarrassing’ for a university and how, in high profile cases, university management come to use such committees as mechanisms for internal discipline

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

"A form of practical machinery”: The origins of research ethics committees in the UK

Given the centrality of ethics review by independent committees (called Research Ethics Committees, or RECs, in the UK) to modern biomedical research, and the ubiquity of complaints about such review on the part of researchers, it is curious that little attention has been paid to these organizations by medical historians in contrast to the work done on the role of institutions such as the British Medical Association (BMA) and the General Medical Council (GMC) in the development of medical professional ethics, and the general evolution of medical professionals' ethical values. Thus while some work has explored the origins of modern medical ethics teaching in the UK and the parallel development of academic bioethics, there has been very little consideration of how Research Ethics Committees specifically were set up and evolved in the late 1960s and early 1970s. Although some scholars have discussed the development of the British REC system, this work tends to provide little beyond an outline of major events. These might include a report from the Royal College of Physicians (RCP) in 1967, the Department of Health's ‘Red Book’ of 1991 outlining the responsibilities of Local Research Ethics Committees (LRECs) and, more recently, the introduction of multicentre RECs (MRECs) in 1997

Taking after a parent: phenotypic resemblance and the professional familialisation of genomics

This article draws on 2 years’ worth of ethnographic observation of team meetings to explore decision-making in an NHS clinical genomics service. The focus of discussions was on ambiguous genomic results known as VUS or Variants of Uncertain Significance, which may be pathogenic but which also may turn out to be benign. In examining decision-making around such results, we note how, in contrast to much policy and promotional material in this area, clinicians in these meetings (clinical geneticists and genetic counsellors) place great emphasis on parental phenotypes and whether the parents of a patient share the symptoms and signs of the suspected condition. This information is then combined with the result of genomic tests to decide whether the variant a patient has is responsible for their condition. This article explores the way in which clinicians attempt to flexibly enrol parents into genomic explanations through informal diagnosis of their possible phenotypes and the way in which actually meeting parents allows some clinicians to trump explanations based on documentary or photographic data. The paper sheds light on the way that earlier scholarly understandings of such decisions (around, say dysmorphology) remain relevant and explores claims that laboratory tests overrule clinical decision-making

Reflexive standardization and the resolution of uncertainty in the genomics clinic

In genomics, the clinical application of Next Generation Sequencing technologies (such as Whole Genome or Exome Sequencing) has attracted considerable attention from UK policymakers, interested in the benefits such technologies could bring the National Health Service. However, this boosterism plays little attention to the challenges raised by a kind of result known as a Variant of Uncertain Significance, or VUS, which require clinical geneticists and related colleagues to classify ambiguous genomic variants as ‘benign’ or ‘pathogenic’. With a rigorous analysis based on data gathered at 290 clinical meetings over a two-year period, this paper presents the first ethnographic account of decision-making around NGS technology in a NHS clinical genomics service, broadening our understanding of the role formal criteria play in the classification of VUS. Drawing on Stefan Timmermans’ concept of ‘reflexive standardisation’ to explore the way in which clinical genetics staff classify such variants this paper explores the application of a set of criteria drafted by the American College of Medical Genetics and Genomics, highlighting the flexible way in which various resources – variant databases, computer programmes, the research literature – are drawn on to reach a decision. A crucial insight is how professionals’ perception of, and trust in, the clinical practice at other genomics centres in the NHS, shapes their own application of criteria and the classification of a VUS as either benign or pathogenic

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

Genetic Determinism and the Innate-Acquired Distinction in Medicine

This article illustrates in which sense genetic determinism is still part of the contemporary interactionist consensus in medicine. Three dimensions of this consensus are discussed: kinds of causes, a continuum of traits ranging from monogenetic diseases to car accidents, and different kinds of determination due to different norms of reaction. On this basis, this article explicates in which sense the interactionist consensus presupposes the innate–acquired distinction. After a descriptive Part 1, Part 2 reviews why the innate–acquired distinction is under attack in contemporary philosophy of biology. Three arguments are then presented to provide a limited and pragmatic defense of the distinction: an epistemic, a conceptual, and a historical argument. If interpreted in a certain manner, and if the pragmatic goals of prevention and treatment (ideally specifying what medicine and health care is all about) are taken into account, then the innate–acquired distinction can be a useful epistemic tool. It can help, first, to understand that genetic determination does not mean fatalism, and, second, to maintain a system of checks and balances in the continuing nature–nurture debates