The current rise in malpractice litigation has led to concern in the research community as to the prospect of litigation against researchers. Clearly as the responsibility for the day-to-day conduct of the research falls upon the researchers they will be potentially liable should there be negligence in the conduct of the research project itself. But to what extent can the research ethics committee and its members be held liable should harm result to the research subject? How far does the prospect (...) of the threat of litigation equate with the reality of the prospect of liability? Although the NHS research governance framework suggests that primary responsibility for the conduct of the trial is with the researcher this does not mean that REC members will be immune from actions in tort where research subjects suffer harm in the conduct of a research project approved by their NHS REC. This paper focuses upon the prospect for liability in the law of tort of NHS RECs and their members. While in practice the vast majority of such claims are unlikely to be successful members of RECs may incur resultant legal costs as a consequence of involvement in proposed litigation. It is submitted that the scope of indemnity provision provided to RECs and their members should be precisely determined, otherwise there is a real prospect that the risk of malpractice litigation may deter individuals from serving on such committees. (shrink)

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the (...) increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research. (shrink)

The aim of this investigation is to discuss the merits of the three radically divergent views as to the nature and function of the categories held by Kant, Ward and Alexander.

This dissertation seeks to contribute to research in the philosophy of social science. The study focuses upon select epistemological and ontological aspects of Hannah Arendt’s work from which methodological implications are drawn pertaining to sociology. Arendt, although critical of the sociology of her time, has become increasingly cited and influential for emerging sociological research and this study seeks to contribute to this by focusing upon the problem of novelty. The aim is to explore the philosophical and methodological implications of novelty (...) for social science by working through three case studies that are theoretically pivotal for social science—action, the ‘social’, and the self—in terms of novelty as expressed in Arendt’s writing. Arendt is critical of methodology and epistemology, aiming to draw her readers to ontological concerns outlined from her preoccupation with the 'world' and social reality. In this aim, Arendt seeks to distance herself from social sciences that she claims ignore human novelty in favour of reading social regularities, tendencies and similarities. Despite her disdain for method, Arendt suggests a anti-methodological 'method' (outlined in an overlooked footnote) for keeping trained upon and for dealing with novel, anomalous events. In the seed of this method lies a unique opportunity for social science to reassess and extend its methods, addressing this oversight and in so doing bring to light the novel social object as a legitimate subject of social research. (shrink)

The pregnant phrase fatale monstrum comes at a crucial point in the third and longest of the three sentences of the ‘Cleopatra Ode’. Before it Cleopatra is being hissed from the stage of history with cries of disapproval; after it she is recalled to receive plaudit after plaudit for her courage and resolution. The phrase is emphasized by its position at the start of a stanza followed by a marked pause. Prima facie it is the climax of the vituperation, and (...) has often so been taken. T. E. Page, for example, comments: ‘Horace speaks of Cleopatra as not human, but a hideous and portentous creature sent by destiny to cause horror and alarm.’. (shrink)

The Human Tissue Act 2004 presents a radical change to the legal regulation of the use of human material in England and Wales. The Act presents a broad regulatory framework but much in the practical operation of the legislation will depend upon regulations to be enacted and a new Code of Practice. This article examines 'appropriate consent' for the use of human tissue for research purposes in the context of the living competent adult. It examines the provision of information as (...) part of the consent process for the use of human materials for research purposes, the question of when consent can be withdrawn, and the controversial exception enabling the use without consent of anonymized material for research purposes where the research has been ethically approved. The paper concludes by highlighting some of the problems which may remain after the legislation comes into force. (shrink)

A pure significance test would check the agreement of a statistical model with the observed data even when no alternative model was available. The paper proposes the use of a modified p -value to make such a test. The model will be rejected if something surprising is observed. It is shown that the relation between this measure of surprise and the surprise indices of Weaver and Good is similar to the relationship between a p -value, a corresponding odds-ratio, and a (...) logit or log-odds statistic. The s -value is always larger than the corresponding p -value, and is not uniformly distributed. Difficulties with the whole approach are discussed. (shrink)