There is widespread discussion concerning the safeguards appropriate for human research subjects. Less discussed is the fact that the safeguards one deems appropriate depend, in large part, on the model of research participation that one assumes. Therefore, to determine what safeguards are appropriate, it is necessary first to clarify the competing models of research participation. The ostensibly obscure debate over informed consent for research on stored biological samples is of particular interest in this regard because such research can involve varying (...) subsets of the three central elements of research involvement. As a result, analysis of this debate provides an opportunity to identify the competing models of research participation. Based on this analysis, this paper describes a new model of research participation that is emerging, and considers its implications for clinical research. (shrink)

Tauber's book outlines a philosophy of medicine that sees an ethos of caring as the central imperative of a doctor. Three broad claims are defended in the text. First, Tauber is sceptical of conceptions of medicine that treat physicians as primarily scientists or the agents of profit-makers or administrators. For such conceptions fail to consider the patient as a whole or his/her personalised suffering as demanding empathy. Second, he criticises conceptions of medical ethics that emphasise personal autonomy. After a brief (...) account of how, he thinks, the ideal of autonomy was invented and developed in Western thought, Tauber questions the significance of autonomy in medicine. Because of …. (shrink)

This special volume of Health Care Analysis is dedicated to a consideration of the status of body parts and products and the roleof law in regulating them. We argue that such a discussion is timely giventhe conflation of technological and academic concerns posed by thecomplex legal framework within which these issues are currentlyaddressed and in the light of debates such as those regardingthe storage of children's organs addressed by inquiries atAlder Hay and Bristol, United Kingdom. The contributors addressspecific legal problems (...) which have been brought before the courts in the UK and other jurisdictions, something which wesuggest is likely to occur with increasing regularity oncethe Human Rights Act 1998 comes into force in October 2000.The issues are also considered on a more theoretical level with papers exploring the role of concepts such as property, donation, commodification and kinship in these debates.While the volume focuses principally upon the manner inwhich these issues have arisen in a UK context, though withreference to certain comparative examples, the concepts discussed here are of more general application acrossother jurisdictions. (shrink)

The furore over the retention of organs at postmortem examination, without adequate consent, has led to a reassessment of the justification for, and circumstances surrounding, the retention of any human material after postmortem examinations and operations. This brings into focus the large amount of human material stored in various archives and museums, much of which is not identifiable and was accumulated many years ago, under unknown circumstances. Such anonymous archival material could be disposed of, used for teaching, used for research, (...) or remain in storage. We argue that there are no ethical grounds for disposing of the material, or for storing it in the absence of a teaching or research rationale. Nevertheless, with stringent safeguards, it can be used even in the absence of consent in research and teaching. Regulations are required to control the storage of all such human material, along the lines of regulations governing anatomy body bequests. (shrink)

“Anonymised screening is a research tool to inform policy and practice and individual decision making, but is not a tool to identify those at risk that could directly benefit from intervention.”1The assumption that the information acquired will be used to prioritise health care resources may prove false. A government, after weighing up the costs and benefits, may choose not to adopt appropriate interventions. Or, even if a policy is proposed,, it may not be adhered to. Even as I write, antenatal (...) clinics that serve populations with the highest concentration of refugees from sub-Saharan Africa, and therefore of those at risk, still do not have a policy of universal screening.Anonymised screening is a form of non-therapeutic research, and should comply with the Helsinki Declaration on Non-therapeutic Research involving Human Subjects. I have already argued that physicians who undertake anonymised screening have abrogated their duty, as outlined in article one, “... to remain the protector of the life and health of that person on whom biomedical research is being carried out”.2In addition, article four states: “In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.”2The desire for an outcome—perfect epidemiological figures—should not override the ethics of the process whereby this is achieved. The …. (shrink)

An Institute of Medical Ethics working party supports the view that explicit permission should normally be sought in the case of testing for HIV antibody. It discusses this in relation to anonymised HIV testing for epidemiological purposes, concluding that this is to be welcomed, given certain safeguards. It next argues that pregnant women may have a greater and more immediate need than others to know their HIV status. It concludes that this need does not justify testing them without their permission, (...) but can be met by voluntary diagnostic testing on an 'opting-out' basis, supported by adequate briefing. (shrink)

An Institute of Medical Ethics working party supports the view that explicit permission should normally be sought in the case of testing for HIV antibody. It discusses this in relation to anonymised HIV testing for epidemiological purposes, concluding that this is to be welcomed, given certain safeguards. It next argues that pregnant women may have a greater and more immediate need than others to know their HIV status. It concludes that this need does not justify testing them without their permission, (...) but can be met by voluntary diagnostic testing on an 'opting-out' basis, supported by adequate briefing. (shrink)