The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent proposed alternatives are. (...) In the process, it evaluates the justification for continuing to use clinical equipoise as the gold standard for randomized control trials. (shrink)

This paper explores early Australasian philosophy in some detail. Two approaches have dominated Western philosophy in Australia: idealism and materialism. Idealism was prevalent between the 1880s and the 1930s, but dissipated thereafter. Idealism in Australia often reflected Kantian themes, but it also reflected the revival of interest in Hegel through the work of ‘absolute idealists’ such as T. H. Green, F. H. Bradley, and Henry Jones. A number of the early New Zealand philosophers were also educated in the idealist tradition (...) and were influential in their communities, but produced relatively little. In Australia, materialism gained prominence through the work of John Anderson, who arrived in Australia in 1927, and continues to be influential. John Anderson had been a student of Henry Jones, who might therefore be said to have influenced both main strands of Australian philosophical thought. (shrink)

A polemical account of Australian philosophy up to 2003, emphasising its unique aspects (such as commitment to realism) and the connections between philosophers' views and their lives. Topics include early idealism, the dominance of John Anderson in Sydney, the Orr case, Catholic scholasticism, Melbourne Wittgensteinianism, philosophy of science, the Sydney disturbances of the 1970s, Francofeminism, environmental philosophy, the philosophy of law and Mabo, ethics and Peter Singer. Realist theories especially praised are David Armstrong's on universals, David Stove's on logical probability (...) and the ethical realism of Rai Gaita and Catholic philosophers. In addition to strict philosophy, the book treats non-religious moral traditions to train virtue, such as Freemasonry, civics education and the Greek and Roman classics. (shrink)

ABSTRACT Ethical thinking about social science research is dominated by a biomedical model whose salient features are the assumption that only potential harms to subjects of research are relevant in the ethical evaluation of that research, and in the emphasis on securing informed consent in order to establish ethical probity. A number of counter‐examples are considered to the assumption, a number of defences against these counter‐examples are examined, and an alternative model is proposed for the ethical evaluation of social science (...) research: a model which can cope with the systemic harms which have been identified. This model is based on John Rawls's idea of original position reasoning and treats social science research as an institutional feature of the basic structure of society. (shrink)

The popularity of empirical methods in software engineering research is on the rise. Surveys, experiments, metrics, case studies, and field studies are examples of empirical methods used to investigate both software engineering processes and products. The increased application of such methods has also brought about an increase in discussions about adapting these methods to the particularities of software engineering. In contrast, the ethical issues raised by empirical methods have received little attention in the software engineering literature. In this chapter, we (...) introduce four ethics principles of primary importance for conducting ethical research. We additionally discuss and provide examples of applying these principles in the context of ethics review. (shrink)

(2003). The Ethics and Governance of Medical Research: What does regulation have to do with morality? New Review of Bioethics: Vol. 1, No. 1, pp. 41-58.

This paper argues that ethics education needs to become more reflective about its social and political ethic as it participates in the construction and transmission of medical ethics. It argues for a critical approach to medical ethics and explores the political context in medical schools and some of the peculiar problems in medical ethics education.

Although recent trends in politics and media make it appear that conspiracy theories are on the rise, in fact they have always been present, probably because they are sustained by natural dispositions of the human brain. This is also the case with medical conspiracy theories. This article reviews some of the most notorious health-related conspiracy theories. It then approaches the reasons why people believe these theories, using concepts from cognitive science. On the basis of that knowledge, the article makes normative (...) proposals for public health officials and health workers as a whole, to deal with conspiracy theories, in order to preserve some of the fundamental principles of medical ethics. (shrink)

Informed consent to medical procedures tends to be construed in terms of principle-based ethics and one or other form of expected utility theory. These constructions leave problems created by imperfect communication; subjective distress and other emotions; imperfect knowledge and incomplete understanding; complexity, and previous experience or the lack of it. There is evidence that people giving consent to therapy or to research participation act intuitively and assess consequences holistically, being influenced more by the magnitude of outcomes than their probability. People (...) avoid decisions they may regret, but modern regret theory has received little attention in discussions of informed consent. This essay suggests ways in which regret may be acknowledged in the consent process and in the assessment of the information that is an intrinsic part of it. (shrink)

In late 1949 the former Soviet Union conducted an open trial of eight Japanese physicians and researchers and four other military servicemen in Khabarovsk, a city in eastern Siberia. Despite its strong ideological tone and many obvious shortcomings such as the lack of international participation, the trial established beyond reasonable doubt that the Japanese army had prepared and deployed bacteriological weapons and that Japanese researchers had conducted cruel experiments on living human beings. However, the trial, together with the evidence presented (...) to the court and its major findings — which have proved remarkably accurate — was dismissed as communist propaganda and totally ignored in the West until the 1980s. This paper reviews the 1949 Khabarovsk trial, examines the West's dismissal of the proceedings as mere propaganda and draws some moral lessons for bioethics today. As an important historical case, set in the unique socio-political context of the Cold War, the West's dismissal of the trial powerfully illustrates some perennial ethical issues such as the ambivalence of evidence and the power of ideology in making (or failing to make) cross-national and cross-cultural factual and moral judgments. (shrink)

This essay argues that individual-oriented informed consent is inadequate to protect human research subjects in mainland China. The practice of family-oriented decision-making is better suited to guide moral research conduct. The family’s role in medical decision-making originates from the mutual benevolence that exists among family members, and is in accordance with family harmony, which is the aim of Confucian society. I argue that the practice of informed consent for medical research on human subjects ought to remain family-oriented in mainland China. (...) This essay explores the main features of this model of informed consent and demonstrates the proper authority of the family. The family’s participation in decision-making as a whole does not negate or deny the importance of the individual who is the subject of the choice, but rather acts more fully to protect research subjects. (shrink)

There is a growing body of literature on the research ethics review process, a process that can have important effects on the nature of research in contemporary times. Yet, many people know little about what the actual process entails once an application has been submitted for review. This lack of knowledge can affect researchers and committee members' responses to the review process. Based on ethnographic research on the ethics review process in 5 countries (Australia, Canada, New Zealand, the United States, (...) and the United Kingdom) this article takes the reader through common aspects of the research ethics review process, including some of the kinds of narratives that influence decision making. Greater understanding of the nature of the review process and the narratives that often form the core of the process can help contextualize responses that researchers get from committees so they can better address them. It may also help committee members reflect on how these narratives influence their decision making and the responses they make to researchers. (shrink)

Australian Human Research Ethics Committees have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007. In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded (...) by its linkage to the Australian Code for the Responsible Conduct of Research in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review. (shrink)

Principles of research ethics, derived largely from Western philosophical thought, are spreading across the world of higher education. Since 2006 the Japanese Ministry of Education has required universities in Japan to establish codes of ethical conduct and ensure that procedures are in place to punish research misconduct. Drawing on semi-structured interviews with 13 academics in a research-intensive university in Japan, this paper considers how research ethics is interpreted in relation to their own practice. Interviewees articulated a range of ethical issues (...) connected with data gathering and interpretation, applying for and using research funds, relationships with peers and research subjects, and the dissemination of results. The paper also explores the effect of personal values and cultural norms on the Japanese interpretation of research ethics identifying the impact in terms of the treatment of graduate research students and decision-making processes. (shrink)

After its establishment in 1948 many Jews emmigrated to Israel from Arab countries, Yemen included. In 1995, a governmental committee was established to investigate the alleged disappearance of about 1000 Yemenite children from hospitals within transit camps where the new immigrants were kept in the 1950s. Interviews with Yemenites present how the bodies of new immigrants were medicalized and commodified in the transit camps during the mass-immigration period of the 1950s, and how people have come to resist it. I conclude (...) with the role of the Israeli medical profession and biomedical technologies in promoting national goals and as mediators of collective, group and individual identities. (shrink)

Substantive scientific letter writing is a cost-effective mode of complementing observational and experimental research. The value of such philosophically uncommitted and unsponsored well-balanced scientific activity has been relegated. Critical letter writing entails the abilities to: maintain rational scepticism; refuse to conform in order to explain data; persist in keeping common sense centre-stage; exercise logic to evaluate the biological significance of mathematical figures, including statistics, and the ability to sustain the will to share insights regarding disease mechanisms on an ostensibly lower (...) research platform. During peer review, innovative letter writing may share the occasionally unfortunate fate of innovative research. Rejected scientific letters do not automatically lose copyright. Periodicals with high letter loads will see some valuable contributions wasted, but that is the price for maintaining autonomy in scientific publication. The scientific community is an integrated whole that must respect the rights of authors at all levels. Unauthorised forwarding of rejected letters sets the dangerous precedent of justifying unjust means. (shrink)

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (shrink)

Since the 1988 Cartwright Inquiry, lay members of ethics committees have been tasked with ensuring that ordinary New Zealanders are not forgotten in ethical deliberations. Unlike Institutional Review Boards in North America, where lay members constitute a fraction of ethics committee membership, 50% of most New Zealand ethics committees are comprised of lay members. Lay roles are usually defined in very broad terms, which can vary considerably from committee to committee. This research queries who lay representatives are, what they do, (...) and what if anything they represent. Our findings are based on data collection with 12 participants: eight semi-structured interviews with lay members from diverse types of ethics committees who described their roles, and commentary from four ethics committee chairs, three of these lay members who commented on this article’s final draft. Findings indicate that the role of New Zealand lay persons – although distinctively valued – is otherwise similar to the documented role of lay persons within North American ethics committees. Lay members see their role as primarily protecting the research participant and at times offering a corrective to non-lay members’ views and the interests of their institutions. However, in spite of their numbers, most lay members do not see themselves as representing any particular constituent groups or institutionally unaffiliated areas of concern. On tertiary education committees especially, there is a good deal of ambiguity in the lay role. (shrink)