The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the (...) development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise. (shrink)

From the 5th edition of Beauchamp and Childress' Principles of Biomedical Ethics, the problem of common morality has been given a more prominent role and emphasis. With the publication of the 6th and latest edition, the authors not only attempt to ground their theory in common morality, but there is also an increased tendency to identify the former with the latter. While this stratagem may give the impression of a more robust, and hence stable, foundation for their theoretical construct, we (...) fear that it comes with a cost, namely the need to keep any theory in medical ethics open to, and thereby aware of, the challenges arising from biomedical research and clinical practice, as well as healthcare systems. By too readily identifying the moral life of common morality with rule-following behaviour, Beauchamp and Childress may even be wrong about the nature of common morality as such, thereby founding their, by now, classic theory on quicksand instead of solid rock. (shrink)

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities (...) and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for the database and (...) its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

It is now 10 years ago that human embryonic stem cell research appeared as a major topic of societal concern following significant scientific breakthroughs.1 2 During these 10 years it has become obvious that stem cell research is embedded in a narrative characterised by hope and hype and that it has created heated moral and political debate. Although it would be tempting to try to deconstruct the importance attributed to hope in this story or to unmask the different instigators active (...) in promoting hype,3–5 the main aim of this editorial is to briefly review the controversies underlying the debate and propose some possible answers to a set of inter-related questions: What are the main disagreements in the stem cell debate? Is there any hope that we can resolve these main disagreements? Has the debate been a fruitful model for future debates about ethically contentious issues in biomedicine, or has it been characterised more by rhetoric than by argument? What kind of ethical debates are most efficient as models for future debates?The two authors agree with regard to the importance of asking these questions, but they disagree about at least some of the answers. Let us start with the questions about the debate and its use as a model for future debates.WHAT KIND OF ETHICAL DEBATE IS MOST EFFICIENT AS A MODEL FOR FUTURE DEBATES?Could it be the case that ethical debates that are characterised by overselling of the potential of the technology are more efficient as models for future debates about ethically contentious issues in biomedicine than more sober and “neutral” debates? The narratives of stem cell research are full of examples of overselling and underselling, and we will suggest that it is precisely for this reason that there is a lot to learn morally from reviewing the narratives. The two main forms of overselling are therapeutic …. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for the database and (...) its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)