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)

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)

Botero’s Della Ragion di Stato has a monarchical character that has been overlooked or taken for granted. This is due to the successful reception of the reason of state formula, which justifies any kind of political regime, including principalities, republics, and monarchies, regardless of the author’s preferences. However, there is a clear distinction between monarchy and reason of state that requires further discussion. Botero not only uses Machiavellian language when referring to a political community (as res publica) or the prince (...) (as a metaphor for centralized monarchies), but also reappropriates it. In addition, he goes beyond this to explain a non-legal path to absolute sovereignty, which differs from Jean Bodin’s (1530–96) idea of the king as being above the law and Thomas Hobbes’ (1588–1679) theory of authorization and the social contract. This paper argues that Botero’s concept of reason of state can be understood as a complex process of reduction to unity, similar to God’s creation and the functioning of the natural world. Despite its contradictions and limitations, it grants the prince an unusual supremacy and control over society. (shrink)