title: Between the needy and the greedy: the quest for a just and fair ethics of clinical research.
abstract: 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.
authors.affiliation: UNESCO Chair of Bioethics-Post-Graduation Program of Bioethics, Public Health Department, Faculty of Health Sciences, University of Brasília, Brasília, Federal District, Brazil. volnei@unb.br
authors.forename: Volnei
authors.initials: V
authors.lastname: Garrafa
authors.forename: Jan Helge
authors.initials: JH
authors.lastname: Solbakk
authors.forename: Susana
authors.initials: S
authors.lastname: Vidal
authors.forename: Claudio
authors.initials: C
authors.lastname: Lorenzo
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002986:Clinical Trials as Topic; D005260:Female; D014943:Global Health; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007391:International Cooperation; D008297:Male; D018579:Patient Selection / Q000941:ethics*; D035842:Research Subjects / Q000191:economics* / Q000523:psychology