April 2011

Theme: Regulation of Bioethics research with human beings in South-South Cooperation

Lecturer: Prof. Dr. Claudio Lorenzo
PhD in Applied Ethics to Clinical Sciences from the University of Sherbrooke, Canada, and professor in the Department of Public Health and in the graduate program at the University of Brasilia (UnB)                                                    
Moderator: Prof. Marisa Palácios
President of the Committee of Ethics in Research of the Center of Studies in Public Health of UFRJ and Professor at the Faculty of Medicine of UFRJ

Summary

Dr. Claudius Lorenzo proposed a critical reflection about the ethical regulatory systems of research involving humans, in the context of internationalization of clinical research. From the context of the relationship between basic research and clinical research, the lecturer pointed out the interrelationship of universities with the pharmaceutical industry, as well as bioethical problems that emerge from this relationship. To reflect critically on regulation ethics, Dr. Lorenzo detailed the phases of clinical research, presenting it as a multicentric randomized scientific research which is held by the “double blind” system. From this presentation, the lecturer has shown the critical reflection on the Bioethics regulation of clinical research. He emphasized that all this scientific process of basic and applied research is a product of the economic and industrial complex of health, in which are related the State, research centers and the pharmaceutical industry. This relationship includes positive and negative aspects.

As for the first, one may refer to the industrial production of drugs on a large scale as having a potential wider distribution than if only the States produced the drugs. As for the second ones, there are issues of bioethics concerning the development of research in populations of developing countries. An example of this is the controversy surrounding the use of placebos when there is already medicine on the market that can be used as comparative reference for research. In concluding, the lecturer returned to the idea that the pharmaceutical industry has strategies ranging from lobbying to pressure, and act according to the logic of the market. To regulate the pharmaceutical research, the lecturer referred to the Declaration of Helsinki, which, although it does not have legal authority, has the moral authority to establish parameters for ethics in research.

After the lecture, the debater, Dr. Marisa Palácios, stressed the main aspects of the lecture and made questions on regulation of Bioethics research with human beings in South-South cooperation. At the end, the debate has been opened to the audience, which could make their considerations and questions to the lecturer and moderator.
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