Garrafa V, Prado MM. Mudanças na Declaração de Helsinski: Fundamentalismo económico, imperialismo ético e controle social . [Changes in the Helsinki Declaration: economic fundamentalism, ethical imperialism, and social control.] Cadernos de Saúde Pública [Public Health Notebooks] (Rio de Janeiro, Brazil) 2001 November-December; 17(6):1489-1496.

Objectives: To reflect critically on attempts to alter the Helsinki Declaration, approved in 1964, concerning research on human subjects.

Methodology: Analytical and interpretive.

Results: As a testimony to the triumph of democratic sentiment, the Helsinki Declaration represents one of the most important documents of the second half of the twentieth century. It is considered a patrimony of humanity in the value that it carries as an ethical reference to guide research that involves human beings. The control that is exercised over this document should therefore be collective and world-wide. Any change in the declaration should entail full debate, participation, and discussion with the aim of avoiding any regressive humanitarian step.

The author analyzes the pressures that certain international organizations, such as the World Medical Association, are applying to justify that methodological protocols for clinical research and access to the best existing diagnostic and therapeutic interventions not be standardized for all countries, but rather remain dependent on the conditions, characteristics, and needs of each individual country. This attempt, originating in the United States , was initially put forward by the American Medical Association. Behind this attempt, however, appears the effort of large pharmaceutical companies and other U.S. research and organizational interests to modify the Helsinki Declaration. These organizations invoke “urgency” as a misleading argument to scale down internationally accepted ethical criteria controlling clinical studies.

The World Health Organization and the World Bank are involved in the creation of “Regional Forums of Ethical Committees for Health Research.” The Forum for Latin America has given rise to considerable doubts, since it has ignored the long experience of Brazil in this area and since its meeting was heavily financed by a private pharmaceutical laboratory. In addition, the Forum failed to communicate formally with the government of Brazil and also lacked participation by numerous countries.

Conclusions: The debate surrounding this attempt to change the Helsinki Declaration must be widely diffused, to involve a greater number of parties and to retain the democratic and egalitarian spirit among countries that the Declaration expresses.

Copyright 2007 University of New Mexico