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The Cultural Framework for the Ethical Review of Clinical Research in Latin America

Ethical review of clinical research in Latin America has not kept pace with the increases in clinical research in the region. The diverse socioeconomic and cultural contexts of clinical research in Latin America have raised new ethical dilemmas and limited resources for ethics committees may cause noncompliance with regulations and guidelines. Attempts to impose ethical review of research as done in the United States or other developed countries may be considered interventionist; on the other hand, substandard ethical review could be regarded as exploitative. This paper examines the main socioeconomic and cultural aspects in Latin America that influence the ethical review of research. We propose an approach in which the cultural elements intrinsic to clinical research are introduced in a process of planned and gradual acclimatization. This process should begin with the recognition and legitimization of cultural differences.