The Cultural Framework for the Ethical Review of Clinical Research in Latin America
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THE CULTURAL FRAMEWORK FOR THE ETHICAL REVIEW OF CLINICAL RESEARCH IN LATIN AMERICA NORA CAVAZOS, MD Western Institutional Review Board and Western International Review Board, Olympia, Washington
D. FORSTER, JD, MA Western Institutional Review Board, Olympia, Washington
OTTOORIVE,CLS Western Institutional Review Board and Western International Review Board, Olympia, Washington
GUSTAVO KALTWASSER, MD Western International Review Board, Santiago, Chile
A. J. BOWEN,MD Western Institutional Review Board, Olympia, Washington
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 culturd 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. Key Words: Culture; Ethical review; Clinical research; Latin America
INTRODUCTION I N THE PROCESS OF economic and cultural globalization, which involves a profound revision and reform of healthcare systems, clinical research is increasing and
Reprint address: Nora Cavazos, MD. Western Institutional Review Board and Western International Review Board. 3535 Seventh Ave SW, Olympia, WA 09502 (e-mail: ncavazosOwirb.com).
extending outside the borders of developed countries to satisfy the needs of both sponsoring and host countries. In Latin America, there was an increase in clinical research from 300 new studies in 1995 to more than 1500 in 1999, and it is likely that this trend will persist at a rate that exceeds the possibility of appropriate cultural acclimatization. Ethical review of research and clinical research practices is not as easy to import as medical technology. Arguably, unethical experiences (1,2,3)
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N. Cavazos. D. Forster, 0. Orive, G. Kaltwasser, and A. J. Howen
have led to the impression that investigations that would be forbidden in developed countries are commonly exported to developing countries in an exploitative manner; in reality, most studies are multicenter and have sites in both developing and developed countries. Ethicists demand that the same rigor be applied to all studies regardless of the country where they are conducted; but the context of research i
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