2003, Number 4
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Gac Med Mex 2003; 139 (4)
The Nazis, the International Conference of Harmonisation Norms for Good Clinical Practice, and Ethics Committees.
Palma-Aguirre JA, Rebollo-Franco DI, Gómez-Delgado A, Villa-Caballero L
Language: Spanish
References: 40
Page: 415-422
PDF size: 87.67 Kb.
ABSTRACT
This article begins with the basic ethical principles in clinical research.
The four moral principles of autonomy, beneficence, non-maleficence, and justice
are reviewed. Likewise, a historical review of the participation of German physicians
and the medical establishment that carried out the policies of the Third Reich
is examined, and delineates several moral failures attributable to these physicians
during the dark period of history known as the Holocaust. Medical ethics were
completely ignored during that period, and thus, the Nuremberg Code was enacted
for regulating human research by means of informed consent. A historical vision
of the universal documents for ethics in clinical research has been reviewed
from the Declaration of Helsinki in 1964 to the ICH Guideline (International
Conference of Harmonization) for Good Clinical Practice (GCP) in 1996. The ICH
Guideline is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting trials that involve participation of human
subjects. The guide was developed with consideration of the current GCP of the
European Union, Japan, and the U.S. Finally, we establish the composition, functions,
and operations of the Ethic Committees that ensure the rights, safety, well-being,
and confidentiality statement of subjects who participate in clinical research
studies and document that protection by reviewing and approving/rejecting a
study protocol, and evaluate research personnel, the research site, and materials
and methods used for obtaining and recording informed consent protocol from
subjects participating in the study.
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