[The Nazis, guide of the International Conference of Harmonization and ethics committees].
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 Harmonisation) 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.
Palma-Aguirre
José Antonio
JA
Unidad de Investigación Médica en Farmacología, Hospital de Especialidades, CMN Siglo XXI, IMSS, Apartado postal 73-032, 03020, México, D. F.
Rebollo-Franco
Dalia Irene
DI
Gómez-Delgado
Alejandro
A
Villa-Caballero
Leonel
L
D003226:Congresses as Topic; D017041:Ethics Committees; D017408:Guidelines as Topic; D006381:Helsinki Declaration; D007391:International Cooperation; D028683:National Socialism