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Essais cliniques et normes d'éthique de Nuremberg à Helsinki: Entre universalisme et relativisme by Mohamed Naceur Krifi

Essais cliniques et normes d'éthique de Nuremberg à Helsinki: Entre universalisme et relativisme

by Mohamed Naceur Krifi
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Book cover type: Paperback
  • ISBN13: 9782336436852
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Editions L'Harmattan
  • Publisher Imprint: Editions L'Harmattan
  • Publication Date:
  • Pages: 202
  • Original Price: USD 25.83
  • Language: French
  • Edition: N/A
  • Item Weight: 232 grams
  • BISAC Subject(s): General

Les scandales provoqu�s par des pratiques inhumaines lors d'exp�riences m�dicales ont permis la naissance et l'�volution des normes modernes encadrant et r�glementant l'�thique de la recherche biom�dicale en g�n�ral et des essais cliniques en particulier (Code de Nuremberg, DoH, rapport Belmont, CIOMS/OMS, directives des BPC de l'ICH, CHRB...). Ces normes ont �volu� d'une approche �thique centr�e d'abord sur le m�decin puis vers le patient, puis finalement la transition s'est faite vers une �thique servant les int�r�ts des industries.
Leur �volution conceptuelle, les controverses soulev�es, leur caract�re non contraignant, leur consid�ration par la communaut� m�dicale comme �tant trop restrictives pour la pratique de la recherche ont men� � une application incoh�rente ou inexistante de ces normes. Ainsi, les violations des r�gles d'�thique demeurent fr�quentes, avec de graves pr�judices pour les volontaires et les patients.
On enregistre particuli�rement ces d�rives non �thiques, les accidents graves y aff�rents et leurs cons�quences scandaleuses au cours d'essais cliniques largement industrialis�s, sous-trait�s et d�localis�s, �chappant ainsi � un contr�le r�glementaire s�rieux.

Krifi, Mohamed Naceur: - Mohamed Naceur Krifi est professeur d'immunologie fondamentale et appliquée. Docteur d'État en immunothérapie et de 3e cycle en endocrinologie métabolique, il est spécialiste en production, assurance et contrôle qualité des immunsérums thérapeutiques et des biomédicaments et biosimilaires en général.

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