Abstract

Interventions in medicine require multicenter clinical trialson a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trialsarecriticizedforthe priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family –usually men – over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects.