Informed consent

Abstract

Informed consent (IC) in clinical experimentation is a process by which a subject voluntarily and freely confirms his/her willingness to participate in a trial, after having been informed of all involved aspects. IC is a concept enough recent within medical tradition. Unquestionably, Nuremberg trials (1945-1947) influenced thought about consent in Medicine. When the idea of IC evolved, discussion for appropriate guidelines moved increasingly from a narrow focus on the physician's/researcher's obligation. IC shall be obtained in writing and documented before a subject is enrolled into clinical investigation. , Particularly in the case of medical devices, it is necessary an adequate information to the patient on possible incidents occurring following placing of devices.