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This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtaindoi:10.4415/ANN_11_04_06 pmid:22194069 fatcat:mmerfxfv4ja2pprxag3xm73nxy