The sponsor and the local site investigators are jointly responsible for writing a site-specific informed consent that accurately informs the potential subjects of the true risks and potential benefits of participating in the study, while at the same time presenting the material as briefly as possible and in ordinary language. FDA regulations and ICH guidelines both require «the information that is given to the subject or the representative shall be in language understandable to the subject or the representative.» If the participant’s native language is not English, the sponsor must translate the informed consent into the language of the participant.