The Informed Consent is the most important document to ensure the doctor has fulfilled the informing obligation and to protect the rights of the participant. This is also one of the most important audit items in the review of the protocol by the institutional review board. The rights of the participant will not be reduced by signing the Informed Consent, which should be written with care and should not be considered as the simplified protocol. The Informed Consent should be written with the spoken language and suitability in mind...More