ABSTRACT
The Informed Consent Form will be developed so that all basic elements of consent and the applicable additional elements are contained in the document according to the regulations. Because the ICH guidelines make no distinction between basic and additional elements (i.e., these guidelines state that all basic and additional elements are required for all consent forms), Informed Consent Forms being developed for trials that will have study sites outside the United States will be developed according to the more strict ICH guidelines.
