【1】ICHGCP282-2
2.8.2 ……New information that could impact a participant’s willingness to continue
participation should be assessed to determine if re-consent is needed (e.g., depending
on the stage of the trial, consideration should be given to whether the new information
is relevant only to new participants or to existing participants). If re-consent is needed
(e.g., information on emerging safety concerns), new information should be clearly
identified in the revised informed consent materials. Revised informed consent
materials should receive the IRB/IEC’s approval/favourable opinion in advance of
use.