Introduction

IC neither begins nor ends with a signature on an IC document. The process continues throughout the research. Withdrawal of the Participant without prejudice at any time must be as free of intentional and unintentional barriers as the initial IC. For the participant to make an informed decision to continue, he or she must have ongoing access to any information about changes in the facts on which the original decision was based. If the ongoing research experience suggests a change in the predicted nature or likelihood of risks; if the benefits turn out to be less than originally hoped for; if other participants are pulling out of the study for reasons that any remaining participant might in retrospect consider relevant - then each active participant must be informed. They trust you to do that.