Informed consent is more than just a signature on a form, it is a process of information exchange.
Risk & Benefits
As a first step the Principal Investigator discusses the trial’s risks, benefits and other aspects with the potential participant before the trial begins in his or her native language.
The potential participant is then given ample time and opportunity to ask questions about the trial and discuss it with relatives and family members.
If the potential participant decides to get involved in the trial, he or she provides voluntary consent by signing and dating the written informed consent document of which he or she also receives a copy.
During the study the participant has the right to withdraw consent at any time without penalty, repercussions or reason.