I am participating in a clinical trial; what are my rights?
As a participant, you have the right:
• to participate voluntarily, without coercion or consequences if you do not participate;
• to leave the trial at any time;
• to receive treatment with the drug under investigation free of charge, and usually to medical examinations free of charge in the context of the clinical trial;
• to reimbursement of any expenses, which is evaluated by the ethics committees and serves as compensation for expenses incurred and for the time spent participating in the trial; the reimbursement of expenses is not determined on the basis of potential risk;
• to all the information necessary to give your consent before any procedure;
• to clear and understandable answers to your questions;
• to be informed immediately, even after the start of the trial, in the event of new data becoming available that could have an impact on your decision to participate;
• to care that is administered in complete safety, while respecting your beliefs;
• to confidential and anonymous treatment of your data;
• to insurance paid for by the sponsor of the trial.
I am participating in a clinical trial; what are my obligations?
As a participant, you commit:
• to provide truthful and complete information about your health status and medical history and any treatments you have received;
• to comply with the clinical trial protocol and to cooperate with medical personnel;
• to attend appointments and additional evaluations, which may be very detailed.
What are the obligations of the clinical trial organiser?
The medical team at the research centre plays an important role in supporting, monitoring and informing participants. This role does not cease to exist when the trial ends.
The clinical investigator is required to explain all aspects of the trial as fully and comprehensibly as possible. This enables you as a potential participant to have with all the information available to decide whether to participate. This will be recorded in a document that you are required to sign as a trial participant. This informed consent describes in an understandable way how the trial will proceed and the process you will follow as a participant. This document also describes your rights and obligations as a participant.
The organiser of a trial must also have "no fault" insurance in place. This means that you as a participant are covered by insurance even if the investigator was not at fault.