Consent and privacy during clinical trials

All participants in a clinical trial must clearly and voluntarily give their consent. Before the trial starts, each participant receives detailed information about the trial’s objective, procedures, possible risks and what is expected of the participant. After that, they will be asked to give their written consent.

Participants always have the right to leave the trial at any moment – this will have no effect on their further treatment or care.

Privacy is carefully protected
One of the privacy measures is to store a participant’s personal data using a code. The code replaces the participant’s name, so that the data cannot be traced back to an individual. Only authorised people within the research team have access to this data.

 

The clinical trial must also comply with the General Data Protection Regulation (AVG) in the Netherlands. Research findings may be shared with other researchers, but always anonymised.