Informed consent

Before participating in a clinical trial, you must consider the advantages and possible risks of the experimental treatment, as well as alternative solutions and their possible drawbacks. To help you, the doctor or his research team will explain to you, both verbally and in writing, the known risks and the possible advantages that participating in the trial carries.

You must understand the treatment as thoroughly as possible, as well as differences between this treatment and other solutions. Do not hesitate to ask the medical staff questions on the trial or on any intervention. Talk about it with people you trust, such as your family doctor or spouse.

This process, which involves obtaining information for a subsequent spoken and written declaration of consent from you, is called informed consent. For children and people not yet of age, informed consent both parents is required. Young people must also indicate their consent as soon as they reach the age of reason (12 years).

After obtaining comprehensive information, you can of course decide not to participate in the clinical trial. In this case, you will be given conventional treatment and will not therefore have access to new, unregistered medicines.

If you decide to participate in a clinical trial, you can easily obtain more detailed or more comprehensive information during the trial.

A few frequently asked questions:

• Can my participation in a clinical trial be refused?
  Yes. Trials carry very strict patient selection criteria. There is every chance that you may be included at the selection or "screening" stage and then not be included in the active phase of the trial, even if you want to be.
• Can I choose the medicine that I will receive?
  In a clinical trial comparing two medicines, neither you nor the doctor can choose the treatment you will receive. The treatment is chosen by lots (this is called randomisation). Often, neither you nor your doctor will know what medicine you are receiving (this is called a double blind study). When the recognised treatment is therapeutic abstention, you may be given a placebo.
• What obligation does participation in a clinical trial carry?
  There are many different obligations, which may be more or less demanding: attendance according to an established timetable, agreeing not to take certain medicines during the trial, completing questionnaires, keeping a diary etc.
• Can I change my mind half way through?
  In most cases, you can withdraw from the trial in which you are participating. The treatment may be irreversible (for example, if surgery has been performed) or if a certain time is needed for a medicine to stop working). However, even after you withdraw from a trial, the investigating doctor may, for safety reasons, ask you to carry on with the planned appointments.

Update: October 2015