Your rights as a trial participant
Information, consent, withdrawal – what you are entitled to before and during participation.
Taking part in a trial is always voluntary. So that you can make a free decision, your rights are laid down by law – in Germany mainly in the Medicinal Products Act and in the EU Clinical Trials Regulation.
Right to information
Before you agree, you must be informed comprehensively and understandably: about the aim, procedure, possible risks and benefits of the trial, and about alternatives. Information is given in writing and in a personal conversation. You have the right to take time to think it over.
Right to consent – and to withdraw
Nothing may happen without your written consent. Just as important: you can withdraw this consent at any time without giving reasons. Your further treatment must not suffer any disadvantage as a result.
Right to information during the trial
New findings that could influence your decision must be communicated to you. You also have the right to access the data stored about you.
Insurance cover
Participants in clinical trials are covered by subject insurance. It applies if the trial causes damage to your health. The insurance conditions are part of the documents you receive before giving consent.
This information is not a substitute for a conversation with your doctor.