What is informed consent?

Informed consent means that you can make a decision about participating with an understanding of the trial and what it involves. We need your informed consent before you can become a participant. Our Informed Consent Form (ICF) contains detailed information about the study and treatment, and you must read it before deciding whether or not to take part in the trial.

The ICF includes explanations about what the trial involves, the duration of the study, the frequency and length of the required visits, as well as any known risks and benefits associated with the study treatment. Crucially, to ensure your safety you must abide by all study restrictions that are outlined in the ICF.

Participation in any clinical trial is completely voluntary, and you’re free to ask questions about the trial – you should only consent to participate in the study (by signing the ICF) once you’re completely happy to do so. As a volunteer, you also have the right to refuse participation in a trial or to withdraw your consent at any time during the study, without penalty.

Your wellbeing and best interests are our primary concern, so if new information becomes available during the course of the trial – information that may affect your decision to continue with the trial – we will share the information with you as soon as possible.

Please note, our physicians can decide to withdraw a participant at any time, without the participant's consent, if it becomes clear that it is not in the participant’s best interest to continue with the trial.

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