Giving consent & assent
Your principal investigator will talk you through the consent process. This can be done by telephone call or in person. In this talk, you will receive more information about the trial itself and alternative options, what kind of tests your child has to do, and the duration and intensity of the clinical trial. Possible risks and benefits are also discussed. Make sure you receive this information in a language you can understand, and discuss this later with another peer, your general practitioner, or your patient organization.
After this conversation, you will receive an informed consent form. This contains all the information that you just discussed and describes which kind of patient data will be collected and how this medical record will be stored. You can always ask additional questions to the principal investigators, members of the research team or someone of your patient organization. Sometimes, this consent form is dynamic, meaning that you always decide how your medical information should be used.
If you have read this document through and agree with this, you sign the form. Although this is final, you are free to withdraw from the clinical trial at any time. The study consent (for a parent, if participant will be under age 18) and assent (for participants age 7 -17) will be described, mailed and later discussed prior to enrolment.
Legally, children are not able to give consent until they turn 18. Instead, they are asked for their assent: they agree to take part. Children must be old enough to understand the trial and what they have to do. They will receive this information from the research team. Additionally, this app is an easy-going way to learn what is going to happen when a child participates in a clinical trial.