The informed consent will give the patient and their families a full picture of the disease, the treatment options and the proposed study. The patients and their parents will be informed about the benefit and the potential risks of the study, alternatives such as the best arm of the most recently completed study are mentioned.
The randomizations are specifically explained including the risk/benefit consideration. The patients/guardians have the option to consent to or decline the participation at each or all randomizations without any disadvantage for the patient and without need to explain the personal decision.
The informed consent is written in a version for 18 years old patients and/or the parents, and specifically for defined age groups with 7-12, 13-17 years of age. The informed consent documents are adapted to the psychosocial and intellectual development of the respective age group. The consent forms for the younger children are commented with cartoons.
The informed consent form contains a section on data protection, on insurance issues and on biologic studies on the patient material. The provision of individual bio-material for bio-banking is described as well as the defined research projects using patient material. The patient/guardian has the option to consent or decline at the participation to each or all scientific projects including the storage of bio-material in the tumour bank.
The consent forms are reviewed by the parent organizations and certainly by the ethical committees to warrant compatibility with all formal and regulatory requirements.
The consent forms are translated into the national languages by the national co-sponsor team. The Consortium is experienced in drafting consent forms for children with oncologic indications and in interacting with parents and ethical committees to achieve optimum results.