Design and process of informed consent form on clinical trial for children

Clinical trial for children plays an important role to evaluate the efficacy and safety of medication for children. However, the risk to recruit children weighs more than to invite adults in clinical trial. In order to protect their rights and keep them away from harms, the informed consent procedure and written informed consent form, based on the general principle of medical ethics, would be fundamental to the clinical trial. What's more, to conduct the clinical trials in children, the protocol design and trials implementation should always take into account that children, as the disadvantaged group, are physically and psychologically underdeveloped, and thus their interests will be above everything.