A so-called clinical investigation plan is carefully reviewed by the responsible ethics committee and the competent authority in Austria, which is then approved. More stringent protective measures apply for studies with children and adolescents. The clinical investigation plan provides information on how the safety of participants will be ensured over the course of the study.
When a study of a medicinal product in children is commissioned by the pharmaceutical industry, it is reviewed in advance by the Paediatric Committee of the European Medicines Agency. This will help determine the likelihood that the medicinal product being studied is able to achieve progress in the treatment of children.
The aim is to evaluate research projects from an ethical, legal and social point of view and to assess the potential risk for children and adolescents. The ethics committee also controls whether the medical facilities and the responsible study physicians meet the respective requirements. The information sheets for the study must also be comprehensible and complete.
If studies are conducted with participants who are minors, it must be ensured that the resultant stress is kept as low as possible. All approved studies are also monitored on an ongoing basis by the ethics committee, which can also decide to prematurely terminate a study if necessary.
If, despite all precautions, health impairments occur during the treatment or during the follow-up phase, these are covered by the insurance. Participation in a study can also be terminated at any time.