Research legislation protects children

Clinical trials in children and adolescents are governed by strict laws and ethical guidelines

Medical research is strictly regulated by international, national and European legislation. In addition, there are numerous official regulations, recommendations and guidelines, as well as ethical declarations aimed at ensuring that investigations are conducted with respect for citizens’ fundamental rights, human rights, the principle of volunteering, and good research practices. Legislation guides and monitors risk minimization, legal status and security.

Medical examinations in children are limited, and children cannot be exposed to unnecessary risks. Children must be legally considered as minors with a dependency and dependency relationship with their guardians. Children also have an undeveloped ability to assess the significance of the study itself and the risks or harms it may entail. Legislation is based on the obligation to protect adults and society in relation to children. Children are a research-vulnerable special group that should be protected from unnecessary risks and harm.

All current key laws, regulations and guidelines concerning paediatric research; see more: Resources.