Children’s participation in research

In clinical trials, participation and the related decision-making processes, children are regarded as minors, i.e., persons under the age of 18 years (legal adulthood). For the success of the studies, it is important that children and young people themselves can participate in the care and decision-making that concerns them, together with their legal guardians and the people who care for them. Children and young people should be given the opportunity to present their own opinions, taking into account the stage of development. Read more: Research panel for children and young people (HUS).

In children, chronological age (age in years) does not tell the stage of development or maturity directly. In studies, children and adolescents can be divided into different age groups depending on the purpose of the study. Various age-group divisions can be seen in both research ethics guidelines (e.g., Ethical Considerations for Clinical Trials on Medicinal Products conducted with Minors; R1; 2017) and other international guidelines (e.g., for drug trials; ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population; R1; 2017). However, the age group distribution is more flexible in practice, as children and young people have significant overlaps and large deviations at different stages of development. In long-term studies, children can move from one age group to another.

Age groups according to research legislation in Finland

Children under the age of 18 can participate in a clinical trial with the consent of their guardian or legal representative (legal permission). When the child has sufficient skills, the child’s own written consent (including those under 15 years of age) is required. In this case, the consent of the child is in parallel with the informed consent of the guardian. Self-consent is not required if the child cannot read or write and is unable to understand the research and its meaning.

Young people over the age of 15 (aged 15-17) are allowed to give their own independent informed consent to the study if the study is of direct benefit to them and they understand the importance of the study or the research measure. In all cases, the adolescent’s level of development, illness, disability, or other incapacity must be considered. When independent consent is given by an adolescent, a notification of participation in the study must also be made to the legal guardian. However, in some special circumstances, a minor may refuse notification to their guardian.