Obtaining consent from children and adolescents

The age categories used to define children and adolescents vary between regions, but children are commonly defined as being under twelve years of age and adolescents as aged 12-16 years. These categories are to some extent arbitrary, however, and it is the person's level of development and understanding rather than age that is relevant.

As a rule, children and adolescents are legally unable to provide informed consent. They are therefore dependent on their parents or legal guardians to assume responsibility for their participation in a clinical study. Fully informed consent should be obtained from parents or guardians in accordance with regional laws and regulations. All such participants should nevertheless be informed to the fullest extent possible about the study using appropriate language and without inappropriate inducements, and age-specific patient information sheets should be provided for younger and older children. Whenever possible, verbal assent should be obtained from children and adolescents after an age-appropriate explanation of the issues involved and, if they are able to do so, they should sign and date the standard study consent form or a separately designed and appropriately worded assent form.

When appropriate, children and adolescents should be told that they can withdraw from the study if they want to, but there may be circumstances in which, in the opinion of the investigator and parent or guardian, the welfare of the participant would be jeopardized by failure to participate. In such circumstances, the consent of the parent or guardian should be sufficient. In some countries, emancipated or mature minors (defined by local laws) may be legally capable of giving autonomous consent.

To minimize risk in studies involving minors, collaborating clinicians should be properly trained and experienced in studying the paediatric population, including the evaluation and management of potential paediatric adverse events.

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