For a minor child this is typically a parent or guardian since as under the age of 18 cannot legally give consent to participate in a clinical trial.
According to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good clinical practice, all trials involving unapproved medical treatments are reviewed for ethics before the study begins.
These groups include minors, prisoners, and the mentally ill. U.S. Food and Drug Administration (FDA) and Office for Human Research Protections regulations require the IRB to make specific "Subpart D" determinations[1] regarding children.
[2] The IRB or IEC is expected to evaluate both the consent and assent process to ensure that children are not coerced into participation.
Reye's syndrome, for example, is a potentially fatal complication of aspirin therapy in children that is very rare in adults.
[5] Subsequent investigations by the Irish government, including the Commission to Inquire into Child Abuse, revealed a broad lack of documentation pertaining to the conduct of the trials at the institutions and the nature of any informed consent, as well as a failure to follow up with the participants.