Informed Consent by Children and Participation in an Influenza Vaccine Trial

Two hundred thirteen school children, ages six to nine, were presented the opportunity to participate in an experimental trial of swine influenza vaccine. In non-directive question and answer sessions, all groups of children except one composed only of six year olds elicited all relevant information on the details of the trial and the associated risks and benefits. Forty-six per cent of the subjects declined to participate. Letters requiring informed consent of the parents were sent to the homes of the others. Almost 15 per cent of these parents agreed to their children's participation. In this setting, children initiate their own visits to the school nurse practitioner. A significant association was found between volunteering for the study and higher use of services (but not for medical reasons). Younger children and boys, regardless of their patterns of use, were less inclined to volunteer for the experiment.