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Informed consent by children and participation in an influenza vaccine trial
Insights
Younger children and boys were less likely to volunteer for a swine influenza vaccine trial. Parental consent was obtained from 15% of eligible children, with higher service use linked to volunteering.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Child psychology
Background:
- School-based trials are crucial for pediatric vaccine administration.
- Understanding children's decision-making regarding vaccinations is essential.
- Swine influenza vaccine trials require careful consideration of participant engagement.
Purpose of the Study:
- To assess children's willingness to participate in a swine influenza vaccine trial.
- To identify factors influencing children's and parents' decisions regarding vaccine participation.
- To explore the relationship between healthcare service utilization and study participation.
Main Methods:
- A cohort of 213 school children (ages 6-9) were invited to participate in a swine influenza vaccine trial.
- Information on trial details, risks, and benefits was provided through non-directive question-and-answer sessions.
- Parental informed consent was obtained via letters sent home.
Main Results:
- 46% of children initially declined participation.
- 15% of parents provided consent for their children to participate.
- Volunteering for the study was significantly associated with higher non-medical service use.
- Younger children and boys were less inclined to volunteer, irrespective of service use patterns.
Conclusions:
- Children's and parents' decisions in vaccine trials are influenced by multiple factors.
- Age and gender play a role in children's willingness to participate in health studies.
- Further research is needed to optimize recruitment strategies for pediatric vaccine trials.
Abstract:
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.