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Informed consent in children and adolescents: age, maturation and psychological state
L D Dorn1, E J Susman, J C Fletcher
1University of Pittsburgh School of Nursing, PA 15261, USA.
Insights
Children
Area of Science:
- Pediatric Psychology
- Medical Ethics
- Child Development
Background:
- Understanding of research participation is crucial for ethical medical research involving minors.
- Factors influencing children's comprehension of research protocols require further investigation.
Purpose of the Study:
- To explore the relationship between understanding of research participation and anxiety, perceived control, and cognitive development in pediatric patients.
- To identify key predictors of children's and adolescents' comprehension of medical research.
Main Methods:
- A cohort of 44 pediatric inpatients (ages 7-20) undergoing cancer treatment or obesity management were interviewed.
- Assessments included knowledge of research participation, perceived global control, anxiety levels, and cognitive development (Piagetian tasks).
Main Results:
- A significant positive correlation was found between knowledge of research participation and global control (r = .40).
- Global control, alone or interacting with anxiety, emerged as the strongest predictor of research participation understanding.
- Emotional factors, rather than age or cognitive stage, were more strongly associated with comprehension.
Conclusions:
- Perceived control and anxiety levels significantly impact children's and adolescents' understanding of research participation.
- Creating supportive medical environments that reduce anxiety and enhance control may improve comprehension of research processes.
Purpose:
The purpose of this investigation was to examine the relationship of understanding of research participation to anxiety, control, and stage of cognitive development.
Methods:
Participants included 44 boys and girls ages 7 to 20 years. All were inpatients for the first time in pediatric units of a research hospital. Twenty participants were admitted for experimental treatment of pediatric cancers and 24 were admitted for a 3-week treatment of extreme obesity. An interview was conducted to assess 12 elements of knowledge of research participation of a medical protocol. The interview was coded for: 1) knowledge of research participation score, 2) weighted knowledge of participation in research score (based on physician ratings of what was most-to-least important for children and adolescents to know), and 3) global control (perceived control over life, illness and treatment). A measure of anxiety and one Piagetian task to measure stage of cognitive development also were administered.
Results:
Pearson correlations, significant at p < or = .05, were as follows: knowledge of participation in research and global control, (r = .40) and weighted knowledge of participation in research score and global control (r = .38). Hierarchical regression showed that the best predictors of knowledge of research participation or the weighted knowledge of research participation score was global control alone or an interaction of global control with anxiety.
Conclusions:
Emotional factors were more frequently related to understanding of research participation than age or cognitive development. Providing medical environments that decrease anxiety and increase control may enhance children's and adolescent's understanding of the research process.