Children's views on their involvement in clinical research.

OBJECTIVE: To examine the level of children's understanding of informed consent in clinical trials and factors that may influence these processes.
DESIGN: Twenty nine children who were included in clinical trials for treatment of cancer or HIV, were offered the possibility to complete a semidirective interview, with parental permission.
METHODS: Children's understanding was measured by a score of 0-9 including items required to obtain a valid consent according to French and European legislations.
RESULTS: Children were 8.5-18 years old (13.6 +/- 2.8 years). The higher percentage of understanding was obtained for the study objectives (n = 18, 62%), the risks (n = 17, 58%), the potential self-benefits (n = 18, 62%) and the potential benefits to other children (n = 17, 58%). The lower percentage of understanding was obtained for the procedures (n = 5, 17%), the possibility of alternative treatments (n = 9, 31%), the duration of participation (n = 6, 21%), their right to withdraw (n = 6, 21%), and the voluntary participation (n = 6, 21%). Sixteen children (55%) thought that the given information was adequate. Understanding was significantly correlated with child's age (r = 0.65; P = 0.0001) and the mean score was higher in patients over 14 years old compared to patients under the age of 14 (4.4 +/- 2.4, n = 14 vs. 2.6 +/- 2.6, n = 15, P < 0.05). The mean score was also higher in children when informed consent was sought some time after the diagnosis (>7 days) rather than at the same time (<7 days) (score: 4.14 +/- 2.59 n = 21 vs. 1.87 +/- 2.03 n = 8; P = 0.03). The clarity of information perceived by children did not influence their understanding (score: 3.6 +/- 2.6 n = 14 vs. 3.5 +/- 2.7 n = 15; P = 0.91).
CONCLUSION: Children have an incomplete understanding of the elements included in the informed consent forms. Understanding is related to age and timing of informed consent. (c) 2008 Wiley-Liss, Inc.