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.