Abstract:
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.
journal_name
Pediatr Blood Cancerjournal_title
Pediatric blood & cancerauthors
Chappuy H,Doz F,Blanche S,Gentet JC,Tréluyer JMdoi
10.1002/pbc.21359subject
Has Abstractpub_date
2008-05-01 00:00:00pages
1043-6issue
5eissn
1545-5009issn
1545-5017journal_volume
50pub_type
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