{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T23:52:13Z","timestamp":1791244333853,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2007,10,25]],"date-time":"2007-10-25T00:00:00Z","timestamp":1193270400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2008,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To examine the level of children's understanding of informed consent in clinical trials and factors that may influence these processes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Children's understanding was measured by a score of 0\u20139 including items required to obtain a valid consent according to French and European legislations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Children were 8.5\u201318 years old (13.6\u2009\u00b1\u20092.8 years). The higher percentage of understanding was obtained for the study objectives (n\u2009=\u200918, 62%), the risks (n\u2009=\u200917, 58%), the potential self\u2010benefits (n\u2009=\u200918, 62%) and the potential benefits to other children (n\u2009=\u200917, 58%). The lower percentage of understanding was obtained for the procedures (n\u2009=\u20095, 17%), the possibility of alternative treatments (n\u2009=\u20099, 31%), the duration of participation (n\u2009=\u20096, 21%), their right to withdraw (n\u2009=\u20096, 21%), and the voluntary participation (n\u2009=\u20096, 21%). Sixteen children (55%) thought that the given information was adequate. Understanding was significantly correlated with child's age (r\u2009=\u20090.65; <jats:italic>P<\/jats:italic>\u2009=\u20090.0001) and the mean score was higher in patients over 14 years old compared to patients under the age of 14 (4.4\u2009\u00b1\u20092.4, n\u2009=\u200914 vs. 2.6\u2009\u00b1\u20092.6, n\u2009=\u200915, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05). The mean score was also higher in children when informed consent was sought some time after the diagnosis (&gt;7 days) rather than at the same time (&lt;7 days) (score: 4.14\u2009\u00b1\u20092.59 n\u2009=\u200921 vs. 1.87\u2009\u00b1\u20092.03 n\u2009=\u20098; <jats:italic>P<\/jats:italic>\u2009=\u20090.03). The clarity of information perceived by children did not influence their understanding (score: 3.6\u2009\u00b1\u20092.6 n\u2009=\u200914 vs. 3.5\u2009\u00b1\u20092.7 n\u2009=\u200915; <jats:italic>P<\/jats:italic>\u2009=\u20090.91).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Children have an incomplete understanding of the elements included in the informed consent forms. Understanding is related to age and timing of informed consent. Pediatr Blood Cancer 2008;50:1043\u20131046. \u00a9 2007 Wiley\u2010Liss, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pbc.21359","type":"journal-article","created":{"date-parts":[[2007,10,25]],"date-time":"2007-10-25T17:42:39Z","timestamp":1193334159000},"page":"1043-1046","source":"Crossref","is-referenced-by-count":44,"title":["Children's views on their involvement in clinical research"],"prefix":"10.1002","volume":"50","author":[{"given":"H\u00e9l\u00e8ne","family":"Chappuy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Doz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"Blanche","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Claude","family":"Gentet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Marc","family":"Tr\u00e9luyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2007,10,25]]},"reference":[{"key":"e_1_2_6_2_2","unstructured":"The Pediatric Exclusivity Provision January 2001 Status Report to Congress.http:\/\/www.fda.gov\/cder\/pediatric\/reportcong01.pdf:8\u201318."},{"key":"#cr-split#-e_1_2_6_3_2.1","unstructured":"European Parliament legislative on the proposal for a regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC)No 1768\/92 Directive 2001\/83\/EC and Regulation"},{"key":"#cr-split#-e_1_2_6_3_2.2","unstructured":"(EC) No 726\/2004 (COM 2004)0599\u2010C6\u20100159\/2004\u20102004\/0217(COD)."},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2005.076141"},{"key":"e_1_2_6_5_2","unstructured":"National Institutes of Health: Policy on the Inclusion of Children as Subjects in Clinical Research. 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