RT Journal Article
SR Electronic
T1 Informed consent, parental awareness, and reasons for participating in a randomised controlled study
JF Archives of Disease in Childhood
JO Arch Dis Child
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 120
OP 125
DO 10.1136/adc.79.2.120
VO 79
IS 2
A1 Margriet van Stuijvenberg
A1 Marja H Suur
A1 Sandra de Vos
A1 Gilbert C H Tjiang
A1 Ewout W Steyerberg
A1 Gerarda Derksen-Lubsen
A1 Henriëtte A Moll
YR 1998
UL http://adc.bmj.com/content/79/2/120.abstract
AB BACKGROUND The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM To assess the quality of the informed consent process in a paediatric setting. METHODS A questionnaire was sent to parents who volunteered their child (230 children) for a randomised, double blind, placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures. RESULTS 181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had difficulty understanding the information provided. Major factors in parents granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials. 89% of participants felt positive about the informed consent procedure; however, 25% stated that they felt obliged to participate. Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about participating in future. Parents appreciated the investigator being on call 24 hours a day (38%) and the extra medical care and information provided (37%) as advantages of participation. Disadvantages were mainly the time consuming aspects and the work involved (23%). CONCLUSIONS Parents’ understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequate measures should be taken to avoid parents feeling obliged to participate, rather than giving true informed consent.