title: Informed consent, parental awareness, and reasons for participating in a randomised controlled study.
abstract: BACKGROUND
  The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Paediatrics, Sophia Children's Hospital, Rotterdam, Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: van Stuijvenberg
authors.forename: M H
authors.initials: MH
authors.lastname: Suur
authors.forename: S
authors.initials: S
authors.lastname: de Vos
authors.forename: G C
authors.initials: GC
authors.lastname: Tjiang
authors.forename: E W
authors.initials: EW
authors.lastname: Steyerberg
authors.forename: G
authors.initials: G
authors.lastname: Derksen-Lubsen
authors.forename: H A
authors.initials: HA
authors.lastname: Moll
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001294:Attitude to Health; D002675:Child, Preschool; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use; D004311:Double-Blind Method; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D007223:Infant; D007258:Informed Consent; D009426:Netherlands; D010290:Parents / Q000523:psychology*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D003294:Seizures, Febrile / Q000517:prevention & control; D011795:Surveys and Questionnaires
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007052:Ibuprofen