INFORMED CONSENT, PARENTAL AWARENESS, AND REASONS FOR PARTICIPATING IN A RANDOMIZED CONTROLLED-STUDY

Background-The informed consent procedure plays a central role in rand omised controlled trials but has only been explored in a few studies o n children. Aim-To assess the quality of the informed consent process in a paediatric setting. Methods-A questionnaire was sent to parents w ho volunteered their child (230 children) for a randomised, double bli nd, placebo controlled trial of ibuprofen syrup to prevent recurrent f ebrile seizures. Results-181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had di fficulty understanding the information provided. Major factors in pare nts granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influe nce initial participation but west European origin of the father was a ssociated with willingness to participate in future trials. 89% of par ticipants felt positive about the informed consent procedure; however; 25% stated that they felt obliged to participate. Although their reas ons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about partici pating in future. Parents appreciated the investigator being an call 2 4 hours a day (38%) and the extra medical care and information provide d (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 designin g less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequat e measures should be taken to avoid parents feeling obliged to partici pate, rather than giving true informed consent.