van Stuijvenberg M, Suur M H, de Vos S, Tjiang G C, Steyerberg E W, Derksen-Lubsen G, Moll H A
Department of Paediatrics, Sophia Children's Hospital, Rotterdam, Netherlands.
Arch Dis Child. 1998 Aug;79(2):120-5. doi: 10.1136/adc.79.2.120.
The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children.
To assess the quality of the informed consent process in a paediatric setting.
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.
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%).
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.
知情同意程序在随机对照试验中起着核心作用，但仅在少数关于儿童的研究中得到探讨。
评估儿科环境中知情同意过程的质量。
向自愿让其孩子（230名儿童）参与布洛芬糖浆预防复发性热性惊厥的随机、双盲、安慰剂对照试验的家长发送问卷。
181名（79%）家长回复。平均而言，73%的家长知晓主要研究特征。少数家长在理解所提供信息方面存在困难。家长给予批准的主要因素是对临床科学的贡献（51%）和对孩子的益处（32%）。社会人口统计学状况不影响最初参与，但父亲为西欧血统与未来参与试验的意愿相关。89%的参与者对知情同意程序持积极态度；然而，25%的人表示他们觉得有义务参与。尽管他们给予批准的原因以及对知情同意程序的评价没有差异，但相对更多的人对未来参与持犹豫态度。家长赞赏调查员一天24小时随叫随到（38%）以及提供额外的医疗护理和信息（37%）是参与的优势。劣势主要是耗时的方面和所涉及的工作（23%）。
通过设计不那么难懂的知情同意书以及调查员给予非西欧家长更多关注和信息，可能会提高家长对试验特征的理解。应采取适当措施避免家长觉得有义务参与，而非给予真正的知情同意。
