John T, Hope T, Savulescu J, Stein A, Pollard A J
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Department of Paediatrics, University of Oxford, Churchill Hospital, Oxford OX3 7LJ, UK.
Arch Dis Child. 2008 May;93(5):379-83. doi: 10.1136/adc.2007.118299. Epub 2007 Dec 18.
To determine the appropriateness of asking healthy children to make a decision regarding participation in a research study.
Participants constituted a group of children taking part in a follow-up to a vaccine study which involved a blood test to look at the persistence of antibodies. Information about the study was given to each child and following venepuncture an oral questionnaire was completed to establish understanding of the vaccine study. Parental views concerning their child's ability to make a decision regarding research participation were also sought.
73 children participated overall. Following venepuncture 59% (n = 43) had grasped some aspect of the reasoning behind venepuncture with 33% (n = 24) unclear. The majority of parents (n = 55) and a substantial number of children (n = 28) believed that the parent should make the decision about study participation, although it is clear that a significant minority of parents thought it is right to involve the child in that process.
New guidance about the requirements for informed consent involving children in research is needed, which can respect the autonomy of the child and the role of the parent, while recognising the limited capacity of some children to understand age-appropriate information.
确定要求健康儿童就参与一项研究做出决定是否合适。
参与者为一组参与疫苗研究随访的儿童，该研究涉及一项血液检测以观察抗体的持久性。向每个儿童提供了有关该研究的信息，在静脉穿刺后完成了一份口头问卷以确定对疫苗研究的理解。还征求了家长对其孩子就参与研究做出决定的能力的看法。
共有73名儿童参与。静脉穿刺后，59%（n = 43）的儿童理解了静脉穿刺背后的某些推理方面，33%（n = 24）不清楚。大多数家长（n = 55）和相当数量的儿童（n = 28）认为应由家长决定是否参与研究，尽管显然有少数家长认为让孩子参与该过程是正确的。
需要有关在研究中涉及儿童的知情同意要求的新指南，该指南可以尊重儿童的自主权和家长的作用，同时认识到一些儿童理解适合其年龄信息的能力有限。
