Cheah Phaik Yeong, Parker Michael
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand.
BMC Med Ethics. 2014 Mar 5;15:22. doi: 10.1186/1472-6939-15-22.
In order to involve children in the decision-making process about participation in medical research it is widely recommended that the child's assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.
In this paper, we outline the current international debate surrounding pediatric consent and assent, and its unique challenges arising in low-income settings. We go on to propose some key requirements for a fit-for-purpose assent model in these difficult settings. The paper recommends that children who are competent, that is, children who are judged to be able to understand and retain relevant information, weigh this information in making a mature judgment, come to a decision and communicate the decision, should be able to consent for themselves. Our proposal is that where the decision about whether to participate in a study is of comparable complexity to the decisions the child is used to making in other aspects of his or her life, it should be made by the child him or herself. The relevant level of complexity should be judged by local standards rather than standards of the developed world. In the paper we explore some of the practical challenges and counter arguments of implementing this proposal. As in high-income settings, we argue that in the case of children who are judged to lack this level of competence both parental consent and assent from the child should be sought and go on to define assent as involving the child to the extent compatible to his or her maturity and with cultural norms and not as obtaining the child's permission to proceed.
The concept of assent in the current guidelines is confusing. There is an urgent need for clearer guidelines that can be adapted for all types of paediatric research wherever it is to be carried out and an evidence-base concerning good assent/consent practice. This paper argues that a context specific approach should be adopted when assessing whether consent or assent should be sought from children in low-income settings.
为了让儿童参与到关于参与医学研究的决策过程中，人们广泛建议除了获得父母同意之外，还应征求儿童的同意。然而，同意这一概念充满困难，导致研究人员和伦理委员会都感到困惑。
在本文中，我们概述了当前围绕儿科同意和同意的国际辩论，以及在低收入环境中出现的独特挑战。我们接着提出了在这些困难环境中适用的同意模型的一些关键要求。本文建议，有行为能力的儿童，即被判定能够理解并保留相关信息、在做出成熟判断时权衡这些信息、做出决定并传达该决定的儿童，应该能够自行同意。我们的提议是，当关于是否参与研究的决定与儿童在其生活其他方面习惯做出的决定具有相当的复杂性时，应由儿童自己做出决定。相关的复杂程度应由当地标准而非发达国家的标准来判断。在本文中，我们探讨了实施这一提议的一些实际挑战和反对观点。与高收入环境一样，我们认为，对于被判定缺乏这种行为能力水平的儿童，应同时寻求父母同意和儿童的同意，并将同意定义为让儿童参与到与其成熟度和文化规范相适应的程度，而不是获得儿童继续进行的许可。
当前指南中的同意概念令人困惑。迫切需要更清晰的指南，这些指南应能适用于所有类型的儿科研究，无论其在何处进行，还需要关于良好同意/同意实践的证据基础。本文认为，在评估是否应在低收入环境中征求儿童的同意或同意时，应采用因地制宜的方法。
