Consent and assent in paediatric research in low-income settings.
Consent and assent in paediatric research in low-income settings.
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DOI：
10.1186/1472-6939-15-22
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发表时间：
2014-03-05
影响因子：
2.7
通讯作者：
Parker M
中科院分区：
文献类型：
--
作者：
Cheah PY;Parker M
为了使儿童参与参与医学研究的决策过程，普遍建议除征得父母同意外，还应征得儿童的同意。但是，“同意”的概念充满了困难，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，以及低收入环境中出现的独特挑战。接下来，我们提出了在这些困难的环境中适合目的的同意模型的一些关键要求。本文建议，有能力的儿童，即被判断为能够理解和保留相关信息，在做出成熟判断时权衡这些信息，做出决定并传达决定的儿童，应该能够自己同意。我们的建议是，当决定是否参加一项研究与孩子在生活的其他方面习惯做出的决定相当复杂时，应该由孩子自己做出决定。相关的复杂程度应以当地标准而不是发达国家的标准来判断。在本文中，我们探讨了实施这一建议的一些实际挑战和反对意见。就像在高收入环境中一样，我们认为，对于那些被认为缺乏这种能力水平的孩子，应该寻求父母的同意和孩子的同意，并继续将同意定义为涉及孩子的程度与他或她的成熟度和文化规范相适应，而不是获得孩子的许可。在目前的指导方针中，同意的概念是令人困惑的。迫切需要制定更明确的指导方针，适用于在任何地方进行的所有类型的儿科研究，以及关于良好同意/同意做法的证据基础。本文认为，在评估是否应寻求低收入环境中儿童的同意或同意时，应采用具体情况的方法。
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.
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