Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.
Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.
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DOI：
10.1186/s12910-015-0067-z
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发表时间：
2015-11-09
影响因子：
2.7
通讯作者：
Lindauer RJ
中科院分区：
文献类型：
--
作者：
Hein IM;De Vries MC;Troost PW;Meynen G;Van Goudoever JB;Lindauer RJ
几十年来，关于儿童在医疗环境中给予知情同意的能力的辩论集中在伦理和法律的方面，几乎没有经验基础。最近，来自实证研究的数据可用于推进讨论。结果表明，儿童的能力，同意临床研究，可以准确地评估修改后的麦克阿瑟能力评估工具的临床研究。研究了被认为有能力决定是否参与研究的儿童的年龄限制：一般来说，11.2岁及以上的儿童有决策能力，而9.6岁及以下的儿童没有。据指出，年龄是儿童能力的关键决定因素。在这篇文章中，我们反映了这些研究结果的政策含义，考虑法律的，伦理，发展和临床的角度。虽然儿童能力的评估具有规范性，但伦理学、法律和临床实践可以从研究数据中受益。这些发现可能有助于公正地对待儿童所拥有的能力以及他们在决定治疗和研究方案时可能面临的挑战。我们讨论的优点和缺点的标准化能力评估的儿童在个案的基础上相比，应用一个固定的年龄限制，并得出结论，有选择地实施个案的能力评估在特定人群中是可取的。我们建议根据经验证据实施年龄限制。此外，我们阐述了一个合适的模式，知情同意涉及儿童和父母，将公正的发展方面的儿童和具体特点的父母-儿童二元体。以往的研究结果表明，儿童的医疗决策能力可以操作成一个标准化的评估工具。对政策的建议包括对12岁至成年的儿童实行包括儿童和父母双方的双重同意程序。对于10至12岁的儿童，以及在精神受损患者的特殊研究人群中超过12岁的儿童，我们建议对儿童的同意能力进行逐案评估。由于这种双重同意程序是从根本上不同的父母许可和儿童同意的程序，并将意味着相当大的转变，目前的一些立法，实际影响进行了阐述。
For many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated.