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

BMC Medical Ethics

Ramón J. L. Lindauer¹  Johannes B. Van Goudoever⁴  Gerben Meynen³  Pieter W. Troost¹  Martine C. De Vries²  Irma M. Hein¹ 

[1] Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, Amsterdam, 1105 AZ, Netherlands;Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, 2300 RC, Netherlands;Tilburg Law School, Tilburg University, Prof. Cobbenhagenlaan 221, Tilburg, 5037 DE, Netherlands;Department of Pediatrics, VU University Medical Center, De Boelelaan 1105, Amsterdam, 1081 HV, Netherlands

关键词: Health care policy;    Assessment;    Informed consent;    Mental competence;    Minors;   

Others  :  1231976
DOI  :  10.1186/s12910-015-0067-z

 received in 2015-06-29, accepted in 2015-10-19,  发布年份 2015

【 摘 要 】

Background

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.

Discussion

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.

Summary

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.

【 授权许可】

   
2015 Hein et al.

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