title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105 AZ, Amsterdam, Netherlands. i.hein@debascule.com.
authors.forename: Irma M
authors.initials: IM
authors.lastname: Hein
authors.affiliation: Department of Medical Ethics and Health Law, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, Netherlands. m.c.de_vries@lumc.nl.
authors.forename: Martine C
authors.initials: MC
authors.lastname: De Vries
authors.affiliation: Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105 AZ, Amsterdam, Netherlands. p.troost@debascule.com.
authors.forename: Pieter W
authors.initials: PW
authors.lastname: Troost
authors.affiliation: Faculty of Philosophy, VU University Amsterdam, De Boelelaan 1105, 1081 HV, Amsterdam, Netherlands. g.meynen@vu.nl.|Tilburg Law School, Tilburg University, Prof. Cobbenhagenlaan 221, 5037 DE, Tilburg, Netherlands. g.meynen@vu.nl.
authors.forename: Gerben
authors.initials: G
authors.lastname: Meynen
authors.affiliation: Academic Medical Center, Emma's Children Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands. h.vangoudoever@amc.uva.nl.|Department of Pediatrics, VU University Medical Center, De Boelelaan 1105, 1081 HV, Amsterdam, Netherlands. h.vangoudoever@amc.uva.nl.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: Van Goudoever
authors.affiliation: Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105 AZ, Amsterdam, Netherlands. r.lindauer@debascule.com.
authors.forename: Ramón J L
authors.initials: RJ
authors.lastname: Lindauer
mesh_terms: D000367:Age Factors; D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D032882:Comprehension; D003657:Decision Making / Q000941:ethics*; D036262:Empirical Research; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D016365:Liability, Legal; D016743:Mental Competency; D010358:Patient Participation / Q000523:psychology / Q000706:statistics & numerical data*; D026684:Personal Autonomy; D045808:Refusal to Participate / Q000941:ethics* / Q000523:psychology / Q000706:statistics & numerical data