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Author
I.M. Hein
Title
Children’s competence to consent to medical treatment or research
Supervisors
J.B. van Goudoever
Co-supervisors
R.J.L. Lindauer
P.W. Troost
Award date
17 April 2015
Number of pages
163
Publisher
Amsterdam: Amsterdam University Press
Document type
PhD thesis
Faculty
Faculty of Medicine (AMC-UvA)
Abstract
In this study, we have explored the issue of children’s abilities to meaningfully decide on complex and important medical options, of which, until recently, little was known except that it often proved difficult to assess a child’s competence in some clinical settings. Nor was there empirical evidence on children’s competence to consent to treatment or clinical research to underpin these problematic areas. Yet problems did arise, when, for instance, pediatric patients did not agree with a recommended treatment. Or, when, in a research context, it remained unclear how to do justice to children’s vulnerable population status while attempting to optimize their research participation.
With our project we aimed at developing a standardized tool for assessing children’s competence to consent and to offer empirical evidence to underpin age limits for alleged competence in children in order to optimize policies regarding children’s decision-making in clinical situations.
The present studies showed that children’s competence to consent to clinical research can be assessed validly and reliably using the MacCAT-CR, and feasibility of the MacCAT-T for assessing children’s competence to consent to treatment was confirmed. Using the MacCAT-CR, age limits for children to be deemed competent to decide on research participation could be estimated: children of 11.2 years and above generally appeared to be competent, whereas children of 9.6 years and younger were generally not competent. The key determining factor, out of all the factors that were considered to influence children’s competency, was age. Considering the implications of these empirical findings for law, ethics and clinical practice, we recommended that 12 years would be a just age-limit for asking children’s consent to clinical research.
Note
Research conducted at: Universiteit van Amsterdam
Permalink
http://hdl.handle.net/11245/1.470172
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  • Thesis (complete)

  • Front matter

  • 1. Introduction

  • 2. Why is it hard to make progress in assessing children’s decision-making competence?

  • 3. Accuracy of assessment instruments for patients’ competence to consent to medical treatment or research

  • 4. Assessing children’s competence to consent to research by a standardized tool: a validity study

  • 5. Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for measuring children’s competence to consent to clinical research

  • 6. Key factors in children’s competence to consent to clinical research

  • 7. Assessing children’s competence to consent to treatment

  • 8. Why do children decide not to participate in clinical research: a quantitative and qualitative study

  • 9. Informed consent instead of assent is appropriate in children from the age of twelve

  • 10. Summary and future perspectives in research on children’s decision-making competence

  • Back matter

  • Stellingen

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