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Key factors in children’s competence to consent to clinical research

Overview of attention for article published in BMC Medical Ethics, October 2015
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Title
Key factors in children’s competence to consent to clinical research
Published in
BMC Medical Ethics, October 2015
DOI 10.1186/s12910-015-0066-0
Pubmed ID
Authors

Irma M. Hein, Pieter W. Troost, Robert Lindeboom, Marc A. Benninga, C. Michel Zwaan, Johannes B. van Goudoever, Ramón JL Lindauer

Abstract

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P < 0.05). Total explained variance in competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that explaines most of to the variance in children's competence to consent, followed by intelligence. Experience with disease did not affect competence in this study, nor did other variables. Development and use of a standardized instrument for assessing children's competence to consent in drug trials: Are legally established age limits valid?, NTR3918 .

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Mendeley readers

The data shown below were compiled from readership statistics for 56 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 56 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 13 23%
Student > Bachelor 7 13%
Other 6 11%
Researcher 5 9%
Professor 4 7%
Other 14 25%
Unknown 7 13%
Readers by discipline Count As %
Medicine and Dentistry 15 27%
Nursing and Health Professions 9 16%
Psychology 8 14%
Social Sciences 3 5%
Agricultural and Biological Sciences 2 4%
Other 7 13%
Unknown 12 21%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 01 November 2015.
All research outputs
#12,430,204
of 15,640,884 outputs
Outputs from BMC Medical Ethics
#624
of 686 outputs
Outputs of similar age
#199,661
of 286,766 outputs
Outputs of similar age from BMC Medical Ethics
#71
of 77 outputs
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