Abstract
BackgroundAlthough 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.MethodsFrom 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.ResultsOut 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).ConclusionsAge 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.Clinical trial registrationDevelopment and use of a standardized instrument for assessing children’s competence to consent in drug trials: Are legally established age limits valid?, NTR3918.
Highlights
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
In our present study we examine which are key determining factors for children’s competence to give informed consent to clinical research
Prior written informed consent was obtained from the parents or guardians of the children who served as participants, and of participants 12 years or older, and assent form participants under 12 years of age
Summary
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. 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. More pediatric drug trials are needed, historically the protection of children from research was often translated as excluding them from research [1]. Research with this vulnerable population involves unique ethical and legal considerations. Resorting to judicial review in every case of suspected incompetence would very heavily burden both the medical and legal systems, there is good reason to continue the traditional practice of having clinicians determine patients’ competence [4]. In clinical practice competence is generally addressed as decisionmaking capacity [5], and in this article we use the terms interchangeably, referring to clinical assessment of capacity and not legal determination of competence [5]
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