Key factors in children's competence to consent to clinical research.
BACKGROUND
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
Development and use of a standardized instrument for assessing children's competence to consent in drug trials: Are legally established age limits valid?, NTR3918.
Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105, AZ, Amsterdam, The Netherlands. i.hein@debascule.com.
Irma M
IM
Hein
Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105, AZ, Amsterdam, The Netherlands. p.troost@debascule.com.
Pieter W
PW
Troost
Department of Clinical Methods and Public Health, Academic Medical Center, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. r.lindeboom@amc.uva.nl.
Robert
R
Lindeboom
Department of Pediatrics, Emma Children's Hospital, Academic Medical Center, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. m.a.benninga@amc.uva.nl.
Marc A
MA
Benninga
Department of Pediatric Oncology, Erasmus Medical Center/Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands. c.m.zwaan@erasmusmc.nl.
C Michel
CM
Zwaan
Department of Pediatrics, Emma Children's Hospital, Academic Medical Center, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. h.vangoudoever@amc.uva.nl.|Department of Pediatrics, VU University Medical Center, De Boelelaan 1117, 1081, HZ, Amsterdam, The Netherlands. h.vangoudoever@amc.uva.nl.
Johannes B
JB
van Goudoever
Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105, AZ, Amsterdam, The Netherlands. r.lindauer@debascule.com.
Ramón J L
RJ
Lindauer
D000293:Adolescent; D000367:Age Factors; D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D032882:Comprehension; D005260:Female; D006801:Humans; D057828:Informed Consent By Minors / Q000941:ethics* / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D008297:Male; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D010290:Parents; D018579:Patient Selection / Q000941:ethics*; D011446:Prospective Studies