Published in:
01-06-2005 | Pediatric Brief Report
Illness severity and parental permission for clinical research in a pediatric ICU population
Published in: Intensive Care Medicine | Issue 6/2005
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Objective
Research in child subjects requires parental permission. We examined whether parental authorization of involvement in a clinical study is influenced by the child’s severity of illness at the time of the consent decision.
Design and setting
Observational study in a multidisciplinary tertiary pediatric and neonatal intensive care.
Patients and participants
Parents of 421 children (age range from preterm to 18 years) were asked to consent for participation in a study focusing on measuring their child’s nutritional status within 24 h after admission to the ICU. Over 20% of the parents (n=88) refused consent, most of them because they expected the study to be too burdensome for their child.
Measurements and results
Patient and disease characteristics were comparable in the children for whom consent had or had not been obtained. A higher illness severity score did not decrease the probability of obtaining informed consent, but parents of children with a history of disease were 3.2 times less likely to consent.
Conclusions
Parents of children with higher illness severity scores are not more likely to decline permission to include their child in clinical observational research on the ICU. History of disease and subjectively perceived burden to the child are important factors that must be considered.