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- Title
Illness severity and parental permission for clinical research in a pediatric ICU population.
- Authors
Hulst, Jessie M.; Peters, Jeroen W. B.; van den Bos, Ada; Joosten, Koen F. M.; van Goudoever, Johannes B.; Zimmermann, Luc J. I.; Tibboel, Dick
- Abstract
<bold>Objective: </bold>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.<bold>Design and Setting: </bold>Observational study in a multidisciplinary tertiary pediatric and neonatal intensive care.<bold>Patients and Participants: </bold>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.<bold>Measurements and Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
NETHERLANDS; NEONATAL intensive care; PEDIATRICS; INFANT health services; PATIENTS; MEDICAL care; HOSPITAL care of newborn infants; INFORMED consent (Medical law); INTENSIVE care units; MEDICAL research; MULTIVARIATE analysis; LOGISTIC regression analysis; SEVERITY of illness index; PATIENT selection
- Publication
Intensive Care Medicine, 2005, Vol 31, Issue 6, p880
- ISSN
0342-4642
- Publication type
journal article
- DOI
10.1007/s00134-005-2647-8