Related Experiment Video
Updated: Aug 18, 2026
Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
Illness severity and parental permission for clinical research in a pediatric ICU population
Jessie M Hulst1, Jeroen W B Peters, Ada van den Bos
1Department of Pediatric Surgery, Erasmus MC, Sophia Children's Hospital, Rotterdam, The Netherlands.
Insights
Parental consent for pediatric clinical research is not deterred by child illness severity. However, a child's medical history and perceived burden significantly impact parental decisions, influencing participation in intensive care unit studies.
Area of Science:
- Pediatric Intensive Care Research
- Clinical Trial Recruitment
- Informed Consent in Pediatrics
Background:
- Parental permission is essential for involving children in clinical research.
- Understanding factors influencing consent is crucial for effective study enrollment.
Purpose of the Study:
- To investigate if a child's illness severity at the time of consent influences parental authorization for research participation.
- To identify key determinants affecting parental consent decisions in pediatric intensive care settings.
Main Methods:
- An observational study was conducted in a multidisciplinary tertiary pediatric and neonatal intensive care unit.
- Parental consent was sought for 421 children (preterm to 18 years) for a nutritional status study within 24 hours of ICU admission.
- Refusal rates and reasons for non-consent were recorded.
Main Results:
- A higher illness severity score did not negatively impact the likelihood of obtaining informed consent.
- Parents of children with a pre-existing disease history were 3.2 times less likely to consent.
- The primary reason for refusal was the perceived burden of the study on the child.
Conclusions:
- Child illness severity in the ICU does not appear to be a barrier to parental consent for observational research.
- A child's medical history and parents' perception of study burden are significant factors influencing consent.
- These factors require careful consideration to facilitate recruitment in pediatric critical care research.
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.
