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Children's views on their involvement in clinical research
Hélène Chappuy1, François Doz, Stéphane Blanche
1Département d'Urgences Pédiatriques, Hôpital Necker Enfants Malades, Assistance Publique Hopitaux de Paris et Laboratoire d'Ethique Médicale Université René Descartes Paris, France. helene.chappuy@nck.aphp.fr
Pediatric Blood & Cancer
|October 27, 2007
Summary
Children participating in clinical trials show incomplete understanding of informed consent, particularly regarding procedures and withdrawal rights. Factors like age and the timing of consent significantly influence comprehension.
Area of Science:
- Pediatric Clinical Research
- Bioethics
- Informed Consent
Background:
- Informed consent is a cornerstone of ethical clinical research.
- Ensuring children's comprehension of clinical trial details is crucial for ethical participation.
Purpose of the Study:
- To assess children's understanding of informed consent elements in clinical trials.
- To identify factors influencing children's comprehension of informed consent.
Main Methods:
- A semi-directive interview was conducted with 29 children (ages 8.5-18) undergoing cancer or HIV clinical trials.
- Understanding was quantified using a 0-9 score based on French and European legal requirements for valid consent.
Main Results:
- Children demonstrated higher understanding of study objectives and potential benefits (58-62%) but lower understanding of procedures, alternative treatments, and withdrawal rights (17-31%).
- Comprehension significantly correlated with age (P=0.0001) and was higher in older children (over 14).
- Informed consent provided more than 7 days after diagnosis led to significantly better understanding (P=0.03) compared to consent at diagnosis.
Conclusions:
- Children possess an incomplete grasp of key informed consent components.
- Age and the timing of the informed consent process are critical determinants of children's understanding.
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