What is Known:
• Several international guidelines and a large body of scientific literature indicate a broad consensus about the basic ethical framework for pediatric clinical trials, based on risk benefit assessment and respect for autonomy.
• Little is known about how researchers implement these broad principles in practice.
What is New:
• Researchers’ risk/benefit assessments about their own studies resembled the assessment of neutral peers, assessing burden was more subjective.
• Researchers were very confident in their ability to obtain valid informed consent.