FDA Ethicist: Fairness Crucial to Pediatric Informed Consent

In getting informed consent for vulnerable subjects, sites should consider the “fairness” of the exchange. Focusing on informed consent for children and adolescents, Robert Nelson, lead medical officer and pediatric ethicist in the FDA’s Office of Pediatric Therapeutics, encouraged sites to look at vulnerability more broadly. Generally, vulnerability has been viewed as the inability to provide voluntary and informed consent.
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