April 14, 2021
Copyright 2021 Compliance Today, a publication of the Health Care Compliance Association (HCCA).
Children are notorious for asking questions, aren’t they? “Mom, can I do this?” “Dad, can I go here?” Parents are tasked with the responsibility and obligation to lead and protect their children; they are expected to do what is in their child’s best interest.
But parents are not always the only ones who hold this responsibility. Sadly, and all too often, children become sick and require knowledge and intervention from medical experts. Once healthcare professionals are involved in the child’s care, they now also share in this solemn responsibility.
In this article, we will discuss informed consent and assent and the associated implications for the institutional review board (IRB), the parent(s) or legal guardian(s), the child, and the investigator.
Ankura is not a law firm and cannot provide legal advice.
“Mother, May I? Obtaining Consent in Pediatric Clinical Trials,” Krieg, Tara.