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In this tenth installment of “More Than Meets the IRB,” we talk with F. Sessions Cole (MD, Assistant Vice Chancellor for Children's Health at Washington University School of Medicine in St. Louis; Chief Medical Officer, St. Louis Children's Hospital; Director, Division of Newborn Medicine; Park J. White, MD, PhD, Professor of Pediatrics), and Robert “Skip” Nelson (MD, Deputy Director and Senior Pediatric Ethicist in FDA’s Office of Pediatric Therapeutics).

Children present unique risks and considerations for researchers involved with Comparative Effectiveness Research (CER). In this conversation, we talk about the nature of these vulnerabilities, the present state of the art in this emerging research, and specific ethical considerations encountered by experts in the field. We conclude by specifically addressing things IRBs should be aware of when reviewing CER involving children. (30:38)

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