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FDA-Regulated Research Track
2019 AER Conference
Melanie Bhatnagar, MD
Medical Officer, Food & Drug Administration
Donna L. Snyder, MD
Senior Pediatric Ethicist and Team Leader, Food and Drug Administration
Albert J. Allen, MD, PhD
Senior Medical Fellow, Pediatric Capabilities, Global Medical Policy Strategy and Operations, Lilly Research Labs, Eli Lilly and Company
FDA regulations permit IRBs to approve pediatric research that presents more than a low level of risk if participation in the research holds out the prospect of direct benefit for the individual subjects. Given that there is no regulatory definition for prospect of direct benefit, how should it be defined? How should IRBs consider the prospect of direct benefit in the context of early-phase clinical trials involving pediatric subjects? During this session, speakers and attendees will: