Robert Nelson

Robert Nelson is the FDA’s Office of Pediatric Therapeutics’ Senior Pediatric Ethicist/Lead Medical Officer. Prior to joining FDA full-time in 2009, Dr. Nelson was Professor of Anesthesiology, Critical Care and Pediatrics at the University of Pennsylvania School of Medicine and The Children’s Hospital of Philadelphia, where he was also the Director of the Center for Research Integrity, an institute established to further the responsible conduct of pediatric research.

Dr. Nelson holds an MD from Yale University School of Medicine, with a Masters of Divinity from Yale Divinity School, and a PhD in the Study of Religion from Harvard University. He completed his pediatric residency at Massachusetts General Hospital and fellowships in pediatric critical care and neonatology at the University of California San Francisco.

Dr. Nelson has lectured and published widely on ethical and regulatory issues in pediatric research and clinical care. His academic research explored child assent and parental permission, including adolescent risk perception, the development of a child’s capacity to assent, and the degree to which parental choice is perceived as voluntary.

Over the past decade, Dr. Nelson has been a consultant on ethical issues in research to the National Institutes of Health, the Environmental Protection Agency, FDA, the U.S. Department of Health and Human Services, and the Institute of Medicine, an independent national advisory organization.

Before joining FDA, Dr. Nelson chaired FDA’s Pediatric Advisory Committee, and prior to that he chaired the committee’s Subcommittee on Ethics. He has been a member of several data and safety monitoring boards, a reviewer and editorial board member for a number of peer-reviewed journals and is Editor-in-Chief of the AJOB – Primary Research, which publishes empirical research in bioethics. Dr. Nelson is also a former Chair of the Committee on Bioethics of the American Academy of Pediatrics.

---