среда, 19 сентября 2012 г.


The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:

The FDA today announced that on October 16, Robert M. Nelson, M.D., M.Div., Ph.D. will join FDA's Office of Pediatric Therapeutics and will be responsible for providing guidance and advice on ethical issues related to pediatric clinical trials and other pediatric issues involving any product regulated by FDA. Mandated by the Best Pharmaceuticals for Children Act, this pediatric ethicist position was most recently held by Sara Goldkind, M.D., M.A., who was instrumental in significantly furthering the Agency's oversight function for helping to ensure the highest ethical standards in all FDA-related activities, and specifically clinical trials, involving children.

Dr. Goldkind will join the FDA's Critical Path team and serve as an advisor to the Bioresearch Monitoring Initiative while continuing her leadership role in emergency research.

'We are extremely pleased to welcome Dr. Nelson to the Agency. His expertise and experience further bolster our ability to ensure the highest level of scientific and ethical rigor in pediatric clinical research' said Dr. Andrew C. von Eschenbach, Acting Commissioner of Food and Drugs. 'Dr. Nelson's insight and knowledge, both of medicine and ethics, are exceptional and will be of enormous benefit to FDA as we continue to improve our scientific understanding of the medical needs of children, and assure that research activities are conducted according to the best ethical and medical principles.'

Dr. Nelson brings to FDA unmatched experience addressing the challenging ethical issues surrounding children and medicine. As an Associate Professor of Anesthesiology and Critical Care at The Children's Hospital of Philadelphia, Dr. Nelson cares for critically ill children and has worked with parents and families for more than two decades. While working at FDA, he will maintain his faculty appointments at the University of Pennsylvania School of Medicine. He has lectured and published widely on ethical and regulatory issues in pediatric research and clinical care. 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.

For the past two years, Dr. Nelson has 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, and is a reviewer and editorial board member for a number of peer-reviewed journals. Dr. Nelson is also a former Chair of the Committee on Bioethics of the American Academy of Pediatrics.

Dr. Nelson is a graduate of Yale University Medical School, with a Masters of Divinity degree from Yale's Divinity School, and a Ph.D. 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 is Director of the Center for Research Integrity, established at CHOP to further the responsible conduct of pediatric research. His current research explores different aspects of child assent and parental permission, including such aspects as adolescent risk perception, the development of a child's capacity to assent, and the degree to which parental choice is perceived as voluntary.

'Along with the United States' many incentives and mandates in the last decade regarding pediatric research, the recent European legislation in this area will only increase the number of clinical studies involving children,' said Dr. Dianne Murphy, Director of the Office of Pediatric Therapeutics at FDA. 'We are all delighted that Dr. Nelson is joining us as a critical member of our agency's pediatric team to help us assure these trials, and all of FDA's interactions with the pediatric community, clearly meet the highest ethical standard.'