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Saturday, May 01, 2010
8:00 AM - 10:00 AM |
| Session Number: 1112 |
| CTSAs: Regulatory Challenges in Pediatric Research |
| PAS Topic Symposium |
| Vancouver Convention Centre ~ 109 |
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| Target Audience: Clinicians and scientists engaged in clinical and translational research related to child health. |
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| Objectives:
- Understand the historical, legal, and policy issues in child health research[br]- Gain insights into special domains of child health research |
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| Chairs: Ronald J. Sokol, University of Colorado Denver School of Medicine, Denver, CO and Lisa M. Guay-Woodford, University of Alabama at Birmingham, Birmingham, AL |
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| Child health research has special safeguards, considerations and responsibilities due to the particular vulnerabilities of children as well as legal and regulatory requirements. The ethical framework is dynamic and continues to be refined through new initiatives, research and interpretations. This symposium will provide a perspective on the historical, legal, and policy issues in pediatric research and explore special domains within child health-related research. |
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Ronald J. Sokol
University of Colorado Denver School of Medicine, Denver, CO |
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Lisa M. Guay-Woodford
University of Alabama at Birmingham, Birmingham, AL |
| 8:00 AM - |
Regulatory Challenges in Pediatric Research: Historical, Legal, and Policy Considerations
Steven Hirschfeld
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD |
| 8:30 AM - |
Making All the Children Above Average: Ethical and Regulatory Concerns for Pediatricians in Pediatric Enhancement Research
Jessica Berg
Case Western Reserve University, Cleveland, OH |
| 9:00 AM - |
Non-Therapeutic Research in Children: Scientific, Clinical, and Ethical Considerations
David Wendler
National Institutes of Health Clinical Center, Bethesda, MD |
| 9:30 AM - |
The National Institutes of Health and the Best Pharmaceuticals for Children Act: Integration of Regulatory and Public Health Priorities with Feasibility and Resources
Anne Zajicek
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD |
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| Program developed by the CTSA Consortium Child Health Oversight Committee and the Pediatric Academic Societies |
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