期刊
PEDIATRIC CLINICS OF NORTH AMERICA
卷 59, 期 5, 页码 1205-+出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1016/j.pcl.2012.07.007
关键词
Ethics; Informed consent; Risk-benefit assessment; Clinical trials; Stem cell transplantation; Genetic testing; Hypoxic-ischemic encephalopathy
类别
资金
- National Institute for Child Health and Human Development [K23HD057994]
- CTSA grant from the National Institute of Health [UL1 RR033179]
Children have been identified as uniquely vulnerable clinical research subjects since the early 1970s. This article reviews the historical underpinnings of this designation, the current regulatory framework for pediatric and neonatal research, and common problems in pediatric research oversight. It also presents 3 areas of pediatric and neonatal research (genomic screening, healthy children donating stem cells, and therapeutic hypothermia for neonates with hypoxic-ischemic encephalopathy) that highlight contemporary challenges in pediatric research ethics, including balancing risk and benefit, informed consent and assent, and clinical equipoise.
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