Roth-Cline Michelle, Nelson Robert M
Pediatric Ethicist, Office of Pediatric Therapeutics, FDA, 10903 New Hampshire Ave, Bldg 32 Rm 5121 Silver Spring, MD 20993.
Curr Pharm Des. 2015;21(39):5619-35. doi: 10.2174/1381612821666150901105146.
The critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. In this chapter, we review key ethical considerations concerning the participation of children. We review a basic ethical framework to guide pediatric research, and suggest how this framework might be operationalized in linking science and ethics. Topics examined include: the status of children as a vulnerable population; the appropriate balance of risk and potential benefit in research; and parental permission and child assent to participate in research.
对药物和生物制品进行儿科研究的迫切需求凸显了确保儿童参与既具有科学必要性又符合伦理道德的临床研究的责任。在本章中，我们回顾了有关儿童参与研究的关键伦理考量。我们回顾了一个指导儿科研究的基本伦理框架，并提出了如何在将科学与伦理联系起来的过程中实施这个框架。所探讨的主题包括：儿童作为弱势群体的地位；研究中风险与潜在益处的适当平衡；以及父母同意和儿童同意参与研究。
