Abstract
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.
Keywords: Ethics, pediatrics, children, neonates, subpart D, parental permission, child assent, clinical research.
Current Pharmaceutical Design
Title:Ethical Considerations in Conducting Pediatric and Neonatal Research in Clinical Pharmacology
Volume: 21 Issue: 39
Author(s): Michelle Roth-Cline and Robert M. Nelson
Affiliation:
Keywords: Ethics, pediatrics, children, neonates, subpart D, parental permission, child assent, clinical research.
Abstract: 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.
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Cite this article as:
Roth-Cline Michelle and Nelson M. Robert, Ethical Considerations in Conducting Pediatric and Neonatal Research in Clinical Pharmacology, Current Pharmaceutical Design 2015; 21 (39) . https://dx.doi.org/10.2174/1381612821666150901105146
DOI https://dx.doi.org/10.2174/1381612821666150901105146 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
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