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In health related research ethical issues relating to children are breached based on the decision making framework to various clinical trials. The selected case involved a randomized controlled trial in a children hospital to compare the efficiencies involved in the application of botulinum toxins injections for children with cerebral palsy. This pilot feasibility targeted children with ten years for diagnosis and classification of gross motor functions system levels (Kelly and MacKay-Lyons, 2010). The current model of clinical trial involving children in research builds on casting protocols for equines gaits of cerebral palsy children. This reflects the ethical principles that allow for the conceptualization of the direct involvement of children in health research to improve and maintain the clinical care in pediatric care.
The ethical issues that were breached included investigating the highly vulnerable children without their consent hence portraying a complex research problem. Kelly and MacKay-Lyons (2010) reiterates that while this required the involvement of many levels of decision makers, the researcher could not address the concept scope of the parents, health care providers and children themselves. As a result, the research underestimated the decisional capacities of children for paying close attention to their life experiences, their context and an extensive provision of appropriate information about the research study vis a vis the development pf the child. In essence, the research largely focused on the assessment of dissent which involved withdrawing the child from the normal and natural spectrum of growth and development.
Kelly, B and MacKay-Lyons, M. Ethics of Involving Children in Health-Related Research: Applying a Decision-Making Framework to a Clinical Trial. Physiother Can. 2010 Fall; 62(4): 338–346
Weijer C. Thinking clearly about research risk: implications of the work of Benjamin Freedman. IRB: Ethics Hum Res. 1999;21:1–5. doi: 10.2307/3564450
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