Neelam Reddy
Independent Researcher
Karnataka, India
Abstract
Pediatric dental research presents unique ethical and regulatory challenges due to the vulnerability and dependent nature of child participants. This review explores the ethical principles, regulatory frameworks, and case-based applications that govern pediatric dental clinical trials. The discussion covers informed consent and assent, risk-benefit analysis, study design constraints, and regulatory oversight, focusing on both global and regional guidelines. Through case-based insights, the manuscript illustrates how practical ethical dilemmas are navigated in real-world dental studies involving children. The work emphasizes the importance of balancing innovation in pediatric dental treatment with rigorous ethical safeguards. The findings highlight the necessity for specialized ethical training, robust informed consent procedures, and vigilant institutional oversight in all pediatric dental investigations.
Keywords
Pediatric dentistry, research ethics, informed consent, regulatory frameworks, clinical trials, assent, IRB, dental research, child protection, bioethics
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