Korean Journal of Pediatrics 2009;52(1):1-5.
Published online January 15, 2009.
Ethical considerations for clinical trials performed in children
Myungho Oh
Department of Pediatrics SoonChunHyang University ChonAn Hospital
소아 임상연구에서의 의료 윤리적 고려사항
순천향대학교 천안병원 소아청소년과
Myungho Oh, Email: omh@schca.ac.kr
Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent but their assent should be obtained using age appropriate information. Institutional Review Board (IRB) need paediatric expertise to balance the benefits and risks of research in children. The lack of consent has implications on the design, analysis and the choice of comparators used in the trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The children requires even more careful review. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Finally, criteria for the protection of children in clinical trials therefore need to be laid down. Specific protection should be defined for research performed in children, at all stages and ages.
Key Words: Institutional review board, Consent investigates, Children

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