소아 임상연구에서의 의료 윤리적 고려사항 = Ethical considerations for clinical trials performed in children

다국어 초록 (Multilingual Abstract)

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.

참고문헌 (Reference)

1 The Ministry of Health and Welfare, "Standard operating procedure of IRB"

2 Korea Food and Drug Administration, "Standard operating procedure for clinical research of children"

3 Korea Food and Drug Administration, "Standard operating procedure for clinical research"

4 "Code of Regulation 45CFR46 404-407 subpart D"

5 "Code of Federal Regulation 45CFR46 111"

6 Western Institutional Review Board, "A guide for researchers"