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KMID : 0614720100530090774
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Journal of Korean Medical Association
2010 Volume.53 No. 9 p.774 ~ p.779
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Clinical trials and ethics
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Lim In-Ae
Rha Sun-Young
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Abstract
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Based on recently developed biotechnology, many new drugs have been developed for improving patient treatment outcomes. To develop novel drugs, proper clinical trials are essential. As clinical trials involve humans in research, the protection of participants is important not only for the participants’ safety but also for future patients. Ethics in a clinical trial is not the same as in clinical practice with enough evidence. Hence, the whole procedure of a clinical trial should be well organized, scientifically and ethically planned, and monitored properly by an Institutional Review Board (IRB). Here the importance of ethics in clinical trials, related issues, and the monitoring system will be discussed.
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KEYWORD
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Clinical trial, Ethics, Institutional Review Board, Human Research Protection Program
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