Clinical trials and ethics

Inae Lim; Sun Young Rha

doi:10.5124/jkma.2010.53.9.774

J Korean Med Assoc > Volume 53(9); 2010 > Article

Lim and Rha: Clinical trials and ethics

Focused Issue of This Month

Clinical Research

Journal of the Korean Medical Association

Journal of the Korean Medical Association 2010; 53(9): 774-779.

Published online: September 07, 2010

DOI: http://dx.doi.org/10.5124/jkma.2010.53.9.774

Clinical trials and ethics

Inae Lim, RN, MPH¹, Sun Young Rha, MD²

¹Human Research Protection Center, Severance Hospital, Yonsei University Health System, Seoul, Korea.

²Department of Internal Medicine, Yonsei University College of Medicine, Human Research Protection Center, Severance Hospital, Yonsei University Health System, Seoul, Korea.

Corresponding author: Sun Young Rha, rha7655@yuhs.ac

Received August 09, 2010 Accepted August 23, 2010

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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.

Clinical trial; Ethics; Institutional Review Board; Human Research Protection Program

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