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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: 7 September 2010

DOI: https://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 9 August 2010       Accepted 23 August 2010

Copyright © 2010 Korean Medical Association

(open-access):

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.

Keywords: Clinical trial, Ethics, Institutional Review Board, Human Research Protection Program

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