Clinical trials and ethics

Article information

J Korean Med Assoc. 2010;53(9):774-779

Publication date (electronic) : 2010 September 07

doi : https://doi.org/10.5124/jkma.2010.53.9.774

Inae Lim, RN, MPH ¹, Sun Young Rha, MD ²

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 2010 August 09; Accepted 2010 August 23.

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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