J Korean Soc Clin Pharmacol Ther.  2011 Jun;19(1):5-13.

The Suggestions for Improving the Institutional Review Board (IRB) in Clinical Trials: Focusing on Continuing Management

• Shin HY

Abstract

As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.

Keyword

Research ethics; Clinical trial; Institutional review board; Continuing review

MeSH Terms

Ethics Committees, Research
Ethics, Research
Humans
Korea