J Korean Med Sci.  2003 Feb;18(1):3-10. 10.3346/jkms.2003.18.1.3.

Current Status of the Institutional Review Boards in Korea: Constitution, Operation, and Policy for Protection of Human Research Participants

• Kim OJ
• Park BJ
• Sohn DR
• Lee SM
• Shin SG

• KMID: 1099785
• DOI: http://doi.org/10.3346/jkms.2003.18.1.3

Abstract

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.

Keyword

Ethics Committees; Research; Ethics Committees; Chinical; Ethics, Institutional; Ethics, Research; Human Experimentation

MeSH Terms

Appointments and Schedules
Clinical Trials/legislation & jurisprudence
Clinical Trials/standards
Data Collection
Epidemiologic Studies
Ethics Committees, Research*/legislation & jurisprudence
Ethics Committees, Research*/standards
Ethics Committees, Research*/statistics & numerical data
Female
Human
Human Experimentation/legislation & jurisprudence
Human Experimentation/standards
Korea
Male
Politics
Public Policy
Research Design/standards