Current status of the institutional review boards in Korea: constitution, operation, and policy for protection of human research participants.
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.
Kim
Ock-Joo
OJ
The Korean Association of Institutional Review Boards (KAIRB), Seoul, Korea.
Park
Byung-Joo
BJ
Sohn
Dong-Ryul
DR
Lee
Seung-Mi
SM
Shin
Sang-Goo
SG
D001071:Appointments and Schedules; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D003625:Data Collection; D016021:Epidemiologic Studies; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000592:standards / Q000706:statistics & numerical data; D005260:Female; D006805:Human Experimentation / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007723:Korea; D008297:Male; D011057:Politics; D011640:Public Policy; D012107:Research Design / Q000592:standards