우리나라 연구윤리심의위원회의 운영실태와 개선방안에 관한 연구

The Current Problems and Proposed Solutions for the Institutional Review Boards in Korea

The role of ethics committees or institutional review boards (IRB) is crucial to ensure the scientific and ethical quality of medical research involving human participants. In April 2002, the Korean Association of Institutional Review Boards (KAIRB) conducted a survey to examine the current constitution and operation of IRBs in Korea. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). The survey analysis shows that the number of the IRBs has abruptly increased since 1995, when the KGCP (Korean Good Clinical Practice), the regulation for clinical trials, began to be enforced. The survey shows that IRB membership has a male: female ratio of approximately 80:20, a predominance of male clinicians (60 %) and a lack of community representatives unaffiliated to the institution (less than 10 %). Most IRBs (80%) confine the scope of their review 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. Many IRBs lack detailed standard operating procedures. While 70% of the IRBs review payment and compensation to patient participants and healthy volunteers in sponsored research, 62% of institutions have never discussed the need for insuring research participants risks or making indemnity arrangements. This survey on the current situation of IRBs in Korea 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.