국내 기관생명윤리심의위원회(IRB)의 현황과 문제점
= Current Status and Problems of Institutional Review Boards in Korea / 이준석 외

제어번호 87017903
저자명 이준석 ( June Seok Lee )  ,김옥주 ( Ock Joo Kim )  ,김수연 ( Soo Youn Kim )  ,박병주 ( Byung Joo Park )
학술지명 한국의료윤리학회지
권호사항 Vol.9 No.2 [2006] 
발행처 한국의료윤리학회 
발행처URL http://www.medicalethics.or.kr/
자료유형 학술저널
수록면 203-222(20쪽)
언어 Korean
발행년도 2006년
등재정보 KCI등재
중단사유 발행기관의 정책으로 인하여 개인 판매가 중단된 논문입니다. 구독기관 이용자는 [한국학술정보 한국학술정보] 홈페이지에서 원문을 이용해 주시기 바랍니다.

 
초록
The recent scandal involving Korean stem cell researcher Hwang Woo-Seok shows that biomedical research in Korea is not yet governed by an established code of research ethics. In January 2001, the Korea Food and Drug Administration (KFDA) renewed the Korean Good Clinical Practice (KGCP) guidelines. In the newer version of the KGCP, the purposes, structures, functions and operating procedures of Institutional Review Boards (IRBs) are defined. Also, according to the Bioethics and Biosafety Act (Bio-Act) enacted in January 2005, all research institutions are required to create their own IRBs to review the ethical aspects of all research conducted within their institutions. The reviews carried out by these IRBs are required to cover all research procedures, from the submission of proposals to the obtaining of informed consent, in order to ensure that research is conducted in accordance with accepted ethical guidelines. Ever since the enactment of the Bio-Act in 2005, there has been a great deal of confusion between the existing IRBs required by the KGCP for clinical trial reviews and the newly established IRBs required by the Bio-Act. This confusion is due to the fact that there is no clear distinction between the different roles of these two types of IRB, no guidelines on their mutual relationships, and a lack of standard operating procedures. The present study was designed to contribute to the standardization of IRBs in Korea. In order to learn more about the current functioning of Korean IRBs questionnaires were sent out to 281 research institutions, 121 of which responded (response rate of 43.1%). The results indicate that the IRBs required by the KGCP have many common features and functions with the IRBs required by the Bio-Act. This overlapping of features and functions has led to waste in manpower and financial resources. Therefore, the guidelines provided by the current Bio-Act need to be reformed in order to improve the efficiency of IRBs in Korea.

주제어
기관생명윤리심의위원회  ,임상시험심사위원회  ,생명윤리 및 안전에 관한 법률  ,KGCP  ,Institutional Review Board  ,IRB  ,Korean Good Clinical Practice  ,Bioethics and Biosafety Act