국내 기관생명윤리심의위원회(IRB)의 현황과 문제점*

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.