건국대학교 의과대학에서의 임상연구를 위한 기반 조성에 관하여
 :  연구윤리심의위원회(의학윤리위원회)의 설치 및 운영 Establishment and Operation of Institutional Review Board (Medical Ethics Committee) = For Foundation of Infrastructure for Clinical Study in Konkuk Medical College / 배진우

제어번호 30110978
저자명 배진우
학술지명 건국의과학학술지(The Kon-Kuk Journal of Medical Sciences)
권호사항 Vol.13 No.- [2003] 
발행처 건국대학교 의과학연구소(The Research Institute of Medical Sciences Kon-Kuk University) 
자료유형 학술저널
수록면 1-6(6쪽)
언어 Korean
발행년도 2003년
KDC 510.000
소장기관 경북대학교 중앙도서관

초록
Clinical study is undoubtedly essential in the development of medical science. All proposals for clinical study should be submitted to the Institutional Review Board (IRB) for scientific and ethical review. IRB is the fulfillment of the governments obligation to establish an institution of clinical study. Thus, some important factors for the establishment and operation of IRB were introduced in this manuscript to reiterate the importance of IRB among faculty members.
 While each hospital usually establishes its own IRB, it will probably be better to establish one IRB at Konkuk University Clinic to do away with manpower and financial burdens. IRB should consist of more than five persons including a physician, a statistician, a scientist, a lawyer, and a non-medical expert. Likewise, there should also be at least one female member.
 In addition, IRB should prepare several forms including standard operating procedures(SOP), application forms, informed consent, and their exemplar. The SOP of IRB should consider the regulations of IRB particularly on membership, conference, finance, review procedures, etc. IRB should determine whether the clinical study is scientific and ethical, given that unscientific study is also unethical. The quality of investigator and facilities, control group, informed consent, and recruitment of subjects should also be reviewed. In particular, informed consent is very important in the review of ethicality. It should be comprehensible; subjects should be well informed of the risks and benefits. Participation in and withdrawal from the study should also be unrestrictive and also do not influent to the relationship between medical doctor and patient

주제어
Clinical study  ,good clinical practice  ,institutional review board  ,medical ethics committee