임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)
- 제14권2호
- /
- Pages.142-151
- /
- 2006
- /
- 1225-5467(pISSN)
공동연구윤리심의위원회의 외국 현황과 국내 운영 방안
Current Status of the Joint Institutional Review Boards in Foreign Countries and Suggestion for Operating in Korea
- 이승미 (서울대학교 의과대학 예방의학교실) ;
- 김선하 (서울대학교 의과대학 예방의학교실) ;
- 김화정 (서울대학교 의과대학 예방의학교실) ;
- 김옥주 (서울대학교 의과대학 의사학교실) ;
- 배균섭 (울산대학교 의과대학 임상약리학교실) ;
- 박병주 (서울대학교 의과대학 예방의학교실)
- Lee, Seung-Mi (Department of Preventive Medicine, Seoul National University College of Medicine) ;
- Kim, Seon-Ha (Department of Preventive Medicine, Seoul National University College of Medicine) ;
- Kim, Hwa-Jung (Department of Preventive Medicine, Seoul National University College of Medicine) ;
- Kim, Ock-Joo (Department of the History of Medicine and Medical Humanities, Seoul National University College of Medicine) ;
- Bae, Kyun-Seop (Pharmacology and Theapeutics, Asan Medical Center, University of Ulsan College of Medicine) ;
- Park, Byung-Joo (Department of Preventive Medicine, Seoul National University College of Medicine)
- 발행 : 2006.12.30
초록
As the number of multicenter clinical studies has been increased very rapidly in recent years, the necessity of joint institutional review board (IRB) gets realized for making review process more efficiently. Large private joint IRBs such as Western IRB have been established and providing wide range of IRB activities in the United States. In Taiwan, Joint IRB was founded as a non-profit institute, which has been performing the review activities for premarketing multicenter clinical trials. In the United Kingdom, multicenter clinical studies should be reviewed by Multi-centre Research Ethics Committee. It is institutionalized that any IRB recognizes and accepts the review result of other Institution's IRB in Australia. The profit IRB, non-profit IRB, ad hoc IRB, regional IRB, or mutual recognition can be considered as models of joint IRB in Korea.