GCP와 임상시험의 윤리적 측면
= GCP and Ethical Aspects of Clinical Reseach / 윤영란 외

제어번호 40019027
저자명 윤영란  ,차인준
학술지명 仁濟醫學(Inje medical journal)
권호사항 Vol.23 No.1 [2002] 
발행처 인제대학교 백병원 
자료유형 학술저널
수록면 47-52(6쪽)
언어 Korean
발행년도 2002년
KDC 510.000

초록
To make clinical research ethical, the ethical committee, Institutional Review Board(IRB) is needed and is being controlled by the governmental regulations, Good Clinical Practice(GCP). This short review introduces some of the important concepts in ethics in clinical trial, especially in IRB. In IRB review, 7 necessary requirements should be considered : (1) value : enhancements of health or knowledge must be derived from the research; (2) scientific validity the research must be methodologically rigorous; (3) fair subject selection : scientific objectives, not vulnerability or privilege. and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio : within the context of standard clinical trial and research protocol, risks must be minimized, potential benefits enhanced. and the potential benefits to individuals and knowledge gained for society must outweigh the risks, (5) independent review : unaffiliated individuals must review the research and approve, amend, or terminate it, (6) informed consent : individuals should be informed about the research and provide their voluntary consent, and (7) respect for enrolled subjects : subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. To review protocols of clinical research, IRB members should have not only the scientific and statistical knowledge, but also ethical and legal knowledge.

주제어
Institutional review board(IRB)  ,clinical trial  ,ethics  ,good clinical practice(GCP)