医学伦理审查在临床科研中的实践

Practice of Medical Ethic Censorship in Clinical Scientific Research

在临床科研管理中,通过对科研课题的医学伦理审查实践,提出了在伦理审查中采取快速审查、常规审查“两条通道”审查及会议审查与书面审查相结合的方法,既方便了临床,又达到简化程序,提高效率的目的。伦理委员会办公室设在科研部,秘书由科研管理人员担任,保证了科研课题申报工作与伦理审查工作的协调一致。同时,也提出了在医学伦理审查中目前迫切需要解决的问题:制定统一的涉及人体的生物医学研究伦理审查规范;对伦理审查委员进行系统地伦理知识培训;在医务人员及科研管理人员中普及伦理知识。

The author puts forward the ethic censorship methods of ＂ two - channel＂ censorship of regular censorship and fast censorship as well as combined conference and paper censorship in ethic censorship through the practice of medical ethic censorship on projects in clinical scientific research management. The methods will facilitate clinic, simplify procedure and improve efficiency. The setup of Ethic Committee in Scientific Research Department and the management of scientific research taking the role as Secretary of the Ethic Committee will ensure the consistency for the declaring of research proposals and ethic censorship. Further more, the author points out the problems existing in current medical ethic censorship： the establishment of unified criteria in biomedical （including human ） ethic censorship; the systematical training of ethic knowledge to members of the Ethic Committee; the popularization of ethic knowledge among medical staff and research management. To solve these problems is rather urgent.