医院人体研究伦理审查工作的实践和体会  

Practice and experience of ethical review of human body research in hospital

作　　者：蔡怡嘉[1] 张志明[1] 吴永良[1] 林民强[1] 

机构地区：[1]厦门大学附属第一医院科研部,361003

出　　处：《中华医学科研管理杂志》2017年第4期255-257,262,共4页Chinese Journal of Medical Science Research Management

摘　　要：目的通过对医院近年来人体研究伦理审查工作的整理总结，进一步完善伦理审查工作，强化伦理审查的职能实现。方法通过借鉴国外的研究成果和对近年来医院人体研究伦理审查工作的实践经验进行总结。结果我国伦理委员会发展尚处于起步阶段，实际监管能力仍存在缺陷和不足，健全、可操作性强的伦理审查机制有待在审查实践中逐渐完善。结论在完善人体研究伦理审查工作方面除了加强组织建设、制度建设和能力建设外，建议进一步完善伦理委员会监督评价机制，明确不同类型研究项目的审查要素，多层次开展伦理培训，结合信息平台建设对临床研究进行持续监督，确保人体研究项目的客观性、科学性及符合伦理要求，促进临床科学研究工作的健康、可持续发展。Objective To improve the ethics review process and ethical standards, strengthen the implantation of ethical review of research involving human subject in our hospital. Methods Evaluating the review practice of research involving human subject in our hospital practices, learn and bring in the latest international experiences. Results As China＇s Ethical Committee is in its initial stage, the regulatory ability is still in defective and insufficient. A healthy and operable ethic review mechanism needs to be perfected gradually along with the practice. Conclusions In the aspect of improving the ethical review work of human subject research, some new methods and ideas were dis- cussed. In addition to strengthen the current organizational system, we should clarify the elements of the review of different types of research and carry out multi-level ethical trainings. The establishment of a unified, specific evaluative system, combined with this information platform is continuously monitoring the clinical study. This will ensure the human research projects comply with ethical requirements, and further promote the sustainable development of clinical research.

关 键 词：伦理委员会 人体研究 伦理审查 

分 类 号：R197.3[医药卫生—卫生事业管理]