基于中医医联体中医院区域伦理委员会的建设与研究

Construction and Research of Regional Ethics Committee of Municipal Traditional Chinese Medicine Hospitals Based on Traditional Chinese Medicine Medical Partnership Mode

伦理审查是国际通行的研究风险控制的重要手段。医学伦理学在世界各个国家的起步时间不同、发展水平和程度不均,但是,当今世界各国的伦理审查建设都在朝着建设区域伦理委员会的方向发展。我国在建设区域伦理委员会的过程中,面临着探索伦理互认机制、监管伦理持续审查、保护受试者的权益等挑战。本文分享了依托于中医医联体模式建设北京市属中医院区域伦理委员会的探索与实践。在建设市属中医院区域伦理委员会的过程中,通过搭建工作交流平台,达到协作课题伦理审查以及跟踪监管,接受托管医院委托代为伦理审查,逐步扶助托管医院建立伦理审查的目的。本文提出在中国区域伦理委员会建设过程中,需要统一伦理审查标准、形成合理工作程序、提高伦理审查效率。

Ethical review is an important means of risk control of clinical researches internationally. The starting time of medical ethics in various countries in the world is different, and the level and degree of development is uneven, but the construction of ethics review in the world today is moving towards the construction of regional ethics committee(EC).In the process of establishing regional EC in China, we are faced with challenges of exploring the mutual ethics recognition mechanism, continuing examination of supervision ethics and protecting the rights and interests of research subjects. This paper shared the exploration of the regional EC of Beijing municipal hospital based on the model of traditional Chinese medicine(TCM) medical association mode. In the process of establishing the regional EC of municipal TCM hospital, a working communication platform was built to achieve the ethical review and supervise the follow-up collaborative subjects, and to accept the ethical review entrustment of trusteeship hospitals, finally to gradually help the trusteeship hospital to improve their own ethical review system and level. This paper put forward that in the process of constructing regional EC in China,it is necessary to unify the ethical review standards, to form a reasonable working procedure and to improve the ethical review efficiency.