基于医联体的伦理协作审查模式构建与实施

Construction of ethical cooperative review mode based on medical union

随着我国生物医学科技的迅猛发展,临床研究项目数量急速增长,伴随而来的是伦理审查面临的挑战。近年来国内已有多家区域伦理委员会陆续成立,在区域伦理审查方面取得了一定经验,但区域伦理审查在操作层面存在着一定难度。针对区域伦理审查中的难点,借鉴国外区域伦理审查经验,并结合江苏地区已广泛成立的从县级基层医院到地市级三级医院医联体结构的特点,构建以牵头单位伦理审查为核心的医联体伦理协作审查模式,辐射带动促进医联体单位的伦理审查能力,有望充分发挥区域伦理委员会的灵动优势。

With the rapid development of biomedical science and technology in China,the number of clinical research projects is increasing rapidly,which is accompanied by ethical challenges.In recent years,a number of regional ethics committees have been established in China,and some experience has been gained in regional ethical review,but there is a certain difficulty in implementing it.In response to the difficulties in regional ethical review,the ethical cooperative review mode of medical union with the leading units as the core has been established based on the experience of foreign regional ethical review and the characteristics of the medical consortium structures that have been widely established in the county-level hospitals and prefecture level tertiary hospitals in Jiangsu region.It is expected to give full play to the flexible advantages of regional ethics committees by radiating and promoting the ethical review ability of medical union.