生物医学科研伦理可持续发展之研究

我国生物医学科研伦理的发展经历了不到10年的时间,作者简要归纳了我国目前伦理委员会的工作存在的综合问题,其中主要为:知情同意不充分、目前的审查相对宽松、伦理委员会自身科研伦理审查的能力和对本单位提供教育均较缺乏和尚未顾及到审查通过之后的持续审查等.本文通过了解美国在发展过程中存在的问题和我国的现状进行比较,发现存在诸多相似之处,因此着重介绍了其改革思路--地区性伦理审查模式,以资借鉴.作者的目的是就我国进行科研伦理能力建设、继续进行培训、加强政府监管和需要注意的文化因素等方面提出自己的初步设想.

Sustainable Development of Biomedical Research Ethics

Traced back to the one decade's development of research ethics in China,the author summarizes the current issues,such as: not sufficient implementing of informed consent,relatively loose review of IRB,IRBs lack ability to improve the review level and not provide much education opportunities to researchers,and not yet take account into the continuous review to the protocols approved before.By comparing the current issues of China and the conditions of U.S.in 1998,we can find some similarities exist,so we can learn from the lessons and experiences of the development of research ethics in the United and the other country,such as adding the model of region ethical review committee,instead of only institutional IRB.The author aims to point out some general ideas about research ethics capacity building,enforce training continuously,government pay much attention to IRB regulation and consider much on cultural elements,which are all bases for the road of sustainable development of research ethics in China.