Macpherson C C
St. George's University School of Medicine, Grenada, West Indies.
Theor Med Bioeth. 1999 Apr;20(2):161-79. doi: 10.1023/a:1009989104496.
Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures.
国家和国际层面都存在机构审查委员会(IRB)或研究伦理委员会的指导方针。这些指导方针基于伦理原则,为医学研究的审查和开展确立了国际认可的标准。在就这些基本指导方针应包含的内容达成跨国共识后,IRB负责解读这些指导方针并设计自身的实施方式。个人和社区价值观会影响对指导方针的解读,因此不同的IRB有效性水平各异。在加勒比和泛美地区,IRB数量很少。在这样的发展中地区,语言、识字率和当地价值体系的差异加剧了IRB设立和运作的障碍;教育、行政专业知识、设施以及信息获取也都有限。一个区域性IRB网络或许能促进发展中国家进行更统一的伦理审查,并简化IRB程序。