Rothman David J
Center for the Study of Society and Medicine, Columbia University, New York, USA.
Z Arztl Fortbild Qualitatssich. 2003 Dec;97(10):695-702.
With increasing frequency, clinical trials are carried through in countries of the "third world". In particular, recent studies aimed at establishing the efficacy of new AIDS therapies, or AIDS vaccines, applied lower ethical standards than those formulated by the Declaration of Helsinki of the World Medical Association, and accepted in the US and internationally,--although American researchers and institutions were involved in these studies. The paper reconstructs the controversies following the publication of these studies, and analyses the conditions for the existence of such double standards of research ethics. Particular attention is given to the concept of informed consent and the difficulties to put it into practice in different cultural contexts.
越来越频繁地，临床试验在“第三世界”国家开展。特别是，近期旨在确定新型艾滋病疗法或艾滋病疫苗疗效的研究，所采用的伦理标准低于世界医学协会《赫尔辛基宣言》所制定的、在美国及国际上被认可的标准——尽管美国研究人员和机构参与了这些研究。本文重构了这些研究发表后的争议，并分析了研究伦理双重标准存在的条件。特别关注了知情同意的概念以及在不同文化背景下将其付诸实践的困难。
