The standard of care debate: Can research in developing countries be both ethical and responsive to those countries' health needs?
The standard of care debate: Can research in developing countries be both ethical and responsive to those countries' health needs?
复制标题
DOI：
10.2105/ajph.94.6.923
复制
发表时间：
2004-06-01
影响因子：
12.7
通讯作者：
Lie, RK
中科院分区：
文献类型：
--
作者：
Wendler, D;Emanuel, EJ;Lie, RK
许多评论家认为，为了避免对东道社区的剥削，受试者必须接受全世界现有的最佳方法。其他人担心这一要求可能会阻碍旨在改善医疗保健的重要研究，特别是在发展中国家，为了解决这一困境，我们提出了一个框架的条件下，它是可以接受的，为受试者提供低于最好的方法。具体而言，机构审查委员会应假设默认要求“全球最佳”方法，即在所有情况下，世界任何地方都可以使用的最佳方法。然而，机构审查委员会应愿意对满足以下4个条件的研究给予例外：（1）科学的必要性，（2）与宿主社区的相关性，（3）足够的宿主社区利益，（4）受试者和宿主社区的无害性。
To avoid exploitaiton of host communities, many commentators argue that subjects must receive the best methods available worldwide. Others worry that this requirement may block important research intended to improve health care, especially in developing countries.To resolve this dilemma, we propose a framework for the conditions under which it is acceptable to provide subjects with less than the best methods. Specifically, institutional review boards should assume a default of requiring the "worldwide best" methods, meaning the best methods available anywhere in the world, in all cases.However, institutional review boards should be willing to grant exceptions to this default for research studies that satisfy the following 4 conditions: (1) scientific necessity, (2) relevance for the host community, (3) sufficient host community benefit, and (4) subject and host community nonmaleficence.