Ethical issues in clinical trials in developing countries

Ethical issues in clinical trials in developing countries
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DOI:
10.1002/sim.1289
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发表时间:
2002-10-15
影响因子:
2
通讯作者:
Brody, BA
Brody, BA
中科院分区:
医学3区
文献类型:
--
作者:
Brody, BA

文献摘要

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来自较发达国家的研究人员在多个发展中国家进行的垂直传播试验说明了各种关键的伦理问题。三个关键问题是使用安慰剂对照组的不公正性、参与提议的强制性以及对第三世界国家的剥削。本文分别研究了这些问题。它为何时可以接受此类对照组制定了新标准。其结论是,强制要约问题没有充分依据。它还得出结论,通过保证试验中受试者的未来护理比保证药物在全国范围内的可用性可以更好地解决对剥削的担忧。版权所有 (C) 2002 John Wiley Sons, Ltd.
The vertical transmission trials conducted in a variety of developing countries by researchers from more developed countries illustrate a variety of crucial ethical issues. Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. This paper examines each of these issues separately. It develops a new standard for when such control groups are acceptable. It concludes that the issue of coercive offers is not well founded. It also concludes that concerns about exploitation are better addressed by assurances about the future care of the subjects in the trial than by assurances of availability of the drugs in the country in general. Copyright (C) 2002 John Wiley Sons, Ltd.