Hidden risks associated with clinical trials in developing countries
Hidden risks associated with clinical trials in developing countries
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DOI：
10.1136/jme.2009.031708
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发表时间：
2010-02-01
影响因子：
4.1
通讯作者：
Vidal, Susana
中科院分区：
文献类型：
--
作者：
Lorenzo, Claudio;Garrafa, Volnei;Vidal, Susana
在过去十年中，研究伦理学的学术文献的特点是更加广泛地关注保护接受国际临床试验的发展中社区的必要性。由于临近2008年10月完成的赫尔辛基宣言修订版，大多数论文都讨论了使用安慰剂后的双重标准治疗问题。然而，其他同样重要的问题，如低收入社区的生活方式结构之间的相互作用和风险最小化程序的效率也值得关注。本文的目的是讨论贫困和低收入国家临床试验中涉及的不确定性形式，这些不确定性不能通过传统的风险评估方法来解决。此外，还将处理通过传统评估方法查明的风险规模增加的问题。此外，适当应用风险最小化程序的困难将被讨论。最后，本文建议研究伦理委员会参与风险评估过程，建立国家伦理评估体系。
The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems.