Department of Public Health, University of Brasilia, Brazil.
J Med Ethics. 2010 Feb;36(2):111-5. doi: 10.1136/jme.2009.031708.
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.
过去十年，研究伦理领域的学术文献更加关注需要保护那些接受国际临床试验的发展中社区。由于 2008 年 10 月完成的《赫尔辛基宣言》修订版，大多数论文都涉及到使用安慰剂后护理的双重标准问题。然而，其他同样重要的问题，如低收入社区的生活方式结构与风险最小化程序的效率之间的相互作用，也值得关注。本文旨在讨论在贫穷和低收入国家进行临床试验所涉及的不确定性形式，这些不确定性形式不能用传统的风险评估方法来解决。此外，还将讨论传统评估方法所确定的风险增加的问题。此外，还将讨论适当应用风险最小化程序的困难。最后，本文提出了研究伦理委员会参与风险评估过程和建立国家伦理评估体系的建议。
