Michael Kirby Centre for Public Health and Human Rights, Dept. of Epidemiology and Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia.
Dev World Bioeth. 2011 Aug;11(2):75-81. doi: 10.1111/j.1471-8847.2010.00296.x. Epub 2010 Nov 30.
Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines.
关于国际临床研究中的正义问题的争论,将两种截然不同的义务形式混淆在一起,这是有问题的。国际研究伦理准则旨在描述如何以公正的方式在微观或临床层面(在研究人员-参与者的互动中)进行生物医学研究,但已经包括了显然旨在促进全球层面正义的要求。伦理学家也对国际研究应该为全球正义做出什么贡献提出了各种主张。本文认为,将微观和宏观层面的正义争论混为一谈,不仅导致将义务强加给了错误的行为者,而且还使相关行为者被排除在伦理图景之外。本文为谁应该承担国际临床研究中的宏观层面正义义务提出了建议。本文进一步认为,与违反知情同意要求的研究人员不同,对于全球正义的义务,不存在类似的问责制,即使是对于当前伦理准则(错误地)确定的那些义务承担者。