Musschenga A W, Van Luijn H E M, Keus R B, Aaronson N K
Department of Philosophy, Vrije Universiteit, Amsterdam, The Netherlands.
Account Res. 2007 Jul-Sep;14(3):179-96. doi: 10.1080/08989620701455217.
Institutional review boards (IRBs) are legally required to determine whether the balance between the risks and benefits (the risk-benefit ratio or RBR) of a proposed study is "reasonable" or "proportional". This obligation flows from their duty to protect the interests of research subjects. It has been argued that it is difficult, perhaps even impossible for IRBs to determine the RBR of studies, because the risks and benefits are not only heterogeneous, but also incommensurable. After arguing that the relevant meaning of incommensurability is incomparability, we discuss whether the risks of participating in a trial and the benefits are comparable. We conclude that at least the risks and the benefits to participants are comparable. In the last section we show that the main problem of RBR analyses is that of interpersonal incompensability. IRBs have to assume that risks to research subjects be compensated by benefits to others. The question is: To what extent? When does it become unreasonable to ask that patients accept the risks of participating in a trial for the benefit of science and/or future patients?
机构审查委员会(IRB)在法律上被要求确定一项拟议研究的风险与收益之间的平衡(风险收益比或RBR)是否“合理”或“相称”。这项义务源于它们保护研究对象利益的职责。有人认为,IRB很难,甚至可能无法确定研究的RBR,因为风险和收益不仅种类繁多,而且不可通约。在论证了不可通约性的相关含义是不可比性之后,我们讨论了参与试验的风险与收益是否可比。我们得出结论,至少参与者面临的风险和收益是可比的。在最后一节中,我们指出RBR分析的主要问题是人际间的不可补偿性问题。IRB必须假定研究对象所面临的风险会由他人获得的收益来补偿。问题是:在何种程度上?在什么时候要求患者为了科学和/或未来患者的利益而接受参与试验的风险变得不合理?