Ehni Hans-Jörg, Wiesing Urban
Institut für Ethik und Geschichte der Medizin, Bereich Ethik in der Medizin, Schleichstr, Tübingen.
Bioethics. 2008 Jan;22(1):64-74. doi: 10.1111/j.1467-8519.2007.00587.x.
The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo-use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions justifying placebo-use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo-use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptability of placebo-use.
在过去十年中，临床试验中安慰剂对照的伦理问题一直存在广泛且有争议的讨论。然而，对于现有的不同国际法规、其术语以及关于安慰剂的伦理原则进行全面的分析比较仍然欠缺。当前争议的核心问题是，如果存在已证实的治疗方法，使用安慰剂的正当理由。所有被审查的指南版本都提出了此类正当理由，但每个指南在相关细节上都彼此不同。因此，根据每个指南证明安慰剂使用合理的条件是我们关注的焦点。我们首先将提出一个形式化的一般原则，该原则定义了安慰剂使用的伦理可接受性。然后，我们将分析不同文件提出的三类条件：伤害或负担风险、令人信服的科学理由以及已证实治疗方法的可获得性。分析表明，被审查的指南之间存在重要的规范性差异和矛盾。特别引人注目的是，一些指南允许临床试验参与者面临严重伤害的风险，而另一些则不允许。最后，我们试图展示每个指南的规范性差异如何影响研究人员或机构审查委员会关于安慰剂使用伦理可接受性的决定。
