Appelbaum Paul S, Lidz Charles W
Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY, USA.
Kennedy Inst Ethics J. 2006 Dec;16(4):367-73. doi: 10.1353/ken.2006.0021.
Responding to the paper by Miller and Joffe, we review the development of the concept of therapeutic misconception (TM). Our concerns about TM's impact on informed consent do not derive from the belief that research subjects have poorer outcomes than persons receiving ordinary clinical care. Rather, we believe that subjects with TM cannot give an adequate informed consent to research participation, which harms their dignitary interests and their abilities to make meaningful decisions. Ironically, Miller and Joffe's approach ends up largely embracing the very position that they inaccurately attribute to us: the belief that, with some exceptions, it is only the prospect of poorer outcomes that should motivate efforts to dispel TM. In the absence of empirical studies on the steps required to dispel TM and the impact of such procedures on subject recruitment, it is premature to surrender to the belief that TM must be widely tolerated in clinical research.
针对米勒和乔菲的论文，我们回顾了治疗性误解（TM）概念的发展。我们对TM对知情同意的影响的担忧并非源于认为研究受试者的结局比接受普通临床护理的人更差。相反，我们认为存在TM的受试者无法对参与研究给予充分的知情同意，这损害了他们的尊严利益以及做出有意义决策的能力。具有讽刺意味的是，米勒和乔菲的方法最终在很大程度上接受了他们错误地归因于我们的立场：即认为，除了一些例外情况，只有结局较差的可能性才应该促使人们努力消除TM。在缺乏关于消除TM所需步骤以及此类程序对受试者招募的影响的实证研究的情况下，屈服于认为TM在临床研究中必须被广泛容忍的信念还为时过早。
