Sisk Bryan A, Kodish Eric
Washington University School of Medicine.
Cleveland Clinic.
IRB. 2018 Jul-Aug;40(4):13-20. doi: 10.1002/eahr.406003.
Appropriate enrollment in early-phase clinical trials demands that potential research participants understand and appreciate critical study-related information, because discrepancies in understanding or appreciation can potentially invalidate informed consent to participate in research. Four terms were previously developed to categorize these discrepancies: therapeutic "misconception," "therapeutic misestimation," "therapeutic optimism," and "unrealistic optimism." In this article, we propose a continuous framework of therapeutic misperceptions, rather than discrete categorical concepts. One end of this continuum contains discrepancies in understanding, and at the other end are discrepancies in appreciation. Categorical terminologies represent points along this continuum. Discrepancies in understanding and appreciation each lead to unique ethical concerns and likely require different interventions. This framework highlights the dearth of empirical work on the appreciation end of the continuum, especially related to navigating persistent discrepancies in appreciation. Employing a continuous framework of therapeutic misperceptions supports a nuanced approach to the unique circumstances of each research subject, aiding researchers in supporting truly informed consent.
早期临床试验的适当入组要求潜在研究参与者理解并领会与研究相关的关键信息，因为理解或领会方面的差异可能会使参与研究的知情同意无效。之前提出了四个术语来对这些差异进行分类：治疗性“误解”、“治疗性误判”、“治疗性乐观”和“不切实际的乐观”。在本文中，我们提出了一个关于治疗性误解的连续统一框架，而非离散的分类概念。这个连续统一体的一端包含理解方面的差异，另一端是领会方面的差异。分类术语代表了这个连续统一体上的各个点。理解和领会方面的差异各自引发独特的伦理问题，并且可能需要不同的干预措施。这个框架凸显了在连续统一体领会一端实证研究的匮乏，尤其是与处理领会方面持续存在的差异相关的研究。采用治疗性误解的连续统一框架支持针对每个研究对象的独特情况采取细致入微的方法，有助于研究人员支持真正的知情同意。
