Therapeutic Misconception and Scientific Reframing

描述(由申请人提供)：人们普遍认为，有意义的知情同意是人类受试者参与临床研究的伦理前提。要想获得有意义的同意，受试者必须能够做的不仅仅是重复一系列事实；他们必须理解决定中涉及的问题。治疗误解(TM)涉及患者/受试者未能理解参与临床试验之间的差异 并接受普通的临床护理。因此，治疗误区已成为临床试验知情同意中的主要伦理问题之一。尽管许多人表示担心，治疗误解会促进招募参加临床试验，消除这种误解会减少招募，但如果受试者开始相信，尽管他们参与的研究在某些方面比普通治疗更好，但在某些方面对他们来说也不那么重要，那么这可能会以随后的退出为代价。因此，不仅在伦理上很重要，而且潜在的受试者清楚地意识到他们在普通临床实践中接受的护理的性质与临床试验中的护理之间的区别，也可能符合临床试验有效性的长期利益。这项研究将朝着确定如何在临床试验中减少TM的方向迈出重要的一步。它将为变革的方式提供基础 临床研究人员获得参与者的同意，大大减少了真正知情同意研究的主要障碍之一。这项研究被设计为一项假设性随机试验，比较了使用旨在减少TM的科学重塑强化披露与常规披露。这项假设的研究将尽可能接近真实的研究，包括在真实的临床环境中获得符合模拟方案的真实患者的同意，该方案将非常类似于最近关闭的方案。这项研究将涉及一所大学医学中心的三种不同的临床服务。这一设计将被用来测试科学重组披露减少TM的能力，并测试这种披露是否降低了潜在受试者自愿参加临床试验的倾向。

DESCRIPTION (provided by applicant): It is widely accepted that a meaningful informed consent is a precondition to the ethical involvement of human subjects in clinical research. For consent to be meaningful subjects must be able to do more than repeat back a list of facts; they must appreciate the issues involved in the decision. The Therapeutic Misconception (TM) involves patient/subjects failing to grasp the difference between participating in a clinical trial and receiving ordinary clinical care. For this reason, therapeutic misconception has become one of the major ethical issues in informed consent to clinical trials. Although many have expressed the concern that therapeutic misconception facilitates recruitment to clinical trials and removing it would reduce recruitment, this may come at the cost of subsequent dropouts if the subjects come to believe that, although the research in which they are participating is in some ways better than ordinary treatment, it is also, in ways significant to them, something less than ordinary treatment. Thus, not only is it ethically important, but it also may be in the long-term interests of the validity of clinical trials that potential subjects have a clear sense of the distinction between the nature of the care that they receive in ordinary clinical practice and the care in clinical trials. This study will take a major step in the direction of determining how to reduce TM in clinical trials. It will provide the basis for a transformation of the manner in which clinical researchers gain consent from participants, and substantially reduce one of the major barriers to genuine informed consent to research. This study is designed as a hypothetical randomized trial comparing an enhanced disclosure using scientific reframing designed to reduce TM versus disclosure as usual. The hypothetical study will be as close to a real one as possible, including gaining consent in real clinical settings with real patients who would be eligible for the mock protocol that will be very similar to a recently closed protocol. The study wll involve three different clinical services at a university medical center. This design will be used o test the ability of a scientific reframing disclosure to reduce TM and also test whether such disclosure reduces the inclination of potential subjects to volunteer for a clinical trial.