治疗误区现象:生物伦理方面

Maria A. Nartova
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引用次数: 0

摘要

导言:在临床试验过程中必须对药物进行研究,这可以说是循证医学的基本原则之一。文章探讨了参与此类试验的志愿者中出现的治疗误解现象,他们不理解临床试验的科学目标,错误地期望参与此类试验能带来治疗优势。文章分析了哪些方法决定可能导致治疗误解,并指出了与这一现象相关的主要生物伦理风险。理论分析。研究表明,接收知情同意书的程序是志愿者充分理解临床试验目标的主要问题所在,而违反患者自主权原则则是主要的生物伦理风险。在 COVID-19 大流行期间,由于缺乏对新病原体的了解,治疗策略也不尽相同。因此,病人和医生都无法充分评估预期治疗的风险成为造成治疗误区的新因素。结论获取知情同意书的程序应予以修订,并应对临床试验的方法进行补充分析,以降低治疗误解的风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Phenomenon of a therapeutic misconception: Bioethical aspect
Introduction.The obligatory study of medical drugs during clinical trials conduction can be named as one of the fundamental principles of evidence-based medicine. The article deals with the phenomenon of a therapeutic misconception occurring in volunteers participating in such experiments, who failed to understand the scientific goals of clinical trials and incorrectly expect the therapeutical advantages linked with such a participation. It is analyzed which methodological decisions can cause a therapeutic misconception, and also the main bioethical risks associated with this phenomenon are indicated. Theoretical analysis. It is shown that the procedure of the receipt of informed consent form is the main problematic aspect for an adequate understanding of clinical trials’ goals by its volunteers, and violation of the principle of patient autonomy can be named as a primary bioethical risk. During the COVID-19 pandemic there has been a heterogeneity of therapeutic strategies fixed because of the lack of knowledge about the new pathogen. As a result, the inability to adequately assess the risks of the intended treatment both by a patient and a doctor became a new factor that caused the therapeutic misconception. Conclusion. The procedure for obtaining informed consent form is supposed to be revised, the additional analysis of the methodology of clinical trials should be done to reduce the risk of a therapeutic misconception.
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