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不仅仅是关于伦理开放性安慰剂研究的同意。

More than consent for ethical open-label placebo research.

作者信息

Specker Sullivan Laura

机构信息

Philosophy, College of Charleston, Charleston, South Carolina, USA

出版信息

J Med Ethics. 2020 Sep 3. doi: 10.1136/medethics-2019-105893.

Abstract

Recent studies have explored the effectiveness of open-label placebos (OLPs) for a variety of conditions, including chronic pain, cancer-related fatigue and irritable bowel syndrome. OLPs are thought to sidestep traditional ethical worries about placebos because they do not involve deception: with an OLP, patients or subjects are told outright that they are not given an active substance. As deception is framed as the primary hurdle to ethical placebo use, the door is ostensibly opened to ethical studies of OLPs. In this article, I suggest that even though OLPs seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use. Research ethics often focusses on informed consent-of which, deception and honesty are a piece-as a means to justify research practices with human subjects. Yet, it is but one of the ethical considerations that should be taken into account. With research into placebo effects in particular, I argue that the history of clinical placebo use grounds special considerations for OLP research that go beyond respect for the autonomy of individual patients through informed consent and encompass structural concerns about the type of patient for whom a placebo has historically been thought appropriate.

摘要

最近的研究探讨了开放标签安慰剂(OLP)对多种病症的有效性,包括慢性疼痛、癌症相关疲劳和肠易激综合征。人们认为OLP规避了传统上对安慰剂的伦理担忧,因为它们不涉及欺骗:使用OLP时,会直接告知患者或受试者他们服用的不是活性物质。由于欺骗被视为伦理上使用安慰剂的主要障碍,OLP的伦理研究表面上有了开展的可能。在本文中,我认为尽管OLP看似不涉及欺骗,但在其临床研究及后续使用中还存在其他伦理考量。研究伦理通常将知情同意(其中欺骗与诚实是一部分)作为对人体受试者研究行为进行正当性论证的一种方式。然而,它只是众多应被考虑的伦理因素之一。特别是对于安慰剂效应的研究,我认为临床使用安慰剂的历史为OLP研究带来了特殊考量,这些考量不仅包括通过知情同意尊重个体患者的自主权,还涵盖了对历史上认为适合使用安慰剂的患者类型的结构性担忧。

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