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知情同意的量化方面:在估计信息量时考虑剂量反应曲线。

Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information.

作者信息

Lynöe N, Hoeyer K

机构信息

Centre for Bioethics, LIME, Karolinska Institutet, Stockholm, Sweden.

出版信息

J Med Ethics. 2005 Dec;31(12):736-8. doi: 10.1136/jme.2005.012013.

Abstract

Information is usually supposed to be a prerequisite for people making decisions on whether or not to participate in a clinical trial. Previously conducted studies and research ethics scandals indicate that participants have sometimes lacked important pieces of information. Over the past few decades the quantity of information believed to be adequate has increased significantly, and in some instances a new maxim seems to be in place: the more information, the better the ethics in terms of respecting a participant's autonomy. The authors hypothesise that the dose-response curve from pharmacology or toxicology serves as a model to illustrate that a large amount of written information does not equal optimality. Using the curve as a pedagogical analogy when teaching ethics to students in clinical sciences, and also in engaging in dialogue with research institutions, may promote reflection on how to adjust information in relation to the preferences of individual participants, thereby transgressing the maxim that more information means better ethics.

摘要

通常认为,信息是人们决定是否参与临床试验的前提条件。先前进行的研究和科研伦理丑闻表明,参与者有时缺乏重要信息。在过去几十年里,人们认为足够的信息量显著增加,在某些情况下,一条新的准则似乎已经确立:信息越多,在尊重参与者自主性方面的伦理就越好。作者推测,药理学或毒理学中的剂量反应曲线可作为一个模型,用以说明大量书面信息并不等同于最优。在向临床科学专业的学生讲授伦理学时,以及在与研究机构进行对话时,将该曲线用作教学类比,可能会促使人们思考如何根据个体参与者的偏好调整信息,从而突破“信息越多意味着伦理越好”这一准则。

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