针灸试验与知情同意。
Acupuncture trials and informed consent.
作者信息
Miller F G, Kaptchuk T J
机构信息
Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland, USA.
出版信息
J Med Ethics. 2007 Jan;33(1):43-4. doi: 10.1136/jme.2006.016535.
Abstract
Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo-controlled acupuncture trials should be provided an accurate disclosure regarding the use of sham acupuncture, consistent with the practice of placebo-controlled drug trials.
摘要
在进行随机、安慰剂对照针灸试验的研究者通常不会告知参与者他们可能会接受假针灸干预。相反，他们被告知研究中正在比较一种或多种形式的针灸。这种具有欺骗性的披露做法缺乏令人信服的方法学依据，并且违反了获得知情同意的伦理要求。与安慰剂对照药物试验的做法一致，安慰剂对照针灸试验的参与者应得到关于使用假针灸的准确披露。
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