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临床试验中受伤害患者的补偿。

The compensation of patients injured in clinical trials.

作者信息

Barton J M, Macmillan M S, Sawyer L

机构信息

Borders Health Board, Edinburgh University.

出版信息

J Med Ethics. 1995 Jun;21(3):166-9. doi: 10.1136/jme.21.3.166.

Abstract

The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of qualifications being applied by pharmaceutical firms which are not in the spirit of the guidelines, let alone the interests of the patient, and we suggest a means whereby the patients can be assured of fair treatment in the event of 'no fault' injury.

摘要

根据英国制药工业协会(ABPI)发布的指南以及我们最近审查提交给当地外科研究伦理小组委员会的方案的经验,讨论了参与临床试验的患者出现不良反应时的“无过错”赔偿问题。我们发现制药公司采用了各种不符合指南精神的限定条件,更不用说患者的利益了,我们建议采取一种方法,使患者在发生“无过错”伤害时能得到公平对待。

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本文引用的文献

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Medical ethics in the European Community.欧洲共同体的医学伦理学
J Med Ethics. 1993 Mar;19(1):7-12. doi: 10.1136/jme.19.1.7.
2
Compensation and drug trials.补偿与药物试验。
Br Med J (Clin Res Ed). 1983 Sep 3;287(6393):675-7. doi: 10.1136/bmj.287.6393.675.
4
Medical negligence.
BMJ. 1992 Feb 29;304(6826):576. doi: 10.1136/bmj.304.6826.576.

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