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兽医临床实践中新型疗法的伦理原则。

Ethical principles for novel therapies in veterinary practice.

作者信息

Yeates J W

机构信息

RSPCA, Horsham, West Sussex, RH13 9RS.

出版信息

J Small Anim Pract. 2016 Feb;57(2):67-73. doi: 10.1111/jsap.12402. Epub 2015 Oct 28.

Abstract

OBJECTIVES

To present insights to aid decision-making about novel veterinary treatments from regulations concerning animal experimentation and human clinical medical trials.

MATERIALS AND METHODS

EU Directive 2010/63/EU on the protection of animals used for scientific purposes and EU Regulation 536/2014 on clinical trials on medicinal products for human use were analysed, evaluated and "translated" into relevant principles for veterinary surgeons.

RESULTS

A number of principles are relevant, relating to treatment expectations, thresholds and objectives; client consent; minimising harms; personnel; review committees; assessment and publication.

CLINICAL SIGNIFICANCE

These principles should assist veterinary surgeons to make good ethical decisions about novel treatments.

摘要

目的

通过有关动物实验和人类临床试验的法规,提供见解以辅助关于新型兽医治疗方法的决策。

材料与方法

对欧盟关于用于科学目的的动物保护的2010/63/EU号指令以及欧盟关于人类用药品临床试验的2014/536号法规进行了分析、评估,并“转化”为兽医的相关原则。

结果

有若干相关原则,涉及治疗期望、阈值和目标;客户同意;将危害降至最低;人员;审查委员会;评估和发表。

临床意义

这些原则应有助于兽医就新型治疗方法做出良好的伦理决策。

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