对埃博拉疫苗临床试验伦理审查的思考

药物临床试验的伦理审查是对受试者安全和权益的保障。在埃博拉疫情大规模爆发,严重威胁人类健康与安全的危急形势下,如何加快埃博拉疫苗的临床试验进程,同时又规范、合法地遵守伦理审查,是药物研发进程中面临的难题。本文对埃博拉疫苗临床试验的伦理设计及执行过程做了回顾和思考,分析了各类研究设计的合理性,及在疫苗试验的招募分配上如何遵守伦理的公平、公开、公正原则。...

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Bibliographic Details
Published in药学服务与研究 Vol. 16; no. 5; pp. 346 - 349
Main Author 陈晓云 刘胜
Format Journal Article
LanguageChinese
Published 上海中医药大学附属龙华医院医学伦理委员会,上海,200032 2016
Subjects
临床试验
伦理审查
埃博拉病毒
疫苗
Ebola virus
clinical trial
埃博拉病毒
疫苗
vaccine
ethical review
临床试验
伦理审查
Online AccessGet full text
ISSN1671-2838
DOI10.5428/pcar20160507

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Summary:药物临床试验的伦理审查是对受试者安全和权益的保障。在埃博拉疫情大规模爆发,严重威胁人类健康与安全的危急形势下,如何加快埃博拉疫苗的临床试验进程,同时又规范、合法地遵守伦理审查,是药物研发进程中面临的难题。本文对埃博拉疫苗临床试验的伦理设计及执行过程做了回顾和思考,分析了各类研究设计的合理性,及在疫苗试验的招募分配上如何遵守伦理的公平、公开、公正原则。
Bibliography:31-1877/R
CHEN XiaoYun, LIU Sheng （Medical Ethical Council, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China）
Ethical review of clinical trails is the guarantee for the safety and rights of human subjects. In the crisis of Ebola epidemic outbreak that may seriously threaten human health and safety, the problem as to how to accelerate the process of vaccine clinical trials on the one hand, and formally and legally follow the steps of ethical review on the other is really a hard nut to crack in the process of drug development. In this paper, the problems about the design and implementation of ethical re- view in clinical trials of Ebola vaccine were reviewed and thoroughly pondered, and at the same time, the rationality of various research designs and the problems as to how to follow the principles of fairness, openness and justice in recruit distribution were also analyzed.
Ebola virus; vaccine; clinical trial; ethical review
ISSN:1671-2838
DOI:10.5428/pcar20160507