低收入和中等收入国家临床试验的保护措施需要加强而非削弱。
Protections for clinical trials in low and middle income countries need strengthening not weakening.
作者信息
Dal-Ré Rafael, Ndebele Paul, Higgs Elizabeth, Sewankambo Nelson, Wendler David
机构信息
Clinical Research, BUC (Biosciences UAM+CSIC) Program, International Campus of Excellence, Universidad Autónoma de Madrid, E-28049 Madrid, Spain
Medical Research Council of Zimbabwe, Causeway, Harare, Zimbabwe.
出版信息
BMJ. 2014 Jul 4;349:g4254. doi: 10.1136/bmj.g4254.
Abstract
The latest revision of the Declaration of Helsinki weakens protections for trial participants in low and middle income countries. argue that this is a step in the wrong direction
摘要
《赫尔辛基宣言》的最新修订削弱了对低收入和中等收入国家试验参与者的保护。有人认为这是朝着错误方向迈出的一步。
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2
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3
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4
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PLoS Med. 2013;10(3):e1001407. doi: 10.1371/journal.pmed.1001407. Epub 2013 Mar 19.
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6
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