Healthy Skepticism Library item: 14911

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Publication type: Journal Article

Kimmelman J, Weijer C, Meslin EM.
Helsinki discords: FDA, ethics, and international drug trials
The Lancet 2009 Jan 3; 373:(9657):13-4
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61936-4/fulltext

Abstract:

Since 1964, the Declaration of Helsinki has stood as one of the world’s most authoritative statements on ethical standards for human research. 1 Drafted by the World Medical Association to provide medical researchers with ethical guidance, the Declaration has undergone six major revisions, most recently in October, 2008. 2 For many years the US Food and Drug Administration (FDA) has required that foreign clinical studies supporting applications for drug licensure comply with the Declaration. However …