Healthy Skepticism Library item: 14911
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
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 …
