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Final new version of Declaration of Helsinki is Approved February 4, 2014

Posted by Michael Hamrell in Regulatory Thoughts.
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In October 2013, the World Medical Association (WMA) approved the final new version of the Declaration of Helsinki (DoH). Since its adoption in 1964, this document has served as the foundation basis for the ethical conduct of medical research in humans. The document has been revised eight (8) times so far since 1964, most recently in 2008.

According to the WMA, the current changes “provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos.” 2014 will be the 50th anniversary of the first edition of the Declaration from 1964. There is a nice editorial in the Journal of the American Medical Association from November 2013 that discusses the newest version along with the history of the document at: JAMA article .

For more details on the final document and to obtain a copy visit: WMA page