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New draft of Declaration of Helsinki is released for comment April 28, 2013

Posted by Michael Hamrell in Regulatory Thoughts.

In April 2013, the World Medical Association (WMA) released a draft of the revised language for a 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. The draft is proposed for finalization and release later in 2013.

According to the WMA, the current round of proposed changes is intended “to 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.” The working group will then produce a final revised draft to be considered by the WMA’s ethics committee and Council at their meetings in Fortaleza, Brazil in October 2013, when a decision will be taken whether to forward the document to the WMA Assembly at the same meeting for adoption.

For more details on the proposed changes and to see a draft of the language visit: WMA page



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