jump to navigation

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

Posted by Michael Hamrell in Regulatory Thoughts.
trackback

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

About these ads

Comments»

No comments yet — be the first.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

%d bloggers like this: