Revising the Declaration of Helsinki: a work in progress
The World Medical Association (WMA), the organisation that issues the Declaration of Helsinki (DoH), is planning another revision of this influential ethics guidance document. The last revision in 2008 strengthened the guidelines in some respects and weakened them in others. I described some of the changes from the previous version in these pages early in 2009. The 2008 revision strengthened the paragraph that addresses the control group in a randomised controlled trial by significantly limiting the circumstances in which a placebo control is acceptable. The most critical weakening from the previous version is the paragraph that describes post-trial benefits. To this day, these two paragraphs remain contentious, with supporters and critics on both sides.
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