50th Anniversary of the Declaration of Helsinki: The Double Standard Was Introduced

The Declaration of Helsinki (DoH), adopted by the World Medical Association (WMA), is one of the most influential international documents in research ethics, is turning 50 in 2014. Its regular updates, seven versions (1975, 1983, 1989? 1996, 2000, 2008, 2013) and two notes of clarification (2002, 2004), characterize it as a 'live' document. The seventh version of the DoH was amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. The new version was reorganized and restructured, with paragraphs subdivided and regrouped. However, the DoH remains controversial and some ethical issues are still uncovered. The major problem was the insertion of the phrase 'less effective than the best proven' on placebo paragraph in order to allow double standard in medical research in low-resource countries. The DoH is a 'live' document, which will continually have to deal with new topics and challenges. Health equity needs to be a priority, and with that, a single ethical standard for medical research. (C) 2014 IMSS. Published by Elsevier Inc.