title: 50th anniversary of the Declaration of Helsinki: the double standard was introduced.
abstract: 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.
authors.affiliation: Research Ethics Committee, University of Southern Santa Catarina, Palhoça, SC, Brazil; Department of Public Health, Federal University of Santa Catarina, Florianópolis, SC, Brazil. Electronic address: fernando.hellmann@unisul.br.
authors.forename: Fernando
authors.initials: F
authors.lastname: Hellmann
authors.affiliation: Department of Public Health, Federal University of Santa Catarina, Florianópolis, SC, Brazil.
authors.forename: Marta
authors.initials: M
authors.lastname: Verdi
authors.affiliation: Department of Medicine, University of the West of Santa Catarina, Joaçaba, SC, Brazil.
authors.forename: Bruno Rodolfo
authors.initials: BR
authors.lastname: Schlemper
authors.affiliation: Department of Sociology and Political Science, Federal University of Santa Catarina, Florianópolis, SC, Brazil.
authors.forename: Sandra
authors.initials: S
authors.lastname: Caponi
mesh_terms: D000846:Anniversaries and Special Events; D001938:Brazil; D003906:Developing Countries / Q000266:history; D006381:Helsinki Declaration / Q000266:history*; D049673:History, 20th Century; D006801:Humans; D010919:Placebos / Q000266:history*
chemical_list: D010919:Placebos
keywords: Biomedical research/ethics; Codes of ethics; Helsinki Declaration; Human research