Declaration of Helsinki
Fifth revision

Even though most meetings about the proposed revisions failed to achieve consensus, and many argued that the declaration should remain unchanged or only minimally altered, after extensive consultation the Workgroup eventually came up with a text what that was endorsed by WMA's Council and passed by the General Assembly on October 7, 2000, and which proved to be the most far reaching and contentious revision to date. The justification for this was partly to take account of expanded scope of biomedical research since 1975. This involved a restructuring of the document, including renumbering and re-ordering of all the articles, the changes in which are outlined in this Table Archived 2010-06-05 at the Wayback Machine. The Introduction establishes the rights of subjects and describes the inherent tension between the need for research to improve the common good, and the rights of the individual. The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards. The distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine was removed to emphasize the more general application of ethical principles, but the application of the principles to healthy volunteers is spelt out in Articles 18–9, and they are referred to in Article 8 ('those who will not benefit personally from the research') as being especially vulnerable. The scope of ethical review was increased to include human tissue and data (Article 1), the necessity to challenge accepted care was added (Article 6), as well as establishing the primacy of the ethical requirements over laws and regulations (Article 9).
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