Declaration of Helsinki

When a Declaration of Helsinki Declaration of the World Medical Association is referred to Ethical Principles for Medical Research Involving Human Subjects. It was adopted by the 18th General Assembly of the World Medical Association in Helsinki in June 1964. The text has been revised several times:

  • In October 1975 by the 29th General Assembly, Tokyo, Japan
  • In October 1983 by the 35th General Assembly in Venice, Italy
  • In September 1989 by the 41st General Assembly in Hong Kong
  • In October 1996 by the 48th General Assembly, Somerset West, South Africa
  • In October 2000 by the 52nd General Assembly, Edinburgh, Scotland
  • A clarification ( " Note of Clarification " ) to the use of placebo- controlled trials (paragraph 29) was made in October 2002 in Washington.
  • A clarification ( " Note of Clarification " ) to paragraph 30 made ​​in Tokyo in 2004. Herein, it is asserted again that after the end of the study, the patient should have access to the most effective proven prophylactic, diagnostic and therapeutic procedures.
  • Revision of October 2008 by the 59th General Assembly in Seoul, South Korea. The clarifications of 2002 and 2004 were included in the Declaration of Helsinki. In addition, the registration of studies in clinical trial registries has been introduced.
  • Latest revision of October, 2013 by the 64th General Assembly in Fortaleza, Brazil

The declaration is generally regarded as a standard of medical ethics. It is used in many countries, but in different versions. Also in Germany, the ethics committees in clinical trials relate today to various revisions of this declaration. The World Medical Association ( WMA), however, accept only the current version as valid.

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