Declaration of Helsinki

Article Index
Declaration of Helsinki
First Revision (1975)
Second to Fourth revisions (1975-2000)
Fifth revision (2000)
Sixth revision (2008)
References
All Pages

The Declaration of Helsinki was developed by the World Medical Association[1] (WMA), as a set of ethical principles for the medical community regarding human experimentation, and is widely regarded as the cornerstone document of human research ethics. (WMA 2000, Bošnjak 2001, Tyebkhan 2003)

It is not a legally binding instrument in international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations (Human and Fluss 2001). Its role was described by a Brazilian forum in 2000 in these words "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity" (Human and Fluss 2001).

History

The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone six revisions (the most recent at the General Assembly in October 2008) and two clarifications, growing considerably in length from 11 to 32 paragraphs. The Declaration is an important document in the history of research ethics as the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents.

Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies [3a]. The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physician's ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1).



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