Reconsidering the Declaration of Helsinki : The Lancet

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Reconsidering the Declaration of Helsinki : The Lancet

Fundamentación de la bioética : Reconsidering the Declaration of Helsinki

Enviado por Biblio on 31/1/2014 13:39:58 (152 Lecturas)

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The Lancet, Volume 381, Issue 9877, Pages 1532 - 1533, 4 May 2013 
doi:10.1016/S0140-6736(13)60970-8Cite or Link Using DOI
Copyright © 2013 Published by Elsevier Ltd. All rights reserved.
Reconsidering the Declaration of Helsinki

Ezekiel J Emanuel aEmail Address
Next year will mark the 50th anniversary of the Declaration of Helsinki. Consequently, the World Medical Association (WMA) is developing its eighth version of the Declaration. This anniversary presents an excellent opportunity to reconsider the problems of the Declaration and how they can be remedied to ensure the document retains its prominent status.

The Lancet, Volume 381, Issue 9877, Pages 1532 - 1533, 4 May 2013

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doi:10.1016/S0140-6736(13)60970-8Cite or Link Using DOI

Copyright © 2013  Published by Elsevier Ltd. All rights reserved.

Reconsidering the Declaration of Helsinki

Ezekiel J Emanuel a

Next year will mark the 50th anniversary of the Declaration of Helsinki. Consequently, the World Medical Association (WMA) is developing its eighth version of the Declaration. This anniversary presents an excellent opportunity to reconsider the problems of the Declaration and how they can be remedied to ensure the document retains its prominent status.

In 1964 when the Declaration of Helsinki was initially enacted, it contained 11 articles and 713 words. At that time, the Declaration was unique. Over the years, ethical guidance on research involving human participants has proliferated substantially to encompass the Belmont Report by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences; multiple laws and regulations, such as the US Federal Policy for the Protection of Human Subjects (known as the “Common Rule”, 45 CFR part 46) and the European Union's Clinical Trials Directive; and the eight principles of What Makes Research Ethical?. Simultaneously, the Declaration of Helsinki has been revised six times and tripled in size with its 35 articles and 2045 words. The revisions have often been extensive. For instance, the distinction between “clinical research combined with professional care” and “non-therapeutic clinical research” was eliminated after much withering criticism. The article that relates to use of placebos was revised and scaled back multiple times between 2000 and 2008.