BMJ  2007;335:624-625 (29 September), doi:10.1136/bmj.39339.610000.BE

Editorials

The Declaration of Helsinki

Mosaic tablet, dynamic document, or dinosaur?

The first 150 words of the full text of this article appear below.

The Declaration of Helsinki is a respected institution and one of the most influential documents in research ethics,1w1-w7 having withstood five revisions and two clarifications since its conception in 1964. Its guardian, the World Medical Association, recently invited submissions for further revision.2

The history of the declaration has been well documented.3 4 5 The Nuremberg Code (1947) was one of the first statements of the ethical principles involved in human experimentation.w8 However, because of its association with Nazi war crimes it had relatively little effect on practice.w9 The Declaration of Helsinki dealt with clinical research more directly, but was portrayed as a weakening of the stringent protections of Nuremberg. Nevertheless, for a quarter of a century only minor changes were made and it became engrained in the international culture of research ethics.

In 1996, the declaration added a reference to placebos in response to concerns about trials in perinatal HIV transmission in . . . [Full text of this article]

Michael D E Goodyear, assistant professor of medicine1, Karmela Krleza-Jeric, clinical research officer2, Trudo Lemmens, associate professor, faculties of law and medicine3

1 Dalhousie University, Halifax, Nova Scotia, Canada B3H 2Y9, 2 Canadian Institutes of Health Research, Ottawa, Ontario, Canada K1A 0W9 , 3 University of Toronto, Toronto, Ontario, Canada M5S 2C5

mgoodyear@dal.ca


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Acknowledgements
Michael DE Goodyear, et al.
bmj.com, 28 Sep 2007 [Full text]
The Delaration of Helsinki is DEAD
John H Noble Jr
bmj.com, 29 Sep 2007 [Full text]
Re: The Delaration of Helsinki is DEAD
udo schuklenk
bmj.com, 8 Oct 2007 [Full text]
The Declaration of Helsinki and The Ottawa Statement on trial registration
Michael DE Goodyear, et al.
bmj.com, 18 Dec 2007 [Full text]
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