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The Declaration of Helsinki is a respected institution and one of the most influential documents in research ethics, 1 w1-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 developing countries. Critics pointed out that continuing to use placebos when efficacy had been demonstrated implied a different ethical standard for developing countries than for developed ones. Having entered into the specifics of trial design the declaration was drawn into a debate on whether ethical principles are universal or are relative to the context in which they are applied 6 and also into related principles of research in developing countries.
The World Medical Association was then pressured to make more radical reforms. An American proposal, seen by some as a further attempt to weaken the declaration, resulted in a vigorous debate, but despite lack of consensus and strong feelings by some that it should not be changed, 7 a major revision was approved in 2000. This did little to improve acceptance.
Concerns were also expressed that the cumulative changes represented a shift towards protecting the efficiency of research at the expense of the protection of human subjects. A division between developed and developing countries also emerged with claims...