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 …