The World Medical Association's Declaration of Helsinki has been revised five times since its inception in 1964. Although the Declaration itself has no legal force, it is influential and widely acknowledged as the 'cornerstone of research ethics'.

The most recent revision of the Declaration (2000) contains provisions about the responsibilities of physicians, in addition to basic principles for all medical research and specific principles for situations when medical research is combined with medical care.

Concerns have been expressed that sections 29 and 30 of the 2000 revision — relating to standards of care during research and what happens after research is over — cannot always be met when research is conducted in developing countries. A note of clarification on section 29 was published in 2002.

[The guidance is also available in French and Spanish.]