WMA starts Process for revising Helsinki Declaration

Proposals for changes to the World Medical Association’s Declaration of Helsinki on medical research have been put forward at the start of a process to revise the document for the first time for seven years.

A WMA working group has suggested several ideas for minor revisions to the Declaration which have now been sent out to national medical associations across the world for comment.

Because of the large number of potential stakeholders involved, WMA secretary general Dr. Otmar Kloiber has asked all national medical association members of the WMA to conduct a consultation in their own country and combine the responses into one submission to the WMA. The consultation will also include all relevant international organizations, such as the World Health Organisation and medical, health care and medical research associations.

The deadline for comments is 25 February next year, when the comments will be analyzed by the workgroup. A second draft will be considered by the WMA’s Medical Ethics Committee and Council at their May 2008 meetings and circulated for comment. It is hoped that a revised Declaration may be ready for adoption by the WMA General Assembly, Seoul in October 2008.

The Helsinki Declaration, which is widely regarded as the foundation document for research ethics worldwide, was first adopted by the World Medical Association in 1964 and has been revised five times, the last being in 2000.

Among the changes being proposed are ideas for providing extra protection for participants in medical research and a new provision making it clear that the well-being of the individual should take precedence over the interests of the sponsors of research as well as those of science and society.

Other changes suggested relate to the treatment of participants who suffer injury as a result of research interventions, the ability of the public to access a register of all clinical trials and the need for populations that have previously been underrepresented in medical research, such as children and pregnant women, to be provided equitable access to participation in research.

Progress reports will be posted on the WMA website.