Final Proposed Revisions To Declaration Of Helsinki

A final proposed revision of the Declaration of Helsinki has been agreed for consideration at next month’s annual general assembly of the World Medical Association in Edinburgh (Oct 3-7, 2000).

The document has been posted on the WMA’s website (www.wma.net) for further comment before physicians’ representatives from around the world gather to discuss the proposed revisions.

Dr Delon Human, secretary general of the WMA, said: “This proposed revision is the product of several years’ consultation and hard work and is an attempt to ensure that this historic document is brought up to date so that it is relevant to today’s medical practice and appropriately protects human participants involved in biomedical research.

“During our review, in which we have consulted as widely as possible, the best interests of patients have been our predominant consideration”.

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Note to Editors: The Declaration of Helsinki is the most widely accepted guidance worldwide on medical research involving human participants. It was drawn up in 1964 by the World Medical Association largely as a result of the atrocities of the Second World War and has since become the cornerstone for biomedical research ethics. The aim of the Declaration is to protect patients involved in biomedical research by providing the guiding principles that should be followed by physicians involved in this kind of work.

During the Nuremberg trials which followed the Second World War, 23 physicians and scientists were accused of murder and torture in the conduct of medical experiments in concentration camps. It was the involvement of physicians in this unethical activity that led directly to the formation of the World Medical Association in 1947.

The Declaration had been revised four times since 1964 and has become a global document used by the wider research community and patient representative groups. The WMA believes the current Declaration has not kept abreast of the changing research activities of the world and has acknowledged the calls for more explicit rules to guide researchers when they make difficult decisions regarding protocol designs for research.
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The possibility that the Declaration might be changed has led to vigorous debate about whether any revisions might weaken the protection given to patients involved in research. Some patient groups have expressed the fear that liberalizing the guidelines would open the floodgates to large-scale research involving human subjects, especially in poorer countries. Arguments against revising the Declaration have centred on its global status in research ethics, even to the extent of being incorporated into quasi-legal national and international guidelines.

Controversy has centred on proposed changes relating to placebo trials and to the distinction between clinical and non clinical trials (research). This distinction refers to research in which the aim is essentially diagnostic or therapeutic (ie beneficial) for a patient and non therapeutic research where the essential object is purely scientific, without implying direct value to the person subjected to the research.

The issue relating to placebo trials concerns the requirement that every patient in a trial should be assured of the best proven diagnostic and therapeutic method and the extent to which best proved methods are not available in poorer countries. The purpose of research in some such cases is to find a less expensive and more sustainable proven therapy, rather than measuring new treatments against the benchmark of rich countries’ ‘proven therapies’.

NOTE: The World Medical Association’s annual general assembly takes place at the Sheraton Hotel, Edinburgh from October 3-7.

The full text of the proposed revisions to the Declaration of Helsinki can be found on the WMA’s website www.wma.net