The Declaration of Helsinki, widely regarded as the foundation document for research ethics worldwide, is being reviewed by the World Medical Association.
At its annual General Assembly in Copenhagen this weekend, the WMA announced the results of an extensive consultation with its member national member associations and the larger medical research community. Dr Eva Bågenholm, chair of the WMA’s medical ethics committee, said there was ‘nearly unanimous’ agreement that the principles of the Declaration were sound.
‘However there was a desire for clarification of how these principles should be applied. In addition, new issues have arisen since the current version of the Declaration was adopted in 2000 and some of these may need to be addressed in the next version’.
Dr Bågenholm said that unlike the last revision, which resulted in major changes in both the organization and the contents of the Declaration, this review is limited to clarifications and possible additions.
‘Our consultation has given us numerous suggestions for improving the Declaration and our next task will be to analyse these and decide which ones to incorporate’.
A WMA working group, comprising representatives from the Brazilian, German, Japanese, South African and Swedish medical associations, will prepare a set of draft amendments for another round of consultation this winter. Comments received will then be analysed and a second draft will be prepared for the next meeting of the medical ethics committee in May 2008. Final approval of any amendments may take place at the WMA’s next General Assembly in Seoul in October 2008.
Dr Bågenholm expressed the WMA’s appreciation for the many comments received to date. ‘We look forward to continued collaboration with our stakeholders on this very important initiative’.
Progress reports will be posted on the WMA website www.wma.net.