A draft revision of the Declaration of Helsinki on medical research involving human subjects was approved for stakeholder consultation today (Saturday) by the World Medical Association Council.
Meeting in Bali, Indonesia, the WMA Council decided that the proposed revisions should now be put out for public consultation and sent to national medical associations. It will then be for the WMA’s Council in October to decide whether the new document should be forwarded to the General Assembly for adoption at the same meeting.
This follows more than two years of discussion within the WMA and at several expert conferences.
The changes proposed provide for:
- more protection for vulnerable groups;
- more protection for participants by including the issue of compensation for the first time;
- more precise and specific requirements regarding post-study arrangements;
- more quality and transparency in the functioning of research ethics committees;
- a more systematic approach to the use of placebos, but no weakening in the ethics of placebo use;
- more readability by reorganising and restructuring the document with sub headings
Dr. Cecil Wilson, President of the WMA, said: ‘The Declaration of Helsinki is widely recognized as the core standard that guides physicians, governments and industry on doing medical research on human subjects. ‘It was first adopted in 1964 and next year will celebrate its 50th anniversary. During this time it has been revised, but the central principles have remained unchanged.
‘The revisions considered by Council today retain these core principles and follow an extensive process of discussion within the WMA and among the research community. Now we want to hear the views of the wider public before deciding on whether to approve the changes’.
The proposed revisions will be posted on the WMA website within the next few days and the public will have two months until the middle of June to comment on the text. A WMA workgroup will then consider all the comments and will finalise a revised Declaration for consideration by the WMA’s ethics committee and Council at their meetings in Fortaleza, Brazil in October 2013 when a decision will be taken whether to forward it to the WMA Assembly at the same meeting for adoption. The revised Declaration will then be published.