The Council of the World Medical Association has approved a draft revision of the Declaration of Helsinki for stakeholder consultation at a meeting in Bali, Indonesia. The proposed revisions will be posted on the WMA website within the next few days. In October, the Council will to decide whether the resulting document should be forwarded to the General Assembly for adoption at the same meeting, just ahead of the Declaration’s 50th anniversary in 2014.
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 subheadings
Dr Cecil Wilson, President of the WMA, said: “The revisions considered by Council today retain these core principles [that have underpinned the Declaration since 1964] 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.”
In the next few days, ClinDev will also publish an exclusive interview with Dr Jeff Blackmer, Chief Ethics Advisor and Consultant to the World Medical Association, who has been closely involved with drafting the revised Declaration.