WMA Declaration of Helsinki is made up 12 titles consisting of 37 principles: Preamble, General Principles, Risks, Burdens and Benefits,  Vulnerable Groups and Individuals, Scientific Requirements and Research Protocols, Research Ethics Committees, Privacy and Confidentiality, Informed Consent, Use of Placebo, Post-Trial Provisions, Research Registration and Publication and Dissemination of Results, Unproven Interventions in Clinical Practice.

A seminar, attended by WMA leaders and addressed by the President of Finland, His Excellency Sauli Niinistö, heard speakers commend the achievements of the Declaration, which resulted from the unethical research carried out by physicians during the Second World War.

The WMA President Dr. Xavier Deau presented the latest version of the Declaration of Helsinki to President Niinistö marking the 50 years since the first edition was presented to the His Excellency Urho Kekkonen, the President of Finland in 1964.

At today’s seminar speakers from around the world emphasised the living nature of the Declaration and the fact that millions of people have benefited from research carried out under its guidelines. They also emphasised its relevance today, with the issue of the Ebola outbreak and the use of unproven interventions.

Dr. Ames Dhai, President of the South African Medical Association said that because no cure or vaccine existed for Ebola, the World Health Organisation had said it was ethical to offer unproven interventions with unknown efficacy and adverse effects as potential treatment or prevention. The ethical criteria to guide the provision of such interventions should include transparency regarding all aspects of care, ensuring freedom of choice and informed consent, respecting confidentiality, human dignity and involving the community, and this was in line with the Declaration of Helsinki.

She said the moral authority of Declaration was intricately linked with respecting the human dignity of participants in research and this was both implicit and pervasive in the Declaration and translated into safeguards for vulnerable participants.

Prof. Dr. Lasse Lehtonen, Administrative Chief Physician at Helsinki University Central Hospital, said the Declaration had been the basis of research ethics in medicine for the past 50 years and its recommendations had become an integral part of binding European regulations.

Dr. Xavier Deau noted that the changes to the Declaration of Helsinki over the last 50 years reflected emerging medical innovation and trends and the guidance provided to medical research internationally.

‘This is a living document and will change further as we address the latest challenges in medical research and practice including genomics, health databases and bio-banks’, he said. 

Dr. Shima Naghavi, Director of International Affairs