Revisions to Helsinki Declaration circulated for Comment

A new draft of the World Medical Association’s Declaration of Helsinki on the ethical principles for medical research involving humans is being widely circulated for discussion. It is being circulated both among the medical profession and the public.

The latest revisions to the Declaration have been agreed with the aim of identifying gaps in the content while avoiding a complete re-opening of the document. The Declaration, the world’s most widely recognised source of ethical guidance for medical research, was originally adopted in 1964 and has been amended on several occasions since then.

The WMA is now hoping that agreement can be reached on a revised version in time for its adoption at the Association’s annual General Assembly in Seoul, South Korea, in October this year.

Dr. Eva Bågenholm, chair of the WMA’s ethics committee, said:
‘Although many of the amendments are minor ones, there are some significant changes being suggested, particularly to strengthen the protection and benefits for research subjects and new issues relating to the registration of data and consent on research using human tissues.’

The revised consultation draft and the comment submission form can be accessed on the WMA’s website.