WMA Publishes its Revised Declaration of Helsinki

Increased protection for people taking part in medical research has been proposed by the World Medical Association in changes to its Declaration of Helsinki.

After a revision process lasting two years, the WMA today adopted and published a revised version of the Declaration on medical research, which next year celebrates its 50th anniversary.

Delegates at the WMA’s annual Assembly in Fortaleza, Brazil, voted overwhelmingly to support changes to the Declaration, which not only provide for increased protection for vulnerable groups involved in research, but also include a new provision for compensating people harmed as a result of participating in research. In addition there are expanded requirements for post-study arrangements to ensure that participants involved in research are informed of the results and have access to any beneficial treatments that emerge.

Dr. Margaret Mungherera, President of the WMA, said: ‘The changes agreed today are all about providing a greater degree of protection for those involved in research. We have spent two years consulting our national medical association members, outside experts and the public and we are satisfied that today we have a Declaration that requires greater transparency about medical research, greater accountability and increased patient safety.

‘The changes also place more obligations on the sponsors of research, on the researchers themselves and on host governments to protect research subjects.’

This is the seventh time the Declaration of Helsinki has been revised since its inception, with notes of clarification being added in 2002 and 2004. It is one of the most important international ethical regulations in biomedical research and is a core document of the WMA. It was adopted by the 18th General Assembly of the WMA in Helsinki, Finland in 1964 and consists of a collection of ethical principles which set out clear and easily readable guidelines for medical research involving human subjects.