The World Medical Association has embarked on a worldwide public consultation exercise on the revision of its historic Declaration of Helsinki, which seeks to protect patients involved in biomedical research.
The association is inviting comments on its website from anyone who believes that amendments should be made to the Declaration, which has become the cornerstone of guidelines for biomedical research involving humans. The website (www.wma.net) sets out key sections of the original text and asks people whether changes should be made and if so what.
Dr Delon Human, secretary general of the WMA, said this was the first time the association had undertaken such a widespread consultation exercise and he hoped that the public, as well as representative bodies and health and research professionals, would respond. He added: “In a time of rapid change in the area of research, it is essential to make sure that the Declaration continues to provide adequate protection for patients and appropriate guidance to physicians and other researchers”.
At its annual general assembly meeting in Tel Aviv in October last year WMA representatives heard of widespread support for retaining the existing structure of the Declaration of Helsinki. However, there were some specific areas where it was thought the policy could be strengthened by only the most essential changes. It is these areas that the consultation process is seeking to identify.
A WMA working group, headed by Dr Nancy Dickey, of the American Medical Association, is currently considering possible amendments to the Declaration and is expected to make an interim report to the WMA’s next Council meeting in May.
The Declaration of Helsinki was drawn up in 1964 by the WMA largely as a result of the atrocities of the Second World War. It was the involvement of physicians in this unethical activity that led to the formation of the WMA in 1947. The Declaration had been revised four times by the WMA, the most recent being in 1964.