Concerns Over Revised Declaration Of Helsinki

3 May 2001

World Medical Association To Examine Concerns Over Revised Declaration Of Helsinki

The World Medical Association, meeting in Divonne, France, this week, has agreed to examine concerns about the way ethical guidelines in placebo control trials are being implemented.

This follows last year's approval by the WMA of a revised Declaration of Helsinki governing the ethics of medical research involving human participants.

Dr Delon Human, secretary general of the WMA, said today:

"These revisions to the Declaration of Helsinki have been well received by patients' groups and by the world's research community. They have supported the moves towards increased transparency, the more systematic process of informed consent and the increased role being played by ethics review committees in evaluating research trials.

"However, there is disagreement over the ethical use of placebo control trials. The changes made to the Declaration might be in contravention to some countries' ethical guidelines. Whereas the Helsinki Declaration says that placebos should only be used where there is no standard treatment available, in some countries some exceptions are allowed.

"To address this disagreement, the WMA has decided to set up a working group to investigate issues relating to placebos and standards of care. Meetings will be held with other bodies to harmonise guidelines, and focus groups and discussion forums will be established.

"We are anxious to ensure that no good ethical research is restricted, while at the same time we are adamant not to compromise the ethical principles the medical profession stands for".

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