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".
|