E-DRUG: BMJ: Doctors revise Declaration of Helsinki
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[copied as fair use from BMJ at:
http://bmj.com/cgi/content/full/321/7266/913\]
BMJ 2000;321:913 (14 October) [WB]
Doctors revise Declaration of Helsinki
Bryan Christie, Edinburgh
The World Medical Association (WMA) has sent out its strongest
ever signal to pharmaceutical companies and research
organisations around the world that rich populations should not
exploit poor populations by testing on them new treatments from
which they will never benefit.
The WMA General Assembly, meeting last week in Edinburgh,
approved a revised Declaration of Helsinki, which was first drawn up
in 1964 and has since become the most widely accepted guidance
worldwide on medical research involving human participants.
The new declaration emphasises in much clearer terms than ever
before the duty that doctors owe to participants in medical
research. It says that freely given informed consent, preferably in
writing, should be obtained from all participants and that people
who cannot give informed consent should be included in research
only under exceptional conditions.
It also specifies that research is justified only if the populations to
be studied stand to benefit and that doctors participating in
research have an obligation to declare any financial or other
potential conflict of interest.
The meeting was particularly concerned about protecting people in
poorer countries from being used as research subjects for the
benefit of others. It has done that by specifying in the revised
declaration that every patient entered into a study should have
access to the best treatment identified by the study, after the
study is completed.
Furthermore, the revised declaration calls for testing of any new
treatment to be done against the best current method, where that
exists, and not against a placebo. The implementation of this
would mean that people in developing countries would at least get
access to the best current treatment if they agreed to take part in
research into new treatments.
Dr Anders Milton, chairman of the WMA, said: "Research should
not be carried out in countries in development just because it is
cheaper and the laws are more lax. The same ethical rules should
apply wherever research is being conducted.
"We have strengthened the position of participants in research,
where we have made it much clearer than before that the
population involved should benefit, studies should be done against
the best proven method, and there should be access to the therapy
at the end of the study."
This is the fifth revision of the Declaration of Helsinki, which was
first drawn up in response to the atrocities of the second world war,
when prisoners of the Nazis were used for experimentation.
The latest changes have resulted from several years' consultation
and are aimed at making the document relevant to today's medical
practice. Dr Delon Human, secretary general of the WMA, said that
because of significant changes in the field of medical research, it
was essential to revise the ethical guidelines applicable to
research.
The revised Declaration of Helsinki will be distributed to the World
Health Organization, national bioethics commissions, patients'
representatives groups, and other relevant stakeholders.
The full text of the revised Declaration of Helsinki can be found on
the WMA's website (www.wma.net).
The WMA also agreed to:
Reinforce its guidance to doctors not to take part "in any way" in
capital punishment
Support informed donor choice in organ transplantation (countries
which have adopted an "opt-out" system whereby people's organs
will be used for transplantation if they have not stated otherwise are
urged to ensure this does not diminish informed donor choice)
Express concern about prison conditions, which provide the
breeding ground for infectious diseases such as tuberculosis and
HIV
Support the Indian Medical Association in condemning the practice
of female feticide and circulate national medical associations with a
statement on the issue
Issue a public statement making it clear it is improper for
pharmacists to be involved in diagnosing and treating illness
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