http://www.theaustralian.com.au/index.asp?URL=3D/national/4289538.htm

Consent-free research proposed
By MARK RAGG

21apr99

AUSTRALIANS could be subjected to medical research without their consent if
changes before the world's leading doctors' body are approved.

That changes being considered by the World Medical Association would
abrogate a principle established after Nazi experimentation in World War II.

Other changes being considered by the association, which comprises more
than 60 groups including the Australian Medical Association, include the
right to withhold treatment on economic grounds.

The changes were recommended initially by the association's medical ethics
committee and were put to the WMA council in Santiago, Chile, last week.
The council decided to present them to the association's general assembly
in Israel in October.

If passed, they would have great influence on how medical research is
conducted throughout the world. They would also strongly influence the
policies of the AMA and of Australian ethics committees, which approve
proposals from Australian researchers.

The AMA has not yet seen the proposed changes.

The proposals come as some Western doctors' behaviour in carrying out
research in the developing world has been called unethical.

For example, US-based researcher Harry Heimlich wanted to inject live
malarial parasites into people with HIV. He was refused permission in the
US, so he conducted the experiment in China.

Some US-funded trials in Asia investigating the transmission of HIV from
pregnant women to their children have withheld the drug AZT, a known
effective treatment.

Internationally, the standard for medical research ethics is the WMA's 1964
Declaration of Helsinki (since amended three times). The proposal seeks to
rewrite this, giving researchers far greater control and fewer restrictions.

Helsinki stated: "The physician should . . . obtain the subject's freely
given informed consent, preferably in writing."

Under the changes, researchers could avoid that if they believe "the
research involves only slight risk, (or) when the procedures to be used are
customarily used in the practise of medicine without documentation of=
 consent".

Helsinki said: "In any medical study, every patient . . . should be assured
of the best proven diagnostic and therapeutic method."

The proposal is that subjects "will not be denied access to the best proven
diagnostic, prophylactic or therapeutic method that would otherwise be
available to him or her".

Those italicised words allow doctors to carry out research in less
privileged areas =AD whether in developing nations or in parts of Australia =
=AD
while not offering the best possible healthcare to the participants in the
research.




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