Enrolling unconscious patients in medical trials is not
unethical, and should probably happen more, a University of
Otago philosopher says.
Associate Prof Andrew Moore, the founding chairman of the
National Ethics Advisory Committee, was asked to comment
about revelations yesterday that thousands of critically ill
or unconscious hospital patients had been enrolled for
antibiotics research in Auckland and Christchurch.
''It's important not to insist on consent from people who
aren't able to give it.''
Propertrial designprovided safeguards for people who could
not give consent, and New Zealand's regulatory framework was
''Consent makes sense and is required for people who are able
to give it. But there are people who aren't able to give it,
and who need help, basically.
''The advances in medicine come from research, and actually
the people who aren't able to consent are some of the sickest
people, so they're the people who most need better
''Because some people are inclined to insist on consent
whether or not people are able to give it, it's in fact some
of the sickest people who tend to miss out on the research
and, therefore, on the benefits.''
Researchers feared controversy arising from research on
unconscious patients, which limited potential for medical
''I think it would be a good thing if there was more research
in this area.''
Auckland Women's Health Council co-ordinator Lynda Williams,
whose newsletter this month raised the alarm about the
research, said when contacted New Zealand's regulation of
medical research had become ‘‘slushy''.
Patients receiving the trial antibiotics were not getting the
treatments they would have otherwise, so there was likely to
be little benefit for them as individuals.
Unconscious patients should not be used for research in which
they were used to gain evidence for drugs under development,
''This is all about money,'' she said.
Otago University professor of medical ethics Grant Gillett
disagreed that non-consensual clinical trials were a case
of‘‘doctor knows best''.
''It's actually opposed to the idea that your own doctor can
do what he or she thinks is best for you,'' he said.
''It's aligned with the idea that your own doctor has to give
you the best available, widely accepted treatment, as a
default position and with your consent, but if you need that
treatment and cannot give consent, then the doctor has a duty
to give it to you.''
Prof Gillett said the measure had to be predicated on the
fact that what was being offered as a trialled treatment had
to be at least as good as, and no more risky, than what would
be given anyway.
Prof Gareth Jones, of Otago University's bioethics centre,
said retrospective consent also set a dangerous precedent.
- additional reporting The New Zealand Herald