Radio New Zealand
Saturday, January 14, 2017
The health watchdog wants public feedback on whether researchers should be allowed to carry out certain medical studies when patients are not able to give consent.
Anthony Hill said researchers should continue to get informed consent wherever it was possible to do so.
Consultation next month
However, he will begin a consultation process next month to question what should happen when patients cannot explicitly consent to medical research being carried out on them.
The code of patients’ rights states that any trial where someone cannot give consent must be in the patients’ best interests.
That law has existed for nearly 30 years, following the 1988 Cartwright Inquiry into unethical research at National Women’s Hospital, where studies were carried out without patients’ knowledge or consent.
Since then, the concept of research without consent had been “anathema” to New Zealanders, Dr Hill said.
However, there were certain instances where researchers wanted to improve care for patients but could not test new treatments, because of the requirement to get consent.
Trial on unconscious patients
In 2014, Auckland DHB announced it would conduct a trial of a new antibiotic on unconscious patients in intensive care.
The trial prompted concerns from health consumer advocates and medico-legal experts.
Dr Hill gave the example of a UK trial, where researchers wanted to trial whether adrenalin or a new treatment was more effective for unconscious patients who had suffered heart attacks.
Because the patients would be unconscious at the time of treatment, it was impossible to gain their consent.
“Nobody could give consent for that and in New Zealand that study couldn’t go ahead,” Dr Hill said.
The UK researchers ended up widely advertising the trial, and providing bracelets to people who thought they could be at risk of a heart attack and in the right age bracket for the study, but did not want to participate.
In New Zealand, it was worth having the discussion, he said.
“Informed consent is at the absolute heart of the code of consumer rights and we need to be very careful indeed about opening that door.
“If you’re going to vary that principle, you need to do it in a very surgically precise way and that’s the public conversation I’d like to have.”
Options might include gaining consent from an immediate family member, an ethics committee or the researcher – the last option being the least palatable, he said.
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