- A Victorian research trial on premature babies has raised ethical questions.
- The trial tests different levels of oxygen to support babies.
- It is being done without parental consent.
- The researchers argue getting consent is almost impossible.
- But other ethicists are sceptical of that claim.
A new clinical trial comparing different oxygen levels on preterm babies in Victorian hospitals – without telling their parents – is raising major concerns among ethics experts and hospital staff.
Premature babies often need help breathing in the first few minutes of life. The AIROPLANE Trial will test two different oxygen concentrations, 21 per cent and 30 per cent, on 1200 infants to see if it affects their health.
There is no standard level of oxygen support for babies born four to eight weeks early in Victoria, nor is there enough evidence to prove 21 per cent is better than 30. Different hospitals use concentrations between 21 and 30 per cent.
Therefore, the researchers say their trial does not pose any extra risk to the babies. Furthermore, seeking consent from 100,000 parents-to-be would be almost impossible, they say.
The trial was approved by the Royal Children’s Hospital in Melbourne; the researchers hope to run it at about 20 sites across the state. The researchers also received a sign-off from a consumer panel of parents and preterm survivors.
But The Age understands research ethics staff from at least one hospital hold major concerns, which are shared by some independent ethics experts.
Informed consent is a sacred scientific principle, so sacred Victoria’s Charter of Human Rights bans scientific experimentation without consent.
“The bar is very high” for experimenting without consent, said Dr David Hunter, a medical ethics researcher at the University of Adelaide, “and it should be”.
Outcomes measured in the study include whether the baby needs continuing breathing support, how long they stay in hospital, and mortality.
It is possible the study may discover higher oxygen concentrations may be better for a baby than lower concentrations. If a baby died, and their parents later discovered they had been unknowingly enrolled in the low-oxygen group, it could lead the parents to blame the researchers, Hunter said.
“‘My kid died – and that’s the fault of the research’, they might think. It’s not the fault of the research, but it’s a perfectly reasonable thing for some people to come to because getting your head around the complexities of the research is hard,” he said.
“Even if you’re not subjecting children to additional harms, the feeling of the absence of control, the not knowing about it, that is damaging to the broader project of research.”
Merle Spriggs, an honorary senior research fellow at the University of Melbourne and a pediatric bioethics expert, said the need to know if one oxygen concentration was better than the other was a good reason to run the trial.
“It is not a justification for withholding information from parents,” she said.
In a statement to The Age, the research team said it would be “ethically inappropriate” and extremely difficult to approach tens of thousands of pregnant women to get their consent for the trial when the vast majority would not birth a preterm baby.
“Without this design, we will not be able to answer this question and newborns will continue to be exposed to treatments without any proven benefit,” the researchers said.
Spriggs argued this was not a good enough reason to not seek consent.
“Taken to its logical conclusion, this suggests we should dispense altogether with consent,” she said. “Feasibility and recruitment rates do not provide an ethical justification for dispensing with consent”.
Dr David Hunter said the researchers could enrol pregnant women at prenatal screenings.
“I can’t think of why you can’t do that here. This is where I really come unstuck,” he said.
Several ethicists told The Age they could see no problem with the study at all.
“There is no ethical problem here,” said Professor Paul Komesaroff, director of the Centre for Ethics in Medicine and Society.
“There is no empirical basis for favouring one treatment rather than the other,” he said. “It would be perfectly reasonable for a hospital to toss a coin to decide whether a baby gets 30 per cent or 21 per cent oxygen – and there would be nothing unethical about that.”
But Dr David Hunter’s concerns stem in part from the response to a US clinical trial – one that ended in lawsuits from parents claiming their children had been harmed.
It was entirely possible for a parent to feel the trial had harmed their baby, even if it hadn’t, he said. “Why do I think this? Because it’s what we saw in SUPPORT.”
SUPPORT tested different levels of oxygen, both standards of care, on babies in American hospitals.
SUPPORT did seek consent from parents, but those consent forms failed to make all the risks clear, an investigation by America’s medical research watchdog claimed. That later led to an unsuccessful lawsuit by some parents involved in the trial.