A premature infant study has recently sparked debate over exactly what parents need to be told before they give consent for their babies to participate in a clinical trial.
Disagreement regarding the study may boil down to a difference in perspective: The researchers who conducted the trial said the treatment they were providing to the babies was the standard of care, but others say they were really conducting an experiment, and should have better explained the risks to the parents.
The study, which attempted to find the optimal level of oxygen for premature babies, did not properly disclose the risk of treatment, according to a government agency that reviewed trial's consent forms.
Specifically, the consent forms did not make clear that the risk of side effects, which included blindness and death, might differ depending on which group the babies were assigned to (either a "high" or "low" oxygen group), the agency said.
Instead, the consent forms stated "because all of the treatments proposed in this study are standard of care, there is no predictable increase in risk for your baby." (In medical research, "the standard of care" means the treatment that is currently considered the best for a certain condition.)
In an editorial published today (July 9) in the British Medical Journal, Dr. Sidney Wolfe, founder and senior adviser to the Health Research Group at Public Citizen, a consumer advocacy group, said the study conditions were "clearly experimental procedures" that differed from what would happen under normal circumstances.
For example, part of the trial required that doctors not know the specific oxygen levels for the premature infant (oxygen monitors were miscalibrated to read a number that was slightly different from the real value, and doctors were told to keep oxygen levels within a certain range to account for this miscalibration), a practice that would not have taken place outside of the study, Wolfe said.
The study, called SUPPORT, "failed to distinguish the important differences between these clearly experimental procedures for managing the oxygen therapy, and the usual individualized standard of care the babies would have received had they not been enrolled in the study," Wolfe wrote.
The standard treatment for preemies is to maintain their oxygen levels between 85 and 95 percent, based on the judgment of a given doctor and the wishes of the parents. In the trial, oxygen levels were maintained between either 85 and 90 percent, or 90 and 95 percent.
The SUPPORT researchers have said that survival of infants in their trial was actually better than infants not included in the trial.
In an interview in April, bioethicist Arthur Caplan, of New York University School of Medicine, told LiveScience that, because the SUPPORT study did not employ a new treatment — rather, it studied the standard treatment in hopes of improving it — those tasked with reviewing the study's ethics may have been less aggressive about what needed to be included on the consent form.
Some point out that there are many uncertainties in medicine, including uncertainties surrounding existing treatments. Such is the case for preemie oxygen levels: The optimal level is still not known, high levels have been shown to increase risk of blindness and low levels increase risk of death.
In an editorial published in June in the same journal, Dr. Neena Modi, neonatologist at Imperial College London, said that to resolve such uncertainties, patients should, by default, be randomly assigned to treatments within the standard of care. Rather than being asked for their consent to opt into the study, as they were in this trial, they should be given the opportunity to opt out.
"This would reduce the burden of decision-making at difficult and stressful times. It would also reduce the risk of 'injurious misconception,' where participation is inappropriately rejected because of an exaggerated and disproportionate perception of risk, and speed trial completion," Modi said.
However, Wolfe countered that the underlying principle behind these arguments "is that it is necessary, via inadequately informed consent, to blur the line between research and standard of care to facilitate more consent and participation."