Skip to main content
Premium Trial:

Request an Annual Quote

And the Risks, Too

A large study investigating the best oxygen dose for premature infants did not adequately spell out the risks of the investigation to the infants' parents in the informed consent form, the New York Times reports.

The consent form pointed out possible benefits of being in the high- or low-oxygen groups, but did not mention risks related to being in either of those groups, according to a letter from the Office for Human Research Protections, which is part of the US Department of Health and Human Services, to the lead institution on the study, the University of Alabama at Birmingham. High levels of oxygen can result in blindness or other eye problems in infants while low levels of oxygen increase the chance of death. Instead, the consent form mentioned that there was a risk of abrasion to infants' skin from the oxygen monitoring device, the Times adds.

Slightly more than 1,300 infants took part in the study, which was published in the New England Journal of Medicine in 2010. That article reported that there was no difference in retinopathy or death between the high- and low-oxygen groups.

UAB tells the Times that the consent form was developed by researchers at the University of California, San Diego, and that the review boards of all 23 participating institutions approved the form. UAB's Richard Marchase also tells the Times that the infants in the study had a lower mortality rate than other infants who were eligible for the study but did not enroll.

He adds that he told the Office for Human Research Protections that, going forward, "we will to the best of our ability let the subjects or their parents know as thoroughly as possible what previous studies suggest in terms of risk" and that "we are going to be very sensitive to that going forward as we look at these consent forms."

Still, Michael Carome from Public Citizen's Health Research Group, which uncovered the letter to UAB, said HHS needs to investigate this matter and apologize to the participants' families, according to NPR. "The word 'unethical' doesn't even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study," he said in a statement.