The Office for Human Research Protections, which safeguards the people who participate in government-funded research, sent a letter to the University of Alabama at Birmingham last month, detailing what it said were violations of patients' rights.
The university, which was a lead site for the study, had not detailed the risks in consent forms that were the basis of parents' participation, the office said in the letter. Specifically, babies assigned to a high-oxygen group were more likely to go blind and babies assigned to a low-oxygen group were more likely to die than if they had not participated. Ultimately, 130 babies out of 654 in the low-oxygen group died, and 91 babies out of 509 in the high-oxygen group developed blindness.
Some of the 1,300 infants who participated in the study, which took place between 2004 and 2009, would probably have died or developed blindness even if they had not taken part. They were born at just 24 to 27 weeks gestation, a very high-risk category. But being assigned to one or the other oxygen group in the study increased their chances further, a risk that was not properly disclosed, the office said
Richard B. Marchase, vice president for research at the University of Alabama at Birmingham, said in a telephone interview that a similar group of infants born around the same time who did not participate in the study actually died at higher rates than those in the low-oxygen group. Those infants were not a control group in the study, but were roughly similar in number and in age to those in the study group; they had a 24 percent mortality rate, compared with a 20 percent mortality rate for the infants in the low-oxygen group.
He said the study kept the infants within the standard band of treatment for oxygen levels — 85 percent to 95 — and that its findings were forming the basis for a definition by the American Academy of Pediatrics about what the standard of care should be.
He said he had assured the Office for Human Research Protections that in the future, "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." He added, "We are going to be very sensitive to that going forward as we look at these consent forms."
Image: Infant in incubator, via Shutterstock