The lead investigators on a large study of the effects of oxygen levels on extremely premature babies failed to inform the infants' parents that the risks of participating could involve increased chances of blindness or death, the U.S. Department of Health and Human Services has warned in a letter.
The Office for Human Research Protections, which safeguards participants in federally funded research, sent a letter to the University of Alabama last month, detailing what it said were patients' rights violations.
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 of 654 in the low-oxygen group died, and 91 babies of 509 in the high-oxygen group developed blindness. Some of the 1,300 infants who participated in the study, conducted 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 group in the study increased their chances further -- a risk that was not properly disclosed, the office said.
Richard B. Marchase, University of Alabama-Birmingham vice president for research, said in a phone 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 study control group but were roughly similar in number and age to those in the 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 percent -- 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.
Mr. Marchase 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."
More than 20 major academic research centers were involved in the study, financed by the National Institutes of Health, and University of Alabama researchers aggregated the data.
Boards from each institution reviewed the forms, but none took issue with them.