NEW YORK — 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 federal Department of Health and Human Services has warned in a letter.
The Office for Human Research Protections, which safeguards people in government-funded research, sent a letter dated March 7 to the University of Alabama at Birmingham 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 between 2004 and 2009 would probably have died or developed blindness 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 increased their risk further.
Richard B. Marchase, vice president for research at the University of Alabama at Birmingham, said 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.
In the letter, the office stated that the consent form should have explained that “there is significant evidence from past research indicating that the oxygen provided to an infant can have an important effect on many outcomes including whether the infant becomes blind, develops a serious brain injury, or even possibly whether the infant dies.”
The risk the study did mention was of abrasion of the infants’ skin by an oxygen monitoring device.
The letter was brought to the attention of media outlets by a consumer advocacy group, Public Citizen, on Wednesday.