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U.S. says study of babies failed to disclose risks

/ Source: The New York Times

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 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.”

A spokesman for the university said that researchers at another university participating in the study wrote the forms, but that they were approved by all 23 academic institutions that took part.

More than 20 major academic research centers were involved in the study, which was financed by the National Institutes of Health, and researchers at the University of Alabama aggregated the data. Boards from each institution reviewed the forms, but none took issue with them.

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. And it mentioned a possible benefit — a decrease in need for eye surgery depending on the group the child was assigned to.

The letter was dated March 7. It was brought to the attention of media outlets by a consumer advocacy group, Public Citizen, on Wednesday.

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