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U.S. says preemie study didn’t fully disclose risks
The informed-consent document that parents had to sign to enroll in the study for very premature infants failed to spell out all the risks, according to the government’s Office for Human Research Protections.
The New York Times
A federal agency has found that a number of universities failed to tell more than 1,000 families in a government-financed study of oxygen levels for extremely premature babies that the risks could include increased chances of blindness or death.
The study’s stated intent was to determine how much oxygen minimized the chances of blindness in very premature infants without increasing the risks of other problems, including death or brain damage.
The problem: The informed-consent document that parents had to sign to enroll didn’t spell out those risks, according to the government’s Office for Human Research Protections.
None of the families have been notified of the findings from the research-protections agency. But the agency’s conclusions were listed in detail in a letter last month to the University of Alabama, Birmingham, the lead site in the study. In all, 23 academic institutions took part, including Stanford, Duke and Yale.
The letter said the study had an effect on which infants died and which developed blindness, and that those risks were not properly communicated to the parents, depriving them of information to make a decision about whether to participate.
The 1,300 infants who participated in the study, which took place between 2004 and 2009, and whose results were published in The New England Journal of Medicine in 2010, were born at 24 to 27 weeks’ gestation, a very high-risk category already prone to death and eye disease.
Babies assigned to a high-oxygen group were more likely to develop eye disease and blindness, and babies assigned to a low-oxygen group were more likely to die. Ultimately, 130 babies of 654 in the low-oxygen group died, and 91 babies of 509 in the high-oxygen group developed an eye condition, which in serious cases can lead to blindness.
Richard Marchase, vice president for research at the University of Alabama, Birmingham, said the study kept the infants within the standard band of treatment for oxygen levels: 85 to 95 percent.
The consent forms were written by researchers at the University of California, San Diego, said a spokesman for Alabama-Birmingham, and were approved by the review boards of all 23 institutions in the study. It was financed by the National Institutes of Health.
Material from The Associated Press is included in this report.