Study of Premature Babies Failed to Warn Parents of Potential Blindness and Death, Feds Say
A new report showed that nearly two dozen U.S. medical centers conducted a four-year long study to test oxygen levels in premature newborns, but failed to tell parents that a possible side effect includes blindness and even death.
The U.S. Department of Health and Human Services, which protects people who participate in government-financed research, sent a detailed letter last month to the University of Alabama at Birmingham, which led the study. In the letter, the federal agency criticized the lead medical cente for providing families with a consent form that failed to disclose risks to the newborn babies who were part of the study, other than skin irritation where a device was attached to measure the saturation of oxygen in the infant's blood.
The letter said that "the researchers had sufficient available information to know, before conducting the study, that participation might lead to differences in whether an infant survived, or developed blindness, in comparison to what might have happened to a child had that child not been enrolled in the study."
"For many of those infants, the level of oxygen they received was different from what they would have received had they not participated in the study," HHS wrote.Calling the conduct of the study "highly unethical," the Washington-based consumer advocacy group Public Citizen on Wednesday called on HHS Secretary Kathleen Sebelius to issue expanded findings concerning the participating universities' procedures for obtaining consent from the parents of the premature newborns, and to require corrective actions from the medical schools and their institutional review boards, academic committees that oversee the ethical and other details of human research.
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 just 24 to 27 weeks gestation, a very high-risk category that was already prone to death and eye disease.
In total, 23 academic institutions took part, including Stanford, Duke and Yale.