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OHRP Finds Study of Infants Failed to Disclose Risks to Parents

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The function of the federal agency Office for Human Research Protections (OHRP) is to safeguard people who participate in government-financed research. The agency recently discovered that a number of universities failed to tell more than a thousand families in a government-financed study of oxygen levels for extremely premature babies of the potential health risks of the study. These risks included increased chances of blindness or death.

The study took place between 2004 and 2009, at twenty-three universities, including the University of Alabama at Birmingham (which was the lead site in the study), Duke, Stanford and Yale. There were 1,300 infants participating in the study, all born at just 24 to 27 weeks of gestation, a very high-risk category that is prone to death and eye disease.

The OHRP notified the University of Alabama in writing that 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 needed to decide whether to participate.

The OHRP found that 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 out of 654 in the low-oxygen group died, and 91 babies out of 509 in the high-oxygen group developed an eye ailment that in serious cases can lead to blindness.

The agency concluded that the consent form provided to parents did not sufficiently provide information about the seriousness of the risks. The OHRP added that even before beginning the study, researchers had enough scientific information to better outline the potential outcomes. The letter 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 consent forms used in the study were written by researchers at the University of California, San Diego and approved by the review boards of all the participating universities. The only risk the consent form mentioned was the possible skin abrasion from an oxygen monitoring device.

Parents of premature infants are already faced with a multitude of potential health issues their baby may have – apnea, respiratory distress, bleeding in the brain, problems with the heart, liver, intestines or lungs, jaundice, anemia and all kinds of infections. Long-term health issues include autism, cerebral palsy, lung problems and loss of vision and hearing. Premature births and child birth injuries can leave a family devastated, both emotionally and financially, and often leading to medical malpractice suit against the physician.