Last week, the Officer for Human Research Protections notified a network of 23 research institutes that they had failed to adequately warn parents about the risks' of their premature babies taking part in a oxygen study.
Premature infants need oxygen because their lungs are not fully formed. However, too much oxygen can cause blindness. The American Academy of Pediatrics currently set the standard treatment at between 85 and 95 percent.
The purpose of the study, known as Support, was to find the perfect amount of oxygen concentration in an infant. However, the federal watchdog believes their methods were not admirable. Researchers randomly assigned two groups, with one getting the low end, around 85 percent, while the other group got 91 to 95 percent.
The study, which was published in 2010, involved more than 1,300 premature babies.
Researchers failed to explain to parents the risk of eye disease, was greater in the higher oxygen group and an increased risk of brain injury and death in the low-oxygen group.
The study did in fact reveal that infants in the higher group did develop eye disease at twice the rate of those in the lower group, and the study's designers agreed the risk of blindness should have been more clearly explained.
Federal officials have demanded that researchers including University of Alabama in Birmingham, Stanford, Duke and Yale take corrective action to prevent a reoccurrence. The research institutes also run the risk of not being able to conduct federally funded research on human subjects in the future.
For more information, please contact us.
Source: The New York Times, "Balancing Risks and Benefits in Clinical Trials," April 16, 2013.