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Tuesday, April 23, 2013

Study of Babies Did Not Disclose Risks, U.S. Finds

By Sabrina Tavernise
The New York Times
Originally published on April 10, 2013

A federal agency has found that a number of prestigious universities failed to tell more than a thousand families in a government-financed study of oxygen levels for extremely premature babies that the risks could include increased chances of blindness or death.

None of the families have yet been notified of the findings from the Office for Human Research Protections, which safeguards people who participate in government-financed research. But the agency’s conclusions were listed in great detail in a letter last month to the University of Alabama at Birmingham, the lead site in the study. In all, 23 academic institutions took part, including Stanford, Duke and Yale.

The letter stated that the study did have 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.