As reported in yesterday’s New York Times, more than a thousand families who allowed their premature babies to receive oxygen treatment as part of a government-funded study were never told by the universities conducting the study of serious risks to the newborns, including blindness and death.
The Office for Human Research Protections — whose job it is to safeguard participants of government-funded studies — sent a letter to the 23 academic institutions that participated in this study, including Yale, Brown Duke and Stanford, raising these concerns.
In total, 1,300 premature newborns participated in this study. About half of the babies were given a high-oxygen course of treatment, and the other half were treated with low-oxygen. The study found that babies in the high-oxygen group were more likely to develop eye disease and blindness, and babies in the low-oxygen group were more likely to die.
Given the extremely premature delivery (prior to 27 weeks gestation) of the babies involved in this study, they were already at higher risk for eye disease and death. Still, the government office’s letter indicates that the oxygen treatment in the study was associated with increased rates of death and blindness.
However, parents of these children were never advised that the risks of participating in this study included blindness and death. This is completely unacceptable and reprehensible.
The law regarding “informed consent” clearly required the universities to advise parents that this type of high-oxygen and low-oxygen therapy may result in increased risk of blindness or death. The failure of these universities to do so is outrageous and may very well serve as a basis for a civil action for negligence or wrongful death.
To speak with one of Passen Law Group’s top-rated attorneys, call us at 312-527-4500.