By David Brown
The Washington Post
WASHINGTON — A clinical experiment involving 1,300 premature infants at two dozen hospitals "failed to adequately inform parents" of the risks of the treatment, which included blindness, brain damage and death, according to a watchdog agency at the Department of Health and Human Services.
The description of the experiment that parents read before deciding whether to enroll their babies downplayed the risks and emphasized possible benefits of getting a less-than-average amount of supplementary oxygen in the critical weeks after birth.
"The consent form was written in a slanted way," said Jerry Menikoff, director of the Office for Human Research Protections (OHRP), which found that the study was "in violation of the regulatory requirements for informed consent" required by federal law.
"They went out of their way to tell you that your kid might benefit," he said in an interview. "But they didn't give the flip side, which is that there is a chance your kid might end up worse off. You can't have it both ways."
Research done more than 50 years ago showed that supplemental oxygen can cause blindness in preemies but that withholding it can increase the risk of death. The study in question was trying to discover whether a sweet spot exists between too much and too little oxygen where premature babies avoid both blindness and a higher risk of death.
It found — contrary to expectations — that babies who got supplementary oxygen in the higher end of the acceptable range had no more blindness, but greater survival, than babies that got slightly less oxygen. As a result, practice is starting to shift.
"People are thinking twice about keeping babies in the lower part of the range," said Yvonne Vaucher, a neonatologist at the University of California at San Diego, who published a paper in December describing the health of the infants at age 2.