Preemie Study Didn't Fully Disclose Risks, Health Officials Say
WASHINGTON — Federal health officials say the parents of premature babies enrolled in a study of oxygen treatment several years ago weren't properly informed of the risks: a kind of blindness or death.
Oxygen has been a mainstay of treatment for very premature babies. But too much has long been known to cause a kind of blindness called retinopathy of prematurity, and too little can increase risk of death. The study in question enrolled 1,300 babies at 23 hospitals between 2005 and 2009, to hunt the best dose somewhere in between.
Standard practice at that time was to use a particular range of oxygen, and researchers in the study, funded by the National Institutes of Health, randomly assigned babies to receive either the low end or the high end of that range.
The study's stated intent was to determine how much oxygen minimized the chances of blindness without increasing the risks of other problems including death or brain damage. The problem: The informed consent document that parents had to sign to enroll didn't spell out those risks, according to the government's Office for Human Research Protections.
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http://www.huffingtonpost.com/2013/04/10/preemie-study_n_3056156.html
