David Brown at The Washington Post has a nice story on a government-funded study of premature infants that "failed to adequately inform parents" of the risks faced by their infants, which included blindness, brain damage, and death.
The failure to obtain adequate informed consent in this study was pointed out by a government watchdog, the Office for Human Research Protections, which said in a March 7 letter that the directors of the study "went out of their way to tell you that your kid might benefit…but they didn't give the flip side, which is that there is a chance your kid might end up worse."
The study dealt with the use of oxygen to treat premature infants. It can boost the infants' survival, but it can also cause blindness by promoting the overgrowth of blood vessels in the eye. The study was intended to determine what amount of oxygen could maximize the benefits and minimize the risks.
But the issue isn't quite that simple. As Brown reports, 23 research hospitals were involved in the study, and at each of them, the local institutional review board–which oversees consent forms, among other things–approved the consent forms.
Was the government watchdog overzealous in its indictment of the study? Or were the institutional review boards all guilty of failing to do their job?
Brown does a very nice job of explaining the study and pointing out that it has changed the treatment of premature infants in a way that is likely to reduce deaths from the treatment. But he doesn't address the question of who was at fault here. He quotes Richard B. Marchase of the University of Alabama at Birmingham, one of the study's participating institutions, who said, "Because all the infants were being treated within the standard of care, investigators agreed that the extent to which risks and benefits were delineated in the consent form was appropriate." That is, because the oxygen levels used in the study were all within the range of what is now used in hospitals, extraordinary warnings were not required. At least, I think that's what he's saying; the quote isn't entirely clear.
And Brown reports that the letter charging the researchers with failure to obtain proper consent was sent to the research team on March 7–but it did not become public until an activist group, Public Citizen's Health Research Group, called upon HHS Secretary Kathleen Sebelius to apologize for funding "unethical" research.
Sabrina Tavernise at The New York Times does a better job of getting at the question of who was at fault–and she gets a better response from Marchase. The March 7 letter, Tavernise reports, said the risks of participating in the trial "were not the same as those receiving standard care." And Marchase, rather than protesting the accusation, tells the Times that in the future "we will to the best of our ability let the subjects or their parents know as thoroughly as possible what previous studies suggest in terms of risk.”
Anna Edney and Michelle Fay Cortez at Bloomberg say the letter demanded that the University of Alabama at Birmingham develop a plan by March 22 to make sure that parents are given better information the next time. But it's now April 11, and unfortunately the reporters did not say whether the university did respond by the deadline.
This would be an interesting story to follow up. Did the 23 institutional review boards fall down on the job? Was the Office of Human Research Protections overzealous? Would any parents of the children in the study act differently if they were told more about the risks? The Times reports that "none of the families have yet been notified" of the controversy, more than a month after the March 7 letter.
Some enterprising reporter might want to find and notify them.
-Paul Raeburn
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