Helpless, helpless, helpless

11 04 2013


As David Brown at the Washington Post wrote,

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.

Where the hell was the Institutional Review Board (IRB)? If they do nothing else, IRB’s are to ensure that risks are clearly and correctly spelled out in the consent form.

“The consent form was written in a slanted way,” said Jerry A. 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.”

To repeat, where the hell was the IRB?

They don’t design studies, don’t enroll subjects, don’t collect data; the IRB is there to review the study, make sure it is valid and designed to reveal reliable results, scrutinize the risk/benefit tradeoffs, and make sure the consent form gives potential subjects sufficient information of all of the above so that they can make an informed decision of whether or not to participate.

Absent that information, it cannot be said that subjects gave informed consent.

The study was an important one—what is the optimal range of oxygen to be given to premature infants to ensure survival—and apparently yielded significant results which will lead to changes in the treatment of preemies. That good information was extracted from the research does not, however, justify the slipshod manner in which subjects were enrolled.

The consent form made a big point that all babies would get oxygen within the “acceptable” range of 85 to 95 percent. It noted that babies in the lower range might have less eye damage. But it didn’t mention that those in the higher range might have more eye damage. And there was no mention that in the days before oximetry — when oxygen was measured more crudely — that premature infants that got higher concentrations of oxygen tended to have greater survival, although often at the cost of their eyesight.

Instead, the only risk the consent form mentioned was skin irritation from the oximeter device, a trivial problem.

What wasn’t made clear to parents was that the study created two groups of babies with different treatments — although both fell within “standard of care” treatment — for which the researchers expected there would be different outcomes. That was the point of the study.

No mention of serious risk. No clear discussion of differential treatment. These are basic basic basic components of any minimally-decent informed consent form.

People associated with SUPPORT defended the consent form and noted that it was approved by 23 “institutional review boards’” (IRBs), which are the committees each research hospital must have to oversee the design and ethics of medical studies involving human beings.

“I don’t have any regrets. Everybody went into this with their best intention. Nobody was trying to deceive anybody,” said Neil N. Finer, a neonatologist at the University of California at San Diego who ran the trial.

Excuse me while I scream GOOD INTENTIONS ARE NOT ENOUGH! It is not about the intentions of the researchers, but about their actions and, importantly, about the well-being of the subjects themselves.

Those IRBs should be re-organized, re-constituted, and all members and researchers retrained as to the conduct of ethical research.

Because this, this ain’t it.




One response

11 04 2013

not to excuse this nightmare but as long as IRBs are funded by the people who they are supposed to be monitoring we are setting them up to fail.

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